Regenity Biosciences Receives Regulatory Approval for Collagen Dental Membrane in China After First-of-its-Kind Breakthrough Clinical Study
Multicenter Clinical Study Demonstrates Benefits of Regenity's Novel Crosslinked Collagen Membrane Compared to Geistlich Bio-Gide® Collagen Membrane and Enables Launch into China
PARAMUS, N.J., Sept. 4, 2024 /PRNewswire/ -- Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced it has received regulatory approval from the NMPA of China for its novel crosslinked bioresorbable, implantable collagen dental membrane intended for use in oral surgical procedures. This approval denotes the company's first Chinese dental product approval and is coupled with a Level 1 randomized clinical study to showcase its efficacy, marking the first-ever head-to-head clinical study comparing Regenity dental membranes to Geistlich dental membranes in the Chinese market.
The Regenity novel crosslinked membrane (Matrixflex™) was evaluated in a 6-month multicenter randomized controlled trial with 174 patients in six major hospitals throughout China that examined and compared the results of bone grafting and guided tissue regeneration (GTR) with the Geistlich non-crosslinked Bio-Gide® Collagen Membrane. The study is innovative based upon the large number of patients enrolled and offers a unique perspective by directly comparing the results of bone grafting and guided tissue regeneration in dental surgery using crosslinked and non-crosslinked collagen membranes of the same tissue source.
The study concluded the Matrixflex™ resorbable membrane is a safe and effective treatment option for periodontal intrabony defects. In addition, patients who received the Matrixflex™ membrane had a higher percentage of sites that achieved scores of "significant effect" in measurements of improved periodontal pocket depth, increased clinical attachment level, and improved hard tissue density, when compared to the Geistlich Bio-Gide® membrane. These measurements reflect the effectiveness of periodontal regenerative treatments and reinforce the benefits derived from the Matrixflex™ novel crosslinked design, which include biocompatibility, conformability, high suture pullout strength, and long barrier function.
"This unique study data demonstrates that our Matrixflex™ membrane, already a leading membrane in the United States and Europe, facilitates significant tissue integration and improved wound healing after dental procedures," said Shawn McCarthy, CEO of Regenity Biosciences. "Representing our third product launch of the year and adding to our regenerative product offerings in China, we plan to continue delivering innovation for the medical community alongside our partners on our mission to improve more patient lives worldwide."
Matrixflex™ is a porcine-derived, crosslinked collagen membrane, which facilitates guided bone regeneration around dental implants and periodontal regeneration around teeth. The membrane is biocompatible, resorbable and provides a natural scaffold for cellular activities. Through a novel crosslinking method, Regenity has proven that crosslinking is safe and effective, and can provide better results than non-crosslinked products, allowing for enhanced mechanical stability and predictable degradation time.
Periodontal disease, a leading cause of adult tooth loss, damages bone and gum tissue. The Matrixflex™ regenerative membrane supports growth of new bone and tissue, reducing pocket depth and improving oral health. This barrier membrane technique prevents or delays the need for dental implants and helps preserve natural teeth.
The market potential for dental membranes in China is significant based on growing demand for dental care services and implants. The market for dental implants in China is expected to reach $586M by 20291, with membranes utilized in the majority of these procedures. Regenity will commercialize the membrane in China through partnerships via its private brand B2B business model.
About Regenity Biosciences
Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey and Groningen, the Netherlands. Regenity's product portfolio includes a variety of collagen-based and synthetic polymer solutions that support the company's platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services. For more information, please visit www.regenity.com.
- Markets + Markets Dental Implants + Prosthetics Market Analysis, 2024
SOURCE Regenity Biosciences
Share this article