MIRAMAR, Fla., June 26, 2019 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (www.generex.com) (GNBT) (https://www.otcmarkets.com/stock/GNBT/quote), announced today that their subsidiary, Olaregen Therapeutix, Inc., received the prestigious “Seal of Approval” from the American Podiatric Medical Association (APMA) for their Cellular Tissue Product, Excellagen Wound Conforming Matrix. Founded in 1912, the APMA is the leading resource for foot and ankle health information. Currently, the organization represents a vast majority of the estimated 18,000 podiatrists in the U.S.
The APMA Seal of Approval/Acceptance Program evaluates the use of therapeutic agents and their adjuncts (pharmaceuticals) and regulated medical devices. The seal is granted to a product after the Podiatric Seals Committee, a standing committee of the American Podiatric Medical Association, evaluates and determines whether the product allows normal foot function and promotes quality foot health. Additionally, evidence of usefulness and safety must be established, either by an appropriately recognized laboratory or clinical investigation, or by the products meeting certain physical standards. A detailed review is conducted by each committee member on every product. The committee then sends its recommendation to the APMA Board of Trustees, which has the authorization to either accept or reject the recommendation.
Excellagen is an FDA- 510(k) cleared Cellular Tissue Product with an indication for the management of wounds including Diabetic Foot Ulcers. Excellagen is a ready to use 3-dimensional wound conforming matrix that supports a favorable wound healing environment. It is designed to accelerate granulation tissue growth by providing a structural scaffold for cellular migration and proliferation, and activates platelets, triggering the localized release of endogenous growth factors including Platelet-Derived Growth Factor (PDGF), a key biological mediator of wound healing.
Joe Moscato, CEO of Generex commented, “Receiving the “APMA Seal of Approval” is tremendous news for our subsidiary, Olaregen Therapeutix. The process for receiving the seal is a rigorous evaluation of clinical utility and value, so our customers can feel confident in choosing Excellagen to manage their hard to heal wounds knowing that our best in class product meets the high standards set by the APMA. In addition, this is a great affiliation with the APMA, and we look forward to working with them and all APMA member surgeons and podiatrists to help manage their diabetic foot ulcers using Excellagen. I would love to hear from APMA members about their experience in the use of Excellagen in managing their patients hard to heal wounds.”
Anthony Dolisi, CEO of Olaregen Therapeutix commented, “Our customers include surgeons, patients, their caregivers and payors. The APMA Seal of Approval strengthens our value with our customer base. With demonstrated superior clinical data and strong economic value, the seal adds additional reason on why we believe Excellagen will be a disruptive technology in the Regenerative Wound Care Market. Equally as important is the impact Excellagen makes on patients with hard to heal wounds that are difficult to manage causing a poor quality of life.”
About Generex Biotechnology Corporation
Generex Biotechnology Corporation 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 immuno‐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. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.
Our newly formed, wholly‐owned subsidiary, NuGenerex Distribution Solutions (NDS), integrates our MSO network with a pharmacy network, clinical diagnostic lab, durable medical equipment company (DME‐IQ) and dedicated call center.
Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.
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.