BioStem Opens First Clinical Site in Diabetic Foot Ulcer Study
Leading regenerative medicine company, BioStem Technologies (OTC: BSEM) has opened the first site and commenced patient recruitment for its clinical trial, which will evaluate the company’s Vendaje® tissue allograft in the treatment of diabetic foot ulcers (DFU). BioStem anticipates that four additional sites will be operational in the forthcoming months.
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.”
Highlights
BioStem’s clinical study is an opportunity for the company to showcase the effectiveness of its products in a real-world clinical setting while also substantiating the distinctive advantages of its BioREtain process.
The company’s Vendaje allografts provide 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.
Vendaje and AmnioWrap2 are placental-derived, minimally manipulated dehydrated tissue allografts that serve as a protective covering for soft tissue wounds.
Diabetic foot ulcers are a widespread and highly serious complication, impacting around 15 percent of individuals with diabetes.
About BioStem Technologies
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida. For more information, visit biostemtechnologies.com and follow us on Twitter and Linkedin.
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