Lynch Regenerative Medicine Expands PDGF Portfolio With GEM 21S® Distribution Agreement

Lynch Regenerative Medicine, LLC (LRM) announced a definitive distribution agreement with Lynch Biologics, a Geistlich North America company, to commercialize GEM 21S®, an FDA-approved recombinant human platelet-derived growth factor (rhPDGF-BB) product, to licensed healthcare providers in the United States. The product, originally developed by LRM founder and chief executive officer Samuel Lynch, MD, PhD, is part of a broader portfolio of PDGF-based regenerative therapies.

GEM 21S® joins LRM’s expanding Pure PDGF portfolio, which also includes REGRANEX® (becaplermin) Gel and ariessence pure PDGF+®. According to the company, rhPDGF-BB has been studied extensively, with more than 500 publications and nearly 100 human clinical studies supporting its safety and efficacy. PDGF-BB is described as a naturally occurring protein involved in wound healing and tissue regeneration.

The agreement reflects a strategic expansion rooted in LRM’s historical involvement in the development of PDGF-based therapies. The company stated that its leadership contributed to advancing PDGF-BB from early-stage research to multiple FDA-approved products, with an estimated millions of patients treated over more than two decades.

GEM 21S® is indicated, per its approved labeling, to promote regeneration of periodontal tissues, including connective tissue and bone. The product will be commercialized through LRM Therapeutics, with sales anticipated to begin in the second quarter of 2026. The company also expects to launch REGRANEX® later in 2026, pending operational readiness and regulatory requirements.

"We are pleased to partner with Geistlich, the global leader in oral regeneration, to expand access to GEM 21S^® through this commercial collaboration with LRM, bringing this proven healing solution to new clinicians and patients,” said Samuel Lynch, MD, PhD. “…This is not a single-product strategy — it's a broad regenerative medicine platform."