BioLife, Shire, Others Turning Regenerative Medicine Industry from Gravel Road to Paved Street

The industry can be broadly called regenerative medicine, life sciences, biologics, stem cells and more. Regardless of the name, it is ubiquitously recognized as a space that is really starting to get its legs under it. What that leaves for investors is a significant opportunity in a burgeoning industry as there is a quickly growing field of leaders with solid upside potential that are still trending at prices that could be construed as undervalued. Some may not look favorably on biologics and focus on Geron (NASDAQ: GERN) discontinuing its stem cell trials without giving clear thought to all the hurdles that the company faced with the very limited scope of their trial to get target patients. Although that trial ceased, it was a ribbon-cutting-type of milestone for the industry and should be recognized as such.

Advanced Cell Technology (OTCBB: ACTC), the second company to ever receive FDA approval for stem cell-related clinical trials, has demonstrated safety using its human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells for the treatment of Stargardt’s macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD).

Shares of Regenicin, Inc. (OTCBB: RGIN) got a lift this week as the junior biotech said that the FDA granted Orphan Status approval for its PermaDerm® product, the only tissue-engineered skin prepared from patient’s own (autologous) skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients. Regenicin’s technology can harvest a small section of the patient’s skin and grow it in as little as one month to graft an area 100 times larger. Being autologous, the body’s immune system tends to not reject the graft as is common with today’s porcine or cadaver skin graft treatments. The FDA had previously designated PermaDerm® to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement). PermaDerm® is the only skin replacement technology to receive this Biological/drug designation.

Also in the news this week, global specialty biotech Shire plc (LSE: SHP, NASDAQ: SHPGY), said that its Regenerative Medicine business, Advanced BioHealing, Inc., has entered into a lease agreement with BioMed Realty Trust, Inc. An industry leader, the move will allow Advanced BioHealing to further expand its operational footprint and presence in the San Diego, California area, including meeting future demand for its lead product, Dermagraft®, a cryopreserved human fibroblast-derived dermal substitute, approved by the FDA for the treatment of diabetic foot ulcers.

A truly compelling company that is blossoming with the industry knows many of the others in the regenerative medicine space quite well as clients, not competition, which can increase its upside potential. BioLife Solutions Inc. (OTCBB: BLFS) develops, manufactures and markets patented hypothermic storage and cryopreservation solutions for cells and tissues. The company has three proprietary products, HypoThermosol®, BloodStor® and CryoStor® on the market today and generating revenue through sales to academic and commercial organizations involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing.

The company’s clinical-grade biopreservation media products provide these organizations with superior technology across a broad range of applications ranging from traditional bone-marrow stem-cell transplants to the banking of newborn umbilical cord blood. Hypothermic storage or freezing is used to reduce metabolism of precious biologic source material, such as cells and tissues, once they are removed from the body.

Now posting seven straight quarters of growing revenue with Q1 2012 revenue topping $830,000, the company is in the midst of expanding their corporate offices and production facility. The expansions should be reflected in future financial reports. As the company stated in a May 14, 2012 press release, “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.”

A member of the Alliance for Regenerative Medicine (ARM), BioLife Solutions is front and center with its offerings in the industry while advocating for the advancement regenerative medicine along with its peers. The company currently works with market leader Lonza and other members of ARM.

The regenerative medicine industry is bursting with opportunities as the field is truly gaining traction and making substantial headway after years of delineating many boundaries and practices akin to the way traditional biotechnology found its footing many years earlier. Similar to legacy-type biotechs, regenerative medicine plays carry high risk/reward characteristics, but as a reasonable hedge to the risk, BioLife Solutions has particular appeal because of its broad value to the industry as a whole. It would seem fair to say the as the industry grows, so grows BioLife.

For more information please see the following resources:

- Company Website
- Recent SEC Filings
- Corporate Overview