Regenity Biosciences, a New Jersey-based global leader in regenerative medicine and a portfolio company of Linden Capital Partners, announced on Sept. 4 that it has received regulatory approval from China’s National Medical Products Administration (NMPA) for its novel crosslinked bioresorbable collagen dental membrane, designed for use in oral surgical procedures.
First Product Approved in China
This approval, the first for Regenity Biosciences in China, was granted following a comprehensive clinical trial involving 174 patients across six major hospitals. The study evaluated Regenity’s Matrixflex membrane in a six-month multicenter randomized controlled trial, comparing the results of bone grafting and guided tissue regeneration (GTR) using Geistlich’s non-crosslinked Bio-Gide Collagen Membrane.
The study is notable for its large patient enrollment and its unique perspective by directly comparing the efficacy of crosslinked and non-crosslinked collagen membranes derived from the same tissue source in dental surgery.
“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.
“As our third product launch this year and an addition to our regenerative product offerings in China, we aim to continue delivering innovation for the medical community alongside our partners, in line with our mission to improve patient outcomes worldwide.”
$586M Market Potential
The market for dental membranes in China is expected to be significant, driven by increasing demand for dental care services and implants. The dental implant market in China is projected to reach $586 million by 2029, with membranes used in the majority of these procedures. Regenity plans to commercialize the membrane through partnerships under its private brand B2B business model.
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