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..
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