Joint Instability

FRANKLIN, TN, USA I March 31, 2025 I 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 TM 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. About Lynch Regenerative Medicine, LLC Lynch Regenerative Medicine, LLC., is a commercial stage biotech company pioneering innovative treatments that aim to revolutionize aesthetics and wound care through skin rejuvenation and regeneration, so that patients can rediscover the joy of healthy skin and natural beauty. LRM is advancing the $100 billion aesthetics and wound-care markets by leveraging our regenerative medicine heritage, and our decades-long commitment to safe and effective regenerative products of the highest quality. LRM’s first solution to come to the market, Ariessence TM Pure PDGF+ ( www.ariessence.com ) , is on the market today and can be found in leading innovative med/spa clinics, and other aesthetic focused offices including dermatology and plastic surgery practices. The company was founded in 2023 by Dr. Samuel Lynch and is based in Franklin, Tennessee. Select Safety Information for REGRANEX® Gel REGRANEX is the only FDA-approved PDGF indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. REGRANEX is indicated as an adjunct to, and not a substitute for, good ulcer care practices. Limitations of use: Contraindication: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application. Warnings and Precautions: The benefits and risks of treatment should be carefully evaluated before prescribing in patients with known malignancy. If application site reactions occur, consider the possibility of sensitization or irritation caused by parabens or mcresol. Interrupt treatment and evaluate (e.g. patch testing) as appropriate. For complete product information, please see the REGRANEX Full Prescribing Information . SOURCE: Lynch Regenerative Medicine

The revision knee implant component — part of the comprehensive Persona Revision Knee System — offers an alternative for patients with sensitivities to certain metals.  It leverages a proprietary surface-hardening treatment designed to enhance wear performance. It delivers surgeons an array of anatomic components, including tibial and femoral cones with various stem choices to address zonal fixation. Warsaw, Indiana-based Zimmer Biomet made its implant solely from a proprietary Tivanium (Ti-6Al-4V) alloy. The alloy has more than 17 years of clinical use backing it. Treated with the Ti-Nidium surface-hardening process, the alloy strengthens to demonstrate hardness comparable to that of metal implants. However, it delivers enhanced wear performance with resistance to particle release. Zimmer Biomet offers the new revision femur in standard and plus sizes to address flexion instability and soft tissue balancing. It also minimizes implant overhang. The company plans to make the Persona Revision SoluTion Femur commercially available in the U.S. in the third quarter of 2025. “We are pleased to expand our proprietary surface-hardening technology into the revision knee space with FDA clearance of the Persona Revision SoluTion Femur, the first metal alternative option for those with certain metal sensitivities,” said Joe Urban, president, Knees at Zimmer Biomet. “We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (Nickel, Cobalt, & Chromium). Metal sensitivity is one of the potential causes of revision procedures, and the Persona Revision SoluTion Femur is yet another innovation that delivers on our commitment to solve the most meaningful challenges in musculoskeletal health.”

A Revision Knee Implant Alternative for Patients with Metal Sensitivities WARSAW, Ind., March 7, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® Revision SoluTion™ Femur, a revision knee implant component offering an alternative for patients with sensitivities to certain metals. The Persona Revision SoluTion Femur, part of the comprehensive Persona Revision Knee System, leverages a proprietary surface-hardening treatment designed to enhance wear performance,1,2 which offers surgeons an array of anatomic components, including tibial and femoral cones with various stem choices to address zonal fixation. "We are pleased to expand our proprietary surface-hardening technology into the revision knee space with FDA clearance of the Persona Revision SoluTion Femur, the first metal alternative option for those with certain metal sensitivities," said Joe Urban, President, Knees at Zimmer Biomet. "We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (Nickel, Cobalt, & Chromium). Metal sensitivity is one of the potential causes of revision procedures, and the Persona Revision SoluTion Femur is yet another innovation that delivers on our commitment to solve the most meaningful challenges in musculoskeletal health." Cutaneous metal hypersensitivity affects 10-15 percent of the general population, while prevalence in patients with metallic implants may be as high as 25 percent.3 Patients may experience an immunological reaction against metallic particles (ions) that are released as a result of implant wear or corrosion.4 When exposed to certain metals commonly used in metal knee implants such as nickel, cobalt and chromium, people with these hypersensitivities can experience an inflammatory response, pain and implant loosening that can require a total knee replacement revision procedure.5 The Persona Revision SoluTion Femur is made solely of a proprietary Tivanium® (Ti-6Al-4V) alloy with more than 17 years of clinical use.6 The alloy is treated with the Ti-Nidium Surface Hardening Process, which results in a strengthened material that demonstrates hardness, comparable to that of metal implants, with enhanced wear performance that provides resistance to particle release.2,7 The new revision femur is offered in standard and plus sizes to address flexion instability and soft tissue balancing while minimizing implant overhang.8,9 Persona Revision SoluTion Femur will be commercially available in the U.S. in Q3 2025. About Zimmer Biomet Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation. For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visit or follow on LinkedIn at or X / Twitter at . Cautionary Statement Regarding Forward-Looking Statements This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release. References: Improved Abrasion Resistance of Nitrogen-Hardened Titanium Alloy Surfaces. Current Topics in Orthopaedic Technology. Zimmer. Vol. 3, No. 6 (1991). Zimmer ZRR_WA_2537_12 Akila S.,et al. Metal hypersensitivity in total hip and knee arthroplasty: Current concepts. Journal of Clinical Orthopaedics and Trauma. 2018 Jan-Mar;9(1):3-6, 2018. Podzimek S. Metal hypersensitivity and pro-inflammatory cytokine production in patients with failed orthopedic implants: A case-control study, Clinical Immunology, Volume 245, 2022. . Hozack, W. et al. Primary Cementless Hip Arthroplasty with a Titanium Plasma Sprayed Prosthesis. Clinical Orthopaedics and Related Research. 333: 217-25, 1996. Rossi SMP, et al. Ten-year outcomes of a nitrided Ti-6Al-4V titanium alloy fixed-bearing total knee replacement with a highly crosslinked polyethylene-bearing in patients with metal allergy. The Knee. 2020;27(5):1519-1524. Improved Abrasion Resistance of Nitrogen-Hardened Titanium Alloy Surfaces. Current Topics in Orthopaedic Technology. Zimmer. Vol. 3, No. 6 (1991). Royal Perth Hospital Dept. of Medical Engineering and Physics. (2005). Implant Technology and Biomaterials Bulletin: No. 4. Australia. Department of Medical Engineering and Physics. Shetty, RH. Surface Hardening of Orthopedic Implants. Biomaterials Engineering and Devices. Vol. 2: 191-202 (2000). SOURCE Zimmer Biomet Holdings, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED