Regenity Biosciences Gains Approval for Innovative Collagen Dental Membrane in China Following Groundbreaking Clinical Study.
PARAMUS, N.J., Sept. 4, 2024 /PRNewswire/ — Regenity Biosciences, a leader in regenerative medicine and a part of the Linden Capital Partners portfolio, has announced that it has received regulatory approval from the National Medical Products Administration (NMPA) in China for its new crosslinked bioresorbable collagen dental membrane.
This product is designed for use in oral surgical procedures and marks the company’s first dental product approval in China.
The approval follows a significant Level 1 randomized clinical study, which is the first of its kind to compare Regenity’s dental membranes directly with those of Geistlich in the Chinese market. The study focused on the efficacy of the Regenity membrane, known as Matrixflex™, in a multicenter trial involving 174 patients across six major hospitals in China.
The six-month trial compared the outcomes 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 the two types of collagen membranes derived from the same tissue source.
Results from the study indicated that the Matrixflex™ resorbable membrane is a safe and effective option for treating periodontal intrabony defects. Patients who received the Matrixflex™ membrane showed a higher percentage of significant improvements in periodontal pocket depth, clinical attachment levels, and 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, “The data from this unique study shows 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 demonstrated that this technique is both safe and effective, offering better results than non-crosslinked products by providing enhanced mechanical stability and predictable degradation times.
Periodontal disease, a leading cause of tooth loss in adults, damages bone and gum tissue. The Matrixflex™ regenerative membrane encourages the growth of new bone and tissue, reduces pocket depth, and improves overall oral health. This barrier membrane technique can prevent or delay the need for dental implants and helps preserve natural teeth.
The potential market 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.