• A Hybrid Approach for Vascular Control and Repair of an Expanding Iatrogenic Femoral Artery Pseudoaneurysm
  • J. Gorecka, J.F Chen, S. Shah, A. Dardik, R.J Guzman, N. Nassiri, Journal of Vascular Surgery Cases and Innovative Techniques (July 18, 2020), doi: https://doi.org/10.1016/j.jvscit.2020.07.010

MIRAMAR, Fla., Aug. 13, 2020 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) is pleased to  announce that physicians at Yale University School of Medicine and the VA Connecticut Healthcare System have published a paper in the Journal of Vascular Surgery Cases and Innovative Techniques describing the use of Excellagen® wound conforming collagen matrix as part of a hybrid surgical protocol to repair a femoral artery pseudoaneurysm. Femoral artery pseudoaneurysms are the most common complication following cardiac and peripheral angiographic procedures, with an incidence ranging from 2-6% following interventional procedures. A pseudoaneurysm occurs when a blood vessel wall is injured and the leaking blood collects in the surrounding tissue. While small pseudoaneurysms (< 2 cm) often thrombose (clot) spontaneously, larger pseudoaneurysms involving blood sac expansion, vascular symptoms, and surrounding hematoma confer a risk of rupture and warrant surgical intervention to prevent serious complications including death.

Naiem Nassiri, MD of Yale University School of Medicine commented, “Excellagen’s purity, versatility, and user-friendly application render it ideal for a diverse array of indications for collagen delivery in vascular surgery. For us to date, these have included, but are not limited to re-explored wounds; topical hemostatic agent by virtue of dead space elimination and granulation tissue formation; a regular adjunct to negative pressure dressings; a precursor to skin grafting; and topical applications in cosmetically sensitive areas following embolotherapeutic procedures.”

Rapid healing of the vascular surgical repair site is needed to prevent recurrence or progression of the pseudoaneurysm. Using Excellagen from Generex’s subsidiary, Olaregen Therapeutix, the surgeons at Yale and the Connecticut VA demonstrated a simple, safe and effective approach to pseudoaneurysm repair. The novel hybrid technique avoided surgical exploration in the face of active hemorrhage, expedited culprit vessel identification, avoided the need for remote percutaneous arterial puncture, reduced blood loss, and minimized overall operative time.

Excellagen is a ready to use 3-dimensional wound conforming matrix that supports a favorable wound healing environment. It is designed to activate collagen, accelerate granulation, and promote new tissue growth by providing a structural scaffold for cellular migration and proliferation. Excellagen has been shown to trigger the localized release of endogenous growth factors including Platelet-Derived Growth Factor (PDGF), a key biological mediator of wound healing.

Anthony Dolisi, CEO of Olaregen commented, “We have been working closely with the VA system using case studies to evaluate the use of Excellagen in numerous wound management applications, including diabetic foot ulcers and vascular surgery procedures. As this peer-reviewed publication demonstrates, Excellagen can be used successfully in complex vascular surgeries like pseudoaneurysm repair to promote healing that lead to better patient outcomes. We look forward to engaging with the VA and the vascular surgery community to introduce our FDA-cleared cellular tissue product Excellagen into their surgical protocols for the benefit of patients with life-threatening conditions.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital.

About Olaregen Therapeutics

Olaregen Therapeutix, Inc. is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the current wound care market. The company aims to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care. Olaregen’s first product introduction, Excellagen (flowable dermal matrix) is a topically applied product for dermal wounds and other indications. Excellagen is a FDA 510K cleared device for a broad array of dermal wounds, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds, enabling Olaregen to market Excellagen in multiple vertical markets. in bone and joint regeneration comprise the current pipeline. The company’s mission is to become a significant force in regenerative medicine and advance the science of healing.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato

Todd Falls
1-800-391-6755 Extension 222


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