BioStem Receives IRB Approval for Clinical Study to Evaluate Vendaje(R) in Diabetic Foot Ulcers

BioStem's Breakthrough: IRB Approval Granted for Diabetic Foot Ulcer Study with Vendaje(R)

BioStem Technologies Inc., a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental derived biologics for advanced wound care, announced that the approval of an Investigational Review Board (IRB) sanctioned clinical study. This study aims to investigate the utilization and effects of Vendaje in diabetic patients suffering from foot ulcers.

"This is a landmark study for us," said Jason Matuszewski, Chief Executive Officer of BioStem. "Our proprietary BioREtain® process is truly special in that it is minimally invasive and gentle on tissue, which results in the natural components inherent in placental tissue to be maintained and available to help heal difficult wounds.

"We have already demonstrated scientifically that our process and product is exceptional. This study will enhance our scientific understanding with meaningful real-world results, providing critical data necessary for acceptance by the medical community and significantly improving the care and quality of life for people with diabetes at risk of amputation due to foot ulcers," said Matuszewski.

Diabetic Foot Ulcers are a significant risk for people with diabetes. According to the American Podiatric Medical Association (APMA), a leading resource for foot and ankle health, approximately 15 percent of people with diabetes develop foot ulcers. Of those 15 percent, six percent go on to be hospitalized due to infection or other ulcer-related complications. The risk to patients with diabetes is significant, as it is the leading cause of lower extremity amputations in the U.S. Approximately 14 to 24 percent of people with diabetes that develop foot ulcers will require an amputation.

Vendaje is a placental-derived, minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds. Composed of the amnion layer of the placenta, Vendaje naturally possesses extracellular matrix scaffolding that provides mechanical protection and functional support for cell attachment, growth factors that help modulate proliferation and angiogenesis, and anti-inflammatory cytokines that inhibit inflammatory effects, all critical in aiding the body's natural healing cascade.

Published on : 27th September, 2023