Lynch Regenerative Medicine acquires exclusive rights to REGRANEX® gel
The company will become the exclusive manufacturer and seller of REGRANEX later this year.
Lynch Regenerative Medicine LLC (LRM) announced on Monday that it has acquired exclusive rights to REGRANEX® gel and recombinant purified platelet-derived growth factor (PDGF) from Smith & Nephew Inc. for use in skin rejuvenation and regeneration as well as other soft tissue wound healing and tissue regeneration applications.
According to the announcement from the Franklin, TN-based company, PDGF is the first and only pure recombinant growth factor to have received approval from the U.S. Food and Drug Administration (FDA) for the treatment of wounds in the lower extremities of diabetic patients. The terms of the transaction were not disclosed.
“We are excited to acquire the exclusive rights to use recombinant cGMP pure PDGF for soft tissue and wound healing indications,” said Dr. Samuel Lynch, Founder and Chief Executive Officer of LRM. He’s a former Chair of the Board of Life Science Tennessee, an inventor on more than 150 patents worldwide, and the author of more than 100 peer-reviewed articles on PDGF and regenerative medicine.
“These rights complement our existing broad patent portfolio covering the composition and use of PDGF for skin rejuvenation and regeneration and hair restoration,” he added. “I have led the development of five pure PDGF products for tissue regeneration and rejuvenation and am confident that we can successfully develop pure PDGF for additional indications in skin and other soft tissue applications.”
The prevalence of diabetes is rising, with an estimated 38.4 million people in the United States, or 11.6 percent of the population, suffering from diabetes in 2021. Of those patients, 15 percent are likely to experience a diabetic foot ulcer (DFU). Approximately 85 percent of diabetes-related lower extremity amputations are preceded by a DFU, and most of these amputations are preventable. REGRANEX is a proven first-line treatment for DFUs when used as an adjunct to good ulcer care. It has been demonstrated in Phase III randomized double-blind placebo-controlled clinical trials to significantly increase healing of DFUs, as compared to a standard good ulcer care.
Under the terms of the transaction, Smith & Nephew will continue to distribute REGRANEX through August 2025, after which LRM will become the exclusive manufacturer and seller of REGRANEX.
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