Generex Biotechnology Subsidiary Olaregen Therapeutix Receives American Podiatry Medical Associations “Seal of Approval” for Excellagen Wound Conforming Matrix
9:00 AM ET, 06/26/2019 - GlobeNewswire
MIRAMAR, Fla., June 26, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (GNBT) (http://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.”
9:00 AM ET, 06/26/2019 - GlobeNewswire
MIRAMAR, Fla., June 26, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (GNBT) (http://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.”
