Patent Granted to BioStem Technologies for Sterile Human Placental Allografts

BioStem Technologies Inc. has been awarded a U.S. patent for human placental allografts, specifically those with various slits, openings, and/or fenestrations.

The patent will be used to develop placental allografts for advanced wound care using BioStem’s BioREtain process, which preserves essential natural factors. The allografts using this technology will feature flaps that open to allow exudate to escape without sacrificing surface area, making them suitable for both acute and chronic wound settings. This technology is unique, as there are no other fenestrated allografts on the market that offer the same benefits, according to the company.

“BioStem continues to drive innovation in the wound care space, and we are pleased to enhance our intellectual property portfolio with the issuance of this significant patent,” BioStem Technologies CEO Jason Matuszewski stated. “This is the first and only patent granted for use in tabular fenestrated allografts, which will support our commercial efforts and expands our IP portfolio. With 27 patents pending and 42 issued, BioStem has a strong portfolio across the wound care landscape that will protect the company as we advance in the market.”

A product using this technology is under development and is currently not commercially available and will be introduced using the HCT/P regulatory pathway. Once developed, the new allografts could be used as a protective covering for exudating wounds across the acute or chronic setting, the company said.

BioStem Technologies harnesses the natural properties of perinatal tissue in developing, manufacturing, and commercializing allografts. The company’s proprietary BioREtain processing method—developed by applying the latest research in advanced wound care—focuses 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 and current Good Manufacturing Processes. Its portfolio of quality brands includes AmnioWrap2, VENDAJE, VENDAJE AC, and VENDAJE OPTIC. Each BioStem Technologies placental allograft is processed at the company’s U.S. Food and Drug Administration-registered and AATB accredited site in Pompano Beach, Fla.