BioStem Technologies has launched a significant clinical trial to evaluate its innovative placental-derived product Vendaje® for treating diabetic foot ulcers, marking a major step forward in advanced wound care development. The study, designated as BR-AM-DFU (BioREtain® Amniotic Membrane - Diabetic Foot Ulcers), will compare the efficacy of Vendaje® against current standard of care treatments.
The trial initiation comes amid strong commercial performance for the Pompano Beach-based MedTech company. BioStem reported preliminary fourth-quarter 2024 net revenue of $102.9 million, contributing to an expected full-year revenue of $301.8 million. This financial growth underscores the market's increasing adoption of the company's advanced wound care solutions.
Clinical Trial Design and Objectives
The BR-AM-DFU study represents a strategic initiative to demonstrate the superior wound healing capabilities of Vendaje® in treating diabetic foot ulcers. This head-to-head comparison against standard care treatments aims to generate compelling clinical evidence to support expanded market access and insurance coverage.
The trial builds upon promising preliminary data. A recent retrospective study published in the International Wound Journal demonstrated breakthrough results for BioStem's BioREtain® technology in treating treatment-resistant chronic wounds, providing a strong foundation for the current prospective trial.
Technology and Patent Protection
Supporting its clinical development program, BioStem recently received a Notice of Allowance from the USPTO for its patent application covering sterile human placental allografts. This marks the company's first patent in the fenestrated wound care market, strengthening its intellectual property portfolio and market position.
The company's proprietary BioREtain® processing technology is central to its product development strategy, designed to harness the natural regenerative properties of placental tissue for advanced wound healing applications.
Commercial Expansion
BioStem has also achieved significant commercial milestones, including establishing national pricing for Vendaje AC® through the Center for Medicare Services, enabling reimbursement across all Medicare Administrative Contractor (MAC) regions. This development facilitates a nationwide launch through the company's partnership with Venture Medical.
Jason Matuszewski, CEO of BioStem Technologies, has been actively presenting these developments at major industry conferences, including Biotech Showcase 2025 and the LD Micro Main Event XVII, highlighting the company's growth trajectory and market expansion strategies.
Market Impact and Future Outlook
The combination of robust clinical development, strong patent protection, and expanding commercial infrastructure positions BioStem Technologies for continued growth in the advanced wound care market. The company has also initiated the process for uplisting to Nasdaq, filing a Form 10 registration statement with the SEC, which could provide increased market visibility and liquidity opportunities.
As the company advances its clinical and commercial initiatives, the focus remains on developing effective regenerative medicine solutions for chronic wound care, supported by scientific evidence and strategic market expansion.
