“I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope,” said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. “As a result of Health Canada’s comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920′s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”

Prochymal was authorized under Health Canada’s Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

“Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.”

Health Canada’s authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal’s safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

“Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses,” said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. “I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD.”

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.

“Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research,” said Peter Friedli, Chairman and Co-founder of Osiris. “It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.”

In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada’s decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.

Webcast and Conference Call

A webcast and conference call is scheduled for tomorrow, May 18, 2012 at 9:00 a.m. ET. To access the webcast, visit the Investor Relations section of the company’s website athttp://investor.osiris.com/events.cfm. Alternatively, callers may participate in the conference call by dialing (877) 303-6133 (U.S. participants) or (970) 315-0493 (international participants).

A replay of the conference call will be available approximately two hours after the completion of the call through May 24, 2012. Callers can access the replay by dialing (855) 859-2056 (U.S. participants) or (404) 537-3406 (international participants). The audio replay confirmation code is 82905846. To access a replay of the webcast, visit the Investor Relations section of the company’s website athttp://investor.osiris.com/events.cfm.

About GvHD

GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.

About Prochymal (remestemcel-L)

Prochymal is the world’s first approved drug which has a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs), which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is currently approved in Canada for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in Phase 3 trials for refractory Crohn’s disease and also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.

About Notice of Compliance with Conditions

An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products approved under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. Such products have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to such products on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world’s first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic areas and wound healing areas. Osiris currently markets Prochymal for refractory GvHD, Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. The company’s pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company’s technology, including 48 U.S. and 144 foreign patents.

Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company’s website, www.Osiris.com. (OSIR-G)

“Fibrocell Science is looking forward to advancing and continuing our successful, long term relationship with The Regents of the University of California and UCLA.  Already, our scientific collaboration with UCLA has produced exciting results that point to outstanding possibilities in the field of personalized, regenerative medicine,” said David Pernock, Fibrocell Science Chairman and CEO.

The license agreement pertains to research led by James A. Byrne, Ph.D., an Assistant Professor in UCLA’s Department of Molecular and Medical Pharmacology at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research.  His recent research published in BioResearch Open Access was related to two subtypes of cells:  SSEA3-expressing regeneration-associated (SERA) cells, which may play a role in the regeneration of human tissue in response to injury, and adult mesenchymal stem cells (MSCs), which are under investigation by many independent researchers for their ability to differentiate into cells that can form bone, fat and cartilage.  Finding these specialized cells within skin cell cultures is important because rather than undergoing a surgical organ or tissue transplantation to replace diseased or destroyed tissue, patients may one day be able to benefit from procedures by which stem cells are extracted from their skin, differentiated into specific cell types and re-implanted into their bodies to exert a therapeutic effect.  Research in this area is ongoing.

The license agreement went into effect on May 3, 2012 and unless terminated earlier, is in effect until the last-to-expire licensed patent. As part of the ongoing collaboration with Fibrocell Science, Dr. Byrne will continue to lead the investigational team at UCLA and in his role as a scientific advisor to the company.

Fibrocell Science has also signed a sponsored research agreement with the Massachusetts Institute of Technology (MIT) to progress the research currently underway at UCLA.  Under the agreement, MIT researchers will investigate viable techniques to maintain the same subpopulations of dermal cells, produce clinically meaningful quantities and deliver them to the body.  The research will be led by Professor Daniel Anderson, PhD, who has a dual appointment in the Department of Chemical Engineering and the Harvard-MIT Division of Health Sciences & Technology.  The sponsored research agreement with MIT also went into effect on May 3, 2012 and will end on June 30, 2015, unless the agreement is extended in the future.

About Fibrocell Science, Inc. Technology

Fibrocell Science has developed an innovative technology to isolate, purify and multiply a patient’s own fibroblast cells (a type of skin cell that makes collagen) for injection. Initially, this patented, proprietary technology was applied for use via the company’s first product on the market, LAVIV™ (azficel T). The technology is also being used by Dr. Byrne and his research team at UCLA to study the composition of skin tissue samples to identify, isolate, purify and multiply specialized cell types as reported in BioResearch Open Access.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB:FCSC.OB) is an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visitwww.fibrocellscience.com.

About UCLA

UCLA is California’s largest university, with an enrollment of nearly 38,000 undergraduate and graduate students. The UCLA College of Letters and Science and the university’s 11 professional schools feature renowned faculty and offer 337 degree programs and majors. UCLA is a national and international leader in the breadth and quality of its academic, research, health care, cultural, continuing education and athletic programs.  Six alumni and five faculty have been awarded the Nobel Prize.

There is no road map to maneuver through the political, medical and regulatory challenges that confront an emerging and potentially transformational field like regenerative medicine.  Helping guide the industry as a whole, Henri Termeer is recognized as a living legend in biotechnology and a leading advocate for cell therapy and tissue engineering.  He built a legacy while convincing the world that cell therapy should be taken seriously as a field.  During 26 years under Termeer’s tutelage, Genzyme established a business model using biological processes and developing products targeting rare genetic disorders that could not be easily copied by generic drug makers.  This innovative strategy, which many predicted could never succeeed, took Genzyme from being a modest upstart into the third largest biotech in the world.

Following the blueprint of most great innovators, Termeer ignored naysayers early in his career and brought multiple products to market, including the first drug to treat Gaucher disease, which affects only about 10,000 people worldwide.  Many successful drugs followed, including the FDA approving a Biologic License Application for Myozyme (alglucosidase alfa, rhGAA), the first treatment for patients with Pompe disease, another rare orphan disease, in 2006.  A true visionary in many respects, Termeer also focused Genzyme on becoming the first biotechnology company to actually commit serious resources and figure out how to get a cell therapy to patients, including solving the complex logistical issues including storage, shipping and handling of these new types of products.  He successfully pursued cartilage repair through cell therapy, and established a separate business unit within Genzyme devoted to the area of regenerative medicine and tissue engineering approaches.  All the while, Termeer was known for focusing on the needs of patients while also displaying an intense commitment to creating shareholder value.

Termeer’s impact extended well beyond the walls of Genzyme, however, as he was a longstanding leader in the Biotechnology Industry Organization (BIO), which has been at the forefront of the industry for years and has been critical in helping to create or refine policies that impact the industry’s ability to develop of novel ways to treat disease.  BIO’s role has been to promote the field of biotechnology, and to help pave the way for new medicines to become a reality.

Geoff MacKay, chief executive at Organogenesis, relies upon many of the same, patient-first characteristics of Termeer to build intrinsic value for the company.  Still a “young gun,” MacKay has exemplified spirit and commitment to advance regenerative medicines with the bulk of his career in leadership positions at Novartis AG (NYSE: NVS), including roles in tissue engineering and immunology, before coming to Organogenesis in 2003.

The Organogenesis chief has successfully advanced two cell therapy products through the complex regulatory process and into the clinic where they now serve the needs of patients.  Apligraf®, a living cell based product indicated for the treatment of venous leg ulcers and diabetic foot ulcers, became the first bio-engineered cell based product to receive FDA approval.  GINTUIT™, a cellular sheet that has been shown to predictably generate new and aesthetically appealing oral soft tissue, has been approved by the FDA for the treatment of mucogingival conditions in adults and is slated for release this summer. The company is also developing other forms of regenerative medicine, including bio-engineered skin for the treatment of burns and other clinical indications.  Two approved cell technologies and a third in the pipeline certainly proves MacKay’s abilities and devotion to regenerative medicines.

In addition to his role at Organogenesis, MacKay currently serves as a member of the Board of Directors of the Canadian Stem Cell Network and as Vice Chairman of the Board of the Massachusetts Biotechnology Council, a not-for-profit organization that represents and provides services and support for the Massachusetts biotechnology industry.  MassBio is the nation’s oldest biotechnology trade association.

Dr. Gil Van Bokkelen is another prescient leader in the regenerative medicine space that that has stood head and shoulders above others for his exhaustive efforts for both Athersys and the industry on the whole.  Under his guidance, Athersys has developed a robust portfolio of therapeutic product candidates centered on therapeutic stem cells and other tissue engineering to promote healing or replacement of diseased and damaged tissue.

Athersys is in the midst of four clinical trials, including two Phase II clinical trials.  Their leading Phase II trial is being conducted in partnership with Pfizer (NYSE: PFE) targeting Inflammatory Bowel Disease utilizing Athersys’ proprietary MultiStem® stem cell technology.  Results are expected early in 2013 from this research.  A second Phase II trial using MultiStem® is being independently conducted by Athersys is targeting ischemic stroke.

MultiStem® is viewed as a very significant technology because of its potential relevance for an assortment of diseases and complications that are in grave need of new therapies.  Similar to Termeer’s approach, Van Bokkelen has Athersys targeting some smaller markets, in addition to larger areas of unmet need, like stroke, heart disease and inflammatory conditions.  One orphan area the company is focused on involves providing treatment support to patients receiving a traditional bone marrow or hematopoietic stem cell transplants as part of treatment for cancer.  Such transplants can provide life-saving help to patients being treated for leukemia or related conditions, but can also come at a cost – as treatment is frequently complicated by Graft Versus Host Disease (GVHD), an occurrence in which the newly transplanted material attacks the transplant recipient’s body.  Athersys has focused on solving this issue, by using applying MultiStem to treat patients at significant risk of GVHD, intervening before the disease becomes a life threatening condition.  With initial clinical testing successfully completed and showing promising results, Athersys recently met with the FDA to discuss advancement of MultiStem® into later stage clinical studies, to evaluate its potential as a new therapy to combat GVHD.

Other uses for MultiStem include repairing damage from acute myocardial infarction and other cardiovascular disease, diabetes and neurological damage (i.e. multiple sclerosis, ischemic stroke, and traumatic brain injury).  The company’s vision and capabilities extend into other areas as well, such as developing a novel treatment for obesity, an area that represents  a sizzling hot button topic today.

Van Bokkelen’s leadership and role in the field of regenerative medicine extends beyond the programs at Athersys however.  His resume includes serving as the current Chairman of the Alliance for Regenerative Medicine, as well as Chairman of the Board of Governors for the National Center for Regenerative Medicine.  He also sits on a number of other boards, including the Biotechnology Industry Organization, the McGowan Institute for Regenerative Medicine and the Regenerative Medicine Foundation.

Work with stem cells has certainly faced a great many obstacles in the last two decades, but that worm is starting to turn as strong bi-partisan support is being demonstrated to enact new laws to expedite development of drugs and therapies to meet unmet medical needs.  It seems likely that a broadened Accelerated Approval Pathway proposal will be enacted into law as part of the PDUFA renewal by the end of summer 2012.  This should provide the FDA and innovators greater latitude in developing new therapies to treat serious and life threatening conditions that are beyond the current standards of care.  While this could benefit the biotechnology industry across the board, regenerative medicine companies may stand to see the greatest rewards because of the large number of new therapies that can fall under the classification of “breakthrough medicines”, which the accelerated approval framework is designed to promote.  Through their innovative nature and targeting of diseases that have proven resistant to traditional medicines, regenerative medicine  approaches could help address some of the biggest and most serious long term challenges facing our healthcare system.

While there are many great leaders in biotechnology, the aforementioned CEO’s have consistently demonstrated vision, empathy and responsibility to bring a wave of novel therapies to the market that can substantially enhance the quality of life of patients and an unwavering dedication to reshape the options allotted to physicians in patient care.  Their devotion to their respective companies is only paralleled by their unselfish efforts to help the industry overcome the many challenges it faces regarding not only inherent development, but also regulatory and political obstacles.

Whether it is in a bottle or a vial, the day of cell-based therapies is nearly upon us with a debt of gratitude being owed to pioneers such as Termeer, MacKay and Van Bokkelen.

Cardium Therapeutics (CXM) today announced a late-breaking poster presentation at the American Society of Gene & Cell Therapy (ASGCT) 15th Annual Meeting being held May 16-19, 2012 at the Pennsylvania Convention Center in Philadelphia, PA.

The new research findings demonstrate that cardiac ischemia plays an important role in adenovector gene transfection (delivery) in mammalian hearts.  Based on this understanding, using a standard balloon angioplasty catheter, researchers have developed and tested a new method to induce transient ischemia during a non-surgical interventional cardiac procedure, which when coupled with the infusion of nitroglycerin, boosts the delivery (cell transfection) of an adenovector gene construct into heart cells.  The increase in adenovector-based gene transfection with the new technique is over two orders of magnitude (>100 fold).

Cardium’s new method of adenovector delivery takes advantage of the findings that transient ischemia appears to alter the permeability barrier of the vascular endothelium and may expose the blood to the coxsackie-adenovirus receptor mediating adenovector uptake by the heart.  Balloon angioplasty catheters have been used for many years to dilate blocked coronary arteries, sometimes with use of a stent, and these catheters have also been used safely by cardiologists in patients with coronary artery disease to study the effects of brief ischemia.  Cardium’s new technique inflates the balloon in non-narrowed areas, and only enough to briefly interrupt flow using inflation pressure that is less than that used for performing angioplasty.

Cardium’s recently initiated Russian-based ASPIRE Phase 3 / registration clinical study uses transient ischemia techniques during non-surgical percutaneous catheterization with a standard angioplasty catheter together with the intracoronary infusion of nitroglycerin with the Generx® [Ad5FGF-4] product candidate for the treatment of patients with myocardial ischemia and stable angina pectoris.  These patients have atherosclerotic coronary artery disease, and the Company’s Generx product candidate is intended to stimulate the growth of new or additional collateral blood vessels to bypass blockages.

These studies were conducted at Emory University School of Medicine, led by Jakob Vinten-Johnasen, PhD., and co-sponsored by a Small Business Innovative Research grant from the National Institutes of Health (Cardium Therapeutics) and the Carlyle Fraser Heart Center (Emory).  At the conference  Gabor M. Rubanyi, MD, PhD, Cardium’s Chief Scientific Officer, will present the late-breaking poster entitled “Transient Ischemia is Necessary for Efficient Adenovector Gene Transfer in the Heart”, on May 17, 2012 from 3:00 to 5:30 p.m. in Exhibit Hall A.  The poster presentation can be viewed at http://www.cardiumthx.com/pdf/Generx-ASGCT-Poster-Presentation-May-2012.pdf.

In addition, Dr. Rubanyi will also make an oral presentation titled: “New Perspectives for Angiogenic Gene Therapy to Treat Myocardial Ischemia in Patients with Coronary Disease” to attendees at the ASGCT Meeting today, May 16.  The presentation will provide a historical overview of the Generx clinical development program and how these new and important preclinical findings have been incorporated into the protocol for the 100-patient Generx ASPIRE Phase 3 registration study which was recently initiated in the Russian Federation for patients with myocardial ischemia and stable angina pectoris.  The presentation is now available for viewing at http://www.cardiumthx.com/pdf/Generx-ASGCT-May-2012-Rubanyi.pdf.

About Generx and the ASPIRE Study

Generx (Ad5FGF-4) is a disease-modifying regenerative medicine biologic that is being developed to offer a one-time, non-surgical option for the treatment of myocardial ischemia in patients with stable angina due to coronary artery disease, who might otherwise require surgical and mechanical interventions, such as coronary artery by-pass surgery or balloon angioplasty and stents.  Similar to surgical/mechanical revascularization approaches, the goal of Cardium’s Generx product candidate is to improve blood flow to the heart muscle – but to do so non-surgically, following a single administration from a standard balloon angioplasty catheter.  The video “Cardium Generx Cardio-Chant” provides an overview Generx and can be viewed at http://www.youtube.com/watch?v=pjUndFhJkjM.

In March 2012, Cardium reported on the ASPIRE Phase 3 registration study to evaluate the therapeutic effects of its lead product candidate, Generx in patients with myocardial ischemia due to coronary artery disease. The ASPIRE study, a 100-patient, randomized and controlled multi-center study to be conducted at up to eight leading cardiology centers in the Russian Federation, is designed to further evaluate the safety and effectiveness of Cardium’s Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S., Europe and elsewhere.  The efficacy of Generx will be quantitatively assessed using rest and stress SPECT (Single-Photon Emission Computed Tomography) myocardial imaging to sensitively measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx.

The Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory in Los Angeles, California, will serve as the central core lab for the ASPIRE study and will be responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centers participating in the ASPIRE study.  Advanced Biosciences Research, an affiliate of bioRASI which is a global clinical research organization, is Cardium’s Russian sponsor and development partner and is responsible for the ASPIRE program management and regulatory compliance.  The Russian Health Authority has assigned Generx the therapeutic drug trade name of Cardionovo™ for marketing and sales in Russia.  Information about the ASPIRE study is available at http://clinicaltrials.gov/ct2/show/NCT01550614?term=cardium&rank=1.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations.  Cardium’s current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company’s in-house MedPodium Health Sciences healthy lifestyle product platform.  The Company’s lead commercial product Excellagen™ topical gel for wound care management recently received FDA clearance for marketing and sale in the United States.  Cardium’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease.  In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities.  In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company’s biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations.  For example, there can be no assurance that enhancements in the uptake of adenovectors can be successfully applied to improve the uptake or therapeutic effects of Generx in human patients; that Generx can be successfully advanced in clinical studies outside of the U.S.; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that improvements in the formulation or use of Generx will be commercially practicable, or that Generx could be successfully advanced as a therapeutic in developing markets or that the results of studies in such markets could be used to advance or broaden the regulatory or commercialization activities of Generx in the U.S. or other markets; that the ASPIRE clinical study will be successful or will lead to approval of Generx by the Russian Health Authority for marketing and sales in Russia or lead to approvals in other countries of the Commonwealth of Independent States; that additional clinical evidence regarding the safety and effectiveness of Generx that might be obtained in Russia would be useful for optimizing and broadening commercial development pathways in other industrialized countries; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.

Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission.  We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2012 Cardium Therapeutics, Inc.  All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics™, Generx®, Cardionovo™, Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen®, Excellarate™, Osteorate™, MedPodium®, Appexium®, Linee™, Alena™, Cerex®, D-Sorb™, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill™, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

In today’s publication, human heart-derived cells were transplanted into the hearts of mice around the time of injury in an animal heart attack model. When transplanted without matrix, the heart cells fared poorly, as is commonly observed in the absence of such support. However, when the cells were transplanted with HyStem^®-C there was a significant increase in the number of surviving transplanted cells.

Another significant finding reported in the study is that transplantation of the cells with HyStem^®-Cinto the injured heart muscle resulted in an increase in left ventricular ejection fraction (LVEF), a measure of the ability of the cells to restore strength to the damaged heart wall.

The lead author on the paper is Ke Cheng of the Cedars-Sinai Heart Institute in Los Angeles, California. Other authors from Cedars-Sinai are Deliang Shen, Baiming Sun, Giselle Galang, and Eduardo Marbán. Authors from Capricor, Inc. of Los Angeles, California are Agnieszka Blusztajn, Rachel R. Smith, and Linda Marbán. Additional authors are Tao-Sheng Li from the Department of Stem Cell Biology at Nagasaki University Graduate School of Biomedical Science in Nagasaki, Japan; Glenn D. Prestwich from the Department of Medicinal Chemistry and Center for Therapeutic Biomaterials at the University of Utah in Salt Lake City; and BioTime author Thomas I. Zarembinski.

“Heart disease remains the number one cause of mortality in the United States,” said William Tew, Ph.D., BioTime’s Chief Commercial Officer. “We are gratified to see the utility of our HyStem^®technology in the field of cardiology as it has been previously reported in neurology and orthopedics. We see the development of these unique matrices as a strategic means of capturing near-term commercial opportunities while building a foundation for a large pipeline of transplantable human cells derived from pluripotent stem cells such as human embryonic stem and induced pluripotent stem cells.”

BioTime’s goal is to obtain approval to market Renevia™ in European Union countries by the end of 2013 for use in the transplantation of adipose tissue for reconstructive and dermatological surgery. A discussion of this use of Renevia^TM in a presentation by Dr. Tew, which also describes BioTime’s other plans for its HyStem^® line of products, is available online at www.biotimeinc.com.

Background

BioTime is a leader in developing, manufacturing, and marketing proprietary biocompatible hydrogels that mimic the human extracellular matrix (ECM). The human ECM is a web of molecules surrounding cells that is essential to the formation, function, and growth of discrete tissues and organs in the body. BioTime’s HyStem^® hydrogels support the growth and directed differentiation of stem cells by mimicking the ECM, and are designed as injectable, resorbable matrices for tissue engineering, regenerative medicine, and for research applications involving the laboratory culture of human cells. Uses of BioTime’s HyStem^® technology has been reported on in over 90 scholarly publications and is presently being used at several leading medical institutions investigating potential cell-based therapies for osteoarthritis, myocardial infarction, stroke, brain tumors, and wound healing. HyStem^® offers a convenient delivery matrix and its in situ polymerization creates a biocompatible, resorbable scaffold for cell proliferation and tissue regeneration.

About BioTime, Inc

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate™ cell lines, HyStem^® hydrogels, culture media, and differentiation kits. BioTime is developing Renevia™ (formerly known as HyStem^®-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. As an injectable product, Renevia™ may address an immediate need in cosmetic and reconstructive surgeries and other procedures by improving the process of transplanting adipose derived cells, mesenchymal stem cells, or other adult stem cells. BioTime’s wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime’s therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime’s majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure’s minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure’s OpRegen™ retinal cell product for use in the treatment of age-related macular degeneration. BioTime’s subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx^TM currently being developed for the detection of cancer in blood samples, and therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime’s proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime’s newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime’s research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime’s lead product, Hextend^®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at www.biotimeinc.com.

(Logo: http://photos.prnewswire.com/prnh/20090814/BIOLIFELOGO)

Summary of Q1 2012 Achievements

• Revenue and BioLife’s customer base continued to grow with shipments of the core products, CryoStor®, HypoThermosol®, and BloodStor® to customers in the Company’s key market segments of biobanking, drug discovery and regenerative medicine. Revenue to direct customers increased 84% compared to the first quarter of 2011 and 15% sequentially over the fourth quarter of 2011.
• Gross margin increased to a record level of 59% of revenue in the first quarter, due to improved utilization of BioLife’s manufacturing facility.
• The Company executed an amendment to its current commercial lease to double the square footage of its existing facilities.  The additional space will be dedicated to the build-out of an additional GMP manufacturing clean room suite to support increasing demand for the Company’s biopreservation media products and also to fulfill the production obligations of a high value multi-year contract manufacturing agreement that was executed in late 2011.

Mike Rice, Chief Executive Officer, commented on the Company’s continued revenue growth by stating, “We had another solid quarter with a number of significant orders from regenerative medicine customers, whose demand for our products should increase as their clinical trials progress, and as they incorporate our biopreservation media products into the manufacturing, storage, freezing, shipping, and patient infusion processes for additional cell- and tissue-based clinical products and therapies.”

First Quarter Financial Results

Total revenue for the first quarter of 2012 was $835,880, compared to $610,799 in the same period of 2011. The increase of 37% from 2011 to 2012 was due primarily to higher sales to customers in the drug discovery and regenerative medicine market segments, which were both up significantly over 2011. Sales to direct customers in the first quarter of 2012 increased 84% compared to the first quarter of 2011.

Gross margin in the first quarter was a record high of 59% due mainly to improved utilization of the Company’s manufacturing facility.

Total operating expenses in the first quarter of 2012 were $669,015, compared to $696,476 in the first quarter of 2011. The primary driver for the increase in expenses was due to higher personnel costs in 2012, offset somewhat by a reduction in consulting expenses due to the termination of a consulting agreement in the third quarter of 2011.

Other income/expense is primarily related to interest expense on the Company’s notes payable. In the first quarter of 2012, the Company also recorded $87,215 in other income related to a non-reciprocal, non-monetary receipt of raw materials.

For the first quarter of 2012, the Company reported a net loss of $296,877, or $(0.00) per share, compared with a net loss of $630,122, or $(0.01) per share, for the first quarter of 2011. Loss from operations in the first quarter of 2012 was $179,264, which was 61% lower when compared to the $454,277 loss from operations in the first quarter of 2011.

Outlook for 2012

Management expects revenue to continue to increase to approximately $4.1 million in 2012. The Company also expects sales to its contract manufacturing customers to increase significantly with the commencement of deliveries to the previously announced new customer. The Company also expects steady increases in revenue shipments to existing and new direct customers, specifically in the regenerative medicine market segment, as customers continue to move their cell- and tissue-based therapies and products through the clinical trial and regulatory approval processes.

The Company expects slightly lower gross margins as a percentage of revenue in 2012, as a result of increased contract manufacturing, in addition to increased operating expenses associated with selling and product development activity.

Finally, management believes the Company will achieve positive cash flow from operations in 2012 and that cash generated from customer collections will provide sufficient funds to operate the business.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets patented hypothermic storage and cryopreservation solutions for cells and tissues.  The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are marketed to academic and commercial organizations involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife’s products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced, delayed-onset cell damage and death.  BioLife’s enabling technology provides academic and clinical researchers significant improvements in post-thaw cell, tissue, and organ viability and function.  For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinson’s disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinson’s.

Secondly, the differentiation of hpSC and embryonic stem cellsinto cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

“These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases,” says Dr. Ruslan Semechkin, Vice President of Research and Development.

The presentations will take place at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com or follow us on Twitter @intlstemcell.

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Cardium Therapeutics (CXM) today announced an agreement with UK-based Angel Biomedical Limited, a subsidiary of Angel Biotechnology Holdings plc (ABH.L), a global biopharmaceutical contract manufacturer, covering the manufacture of formulated collagen for Cardium’s Excellagen® product, which was recently cleared for marketing by the U.S. Food and Drug Administration (FDA). Excellagen is a professional-use high molecular weight fibrillar bovine Type I topical gel (2.6%) specifically engineered as an adjunct to debridement for the management of diabetic foot ulcers and other dermal wounds.

In addition to the manufacturing of Excellagen’s formulated collagen, Angel Biomedical Ltd will assist Cardium to facilitate filing for a CE Mark of Excellagen for marketing and sale in the European Union and in other countries recognizing CE Mark approval.  Additionally, Angel Biomedical will assist Cardium in establishing its own Device Master File with the FDA’s Center for Devices and Radiological Health covering the process for manufacturing the Company’s Excellagen formulated fibrillar collagen gel.

“We are pleased to announce the agreement with Angel following Angel’s recent asset purchase of our current collagen manufacturing facility located in Glasgow, Scotland. This new agreement is a logical next step that provides for ongoing and future supply of the specialized formulated collagen used to support Excellagen’s commercialization activities, and also positions Cardium for the planned expansion of Excellagen commercialization into European and other markets,” stated Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics.

“The team at Angel is excited by this new partnership to provide Cardium’s formulated high molecular weight collagen.  We look forward to the commercial manufacture of Cardium’s Excellagen advanced wound care product and to facilitate its CE marking to assist Cardium expand its global distribution opportunities,” stated Dr. Stewart White, Acting Chief Executive Officer of Angel Biotechnology.

About Excellagen

Excellagen is an FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management.  Excellagen’s unique high molecular weight sterile collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes. Excellagen is intended for physician use following surgical debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients.  Excellagen’s viscosity-optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied following surgical debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.

Cardium’s market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application – and Excellagen’s unique, ready-to-use syringe-based collagen gel requires no thawing or mixing.  Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5cm2 in size using the supplied 24-gauge sterile, single-use flexible applicator tip.  To learn more about new Excellagen and for product ordering information, please visit http://www.excellagen.com/physician-purchase-information.html and view the information video, Excellagen: A New Wound Care Pathway for Diabetic Foot Ulcers, at http://www.excellagen.com/excellagen-video.html.

About Angel Biotechnology/Angel Biomedical

Angel Biotechnology Holdings plc (ABH.L), is a full service contract bio-manufacturing partner to biotechnology and pharmaceutical companies worldwide. Angel specializes in advanced biologics including biopharmaceutical proteins and cell therapies, such as cellular vaccines and stem cells.

Angel has three U.K. facilities: Pentlands Science Park near Edinburgh, Cramlington, near Newcastle-upon-Tyne, and Angel Biomedical Limited encompassing its new collagen manufacturing operation in Glasgow, Scotland.  More information is available at www.angelbio.com .

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations.  Cardium’s current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company’s in-house MedPodium Health Sciences healthy lifestyle product platform.  The Company’s lead commercial product Excellagen® topical gel for wound care management, has recently received FDA clearance for marketing and sale in the United States.  Cardium’s lead clinical development product candidate Generx® is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease.  In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities.  In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company’s biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations.  For example, there can be no assurance that Angel can effectively and efficiently manufacture collagen to support Excellagen commercialization; that  we can successfully introduce Excellagen into wound care markets for the treatment of diabetic foot ulcers or other dermal wounds; that we can obtain a CE Mark for marketing and sale in the European Union and other countries recognizing CE Mark approval; that we can establish our own Device Master File with the FDA’s Center for Devices and Radiological Health covering the Company’s process for manufacturing Excellagen; that we can attract suitable commercialization partners for our products or that such partners will successfully commercialize our products; that our exchange listing compliance can be maintained; that our product or product candidates will not be unfavorably compared to other competitive products that may be regarded as safer, more effective, easier to use or less expensive; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures or in actual use; that clinical studies and regulatory clearances even if successful will lead to product advancement or partnering; that that FDA or other regulatory clearances or other certifications, or other commercialization efforts will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; that new collaborative partners will be found; that additional product opportunities will be established; or that that third parties on whom we depend will perform as anticipated.

Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission.  We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2012 Cardium Therapeutics, Inc.  All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics™, Generx®, Cardionovo™, Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen®, Excellarate™, Osteorate™, MedPodium®, Appexium®, Linee™, Alena™, Cerex®, D-Sorb™, Neo-Energy®, Neo-Carb Bloc®, Neo-Chill®, and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

The company has been diligently assembling a team of industry experts to run the new subsidiary; last year the company brought on board an experienced medical professional with an advanced wound care background, and has recently added another experienced wound care professional to assist with regulatory strategy and business development.

With diseases resulting from antibiotic resistant bacteria on the rise, the wound care industry has an exceptionally great need for a product with no known microbial resistance.  BioLargo’s new products have already achieved high levels of antimicrobial efficacy without cytotoxicity in lab tests, and as a result the company’s products are currently being developed and refined in preparation for market introduction, upon receiving appropriate regulatory approvals.

BioLargo’s president and CEO, Dennis Calvert, states “Armed with positive results from testing and field trials by veterinarians and hoof care specialists of our recently developed hoof and leg products for animals, it became increasingly apparent to us that our technology could play a pivotal role in the human wound care field.  With the need for wound care products without microbial resistance so great, the commitment to this vertical market became the next logical and necessary step.”

Unlike other iodine products, the company’s iodine is non-toxic, non-staining, and can be delivered on demand in precision dosing at much higher levels than traditionally possible.

High-Value Focus Could Unlock Value

BioLargo’s new focus on the wound care industry could generate significant value for shareholders over the long-term. Medical device and technology companies tend to trade at higher price-earnings multiples than many other sectors. Moreover, these companies tend to trade with higher market capitalizations than other sectors prior to realizing any revenues.

Popular wound care companies include:

• Smith & Nephew plc (SNN, 14.53x)
• 3M Company (MMM, 14.19x)
• Johnson & Johnson (JNJ, 17.53x)

BioLargo’s inclusion into the wound care industry could result in a greater market capitalization, and eventually, a higher price-earnings multiple.

Read the Entire Press Release:
http://finance.yahoo.com/news/biolargo-forms-medical-products-subsidiary-101500847.html

About BioLargo Inc.

BioLargo’s business strategy is to harness and deliver Nature’s Best Solution® — free-iodine — in a safe, efficient, environmentally sensitive and cost-effective manner. Its proprietary technology works by combining micro-nutrient salts with liquid from any source to deliver free-iodine on demand, in controlled dosages, in order to balance efficacy of performance with concerns about toxicity. The technology has potential commercial applications within global industries, including but not limited to oil and gas, animal health, beach and soil environmental uses, consumer products, agriculture, food processing, medical, and water. It features solutions for odor & moisture control, disinfection and contaminated water treatment. The company’s goal is to improve the quality of life for people worldwide, while it protects the environment, and produces positive economic results for our customers, partners, and shareholders. Its website is www.BioLargo.com. Its Odor-No-More® product was awarded two Editor’s Choice Awards, including a “Product of the Year” award, by the Horse Journal, a top industry publication, as well as a Best New Product SuperZoo Award, and are sold by BioLargo’s wholly owned subsidiary, Odor-No-More, Inc. (www.OdorNoMore.com). BioLargo® also owns a 50% interest in the Isan System, already commercialized in Australia, which was honored with a Top 50 Water Company for the 21st Century award by the Artemis Project. In early 2011, the company signed an exclusive license agreement for use in pet products with industry leader Central Garden and Pet.

Disc Repair – Non-Surgical Alternative

BioRestorative’s primary focus in the near-term is on an advanced stem cell injection procedure designed to offer relief from bulging and herniated discs (to date over 40 procedures have been performed on patients in the U.S.). This novel therapy offers an alternative treatment designed to fill the large gap that currently exists in disc treatments between non-surgical and surgical therapies. Using a unique medical device that delivers the patients own stem cells to optimal locations, the company’s technology is a minimally invasive and non-surgical way to repair some disc/spine injuries without surgery.

According to Global Industry Analysts, the global spine surgery market is set to reach $9.3 billion by 2017, driven by rising incidences of chronic back pain, an aging population and increased awareness of spine surgery procedures. Ultimately, the Company hopes it can capture a portion of this enormous market and deliver significant value to shareholders.

“Brown Fat” for Treating and Preventing Diabetes and Obesity

In its pipeline, BioRestorative is developing its ThermoStem™ Program that is focused on treating metabolic disorders (diabetes, heart disease, etc.) and obesity by using stem cells from population of adipose (fat) tissue known as  “Brown Fat.” The Company is working to develop a “Brown Fat” stem cell-based solution to potentially reduce glucose and lipid levels while inducing weight loss through a natural cellular “biologic diet” with the ultimate goal of delaying or preventing the onset of diabetes. In addition, according to a recent study at the University of Sherbrooke in Quebec, “Brown Fat” may actually burn calories at a very rapid rate, causing weight loss, by generating heat (thermogenesis).

While the ThermoStem™ Program certainly has a play in the $20 billion weight loss market, the Company is initially targeting metabolic disorders by potentially developing a protocol to lower blood glucose and lipid levels. These markets represent multi billion dollar industries that combine to form a significant opportunity.

Unique Business Model

BioRestorative employs a unique “hybrid” business model with both near-term and long-term revenue opportunities. According to management in an interview, the Company indicated that it could immediately license and sell its disc/spine technology outside of the U.S. (while it fine-tunes its pre-clinical work) and plans on generating revenues as early as this year.

In the end, the Company’s approach to these two enormous markets, combined with its unique business model, make it a compelling investment opportunity at these levels. With a market capitalization of just $18.14 million, there is clearly significant upside potential in the stock over the coming quarters and years.

For more information, please see the following resources:

• Company Website

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company’s 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D™, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D™ and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model — to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective — is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

• University Health Network (UHN)
  We extended through September 2017 and expanded the scope of our primary stem cell research and development collaboration with Dr. Gordon Keller, one of the world’s leading stem cell researchers, and UHN, one of Canada’s largest research hospitals.
• Synterys
  We signed a medicinal chemistry collaboration agreement with Synterys to support our future drug rescue programs.
• Cato Research and Cato BioVentures
  We expanded our 10-year relationship with Cato Research and Cato BioVentures with a right of first offer agreement focused on increasing our access to large market drug rescue opportunities.
• Duke University
  We entered into a drug rescue research collaboration with Duke University aimed at integrating Duke’s complementary expertise at the forefront of cardiac stem cell technology, electrophysiology and tissue engineering.
• Vala Sciences
  We entered into a drug screening collaboration with Vala Sciences to advance current methodologies used to screen new drug candidates by combining our human stem cell-derived cardiomyocytes (heart cells) with Vala’s novel high-speed kinetic imaging.

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

• Launch multiple CardioSafe 3D™ drug rescue programs focused on large market products previously developed by large pharmaceutical companies;
• Generate and license or sell one new lead drug rescue variant from our initial CardioSafe 3D™ drug rescue programs;
• Validate LiverSafe3D™ for drug rescue involving liver toxicity and drug metabolism issues;
• Advance pilot nonclinical iPS Cell-based cell therapy programs, including studies involving heart, liver, cartilage, blood and/or beta-islet cells;
• Complete phase 1B clinical development of AV-101, our drug candidate targeting neuropathic pain, epilepsy, Parkinson’s disease and depression; and
• List our common stock on a major securities exchange.

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission — “putting humans first” — bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.

Sincerely,

Shawn K. Singh, J.D.
Chief Executive Officer, Director
VistaGen Therapeutics, Inc.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen’s small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson’s disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGenor view VistaGen’s Facebook page at http://www.facebook.com/VistaGen.

Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen’s ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen’s stem cell technology-based Human Clinical Trial in a Test Tube™ platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen’s research, development, drug rescue and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

The proceeds will be used for expenses associated with the planned Phase I clinical trial for Kevetrin™, the Company’s flagship anti-cancer compound. In laboratory tests Kevetrin™ has shown the potential to be a breakthrough drug in the treatment of cancers by demonstrating potent anti-tumor activity through the re-activation of p53, “the Guardian Angel Gene;” resulting in significant tumor size reduction and growth delay.

The Company would also like to inform shareholders that the Quality Control testing and stabilities studies required to file an amended Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”) are completed. The new data is being added to the amended IND and undergoing a final review by the Company and then will be collated and submitted to the FDA.

“I am very pleased with the terms of the financing and the nearing of submission of the IND to the FDA,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We have always held our capital structure in the highest regard to preserve shareholder value and we feel that the terms of the agreement are very favorable. We are in a very enviable position. In Kevetrin, we have a new class of drug that in the laboratory shrunk every cancer tumor it was tested against; plan for Phase 1 clinical trials to begin shortly at DFCC; Beth Israel Deaconess Hospital is covering the costs of their research on Kevetrin™ in combination studies with Pfizer drugs; and we have a meeting coming in June with the FDA regarding guidance to advance Prurisol™ into advanced clinical trials as an indication for psoriasis. Add in Jim Boeheim joining our team and 2012 is aligning to be a banner year for Cellceutix and its shareholders.”

About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.

Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix’s success are more fully disclosed in Cellceutix’s most recent public filings with the U.S. Securities and Exchange Commission.

Stem cell technology is still in a nascent stage. The market still lacks substantial data that could establish its long-term efficacy as well as safety. Certain issues pertaining to its administration have also raised concerns. The regulatory and ethical barriers across the world, particularly in Western countries, are the major challenges ahead of stem cells research. The barriers are particularly more in embryonic stem cell research. On the other hand, countries such as India, with comparatively less opposition, are better positioned to conduct stem cell research. Lack of proper funding is also a matter of concern for stem cell research. Countries, such as Thailand, Taiwan, Malaysia, Singapore, China, and India, are engaged in commercial, clinical, and scientific advancements in stem cell research without proper funding.

Over the past few years, the stem cells market has witnessed several breakthroughs that bodes tremendous potential in reshaping the area of medicine. Potential therapeutic applications of stem cells cut across several debilitating and deadly disease areas, including cancer and AIDS. Stem cell research is entering new avenues of medicine, and promises to provide a solution to combat diseases that were hitherto believed to be incurable. There is a growing demand for such therapies, which in turn provokes continued investments in the area, and foretell a remarkable growth in the industry in the coming years. Presently, the field is focused upon the treatment of certain oncological ailments, which include non-Hodgkin’s lymphoma, multiple myeloma, and leukaemia. Additionally, non-cancerous diseases, including lupus, immunodeficiency, and aplastic anaemia, are also being investigated for treatment using stem cell technology.

Mesenchymal stem cells and hematopoietic stem cells, extracted from adult bone marrow, are the leading types ofadult stem cells currently in demand in the area of medicine. Of these types, hematopoietic stem cells hold major share in disease management. The dominance of hematopoietic stem cells is in part due to the difficulty associated with the isolation of mesenchymal from the bone marrow owing to availability of cells in lower levels. The greatest strength of adult stem cells is the presence of genomic stability of a very high degree. Additionally, stem cell therapy does not necessitate pre-treatment or genetic modification that is required when dealing with embryonic stem cells.

The US represents the largest regional market worldwide, as stated by the new market research report on Stem Cell Research. Despite the 9-year ban, which ended in 2009, over federal funding for research in embryonic stem cells, North America is presently dominating the stem cell market. Key factors that have kept North American market on the top of the charts include advanced stem cell research infrastructure and facilities, and federal support for the research. Asia is emerging as the fastest growing regional market for stem cell research worldwide with countries such as Japan, China, Singapore, Korea, and Australia evolving as major hubs for stem cell research.

Major players profiled in the report include Advanced Cell Technology Inc., Athersys Inc., Cytori Therapeutics Inc., Genzyme Corporation, Geron Corporation, International Stem Cell Corporation, Mesoblast Ltd., Osiris Therapeutics Inc., StemCells Inc., ThermoGenesis Corp., among others.

The research report titled “Stem Cell Research: A Global Strategic Business Report” announced by Global Industry Analysts, Inc., provides comprehensive market overview, trends & issues, regulatory overview, overview on therapies under development, recent industry activity and profiles of market players worldwide. The report analyzes global adult stem cell research market in terms of annual investments in value for the years 2008 through 2017, for major geographic markets, including the US, Europe and Rest of World.

For more details about this comprehensive market research report, please visit –
http://www.strategyr.com/Stem_Cell_Research_Market_Report.asp

About Global Industry Analysts, Inc.
Global Industry Analysts, Inc., (GIA) is a leading publisher of off-the-shelf market research. Founded in 1987, the company currently employs over 800 people worldwide. Annually, GIA publishes more than 1300 full-scale research reports and analyzes 40,000+ market and technology trends while monitoring more than 126,000 Companies worldwide. Serving over 9500 clients in 27 countries, GIA is recognized today, as one of the world’s largest and reputed market research firms.

Dr Weiner has been Teva’s head of global research and development for over three decades, most recently as Chief R&D Officer and a member of the Teva Executive Committee. In this role, he has directly overseen all pharmaceutical R&D and innovative branded product pipeline development.

Dr Weiner has been responsible for the development of hundreds of generic products for the US, EU and other markets. In parallel, he has been responsible for the development and regulatory approval of Teva’s innovative product portfolio. Dr Weiner has twice been the recipient of the Rothschild prize for innovation, including for the commercialization of Copaxone in the treatment of multiple sclerosis.

Dr Weiner said: “I am happy and proud to be a Board member of Mesoblast. I trust that stem cell technology is the future of medicine, and that Mesoblast is at the cutting edge of this exciting new field.

“I believe that Mesoblast’s unique technology and professional execution capabilities have the potential to deliver multiple innovative biologic products across a broad range of clinical indications,” added Dr Weiner.

Mesoblast Chairman, Mr Brian Jamieson, said: “Dr Weiner’s extensive pharmaceutical industry experience and his current role as Special Adviser to the Teva CEO make him a very valuable and strategic addition to the Board. We also acknowledge the important contributions and insights provided by Teva’s retiring board representative, Kevin Buchi, and wish him well.

“As Mesoblast expands its clinical product portfolio and approaches product commercialization, we will continue to broaden the mix of skills and international expertise of our Directors to ensure that the Board is in the best position to deliver maximal shareholder value.”

About Mesoblast Mesoblast Limited (asx:MSB) is a world leader in commercialising biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). www.mesoblast.com

For further information, please contact: Julie Meldrum Corporate Communications Mesoblast Limited E: julie.meldrum@mesoblast.com

Diabetes is a worldwide epidemic affecting over 350 million people, including over 25 million people in the United States. The most common long-term complication of diabetes, which affects over half of the diabetic population, is nerve disease or diabetic peripheral neuropathy (DPN). If left untreated, DPN triggers foot ulcers that may require amputation, cause disabling pain, and increase the risk of falling in the elderly.  The annual cost of diabetic neuropathies has been estimated at $14B in the United States.  This represents the company’s key area of focus moving forward.

The company’s products are used by physicians and other clinicians, in retail health settings such as pharmacies, and by managed care organizations to optimize patient care and reduce healthcare costs.  The company markets the NC-statÒ DPNCheck™ device, which is a rapid, accurate, and quantitative test for diabetic neuropathy.  This product is used to detect diabetic neuropathy at an early stage and to guide treatment.  The company is in late stage development of SENSUS, a pain management device that will be used to treat painful diabetic neuropathy, a form of chronic intractable pain.  Currently, painful diabetic neuropathy is treated pharmacologically, which is a $2B annual market.

Refocusing the Business on Diabetes

NeuroMetrix was founded in 1996 as a spinoff from Harvard Medical School and the Massachusetts Institute of Technology (MIT). Over the past 12 years, the company has developed and commercialized general-purpose devices for nerve conduction testing that are sold to primary care doctors and to specialists such as neurologists to aid in the diagnosis of various nerve disorders. The company created the market for point-of-care nerve testing.

Over the past several years, the company’s general-purpose nerve testing business has been challenged due to changes in reimbursement. Management changed strategic direction and restructured the business a year and a half ago to focus specifically on diabetes neuropathy, a market with little to no direct competition from medical device companies. The company’s first diabetes-specific product, NC-stat DPNCheck, was commercially launched in late September of 2011. It has been well received in its initial target market of endocrinology and podiatry. The company has begun to make inroads in the larger markets of retail health clinics and managed care.

Significant Growth Potential

During the first quarter, NeuroMetrix received orders for 227 NC-stat DPNCheck devices and has a goal of placing 1,000 devices with physicians by the end of 2012, according to a management interview. Notably, 91 of these devices were sold to Wal-Mart stores in Canada for use in its pharmacies, which marks a significant vote of confidence in this unique product. The company estimates the market potential for the product could exceed $200 million.

The company recently filed a form 510(k) pre-market notification with the Food and Drug Administration for SENSUS, a therapeutic device for painful diabetic neuropathy. The company estimates that the accessible market could exceed $100 million. Also, the company’s research and development pipeline includes other diagnostic and therapeutic devices addressing DPN. It has a technology-based commitment to building long-term shareholder value.

A Great Investment Opportunity

NeuroMetrix trades with a market capitalization of just $9.32 million, despite a cash position of $15.2 million and strong early adoption of its NC-stat DPNCheck. The market is slow to appreciate the company’s promising position in the diabetes sector, the strength of its technology platform and its product development capabilities. Its legacy general purposes business is in decline and is managed for cash flow. This business tends to obscures the emerging diabetes business and may be to blame for the valuation discount. For investors willing to take a deeper look, the stock appears to be both misunderstood and significantly undervalued at its current levels.

For more information, please see the following resources:

• Company Website
• Latest SEC Filings

What is Pressure Cycling Technology?

Pressure BioSciences’ Pressure Cycling Technology (PCT) is a novel, enabling technology platform that can precisely control the sample preparation process. Based on harnessing the power of high hydrostatic pressure, the PCT process uses alternating cycles of this pressure to safely, conveniently and reproducibly control the actions of molecules in biological samples.

The company’s products include the Barocycler® instrument and single use processing containers called PULSE (Pressure Used to Lyse Samples for Extraction) tubes. Moreover, the firm offers other processing tubes and application specific kits that make up its PCT Sample Preparation System, or PCT Systems, its primary product on the market.  Currently, the company has placed over 200 PCT Systems in some of the leading research labs in the US, including Harvard, Stanford, Merck, Pfizer, the FDA, and the USDA.

The Importance of PCT Technology

Pressure BioSciences’ Pressure Cycling Technology targets the $6 billion global sample preparation industry. Sample preparation is an extremely important part of the scientific process because poor preparation of samples can quickly alter or skew analytical results. Despite the large market and importance, the industry still operates in the proverbial dark ages.

Incredibly, many laboratories still use mortar and pestle grinding when preparing samples, while other technologies like bead-beaters, sonicators and homogenizers aren’t far behind. The company’s PCT Platform takes the guesswork and variability out of sample preparation by increasing the control of individual molecules within a given sample.

Watch a video describing this process here:
http://www.youtube.com/watch?v=TaUqdifHBkw

Numerous Market Opportunities

Pressure Biosciences’ Pressure Cycling Technology can be applied to numerous end markets that require effective DNA, RNA or protein extraction. Combined, these markets represent billions of dollars of opportunity for the company and its shareholders.

Some of these end markets include:

• Mass Spectrometry – A laboratory instrument that’s used in the analysis of biological samples in life sciences research and a billion dollar market for PCT technology.
• Forensic Analysis – Detection of DNA has become an invaluable tool in law enforcement. PCT has been shown by forensic scientists to recover more DNA than currently used methods, which makes the PCT Platform perfect for forensic analysis.
• Histology Techniques – A technique commonly used for the preservation of cancer and other tissues for subsequent pathology evaluation has been shown to benefit from the PCT Platform.

Despite being in a development phase until recently, the company has installed over 200 PCT SPS Systems since it began passively selling its prototype and first generation units in late 2007. These customers have included academic laboratories, government agencies, biotechnology companies, pharmaceutical companies and other life science companies in the U.S. and abroad, marking a strong vote of confidence.

Moving forward into its active commercialization phase, investors have a unique opportunity to capitalize on a technology that could change the sample preparation industry.

Additional Resources

For more information on Pressure BioSciences and its technologies, please see the following resources:

• Company Profile
• Recent SEC Filings

Coach Boeheim has earned icon status in the world of basketball. Coaching on the sidelines of the Carrier Dome court that is now named after him, Boeheim has an 890-305 (.745) overall record; ranking him second in wins among active Division I coaches and third all-time in college basketball. Syracuse has nine Big East regular season championships, five Big East Tournament championships and 28 trips into the NCAA Tournament, including four Final Four appearances with a NCAA championship in 2003. Boeheim has earned bronze and gold medals for his role as assistant coach in the 1990 FIBA World Championship, the 2006 FIBA World Championship, the 2008 Summer Olympics and the 2010 FIBA World Championships in Turkey. This summer, he will once again be filling the position in the latest edition of the “Dream Team” during the Olympics in London, England. In September 2005, Boeheim was inducted into the Basketball Hall of Fame.

Boeheim’s list of basketball accolades are only paralleled by his philanthropic efforts in the field of cancer. Surviving his own battle with prostate cancer, Boeheim now heads the Jim and Juli Boeheim Foundation and has become a major advocate for Coaches vs. Cancer, the Children’s Miracle Network, the Make-A-Wish Foundation, Easter Seals, the Special Olympics and more. His dedication to Coaches vs. Cancer, a non-profit collaboration between the National Association of Basketball Coaches and the American Cancer Society, has helped raise $4.5 million for the American Cancer Society’s Central New York chapter over the past 12 years.

“After speaking with Cellceutix about their planned clinical trial plans at Harvard’s Dana-Farber Cancer Institute and learning about the p53 connection with Kevetrin(TM) as a completely new class of chemistry in medicine, I was compelled to support their efforts,” said Jim Boeheim. “I am genuinely excited to begin this new challenge to bring an underdog to a championship.”

“We are thrilled to have Coach Boeheim joining our own version of a ‘Dream Team,’” commented Cellceutix CEO Leo Ehrlich. “His efforts both on and off the court epitomize a true champion, and that’s exactly what we want to surround ourselves with. Coach’s relationships in the cancer industry and tireless work ethic will help spread the important message about the potential of Kevetrin(TM) to medical experts and members of the public whose lives could be changed for the better as the compound enters into clinical trials.”

The Cellceutix Team:

Advisor Paul Marks, MD, is the former President and Chief Executive Officer of Memorial Sloan-Kettering Cancer Center and current President Emeritus and Member of the Sloan-Kettering Institute (MSKCC). Across 19 years as President and CEO at MSKCC, Dr. Marks made major contributions in developing new and more potent chemotherapy and chemoprevention agents which led to the “Paul Marks Prize for Cancer Research” being established at MSKCC as an award to honor young investigators for promising cancer research.

Advisor Dr. Emil Frei III, MD, is one of the world’s leading oncologists and a pioneer of chemotherapy. Dr. Frei has served as Chief of Medicine at National Cancer Institute and Director and Physician-in-Chief at the Dana-Farber Cancer Institute. He continues today as Physician-in-Chief, Emeritus, at Dana-Farber. Dr. Frei and his colleague Dr. Freireich established drug trials in children with leukemia using intermittent combinations of up to four drugs, each of which targeted a different pathway in the cell’s physiology. The treatment strategy significantly increased the survival rate for childhood leukemia and other types of cancer. In addition, they worked together to modernize chemotherapy trials by defining remission, organizing multi-patient treatment programs, and devising the concept of double-blind studies.

Advisor Dr. Samuel Danishefsky is internationally recognized as a leading chemist in cancer research. A Sterling Professor of Chemistry at Yale University, Dr. Danishefsky currently serves as Director and Chairman of the Laboratory for Cancer Research Bioorganic Chemistry at Memorial Sloan-Kettering Cancer Center.

Advisor Dr. Paul Ginsburg received his Ph.D. in Chemistry from the City University of New York and his law degree from Columbia University where he was a Harlan Fiske Stone Scholar. Dr. Ginsburg retired from Pfizer Inc., where he served as Head of the New York Patent Department and worked on patent matters relating to several blockbuster products, including Viagra and Chantix.

Dr. Krishna Menon is a founder and Chief Scientific Officer of Cellceutix. Dr. Menon has nearly 30 years in drug development for academia and industry, including his position as Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly, where he played a key role in lead selection and pre-clinical development of blockbuster cancer drugs Gemzar and Alimta which earned him a President’s Recognition Award from Eli Lilly.

About Cellceutix

Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin(TM), is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com .

Safe Harbor Forward-Looking Statements To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix’s success are more fully disclosed in Cellceutix’s most recent public filings with the U.S. Securities and Exchange Commission.

Pressure BioSciences, Inc. (PBIO.PK) (“PBI”) and LEAP Technologies(“LEAP”), (together “the companies”), today announced the signing of a strategic co-development, co-marketing, and co-selling agreement (the “Agreement”). Under the Agreement, the companies plan to develop a next generation sample preparation system by combining PBI’s patented pressure cycling technology (“PCT”) platform with LEAP’s proprietary robotics and lab automation equipment. The companies share an industry focus in proteomics sample preparation, primarily in mass spectrometry. PBI and LEAP believe that by combining the best attributes of both technology platforms, they can develop a sample preparation system superior in quality and robustness to current methods.

Proteomics is the study of the structure and function of proteins. The number of researchers studying proteomics has grown in recent years.  Their studies have provided new and important insights into human health, and have resulted in a better understanding of diagnosis, prevention, control, prognosis, and possible cures of various diseases and clinical conditions. High-quality sample preparation is critical to proteomic research studies. To that end, automated sample preparation methods increase the precision and quality of laboratory testing, which in-turn increases the probability of discovery.  Increased discovery leads to the development of new and improved vaccines, therapeutics and diagnostics.

Mr. Werner Martin, CEO of LEAP Technologies, said: “PCT is a powerful and enabling technology platform.  Because of its clear advantages, mass spectrometry laboratories have begun to integrate PCT into their standard sample preparation workflow, even though the PCT method has not yet been fully automated. This has created a wonderful opportunity for us to partner with Pressure BioSciences, as we have the experience and expertise to bring automation to their patented PCT Platform.  Over the past 20 years, we have developed a strong reputation in robotics and laboratory automation while working with many of the leading life sciences companies in the world, such as Waters Corporation and Agilent Technologies. With a growing need for automation, we look forward to developing, marketing, and selling the next generation sample preparation system for proteomics with our colleagues at PBI.”

Mr. Richard T. Schumacher, President and CEO of PBI, remarked: “We are very excited to have this opportunity to partner with a well-established and universally respected robotics and lab automation company like LEAP.  We already have a foothold in the mass spectrometry sample preparation area, but the ability to build PCT into an automated workflow using LEAP’s proprietary equipment and software should help us increase our penetration in the mass spectrometry area, and in other areas of the estimated $6 billion life sciences sample preparation market. We believe that this added penetration will result in increased revenue for both PBI and LEAP in 2012, and beyond.”

About LEAP Technologies

LEAP Technologies has been providing proprietary robotics and laboratory automation equipment and support for specific applications for over 20 years. LEAP’s automation solutions allow the research scientist to walk away and run their samples unattended (such as overnight). LEAP has become the automation application “house of choice” to which even the large analytical instrument companies refer their customers. LEAP’s name is synonymous with great support, and with flexible and innovative ideas. With today’s digital communication and fast proliferation of new analytical techniques, LEAP successfully offers its value-added products and services worldwide (world wide support network) through a carefully selected network of smaller companies that share the same spirit.

About Pressure BioSciences, Inc.

Pressure BioSciences, Inc. (“PBI”) (PBIO.PK) is focused on the development, marketing, and sale of proprietary laboratory instrumentation and associated consumables based on Pressure Cycling Technology (“PCT”).  PCT is a patented, enabling technology platform with multiple applications in the estimated $6 billion life sciences sample preparation market.  PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels to control bio-molecular interactions.  PBI currently focuses its efforts on the development and sale of PCT-enhanced sample preparation systems (instruments and consumables) for mass spectrometry, biomarker discovery, bio-therapeutics characterization, vaccine development, soil and plant biology, forensics, histology, and counter-bioterror applications.

Pioneering stem cell researcher George Q. Daley, M.D., Ph.D. will provide a keynote address at the conference. Dr. Daley is director of the Stem Cell Transplantation Program at HHMI/Children’s Hospital Boston; professor of Biomedical Chemistry/Molecular Pharmacology and Pediatrics at Harvard Medical School, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, Harvard Stem Cell Institute and Manton Center for Orphan Disease Research.

This event aims to enhance the understanding of key issues facing regenerative medicine products as they approach the marketplace. Disease areas to be reviewed will include ophthalmology, metabolic diseases (including diabetes), neurodegenerative disease and spinal cord injury, cardiovascular disease and wound healing.

“This meeting exemplifies the interaction among scientists, clinicians and industry that is necessary to successfully bring regenerative medicine to the clinic, and ultimately, to the market,” said Brock Reeve, Executive Director, Harvard Stem Cell Institute.

Confirmed speakers include representatives from Advanced BioHealing, a Shire Company, Advanced Cell Technologies, Athersys, InVivo Therapeutics, Johnson & Johnson, Organogenesis and StemCells, Inc. In addition, the following researchers and clinicians are confirmed to speak:

Ellen Feigal, M.D., Senior Vice President, Research and Development, California Institute for Regenerative Medicine

Richard Lee, M.D., Professor, Medicine, Harvard Medical School; Leader, Cardiovascular Program, Harvard Stem Cell Institute; Cardiologist, Brigham and Women’s Hospital

Peter Lomedico, Ph.D., Director, Industry Partnerships, Cure Therapies, Juvenile Diabetes Research Foundations

Marc Penn, M.D., Ph.D., F.A.C.C., Director, Research, Summa Cardiovascular Institute; Physician, Cardiovascular, Internal Medicine, Summa Akron City Hospital; Professor, Integrative Medical Sciences; Northeast Ohio Medical University

Jane Sowden, Ph.D., Professor, Developmental Biology and Genetics, Developmental Biology Unit; Group Leader, Eye Development and Repair Group, University College London Institute of Child Health

Michael Young, Ph.D., Associate Scientist and de Gunzburg Director, Minda de Gunzburg Research Center for Ocular Regeneration, Schepens Eye Research Institute; Associate Professor, Ophthalmology, Harvard Medical School

“This conference will provide a unique opportunity to hear directly from clinicians and investigators who have experience with regenerative medicine therapies on the market and in late stage development, and understand the potential of these products to revolutionize patient care,” said Gil Van Bokkelen, Ph.D., Chairman of ARM and CEO of Athersys.

To learn more and to register for the conference, please visit https://alliancerm.wufoo.com/forms/clinical-outlooks-for-regenerative-medicine/ . Complimentary registration is available for credentialed members of the media and HSCI affiliated clinicians and researchers.

About The Alliance for Regenerative Medicine The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit www.alliancerm.org .

About Harvard Stem Cell Institute The Harvard Stem Cell Institute (HSCI) is a scientific collaborative established to investigate the complex biology and therapeutic potential of stem cells. With over 200 faculty members at Harvard and its 11 affiliated hospitals, HSCI supports cutting-edge science through sponsoring research projects, operating core facilities, managing events and offering training opportunities.

Among patients being treated for cancers of the blood and immune system, roughly half will experience GvHD, and many of those will either experience chronic and debilitating disease, or eventually die.  In fact, chronic GvHD kills up to 33 percent of all those who survive long-term after stem-cell transplants for leukemia.  Several companies are pursuing new treatments for treating patients who are suffering GvHD. Acquisition news is in the headlines this week with Jazz Pharmaceuticals (NASDAQ: JAZZ) dolling-out nearly $700 million to acquire EUSA Pharma Inc, whose pipeline includes Leukotac® (inolimomab), an anti-CD25 monoclonal antibody in a phase III pivotal study in Europe for treatment of steroid-refractory acute graft versus host disease.

Many new therapies are designed to manage symptoms after the disease has already gotten out of control – and in the case of GvHD that’s analogous to trying to put out a forest fire after it’s started to rage out of control.  However, one innovative company is taking a different approach – by developing a new therapy designed to prevent the GvHD from ever happening in patients that are at high risk of the condition.  Based in Ohio near the renowned Cleveland Clinic  and other notable medical and research institutions, including University Hospitals and the National Center for Regenerative Medicine, Athersys, Inc. (NASDAQ: ATHX) is moving to the forefront of the industry with some promising new therapies and an approach to preventing GvHD before it’s raging out of control – sort of like putting it out at the campfire stage.

Recently, Athersys, Inc. announced some encouraging initial data from a clinical study involving administration of MultiStem® to patients being treated for leukemia or other conditions that place them at risk of GvHD.  That study showed some promising results, with a reduction in GvHD and potential for other clinical benefits.  Last week, the company announced that it held a scheduled meeting with the FDA to discuss the results of its recently completed clinical trial. Additionally, the company discussed with the FDA its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design. While it will undoubtedly  take some time to map out the specifics of the next phase of clinical development, it would seem that since this could represent an opportunity for “fast track” development for a promising new therapy in a recognized orphan indication, and area of great clinical need.

“This was an important first step in defining the next phase of clinical development for this program. We sincerely appreciate the collaborative approach the FDA is taking regarding the development of innovative new therapies designed to address serious conditions and areas of significant unmet medical need,” commented Gil Van Bokkelen, Chairman & CEO at Athersys. “We look forward to getting additional input from the agency as we work with them to finalize the study design.”

About Graft versus Host Disease

Leukemia and certain related conditions are often treated with radiation and chemotherapy to eliminate cancerous or diseased cells, but this process also severely compromises the native blood forming and immune system in the patient, leaving them susceptible to infection and other complications. To address this, a patient will often receive an allogeneic HSCT, whereby following radiation and chemotherapy treatment a patient’s blood stem cells are replaced with a transplant of hematopoietic stem cells obtained from the bone marrow or peripheral blood of a healthy donor. Donors may be related or unrelated to the patient, but are matched according to tissue type in order to minimize the potential for GvHD, where donor immune cells transplanted with the donor HSCT attack tissue and organs of the patient. Following the transplant, the patient will often remain hospitalized in specialized units until successful engraftment provides a sufficiently functional immune system.

According to the Center for International Blood and Marrow Transplant Research, each year there are approximately 25,000 allogeneic HSCT performed globally, although this number is projected to increase due to the anticipated growth in incidence of hematologic malignancies associated with an aging population. While this treatment approach can be an effective medical therapy for these types of cancer, it is often associated with substantial tissue damage and side effects. GvHD is a frequent complication associated with allogeneic HSCT, affecting approximately half or more of transplant recipients, and advanced GvHD can be severely debilitating or even fatal. Several factors affect a patient’s likelihood of having GvHD and GvHD severity, including the treatment protocol used, the degree of tissue match between donor and recipient (with lower GvHD rates and severity associated with related donors and better tissue matches), and the condition of the patient among other factors.

About MultiStem

MultiStem® cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and represents a unique “off-the-shelf” stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.

About Athersys

Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com <http://www.athersys.com> .

The Non GAAP financial measures included within this release are explained on page 21, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 18 – 20.

Angus Russell, Chief Executive Officer, commented:

“Shire continues to perform strongly with first quarter results in line with our expectations. Product sales increased 24%, Non GAAP operating income was up 18% and Non GAAP diluted earnings per ADS increased 20% to $1.48. Our focus on demonstrating value to the healthcare system through meeting the needs of our patients is continuing to deliver.

In ADHD, our lead treatments VYVANSE and INTUNIV both increased share versus the prior year in a growing US market and we anticipate VYVANSE sales of over $1 billion for the full year.

Following its launch late last year, FIRAZYR has made a very good start in the US and has added further growth to the strong sales performance of our other rare disease treatments ELAPRASE, VPRIV and REPLAGAL.

Our new regenerative medicine product DERMAGRAFT also performed well, contributing to our overall growth in product sales.

Using our strong balance sheet, we’ve recently completed a number of acquisitions to add to the Phase 2 developments in our pipeline, including an exciting hematology asset and a novel cell-based platform for our regenerative medicine business. We’re very pleased with the progress of several other studies across our pipeline, particularly the positive Phase 2 clinical data for VYVANSE in the treatment of binge eating disorder released today.

We’ve made a strong start to the year and reiterate our expectation of good earnings growth in 2012.”

Product sales were up 24% to $1,107 million (q1 2011:$889 million). The growth in product sales was driven particularly by VYVANSE® (up 29% to $260 million), REPLAGAL® (up 28% to $134 million), ELAPRASE® (up 21% to $126 million), VPRIV® (up 22% to $72 million), FIRAZYR® (up 272% to $20 million) and INTUNIV® (up 63% to $69 million). On a constant exchange rate (“CER”) basis, which is a Non GAAP measure, product sales were up 26%. Q1 2012 also included $49 million of DERMAGRAFT® sales (q1 2011:$nil). Excluding sales of DERMAGRAFT, which was acquired with Advanced BioHealing Inc. (“ABH”) in Q2 2011, product sales were up 19%.

Total revenues were up 21%, to $1,172 million (q1 2011:$972 million), as the growth in product sales was partially offset, as expected, by a lower level of royalties and other revenues.

On a Non GAAP basis, operating income was up 18% to $362 million (q1 2011:$306 million) as total operating expenses in Q1 2012 increased at a slightly higher rate than total revenues. Research and development (“R&D”) costs increased 10% and Selling, general and administrative (“SG&A”) costs increased by 25% compared to Q1 2011. The rate of increase in SG&A is significantly higher than we expect to see for the full year as Q1 2012 includes ABH’s SG&A ($31 million) which was not incurred in Q1 2011 and SG&A in Q1 2011 was lower than the level experienced across subsequent quarters in 2011. On a US GAAP basis, operating income was up 11% to $295 million (q1 2011:$267 million), a lower rate of growth than on a Non GAAP basis, due to up-front payments in respect of in-licensed and acquired products charged to R&D, and higher intangible asset amortization expense included in SG&A in Q1 2012.

Non GAAP diluted earnings per American Depository Share (“ADS”) were up 20% to $1.48 (q1 2011:$1.23), due to higher Non GAAP operating income and a lower Non GAAP effective tax rate of 20% (q1 2011:22%). US GAAP diluted earnings per ADS were up 12% to $1.24 (q1 2011:$1.11) due to higher US GAAP operating income and a lower US GAAP effective tax rate of 17% (q1 2011:19%).

Cash generation, a Non GAAP measure, was up 49% to $310 million (q1 2011:$208 million) as higher cash receipts from higher product sales more than offset increased operating expense payments. Cash generation in Q1 2011 was also negatively impacted by the timing and quantum of sales deduction payments. Free cash flow, also a Non GAAP measure, was up 60% to $248 million (q1 2011:$155 million), due to the higher cash generation together with lower capital expenditure, partially offset by higher cash tax payments in Q1 2012 compared to Q1 2011. On a US GAAP basis, net cash provided by operating activities was up 27% to $257 million (q1 2011:$202 million), a lower rate than the Non GAAP free cash flow measure, which does not include the up-front payments in respect of in-licensed and acquired products made in Q1 2012.

Net debt at March 31, 2012 was $214 million (December 31, 2011: $468 million), a reduction of $254 million, principally due to the strong free cash flow generated in Q1 2012.

2012 OUTLOOK

Having made a strong start to the year, we reiterate our confidence in good earnings growth for 2012, while investing in our business to support sustained future growth.

For the full year we now expect product sales growth in the mid teens range. Combining this with lower royalties and other revenues, which are expected to be 15% to 25% lower year on year, we are forecasting revenue growth in the low teens range.

We anticipate the marginal dilution in gross margins seen this quarter will continue, reflecting the full year impact of our acquisition of ABH.

We will continue to advance our promising pipeline of early and late stage programs, and we will be investing in our recent pipeline acquisitions and in the treatment of binge eating disorder, following recent positive data. The rate of increase in operating costs seen in the first quarter will not continue through the full year, but as we invest in our pipeline, continue to expand our international commercial activities and absorb a full year of ABH’s operating costs, we now expect combined Non GAAP R&D and SG&A spending to increase by 12% to 14% compared to 2011.

We expect our tax rate for 2012 to be in the range of 20% to 22%.

FIRST QUARTER 2012 AND RECENT PRODUCT AND PIPELINE DEVELOPMENTS

Products

VPRIV manufacturing update

On February 22, 2012 Shire announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use had approved the production of VPRIV in its new biologics manufacturing facility in Lexington, Massachusetts and this decision was adopted by the European Commission on March 26, 2012. Shire now has two EMA approved facilities – Alewife in Cambridge, Massachusetts, as well as the new Lexington facility – in which to manufacture VPRIV drug substance. Shire has received a Complete Response letter from the US Food and Drug Administration (“FDA”) regarding production of VPRIV drug substance at Lexington. Shire is working closely with the FDA to address their questions and resolve any outstanding issues to the satisfaction of the agency. Notwithstanding the ongoing discussions with the FDA, Shire continues to supply VPRIV to US patients through its existing approved US manufacturing facility at Alewife and has the capacity to meet the anticipated demand for VPRIV from existing and new patients both in the US and globally, recognizing that US inventory levels will be below target levels until the Lexington facility is approved by the FDA.

VYVANSE – for the treatment of Attention Deficit Hyperactivity Disorder (“ADHD”)

On March 6, 2012 Shire announced that it is initiating two Phase 4 clinical trials to compare VYVANSE Capsules to CONCERTA® Extended-Release Tablets. These prospectively designed head-to-head clinical trials will provide important information for physicians, patients, caregivers, and payors to make informed choices, and have been designed to explore differences in efficacy between VYVANSE and CONCERTA in adolescents aged 13 to 17 with ADHD. Together the two trials will enroll approximately 1,000 patients, and results are expected in the second half of 2013.

FOSRENOL® – for the treatment of Hyperphosphatemia in end stage renal disease

On March 8, 2012 Shire announced that it has received approval through the European Decentralised Procedure for an oral powder formulation of FOSRENOL. The oral powder formulation was developed by Shire to give patients more choice in how they take their phosphate binder. Submissions for national marketing authorisations of FOSRENOL in oral powder form have been made to Sweden and the other 27 European markets, with the first national approvals anticipated in Q2 2012.

Pipeline

REPLAGAL – for the treatment of Fabry disease

On March 14, 2012 Shire announced that it had withdrawn its Biologics License Application (“BLA”) for REPLAGAL with the FDA. In 2009, and again in 2011, the FDA encouraged Shire to submit an application for the approval of REPLAGAL in the US. These discussions led Shire to file a BLA in November 2011 in anticipation of a quick review process and eventual approval. Recent interactions with the FDA in Q1 2012 led Shire to believe that the FDA would require additional controlled trials for approval. No concerns over the product’s safety profile were raised by the FDA. Shire has concluded that the likely additional studies would cause a significant delay, and an approval of REPLAGAL for US patients would only be possible in the distant future. Shire therefore decided to withdraw its BLA. Patients currently treated with REPLAGAL in the US under treatment access programs will be transitioned off REPLAGAL therapy by June 30, 2012.

SPD476, MMX® mesalamine – for the treatment of diverticular disease

On March 30, 2012 Shire announced top-line results of the PREVENT2 trial, a Phase 3 investigational study of once-daily SPD476, MMX mesalamine in patients with a history of diverticulitis. The study did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a two year treatment period. Shire will continue to analyze these data and those of the second study, PREVENT1, which was similar in design to PREVENT2 and will report later in the year. Although the results of the second trial are pending, the current intention is not to pursue a regulatory filing for this indication for MMX mesalamine.

Lisdexamfetamine dimesylate (“LDX”) (currently marketed as VYVANSE in the US for the treatment of ADHD) for the treatment of Binge Eating Disorder (“BED”)

Today, Shire announced Phase 2 results from an efficacy and safety clinical study of LDX for the treatment of BED. In this study, in which the pre-defined primary end point was met, treatment of adults with LDX resulted in a statistically significant reduction in binge eating behaviour and increased remission rates from binge eating compared to placebo. There is currently no approved pharmacologic treatment for patients struggling with BED, the most common eating disorder.

FIRST QUARTER AND RECENT BUSINESS DEVELOPMENT ACTIVITY

Since the beginning of the year we have added to our pipeline through the following transactions:

Acquisition of FerroKin Biosciences, Inc. (“FerroKin”)

On April 2, 2012 Shire completed the acquisition of FerroKin and with it SPD 602 (formally referred to as FBS0701), FerroKin’s iron chelator treatment in Phase 2 development. SPD 602 serves a chronic patient need for treatment of iron overload following numerous blood transfusions. Together with our collaboration with Sangamo Biosciences Inc. (“Sangamo”), the acquisition of FerroKin represents a strategic step in building Shire’s hematology business, which already includes XAGRID® and a growing development pipeline, including SPD 535. Cash consideration paid on closing amounted to $94.5 million. Further contingent cash consideration of up to $225 million may be payable by Shire in future periods, dependent upon the achievement of certain clinical development, regulatory and net sales milestones.

Acquisition of certain assets of Pervasis Therapeutics, Inc. (“Pervasis”)

On April 19, 2012 Shire acquired substantially all the assets and certain liabilities of Pervasis. This acquisition adds VASCUGEL® to Shire’s Regenerative Medicine business. VASCUGEL is currently in Phase 2 development for acute vascular repair, focused on improving hemodialysis access for patients with end-stage renal disease.

Acquisition of the US rights to prucalopride (marketed in certain countries in Europe as RESOLOR®) – for the symptomatic treatment of chronic constipation

On January 10, 2012 Shire announced that it had acquired the rights to develop and market prucalopride (marketed in certain countries in Europe as RESOLOR) in the US in an agreement with Janssen Pharmaceutica N.V., part of the Johnson & Johnson Group.

In addition to the above acquisitions, we have entered into the following collaboration and in-license arrangements in the first quarter of 2012:

On February 1, 2012 Shire announced it had entered a collaboration and license agreement with Sangamo to develop therapeutics for hemophilia and other monogenic diseases based on Sangamo’s zinc finger DNA-binding protein (“ZFP”) technology.

On February 3, 2012 Shire exercised its option to acquire a worldwide exclusive license from Heptares Therapeutics Ltd (“Heptares”) to certain novel adenosine A2a antagonist compounds. These compounds are currently in preclinical development and being considered as candidates for central nervous system (“CNS”) disorders.

On February 29, 2012 Shire entered into a collaboration agreement with arGEN-X B.V. to develop novel therapeutic antibody products for the treatment of rare diseases.

OTHER DEVELOPMENTS

$1,100 million 2.75% Convertible Bonds due 2014 (the “Bonds”)

On April 9, 2012 the deadline for bondholders to elect to exercise the option to redeem their Bonds in May 2012 passed. As no elections from bond holders were received by this date the Bonds will become repayable on their maturity in May 2014.

Legal Proceedings

Civil Investigative Demand for ADDERALL XR®, ADDERALL XR Authorized Generics and VYVANSE

On April 5, 2012 Shire received a Civil Investigative Demand (“CID”) from the United States Federal Trade Commission (“FTC”) requesting that Shire provide it with certain information regarding the supply and reported shortages of ADDERALL XR and its authorized generics and the marketing and sale of ADDERALL XR, its authorized generics and VYVANSE. Shire believes the CID was triggered by reports of product shortages of ADDERALL XR and the authorized generic products in 2011. Shire is cooperating fully with the FTC. Separately, members of the US congress are reviewing industry wide drug shortages which have been well publicized in the US media and Shire has responded to a specific inquiry relating to ADDERALL XR.

Investigation into DERMAGRAFT

Shire understands that the Department of Justice, including the US Attorney’s Office for the Middle District of Florida, Tampa Division and the US Attorney’s Office for Washington, DC, is conducting civil and criminal investigations into the sales and marketing practices of ABH relating to DERMAGRAFT. Shire is cooperating in these investigations.

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About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit www.alliancerm.org.

In the interview, Mr. Ehrlich speaks with The Street Beat reporterBolton Flautt about ongoing activities at Cellceutix with the three of its drugs that are actively being developed as indications for cancer, psoriasis and autism. In Part One, Mr. Ehrlich provides commentary on the upcoming clinical trials for Kevetrin™ to be held at Harvard’s Dana-Farber, the combinations studies with two Pfizer drugs that are going to be conducted at Beth Israel Deaconess Medical Center and the possibilities involved with each. In Part Two of the interview, which will be released tomorrow, Friday, April 27th, the conversation turns towards the status of Prurisol™ for psoriasis and KM-391 for the core symptoms of autism.

Interested parties looking to learn more about this exciting biotech are encouraged to listen to the interview at:

The StreetBeat.com Cellceutix Interview

The Street Beat is a new digital financial media company, focusing on small-cap companies and the penny stock markets. By leveraging today’s technology to continuously grow its network of over 1400 financially centric newspaper, television, and radio websites, The Street Beat has quickly become one of the top sources for investors seeking information on today’s emerging companies. Through an array of digital and marketing services, The Street Beat offers users and subscribers daily innovative business news, real-time market commentary, investment tools, market education, as well as stories, articles, videos, and market briefs from a full staff of experienced and dedicated journalists. Visit us today at www.TheStreetBeat.com.

To view the complete report, please follow this link:
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About ALR Technologies Inc.

The ALRT Health-e-Connect (HeC) System is the principal product of the Company. HeC is a web-based patient management platform for medical professionals to improve compliance and management of care plans of patients in their homes. HeC is currently programmed to assist healthcare providers caring for diabetes patients. The platform will be expanded to cover patients with other chronic diseases. More information on ALR Technologies and its products can be found athttp://www.alrt.com.

“DSMB authorization to move to the next higher dosage of cells in our U.S. clinical trial and complete the treatment of the first cohort of patient in our European trial represents yet another significant advancement for our clinical programs,” commented Gary Rabin, chairman and CEO of ACT. “We are pleased with the pace of progress and the continued finding of safety amongst the participants in both the U.S. and European trials. The results so far have been encouraging, and with our SMD programs having been granted ‘orphan’ medicinal product designation in both the U.S. and Europe, we look forward to eventually reaching a stage at which we can further avail ourselves of all the regulatory and financial benefits this designation brings.”

The three procedures comprising the first cohort of patients in the U.S. SMD trial were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute. The first procedure in the E.U. trial was conducted at Moorfields Eye Hospital in London, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London.

“We are gratified to be moving to the next stage in both of our SMD trials,” commented Robert Lanza, M.D., ACT’s chief scientific officer. “We remain very encouraged by the preliminary data in the first four SMD patients treated with the lowest dose of RPE cells at UCLA and Moorfields Eye Hospital. We are doubling the number of cells that will be transplanted in the next group of patients in the U.S. trial. We will be anxious to see if the higher dosage of RPE cells will impact visual function and photoreceptor rescue.”

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt’s macular dystrophy (SMD) at 12 months, the study’s primary endpoint. On January 20, 2012, the first SMD patient enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the company’s SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006, NCT01469832 and NCT01344993.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

An Important & Growing Market

Sample preparation before analysis is extremely important, especially because poor sample preparation can quickly alter or skew analytical results. While there is always a reluctance to change current practices, new sample preparation technologies are becoming more of a necessity than a choice, given the industry’s constantly increasing standards.

The global market for sample preparation reagents and products used in life science research was around $3.6 billion in 2011 and could exceed $8.4 billion by 2016, according to BCC Research. With an 18.8% compound annual growth rate, this equates to an enormous market opportunity for companies in the sample preparation space.

PCT Dramatically Improves Sample Prep

Pressure BioSciences has developed a unique Pressure Cycling Technology (PCT) that dramatically improves sample preparation. The technology utilizes alternating cycles of hydrostatic pressure between ambient and ultrahigh levels to safely, rapidly and reproducibly extract DNA, RNA, small molecules and proteins from a wide array of cells and tissues.

The technology has applications in numerous end markets, including mass spectrometry, forensics, and histology. Meanwhile, the company has been pursuing numerous collaborations within the scientific community to increase the number of applications that PCT can be applied to in order to enhance accuracy and results, and thus grow its user and revenue base.

A Great Investment Opportunity

The sample preparation market is rapidly growing market with a large and immediate need for better technology and very little governmental oversight. With its unique technology and strong patent protection, Pressure BioSciences is uniquely positioned to capitalize on this opportunity. And with a market capitalization of just $5 million, there may be significant upside available.

Assuming the company can garner just 1% of the $8.4 billion market by 2016, that represents revenues of $84 million that would be conservatively worth some $61.7 million today’s dollars. And with its current valuation, this would equate to a price-to-sales (P/S) ratio of just 0.09x today, which significantly undervalues the firm on a growth basis.

Several analysts have commented on this undervaluation, including Zack’s Research Equity Research, which recently issued a $5.00 per share price target on the stock. AMI Research also issued a price target of $5.22 per share on the stock, on February 29, 2012.

Breaking News!

Pressure BioSciences, Inc. and Target Discovery, Inc. Expand Strategic License Agreement and Collaboration Supporting TDI’s Planned Offering of Personalized Medicine Clinical Diagnostic Services

BioTime, Inc. (BTX) and its wholly owned subsidiary LifeMap Sciences today announced that they have signed a definitive agreement to acquire XenneX, Inc. through a merger of XenneX into LifeMap Sciences. The acquisition is expected to close within thirty days.

XenneX holds the exclusive, worldwide licenses to market GeneCards(R) and PanDaTox. GeneCards(R) is a searchable, integrated, database of human genes that provides concise genomic, transcriptomic, genetic, proteomic, functional and disease related information, on all known and predicted human genes. GeneCards(R) was developed by a world-leading bioinformatics team at the Weizmann Institute of Science in Israel. PanDaTox is a recently developed, searchable, database that can be used to identify genes and intergenic regions that are unclonable in E. coli, to aid in the discovery of new antibiotics and biotechnologically beneficial functional genes, and to improve the efficiency of metabolic engineering.

Since 2003, XenneX has been generating revenue from customers worldwide including biotechnology, pharmaceutical and other life sciences companies, as well as organizations dealing with biotechnology intellectual property. GeneCards(R) and PanDaTox are marketed by XenneX under a license from Yeda Research and Development Company Ltd, the Technology Transfer Company of the Weizmann Institute.

Through the merger, XenneX stockholders will receive approximately 1,362,589 shares of LifeMap common stock, which will represent approximately 13% of the LifeMap common stock outstanding upon the closing of the transaction. XenneX shareholders will also receive approximately 448,430 BioTime common shares as part of the transaction.

Separately, LifeMap Sciences announced that it anticipates acquiring a license from Yeda to market the new MalaCards database of human diseases. Like GeneCards(R) and PanDaTox, MalaCards has been developed by the Weizmann Institute and is expected to be launched at the end of 2012.

Background

The field of biomedical research has expanded greatly in recent years due to the enormous growth of DNA sequencing technology, bioinformatics, and stem cell biology. The growth in research has produced a very decentralized body of information. The mission of BioTime’s subsidiary LifeMap Sciences is to centralize access to this information through database technology that will make it much more feasible for researchers around the world to find and utilize information about tens of thousands of genes and thousands of cell types.

LifeMap’s team of scientists is building an integrated map of the thousands of cell types in human development, beginning with the fertilized egg and ending in the developed human. Combined with genomics information, the database is expected to become a “road atlas” of human biology benefiting medicine and research. In addition, LifeMap is developing its own proprietary technology to effectively analyze data gathered from the databases for use in the development of cell-based therapies.

In addition to expanding LifeMap’s database offerings through the acquisition of XenneX, BioTime plans to make LifeMap the principal marketing subsidiary for BioTime research products, including ACTCellerate(TM) human progenitor cell lines, GMP human embryonic stem (hES) cell lines, hES cell lines carrying inherited genetic diseases, and ESpan(TM) growth media for progenitor cell lines for non-therapeutic uses. LifeMap will utilize its databases as part of its online marketing strategy to reach life sciences researchers at biotech and pharmaceutical companies and at academic institutions and research hospitals worldwide.

In a therapeutic discovery collaboration with BioTime, LifeMap scientists will utilize LifeMap’s proprietary discovery platform and stem cell database along with its newly acquired database products as a discovery platform to aid in the development of BioTime’s proprietary ACTCellerate(TM) human progenitor cell lines into products for the treatment of human diseases, especially degenerative diseases that might be treatable by cell replacement therapies. Human therapeutic products require a high degree of purity to meet the hurdles of regulatory approval and acceptance in medical practice. BioTime’s ACTCellerate(TM) technology was invented as a means of generating human progenitor cells from hES cells in a scalable and highly purified state. The LifeMap discovery platform will be applied to select the progenitor cell lines that are most likely to be useful in developing cell based regenerative medicine therapies for various diseases.

“We believe that centralized online databases of biological knowledge will become indispensable tools for research in the field of regenerative medicine,” said Michael D. West Ph.D., BioTime’s Chief Executive Officer. “The rising standards for identity and purity in the development of stem cell therapeutics necessitate an international consensus on cell markers, and building the database is one component of BioTime’s strategy to lead in this emerging field of medicine while capturing near-term revenue.”

David Warshawsky, Ph.D., LifeMap Sciences Chief Executive Officer, who also founded XenneX, Inc. in 2003 and serves as its Chairman stated: “LifeMap has made great progress with the LifeMap database and discovery platform, and we see GeneCards(R), MalaCards and PanDaTox as a perfect fit for making LifeMap the leading source of online database research tools for genetic, biological, and stem cell research and development.” He added, “We are excited about integrating our database offerings with online marketing of cutting edge research products and using our LifeMap’s discovery platforms for the identification and development of therapeutic product opportunities in collaboration with the BioTime family of companies. We are confident that our products will enhance research and provide life-saving cures in the future.”

About LifeMap Sciences, Inc.

LifeMap Sciences (LifeMap), www.lifemapsc.com , is developing a discovery platform, including a web-based database, to aid researchers in the use of embryonic stem cells, progenitor cells, and induced pluripotent stem cells for the development of new products and technologies in the emerging field of regenerative medicine. LifeMap Sciences intends to become the central knowledgebase for stem cell research and discovery of cell-based regenerative medicine therapeutic products. LifeMap Sciences’ core technology and business is based on a state-of-the-art roadmap for stem cell research providing comprehensive coverage of embryonic stem cell biology.

About XenneX, Inc.

XenneX, Inc., www.xennexinc.com , is a privately held company that is dedicated to providing biotechnology, pharmaceutical and other life sciences companies, as well as organizations dealing with biotechnology intellectual property, the highest level of services and tools to enhance their bio-medical research. XenneX’s products help such organizations to optimize their efforts to develop innovative medical products and services. XenneX’s customers include many of the world leading biotech and pharmaceutical companies, located in North America, Europe and Asia.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate(TM) cell lines, culture media, and differentiation kits. BioTime’s wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime’s therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime’s majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure’s minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure’s OpRegen(TM) retinal cell product for use in the treatment of age-related macular degeneration. BioTime’s subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples, and therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime’s proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime’s newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime’s research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime’s lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at www.biotimeinc.com .

Alan Trounson, President of CIRM, says “This initiative is a major new development in the progress towards providing new medical treatments for patients by engaging the most effective global industry partners.”

The goal of the initiative is to attract major biotech, venture capital or pharmaceutical company leverage for advances in Californian research to enable companies to achieve, in 4 years or less, the completion of early phase clinical trials in patients. The objective is to enhance the most promising therapies for patients evolving from stem cell discoveries and move them closer to approval by the Food and Drug Administration (FDA).

“The Strategic Partnership Funding Program represents a new era for CIRM, one that is increasingly focused on moving therapies from the lab to the clinic, while still recognizing the importance of maintaining investments in early stage science,” says Elona Baum, General Counsel and Vice President of Business Development at CIRM. “This new initiative provides a vehicle for attracting industry funding and expertise, which are essential for bringing CIRM-funded research to patients.”

“This initiative reflects the progress that is being made in stem cell research,” says Duane Roth, Vice Chair of the governing board of CIRM. “In the early days of CIRM it was important to focus our attention on basic science. That is paying off and now we are a lot closer to having promising therapies ready for clinical trials, so it makes sense that we step up our engagement with industry to help fund those trials and move those therapies closer to approval by the FDA.”

Under the initiative CIRM plans to issue 3 or more awards of up to $10 million each. The successful applicants will have to match those funds, either dollar for dollar, or by providing in-kind services such as manufacturing and product development.

In addition to demonstrating that their proposed project will result in a completed clinical trial within four years, applicants must also establish evidence of commercial validation in order to be eligible. That means they must either be financially strong enough to move the project through development or be able to attract a partner to help them do that.

“We believe that there are a number of promising candidate stem cell therapies in the research pipeline that are ready for clinical trials,” says Ingrid Caras, a Science Officer at CIRM. “However, trials can be expensive. This Strategic Partnership Awards initiative helps smooth out the path to clinical trials by spreading the cost between CIRM and pharmaceutical or biotech companies”

More information on the initiative can be found here: http://www.cirm.ca.gov/RFA/rfa-12-05-cirm-strategic-partnership-i-awards

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

According to Zack’s report on the topic, the key takeaway points were:

• The deal immediately boosts PBIO’s balance sheet. As of December 31, 2011, PBIO had cash of $223,000, and in February, 2012, PBIO closed on an $800,000 private placement. With current financing, the Company should have cash of about $0.7 million at hand right now.
• This transaction is favorable to PBIO. The conversion price of $1.02 is a premium of 64.5% over the then share price of $0.62 with no warrants and no restrictive provisions. This is unusual since most financing for small cap biotech companies are toxic and diluting to existing shareholders. This validates PBIO’s technology and its commercial potential.
• The relationship could be “the beginning of a long and mutually beneficial partnership” as Ironridge said in the press release. The Fund is not in the habit of doing bridge financings.  There is a good chance that PBIO might be looking to go back to the Fund for additional funding.

To read the entire press release, click on the following link:
http://finance.yahoo.com/news/pressure-biosciences-landed-favorable-financing-135525739.html

About Pressure BioSciences

Pressure BioSciences, Inc. (“PBI”) (OTCQB:PBIO.PK) is focused on the development, marketing, and sale of proprietary laboratory instrumentation and associated consumables based on Pressure Cycling Technology (“PCT”). PCT is a patented, enabling technology platform with multiple applications in the estimated $6 billion life sciences sample preparation market. PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels to control bio-molecular interactions. PBI currently focuses its efforts on the development and sale of PCT-enhanced sample preparation systems (instruments and consumables) for mass spectrometry, biomarker discovery, bio-therapeutics characterization, vaccine development, soil and plant biology, forensics, histology, and counter-bioterror applications.

Please sign the petition for Advancing Breakthrough Therapies for Patients Act of 2012. The petition can be found here.http://www.change.org/petitions/the-fda-fast-track-the-evaluation-and-approval-of-breakthrough-treatments 

After signing the petition, you can ask your friends on Facebook to sign the petition as well!  Please continue on and contact your elected leader in your home state and ask them to vote in support of the Advancing Breakthrough Therapies for Patients Act of 2012 and also Stem Cell Research ACT of 2012 http://investorstemcell.com/forum/advocacy.php

According to experts, it is now taking 15-20 years from drug concept to NDA filing and hundreds of millions of dollars to commercialize a drug. The leader in RegMed calling it quits last year is a wake up call for all of us. GREAT companies like Geron are forced to make tough choices when balancing ROI and staying afloat for the long term.

It is imperative to balance safety and scientific due diligence during the drug approval process. However, for those suffering from terminal disease, 15-20 years is a death sentence. The FDA has served the world very well since June 30, 1906. It is time to give the FDA 21st Century tools and procedures. Many suffering with disease are turning to the internet for treatments. A majority of these treatment centers are focused on the financial aspects of treatment and not the WHO standards of patient protocol.

I am of the opinion that the possible demise of our society will not come from a terrorist hand or some global calamity. It will come from our out of date and broken healthcare model that was never set up to serve 7 billion people.  Right now, we have Phase II/III cellular therapeutic drugs that can heal damaged hearts, cellular PAD drugs that are reversing the need for amputation and ALS cellular treatments improving breathing/swallowing in late stage sufferers just to name a few examples.  It is time to make the FDA a partner in healthcare.

PLEASE do your part today for mankind and take 120 seconds to

1) fill out the petition 2) Post to Facebook/Twitter 3) Email elected representatives. 4) Forward this email

Link to legislation http://www.govtrack.us/congress/bills/112/s2236/text

Fighting a Common Problem in Hospitals

Many people can name a friend or family member that has had pneumonia or sepsis. These are two of the most common hospital acquired infections (HAIs) that lead to nearly 100,000 U.S. patient deaths per year. In addition to the lives at stake, these infections cost some $8.1 billion each year in added costs that come in addition to the $20 billion in costs fighting other bugs.

Accelr8’s primary focus is on the development of BACcel™ – a patented technology designed to rapidly identify bacteria directly from specimen samples in as little as two hours. In intensive care units of hospitals, this technology can be used to reduce the time it takes to find the right drugs to treat HAIs and highly drug-resistant “superbugs” from days to hours.

BACcel™ Technology Garners Publicity

Within the scientific community, BACcel™ gained notoriety after Accelr8 presented at the 51^st ICAAC conference in Chicago last September and received an award. The presentation centered on a 53 patient study wherein the company’s technology correctly identified 100% of the Staphylococcus aureus (“Staph”) and Pseudomonas aeruginosa bacteria directly from specimen samples in just hours instead of days.

The ICAAC is the premiere conference on antimicrobial agents and infectious diseases, showcasing the research from around the world. With over 60% of its attendees  from overseas, the conference provides a rare opportunity where thought leaders in the field meet and reach over 10,000 physicians, clinical microbiologists, researchers and pharmacists.

Solid Business Model Underlying BACcel™

Accelr8’s technology may be in development now, but once a commercialization partner is signed, there’s a great business to be generated. By selling both an instrument and a disposable cassette, the company has developed a razor-razorblade model that could generate both upfront and recurring revenues over the long-term.

The technology can also be used in a number of vertical markets, including bioterrorism and pharmaceutical development. For instance, pharmaceutical companies can use the BACcel™ platform to screen patients in order to ensure they have the right bug that the pharmaceutical is designed to treat, thereby strengthening the statistics and shortening clinical trials.

A Great Investment Opportunity

Accelr8 Technology Corporation (AMEX: AXK) represents a great investment opportunity at its current levels. With a unique technology on the verge of commercialization, the company could be ready to generate significant long-term value for its shareholders.

For more information, please see the following resources:

• Company Website
• Company Fact Sheet
• Recent SEC Filings

VistaGen will be utilizing the licensed technology to develop hematopoietic precursor stem cells from human pluripotent stem cells, with the goal of developing drug screening and cell therapy applications for human blood system disorders. The breakthrough technology is included in a new United States patent application.

Hematopoietic precursor stem cells give rise to all red and white blood cells and platelets in the body. VistaGen will use the UHN invention to improve the cell culture methods used to efficiently produce hematopoietic stem cell populations.

“This technology dramatically advances our ability to produce and purify this important blood stem cell precursor for both in vitro drug screening and in vivo cell therapy applications,” said H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer.

“In addition to defining new cell culture methods for our use, the technology describes the surface characteristics of stem cell-derived adult hematopoietic stem cells. Most groups study embryonic blood development from stem cells, but, for the first time, we are able to not only purify the stem cell-derived precursor of all adult hematopoietic cells, but also pinpoint the precise timing when adult blood cell differentiation takes place in these cultures,” Snodgrass added. “It is our belief that these early cells will be the precursors of the ultimate adult, bone marrow-repopulating hematopoietic stem cells.”

Bone marrow-derived hematopoietic stem cells are able to repopulate the blood and immune system when transplanted into patients prepared for bone marrow transplantation. These cells have important potential therapeutic applications for the restoration of healthy blood and immune systems in individuals undergoing transplantation therapies for cancer, organ grafts, HIV infections or for acquired or genetic blood and immune deficiencies.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen’s drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen’s small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson’s disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGenor view VistaGen’s Facebook page at http://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen’s ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen’s stem cell technology-based Human Clinical Trial in a Test Tube™ platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen’s research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

OxySure Revolutionizes Oxygen Delivery

OxySure Systems is initially focused on the commercialization of a lightweight, portable emergency oxygen system designed for lay person use, known as the OxySure Model 615. This is the only product on the market that can be safely pre-positioned in public and private venues for emergency administration of medical oxygen by laypersons without the need for training.

The Model 615 uses a simple, one-step activation using a dispenser that includes a self-contained, disposable cartridge. With the oxygen being generated from the mixture of two powders, the product is both extremely easy to use and non-explosive. In December of 2005, the U.S. Food and Drug Administration (FDA) cleared the Model 615 as a Class II 510(K) device.

Finally, investors may appreciate that the company’s Model 615 includes disposable cartridges, which can result in recurring revenues over time. In fact, management has indicated that these disposable cartridge revenues are coming in far stronger than originally projected. As a result, this could become a second high margin revenue stream moving forward.

OxySure Targets Enormous End Markets

OxySure’s Model 615 is designed to bridge the gap between the onset of a medical emergency and the time first responders arrive on the scene. It’s intended to allow a lay rescuer – such as a bystander or loved one – to administer oxygen during those first, critical minutes after an emergency occurs, potentially improving medical outcomes and saving lives.

Initially, the company is targeting K-12 educational facilities, colleges, churches, restaurants, and manufacturing facilities with its products. With approximately 102,265 educational campuses, 350,000 churches, 950,000 restaurants and 350,735 manufacturing facilities in the U.S., these end markets are capable of generating significant upfront and recurring revenues, with a disposable product that must be replenished after use, or upon the 2-year expiry, whichever happens sooner.

In the future, the company plans to target additional end markets including recreational vehicles, OSHA compliant buildings, government buildings, municipalities, and other institutional emergency preparedness markets, as well as “at risk” markets such as people with COPD, people with cardiovascular disease, and people with asthma. Combined, these markets encompass millions of buyers in the U.S. alone and countless more worldwide.

Vertical markets beyond Model 615

OxySure’s platform technology also lends itself well to the development of much-needed solutions for additional vertical markets such as aviation, mining, wound care, and sports & recreation. These vertical markets represent new frontiers for the company in the future, and the development effort related to some of these opportunities is well under way.

A Great Investment Opportunity

OxySure represents a great investment opportunity at its current levels. With a market capitalization of just around $40 million, the company trades at a fraction of its potential if its products are successfully deployed in the market. The stock could therefore benefit from ongoing sales increases, as well as the potential M&A opportunities.

For more information, please see the following resources:

• Company Website
• Recent SEC Filings

Diabetic foot ulcers (DFUs) are the most common foot injuries leading to lower extremity amputation, occurring in 15 percent of patients with diabetes and preceding 84 percent of all lower leg amputations.  Globally, 366 million people currently have diabetes with that number expected to mushroom to more than 550 million (10% of the world’s population) by 2030, according to the International Diabetes Federation.  At a 15% clip, that will put the number of people suffering from the ulcers at more than 20 million.  The vast majority of diabetic foot complications resulting in amputation begin with the formation of skin ulcers. In these cases it is difficult to repair and rebuild the lost extracellular matrix (ECM) because diabetes mellitus is a metabolic disorder that impedes normal healing that would be seen in a non-diabetes patient.  This is where Cytomedix, a leader in the commercialization of innovative autologous therapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells, offers a revolutionary technology that outstrips current wound care therapies and provides a convenient and cost-effective new approach.

The company’s PRP (Platelet Rich Plasma)-based AutoloGel™ System revitalizes a patient’s natural healing processes by delivering a topical gel containing growth factors, cytokines and chemokines for cell growth and formation of new tissue.  According to the Cytomedix website, “By delivering both fibrin matrix and platelet releasate to the chronic wound bed, the AutoloGel System re-establishes the natural balance the body needs to escape the inflammatory phase so restoring the natural healing process.”

A prospective, randomized, controlled trial sponsored by Cytomedix demonstrated both safety and efficacy of AutoloGel with 81.3% of wounds in the majority DFU wound size group fully healing as compared to 42.1% in the control group which received a saline gel therapy.  Additional positive data on the AutoloGel System was recently published in a feature article in the April 2012 issue of Ostomy Wound Management showing that in 39 limb salvage patients in Japan, 83% of the wounds progressed to complete healing  in an average of 145.2 days (p=0.00002) using an average of 6.1 AutoloGel treatments.

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Importantly, Cytomedix is awaiting a May 9, 2012 decision from the Centers for Medicare & Medicaid Services (CMS) on reimbursement coverage of the AutoloGel System.  Medicare covers nearly 11 million people with diabetes currently and, traditionally, private insurers will follow the path set forth by CMS in supporting insured treatments.  With approximately 26 million diabetes patients diagnosed in the U.S., sales could catapult ahead for Cytomedix if CMS begins covering AutoloGel.

Clearly, the diabetes population alone could provide a solid backbone for exponential growth for Cytomedix, but it is only a portion of what the company has to offer.  For brevity’s sake, this article has only focused on the massive potential of AutoloGel in the diabetes arena.  Cytomedix’s PRP technology has multiple uses in wound therapy outside of just DFUs and the company’s portfolio covers a wide array of regenerative therapies that are already generating meaningful revenue.  The company has recently completed the acquisition of Aldagen and their robust and differentiated pipeline of regenerative cell therapies.  The newly acquired “ALDH Bright Cell” technology has been shown to be a marker of a cell’s ability to grow.  In other words, it can differentiate, identify and measure the vitality of cells to determine which are highly metabolic to facilitate the growth of new tissue.

Regenerative medicine has become a busy space with numerous companies looking to answer the question, “What is going to be the best therapy across several applications?”  With its wide spectrum covering wound therapy, angiogenesis (which can be used for several types of ischemia and multiple other indications) and inflammation treatments, Cytomedix is answering that question.  It’s uniquely positioned and stands head-and-shoulders above most other OTC biotechnology companies as it already has commercial products in the marketplace generating revenues as it relentlessly pursues advancement of its other proprietary products.

For more information, please see the following resources:

• Company Website
• Recent SEC Filings

Cardium Therapeutics (NYSE Amex: CXM) has announced that its MedPodium Nutra-Apps® products are now available on RonnieColemanNutrition.com.

The MedPodium line, which features a pharmaceutical-type design that many young consumers identify well with, includes easy-to-use dietary supplements developed for active young professionals. The brand is distributed across the United States by Nutritional Products International (NPI), a leading nutraceutical firm.

“We are very pleased to announce that our MedPodium Nutra-Apps products will now be available directly to consumers on Ronnie ColemanNutrition.com,” said Hanna Wagari, Director of Marketing for Cardium Therapeutics. “This website features the world’s top supplements and nutritional products, and we are proud to be a part of it. This means that more active professionals will have access to our innovative line.”

The MedPodium line includes Nutra-Apps’ Neo-Carb Bloc® for weight management and Neo-Energy® for enhanced performance, both available in small, sealed capsules with convenient packaging that allows them to fit into any purse or pocket. With scientifically validated ingredients at the clinically studied amounts for efficacy, the supplements are positioned as “impulse buy” counter items for on-the-go consumers.

RonnieColemanNutrition.com features over 170 name-brand supplements and thousands of sports nutrition products for body builders, athletes and those who simply want to get in better shape and build muscle. The company was started by Coleman, the eight-time winner of the Mr. Olympia body building competition and spokesperson for a number of the top supplements around the world.

“The MedPodium Nutra-Apps line is truly unique in that it gives young, active professionals the vitamins and nutrients they need to perform at their best on a daily basis,” said Brian Gould, Director of Operations for NPI. “These products mesh perfectly with the categories offered at Ronnie Coleman Nutrition.”

NPI (http://www.nutricompany.com) is a leading nutraceutical and cosmeceutical firm that provides sales and distribution services for worldwide brands. The company specializes in working with key buyers, providing a fast track to the world’s most important market—the United States.

To learn more about the MedPodium line, please visit http://www.medpodium.com.