Soft Tissue Injuries

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

FAIRLAWN, Ohio, Feb. 6, 2025 /PRNewswire/ -- Paul Fleissner, M.D., a board-certified orthopaedic and pediatric orthopaedic surgeon at Crystal Clinic Orthopaedic Center, and chairman of the board, has performed the world's first meniscus repair using an innovative, new regenerative implant for meniscal restoration. The procedure treated a college-age athlete who suffered from chronic pain following a prior meniscectomy. Continue Reading Crystal Clinic Orthopaedic Center performs world's first meniscus repair using groundbreaking regenerative implant. Post this Orthopaedic surgeon Paul Fleissner, M.D., (second from left) performed the world’s first meniscus repair using a regenerative implant. Also pictured from left to right are Scott Salvatoriello, Regenity Biosciences; Kodi Veale, P.A., Crystal Clinic Orthopaedic Center; and Jessica Swanson, Regenity Biosciences. Photo courtesy of Regenity Biosciences. Known as RejuvaKnee™, developed and manufactured by Regenity Biosciences, this collagen-based meniscal implant, which recently received FDA clearance, has been shown in pre-clinical studies to support a more complete recovery by facilitating the regeneration of native meniscal tissue (Source: Reginity Biosciences Data on File 2024). "Meniscal repair using this groundbreaking regenerative implant represents a real game-changer and a potential new standard of care for meniscal restoration," said Dr. Fleissner. "It provides an outstanding and most durable solution for patients who have irreparable meniscus tears or have previously lost meniscus tissue." Another key advantage of this regenerative implant involves notable reduced wait times for surgery, given it is readily available. "Extended wait time forces patients to suffer unnecessarily with prolonged pain and the inability to maintain their active lifestyles," Dr. Fleissner said. "Instead, this new implant is able to fit patients immediately, eliminating long wait times and protracted pain." In the coming weeks, Dr. Fleissner will perform several more meniscus repairs using this regenerative implant, which he believes will provide an immediate and long-lasting solution that will improve his patients' quality of life. "As Crystal Clinic is a national destination center of excellence, consistently ranked as a Top 100 hospital in America, I am excited to offer this advanced, breakthrough treatment for patients throughout the U.S.," Dr. Fleissner said. To learn more or to schedule an appointment online 24/7, visit CrystalClinic.com. About Crystal Clinic Orthopaedic Center Nationally renowned for orthopaedic care, Crystal Clinic Orthopaedic Center is a physician-owned, orthopaedic specialty hospital system with board-certified/board-eligible surgeons, most with advanced fellowship credentials in their orthopaedic specialty, who collectively perform thousands of surgeries annually. As a national destination center of excellence, Crystal Clinic is a top 100 hospital in America, and is one of just three out of the 6,120 hospitals in the nation to receive The Joint Commission certifications in total hip, total knee, total shoulder, and spinal fusion procedures. Crystal Clinic hospital system is ranked #1 in Ohio and in the top 100 of U.S. hospitals by CareChex/Quantros Analytics' objective review of all U.S. hospitals and health systems. Crystal Clinic has also earned the nation's highest five-star rating in patient experience and overall hospital quality from the Centers for Medicare & Medicaid Services, and America's 100 Best Hospitals for Joint Replacement by Healthgrades. Crystal Clinic is based in Northeast Ohio with 17 clinic, hospital and surgery locations, including several Crystal Clinic QuickCare™ locations that provide immediate, walk-in care for sports and orthopaedic injuries. Crystal Clinic Plastic Surgeons, a division of Crystal Clinic Orthopaedic Center, are experts in treating soft tissue defects related to orthopaedic injuries and provide the entire spectrum of plastic surgery – from reconstruction to cosmetic procedures. Crystal Clinic's highly advanced, state-of-the-art surgical hospital is the only hospital devoted exclusively to orthopaedics and plastic/reconstructive care. About Regenity Biosciences Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey, and Groningen, the Netherlands. Regenity's product portfolio includes a variety of collagen-based and synthetic polymer solutions that support the company's platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services. For more information, visit regenity.com. SOURCE Crystal Clinic Orthopaedic Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AUSTIN, Texas, Dec. 19, 2024 /PRNewswire/ -- It's estimated that 4 out of 5 adults will have an attack of back pain at some point in their lives. That's the bad news. The good news is that 80% of the time, simple back and neck pain can go away on its own. However, the fellowship-trained spine surgeons at SpineCenterNetwork.com, a national network of independent spine centers, note that there will be thousands of Americans who will self-diagnose themselves incorrectly in 2025, which could lead to permanent numbness in a hand or foot. Continue Reading Spine surgeon Dr. Eeric Truumees consults with Dr. Lee Moroz, a specialist in non-surgical spine care at Texas Spine and Scoliosis, a spine center of excellence in Austin, Texas. Eeric Truumees, MD, a fellowship-trained spine surgeon at Texas Spine and Scoliosis in Austin, Texas, and past president of the North American Spine Society (NASS), the largest international group of spine specialists, lists the five serious mistakes people will make with their back or neck pain in 2025: Mistake #1. Pain is NOT a good indicator of when to go to the doctor. "Unlike other joint problems like knee or hip pain, with back or neck injury pain is NOT a good indicator of when you need to see a doctor," explains Dr. Truumees. "A back strain or spasm can cause excruciating pain. But a strain never requires surgery. It can resolve on its own with anti-inflammatories and some rest. Instead, the emergency symptom that needs to be seen within 48 hours is numbness in a hand or foot caused by a herniated disc in the neck or back." Mistake #2. Waiting too long can cause numbness symptoms to become permanent. Dr. Truumees cautions that a numb hand or numb foot from a herniated disc needs to be seen by a spine specialist within a couple days to prevent permanent numbness. "A herniated disc that presses on a nerve root over several weeks can create a permanent crimp that may not be corrected with a surgery," Dr. Truumees explains. "That can cause that numb foot or numb hand, or weakness in the hand or foot, to become permanent." People can download a symptom chart for back and neck pain, and request a free 36-page Home Remedy Book, through the spine centers listed at SpineCenterNetwork.com. Mistake #3. Using drugs to mask symptoms creates a bigger problem. The other big mistake people make with back or neck pain is reaching for the pill bottle. "Pain pills only mask symptoms, they don't change the physiology of the back," Dr. Truumees cautions. "Worse, painkillers like opioids are quickly addictive, creating a bigger problem." Mistake #4. The wrong home remedies can be counter-productive. A sore back is not like a sore knee. "With back pain, research has shown conclusively that bed rest beyond a day or so is actually bad for the back," says Dr. Truumees. "Instead, some movement is good for a back strain, like specific stretches or a 20-minute walk. Movement is like WD-40 for the back. The other problem relates to over-use of ice and heat which many insurance companies view as palliative, meaning it feels good but cures nothing. Instead, spine therapists use custom stretches and hands-on massage to relieve soft tissue injury symptoms." Mistake #5. Avoid a spinal fusion. "If you've been told you need a spinal fusion, get a second opinion," emphasizes Dr. Truumees. "For years, it was common to recommend a spinal fusion to treat a herniated disc. That's no longer the case with the new artificial disc technology available. The neck has only six disc levels to provide movement and rotation. Fusing one level not only limits rotation, but also increases the stress on other levels above and below which causes other discs to herniate. An artificial disc retains the natural motion in the spine, reducing stress on the other discs." SpineCenterNetwork.com is the only national listing of spine centers that combine the expertise of non-surgical physical medicine MDs working with fellowship-trained spine surgeons and spine therapists. The spine centers within SpineCenterNetwork.com all emphasize non-surgical treatment options, the most advanced minimally invasive spine surgery and artificial disc replacement. More information is also at TexasSpineandScoliosis.com. Media Contact: Bob Reznik [email protected] 817-481-2450 SOURCE SpineCenterNetwork.com WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED