This article was originally posted by Carly Behm from Becker’s Spine. Each headline was provided by her and I just did some more digging into the background details.
1. Royal Biologics and Fair Winds Medical partnered to distribute spine and orthopedic biologics.
Fair Winds Medical and Royal Biologics have announced a partnership to distribute regenerative orthopedic and spine solutions across the United States. This collaboration aims to expand the reach of Royal Biologics’ innovative products, such as the Fibrinet platelet-rich fibrin matrix for spinal fusions and Maxx-PRP for orthopedic applications, to a broader patient population. Additionally, the partnership seeks to promote the adoption of these biologic solutions within the Department of Veterans Affairs and the Department of Defense healthcare systems.[2]
The Fibrinet® System by Royal Biologics is an advanced medical solution designed to efficiently prepare Platelet-Rich Fibrin Membrane (PRFM) and Platelet-Rich Fibrin Gel (PRFG) from a patient’s blood at the point of care. This system enables the concentration of the patient’s own platelets and growth factors into a robust fibrin scaffold without the use of exogenous activators like thrombin. The resulting PRFM offers sustained availability of growth factors for up to seven days, promoting enhanced healing in various clinical applications. Notably, the Fibrinet® System is user-friendly, providing a closed system with high platelet capture efficiency and reproducibility, distinguishing it from other commercially available systems.[3]
The Maxx™ PRP system by Royal Biologics is an advanced regenerative medicine technology designed to prepare customizable platelet-rich plasma (PRP) formulations efficiently at the point of care. Utilizing patented Lead Screw technology, it enables clinicians to precisely access the “buffy coat” layer, achieving 4-6 times baseline platelet concentrations in approximately 8 minutes. This closed, sterile system allows for dual spin capability, adjustable hematocrit levels, and the processing of up to 240cc of PRP in a single cycle, facilitating faster cell collection with reduced clotting. The Maxx™ PRP system delivers both leukocyte-poor and leukocyte-rich PRP, offering a versatile solution for various clinical applications.[4]
Fair Winds Medical specializes in the commercialization of innovative healthcare technologies, providing comprehensive strategic, operational, and distribution support to early-stage and accelerator-stage medical device companies. Leveraging deep industry expertise and a global network of over 74 distributors, the company facilitates market entry and growth for products in various specialties, including orthopedics, spine health, wearables, pain management, neurology, vascular health, and wound care. Their services encompass strategic business planning, regulatory guidance, product development, clinical trial management, sales and marketing support, and revenue cycle management, ensuring that groundbreaking medical devices reach healthcare providers and patients efficiently.[5]
2. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a stand-alone equivalent to autografts in spine surgeries.
According to the 510(k) clearance:
OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.[6]
While this is not SurGenTec’s first 510(k) clearance, it does appear to be the first clearance for a stand-alone synthetic bone graft option. OsteoFlo® HydroFiber™ is a hydrophilic synthetic bone graft developed by SurGenTec for use in spinal surgeries and orthopedic procedures. Its unique composition features web-like interwoven fibers combined with porous synthetic particles, creating a moldable and highly flowable material that maintains cohesion and resists migration during irrigation. This design allows for easy application, including the filling of interbody cages and small bone defects, especially when used with SurGenTec’s GraftGun® delivery system. HydroFiber™ can be customized by mixing with sterile saline, blood, bone marrow aspirate, or autograft, providing versatility for various clinical needs. Extensive pre-clinical testing has demonstrated that HydroFiber™ is comparable to autografts in spinal procedures, supporting its effectiveness in promoting bone healing and integration.[7]
SurGenTec won two spine technology awards back in Sept. Read more in my post from September SurGenTec Wins Two Spine Technology Awards for 2024 | A Summary.
3. LifeNet Health and Johnson & Johnson MedTech launched the PliaFX Flo demineralized bone matrix.
PliaFX® Flo is a demineralized bone matrix (DBM) developed by LifeNet Health to enhance bone healing in orthopedic and spinal procedures. Comprising optimally demineralized cortical bone fibers combined with a glycerol carrier, this graft is designed for precise, direct delivery from a sterile syringe, eliminating the need for intraoperative preparation. The interlocking fibers provide a moldable scaffold that conforms to surgical sites and resists migration, promoting cell attachment and proliferation. Sterilized using LifeNet Health’s proprietary Allowash XG® technology, PliaFX® Flo ensures a high level of safety without compromising its biological properties. It can be used alone or mixed with other biomaterials, offering versatility for various clinical applications.[8]
LifeNet Health and Johnson & Johnson MedTech (J&J MedTech) are business partners and have collaborated to develop and commercialize bone allografts, specifically the PliaFX family of bone void fillers, including PliaFX Pak, PliaFX Prime, and PliaFX Flo. LifeNet Health, a regenerative medicine company, has developed the PliaFX Pak, a versatile bone allograft, while J&J MedTech is responsible for commercializing the PliaFX family of bone void fillers, including PliaFX Pak, PliaFX Prime, and PliaFX Flo.[9]
4. Acuitive Technologies named Wayne Berberian, MD, as its chief medical officer.
Acuitive Technologies, a leading orthopedic medical device company specializing in complex soft tissue repair and regeneration, has appointed Dr. Wayne Berberian as Chief Medical Officer. With over 30 years of experience in clinical, educational, and executive roles at institutions such as Rutgers University Hospital and Hackensack University Medical Center, Dr. Berberian brings extensive expertise to the position. He has authored over 100 peer-reviewed publications and delivered more than 150 lectures on advanced orthopedic topics. In his new role, Dr. Berberian will guide the clinical development of Acuitive’s regenerative orthopedic products, aiming to enhance patient outcomes by delivering innovative tissue regenerative solutions.[10]
Dr. Wayne S. Berberian is an Associate Professor of Orthopaedics at Rutgers New Jersey Medical School, specializing in foot and ankle surgery. He earned his B.A. in Pre-medical Science from Lehigh University and his M.D. from The Medical College of Pennsylvania. Following a General Surgery internship at St. Luke’s-Roosevelt Hospital Center, Dr. Berberian completed a two-year Research Fellowship in Orthopaedic Surgery at The Hospital for Special Surgery – Cornell University Medical Center, focusing on bone regeneration. He then underwent Orthopaedic Surgery residency training at UMDNJ – New Jersey Medical School and further specialized with a Foot and Ankle Fellowship at Hahnemann University Hospital in Philadelphia. Since joining the faculty in 1999, Dr. Berberian has been on staff at University Hospital in Newark and Hackensack University Medical Center. He holds medical licensure in New Jersey and New York and is certified by the American Board of Orthopaedic Surgery.[11]
5. Jamie Antoine, MD, of Seattle-based Proliance Surgeons performed the first case using CartiHeal’s Agili-C implant in Washington state.
Dr. Jamie Antoine is a fellowship-trained, board-certified orthopedic surgeon based in Kirkland, Washington, specializing in sports medicine and arthroscopic surgery, particularly of the knee and shoulder. He earned his medical degree magna cum laude from Albany Medical College, followed by a surgical internship and orthopedic residency at the University of Washington. Dr. Antoine further honed his expertise with a sports medicine fellowship at the Palo Alto Medical Clinic under Dr. Warren King, the head orthopedic surgeon for the Oakland Raiders. He began his practice at Group Health/Kaiser Permanente in Seattle, serving as Chief of Orthopedic Surgery for six years, before joining ProOrtho in 2018. In addition to his clinical practice, Dr. Antoine serves as the Orthopedic Consultant for the Everett Silvertips hockey team, is the volunteer Team Physician for North Creek High School athletics, and acts as the Medical Director for the Seattle Pickleball Classic Tournament. His practice offers advanced treatments, including robotic-assisted knee replacement and cartilage repair procedures utilizing patients’ own cells.[12]
The CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant, developed and manufactured by Smith+Nephew, is an off-the-shelf, single-stage solution designed for the repair of knee cartilage and osteochondral defects. Composed of a porous, biocompatible, and biodegradable aragonite-based scaffold, it promotes natural cartilage and bone regeneration. Clinical studies have demonstrated that the AGILI-C implant provides significant improvements in pain reduction, function, and quality of life, showing superiority over traditional treatments like microfracture and debridement. Notably, it is approved for use in patients with or without mild to moderate osteoarthritis (Kellgren-Lawrence grades 0-3). The implant’s design allows for a straightforward surgical procedure without the need for donor tissue or cell harvesting, offering a versatile treatment option for both small and large lesions.[13]
6. Stem cell therapies can be effective for treating discogenic low back pain, according to a study published in the January 2025 issue of the International Journal of Spine Surgery.
A systematic review published in the International Journal of Spine Surgery evaluated the efficacy of stem cell therapy for treating discogenic low back pain (LBP). The analysis encompassed eight studies with a total of 283 patients, assessing outcomes using the Visual Analog Scale (VAS) for pain and the Oswestry Disability Index (ODI) for daily living activities. Findings revealed significant improvements in both VAS and ODI scores following stem cell therapy, indicating reduced pain and enhanced functional abilities. Additionally, imaging assessments demonstrated notable improvements in disc morphology, as evidenced by changes in Pfirrmann grades. Subgroup analyses focusing on bone marrow aspirate concentrate corroborated these positive outcomes. These results suggest that intradiscal stem cell therapy holds promise as a minimally invasive treatment option for discogenic LBP, potentially offering sustained pain relief and functional recovery. However, the authors advocate for further research to establish standardized protocols and confirm long-term efficacy.[14]
7. The global spine biologics market is on pace to have a 17.51% compound annual growth rate from 2024 to 2034.
I recently made a post about this under Orthobiologics Market Update.
8. Paul Fleissner, MD, of Fairlawn, Ohio-based Crystal Clinic Orthopaedic Center is the first surgeon to use the RejuvaKnee implant for meniscus repair.
Dr. Paul R. Fleissner is a board-certified, fellowship-trained orthopedic surgeon specializing in pediatric and adolescent sports medicine at Crystal Clinic Orthopaedic Center. He earned his medical degree from The Ohio State University College of Medicine, completed his residency at Akron City Hospital, and pursued a fellowship at Denver Children’s Hospital. Dr. Fleissner has a particular interest in treating sports injuries, scoliosis, clubfoot, and fractures. He serves as a clinical professor of orthopedic surgery at Northeast Ohio Medical University and has been recognized for his research contributions, including pioneering the first U.S. Reveille one-stage cartilage transplant. His current research focuses on utilizing platelet-rich plasma to expedite recovery from ACL reconstructions. Dr. Fleissner practices at multiple locations, including Fairlawn I, Canton, and Green.[15]
In October 2024, Regenity Biosciences received FDA 510(k) clearance for RejuvaKnee™, a minimally invasive, collagen-based meniscal implant designed to repair and regenerate damaged meniscal tissue. Preclinical studies demonstrated that within three months, the implant facilitated significant tissue growth—nearly five times more than current standard treatments—and restored full weight-bearing capacity with normal knee function. This advancement offers a promising alternative to traditional meniscectomy, potentially reducing the risk of osteoarthritis and the need for further surgeries. With over a million meniscectomies performed annually in the U.S., RejuvaKnee™ addresses a substantial market need, and Regenity is actively seeking strategic partners for its commercialization.[16]
Regenity Biosciences, formerly known as Collagen Matrix, is a leading global developer and manufacturer of bioresorbable technologies aimed at repairing and regenerating natural tissue and bone. Founded in 1997, the company is headquartered in Paramus, New Jersey, with additional operations in Groningen, the Netherlands. Employing over 275 professionals worldwide, Regenity delivers more than four million medical devices annually to clients across 86 countries. Their diverse product portfolio serves multiple medical fields, including dental, dural repair and closure, ear, nose, and throat (ENT) surgery, spine and orthopedics, and nerve repair. Regenity offers comprehensive services such as medical-grade biomaterials, product development, contract manufacturing, regulatory support, and OEM product distribution. The company’s mission is to create transformative medical and dental solutions that significantly improve patient outcomes, guided by core values of integrity, collaboration, determination, creativity, and urgency. In October 2022, Regenity expanded its capabilities by acquiring Polyganics, a medical technology firm specializing in bioresorbable devices, thereby enhancing its product offerings and global reach.[17]
References:
[1] Behm, C. (2025, February 13). 8 orthobiologic updates. Beckers Spine. https://www.beckersspine.com/biologics/61662-8-orthobiologic-updates.html
[2] Fair Winds Medical LLC. (2025, January 16). Fair Winds Medical and Royal Biologics Partner to Deliver Regenerative Orthopedic and Spine Solutions Nationwide [Press release]. https://www.einnews.com/pr_news/777237561/fair-winds-medical-and-royal-biologics-partner-to-deliver-regenerative-orthopedic-and-spine-solutions-nationwide
[3] Fibrinet® | Royal Biologics. (2025, February 18). Royal Biologics. https://royalbiologics.com/fibrinet/
[4] MAXX PRP® | Royal Biologics. (2025, February 18). Royal Biologics. https://royalbiologics.com/maxx-prp/
[5] Fair Winds Medical. (2024, October 22). Fair Winds Medical – Healthcare Commercialization experts. https://fairwindsmedical.com/
[6] K242797. (2024). FDA, U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242797
[7] SurGenTec Graftgun®. (2025, February 6). OsteoFlo® HydroFiberTM – SurGenTec GraftGun®. SurGenTec Graftgun® – Bone Graft Delivery Systems. https://www.surgentec.com/osteoflo-hydrofiber/
[8] PliAFX® FLO | General Orthopedics | LifeNet Health. (2025, February 18). https://www.lifenethealth.org/flo
[9] LifeNet Health, along with Johnson & Johnson MedTech, Introduce Innovative New Orthopedic Solution | LifeNet Health. (2025, February 18). https://www.lifenethealth.org/news/lifenet-health-along-johnson-johnson-medtech-introduce-innovative-new-orthopedic-solution
[10] Technologies, A. (2025, January 27). Acuitive Technologies, Inc. appoints Dr. Wayne Berberian as Chief Medical Officer. GlobeNewswire News Room. https://www.globenewswire.com/news-release/2025/01/27/3015539/0/en/Acuitive-Technologies-Inc-Appoints-Dr-Wayne-Berberian-as-Chief-Medical-Officer.html
[11] Foot and Ankle – Wayne S. Berberian, MD. (2025, February 18). Rutgers New Jersey Medical School. https://njms.rutgers.edu/departments/orthopaedics/njoi_berberian.php
[12] Antoine, J., MD. (2025, February 18). Dr. Jamie Antoine M.D. Dr. Jamie Antoine M.D. https://antoineorthopedics.com/
[13] CARTIHEAL AGILI c. (2025, February 18). https://www.smith-nephew.com/en-us/health-care-professionals/products/sports-medicine/cartiheal-agili-c
[14] Randy, R., Yosua, K., Guntara, A., & Hardiansyah, N. P. (2025). Stem Cells Therapy as a Treatment for Discogenic Low Back Pain: A Systematic Review. The International Journal of Spine Surgery, 86717. https://doi.org/10.14444/86717
[15] Crystal Clinic Orthopaedic Center. (2024, December 12). Paul R. Fleissner, M.D. – Crystal Clinic Orthopedic Surgeons. https://www.crystalclinic.com/physicians/detail/fleissner-paul-r
[16] Biosciences, R. (2024, October 8). Regenity Biosciences Receives 510(k) Clearance for RejuvaKneeTM, a Groundbreaking Regenerative Meniscus Implant Device to Redefine the Standard of Care [Press release]. https://www.prnewswire.com/news-releases/regenity-biosciences-receives-510k-clearance-for-rejuvaknee-a-groundbreaking-regenerative-meniscus-implant-device-to-redefine-the-standard-of-care-302269177.html
[17] About Regenity – Regenity. (2024, May 31). Regenity. https://regenity.com/about/
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