Study to support differentiated efficacy of Vendaje® structural tissue allograft
October 24, 2023 / BioStem Technologies Inc. (OTC:BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, today announced that the first site is now fully opened for its clinical trial, evaluating the Vendaje® tissue allograft in the treatment of diabetic foot ulcers (DFU).
Jason Matuszewski, Chief Executive Officer of BioStem, said, "This milestone signifies a significant moment in our journey. The initiation of a 100-patient trial not only provides invaluable real-world support for healthcare professionals but also underscores our commitment to deploying Vendaje in the treatment of patients with chronic wounds. Furthermore, it offers a platform to substantiate the inherent advantages of our proprietary BioREtain® process. Patient recruitment has already commenced at our primary site, and we anticipate the remaining four sites will be operational in the forthcoming months."
Diabetic foot ulcers are a widespread and highly serious complication, impacting around 15 percent of individuals with diabetes. Annually, over two million Americans in the U.S. develop diabetic foot ulcers, which are chronic wounds capable of resulting in amputation and, in severe cases, even the loss of a patient's life.
Current standards of care for managing persistent, challenging-to-heal wounds like diabetic foot ulcers often involve absorbable wound dressings. These dressings must create an environment conducive to healing, supporting the development of a structural framework, the growth of new blood vessels (angiogenesis), and the migration of skin cells across the wound bed.
BioStem's Vendaje allografts play a pivotal role by providing a scaffold for tissue healing. They encompass natural growth factors, extracellular matrix components, and anti-inflammatory cytokines known for their support in the body's healing processes. This clinical study is an opportunity for us to showcase the effectiveness of our products in a real-world clinical setting while also substantiating the distinctive advantages of our BioREtain process.
BioStem's structural tissue allograft product portfolio includes VENDAJE®, VENDAJE AC®, VENDAJE OPTIC® and AmnioWrap2TM.