Lynch Regenerative Medicine acquires REGRANEX® Gel and exclusive rights to use recombinant pure PDGF for soft tissue rejuvenation and regeneration
Published on March 31, 2025
FRANKLIN, Tenn.–(BUSINESS WIRE)–Lynch Regenerative Medicine, LLC., (LRM) announced today 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. 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.
The prevalence of diabetes is rising, with an estimated 38.4 million people in the United States, or 11.6% of the population, suffering from diabetes in 2021. Of those patients, 15% are likely to experience a diabetic foot ulcer (DFU). Approximately 85% 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.
LRM is working with leading universities and skin care centers in the United States to identify and develop new formulations of recombinant pure PDGF for additional wound healing and skin rejuvenation and regeneration indications beyond DFUs.
“We are excited to acquire the exclusive rights to use recombinant cGMP pure PDGF for soft tissue and wound healing indications. These rights complement our existing broad patent portfolio covering the composition and use of PDGF for skin rejuvenation and regeneration and hair restoration. 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,” said Dr. Samuel Lynch, founder and CEO of LRM and inventor on more than 150 patents worldwide and author of more than 100 peer-reviewed articles on PDGF and regenerative medicine.
“PDGF is the most powerful, most important growth factor so far discovered for stimulating healing, tissue regeneration and rejuvenation. Our mission at LRM is to harness the power of PDGF to help patients heal skin and other soft tissue wounds faster and with less scarring, and to rejuvenate the skin to achieve optimum aesthetic results. Our vision is that it becomes best practice for every surgical incision and every injury to skin to be treated with pure PDGF to accelerate healing, reduce inflammation and pain, and decrease the opportunity for wounds to become infected,” added Dr. Lynch.
Recombinant pure PDGF has a strong record of regulatory approval in numerous clinical indications. PDGF has been through multiple phase I – IV clinical trials and has received FDA approval four times – twice as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material; once for promoting periodontal regeneration including regeneration of bone and soft tissues lost due to periodontal disease; and once for promoting healing of chronic skin wounds in the lower extremities of diabetic patients.
In addition, LRM, through its wholly owned LRM Aesthetics company, has recently introduced its first commercial product, Ariessence™ pure PDGF+, to the aesthetics market, where it is rapidly gaining adoption as the go-to topical product for skin rejuvenation and improved aesthetic results following laser therapy, microneedling and other skin rejuvenation procedures.
