Regenity Biosciences, a global leader in regenerative medicine and a Linden Capital Partners portfolio company, has announced that it has received regulatory approval from the National Medical Products Administration (NMPA) of China for its novel crosslinked bioresorbable, implantable collagen dental membrane. This membrane is intended for use in oral surgical procedures and marks the company’s first Chinese dental product approval.
The approval is coupled with a Level 1 randomized clinical study, which is the first-ever head-to-head clinical study comparing Regenity dental membranes to Geistlich dental membranes in the Chinese market. The study aimed to showcase the efficacy of Regenity’s novel crosslinked membrane, known as Matrixflex.
The Matrixflex membrane was evaluated in a 6-month multicenter randomized controlled trial involving 174 patients across six major hospitals in China. The study compared the results of bone grafting and guided tissue regeneration (GTR) using the Matrixflex membrane against the Geistlich non-crosslinked Bio-Gide Collagen Membrane.
This study is notable for its large patient enrollment and its direct comparison of crosslinked and non-crosslinked collagen membranes derived from the same tissue source.
The study concluded that the Matrixflex resorbable membrane is a safe and effective treatment option for periodontal intrabony defects.
Patients who received the Matrixflex membrane showed a higher percentage of sites achieving scores of “significant effect” in measurements of improved periodontal pocket depth, increased clinical attachment level, and improved hard tissue density compared to those treated with the Geistlich Bio-Gide membrane. These findings highlight the effectiveness of the Matrixflex membrane in periodontal regenerative treatments and underscore its advantages, including biocompatibility, conformability, high suture pullout strength, and extended barrier function.
Shawn McCarthy, CEO of Regenity Biosciences, stated, “This unique study data demonstrates that our Matrixflex membrane, already a leading product in the United States and Europe, promotes significant tissue integration and enhances wound healing after dental procedures. This launch marks our third product introduction this year and expands our regenerative offerings in China. We are committed to continuing our mission of delivering innovative solutions to improve patient outcomes globally.”
Matrixflex is a porcine-derived, crosslinked collagen membrane that aids in guided bone regeneration around dental implants and supports periodontal regeneration around teeth. The membrane is biocompatible, resorbable, and provides a natural scaffold for cellular activities. Regenity’s novel crosslinking method has proven that this technique is both safe and effective, offering better results than non-crosslinked products by providing enhanced mechanical stability and predictable degradation times.
The market potential for dental membranes in China is substantial, driven by the increasing demand for dental care services and implants.
The market for dental implants in China is projected to reach $586 million by 2029, with membranes being utilized in the majority of these procedures. Regenity plans to commercialize the Matrixflex membrane in China through partnerships, leveraging its private brand B2B business model.