Royal Biologics Announces FDA Clearance for Fibrinet® PRF Wound Matrix for the Management of Cutaneous Wounds

HACKENSACK, N.J., April 7, 2026 /PRNewswire/ -- Royal Biologics, a leader in regenerative medicine and advanced wound care technologies, today announced that Fibrinet® PRF Wound Matrix has received U.S. Food and Drug Administration (FDA) clearance for the management of exuding cutaneous wounds, including diabetic and venous ulcers.

Fibrinet® PRF Wound Matrix is a point-of-care system designed to harness and concentrate a patient's own platelets and associated growth factors into a durable Platelet-Rich Fibrin Matrix (PRFM). The system enables clinicians to create a structured, autologous fibrin scaffold that can be applied directly to the wound site to support the body's natural healing processes. Under the supervision of a healthcare professional, the PRFM Matrix produced may be applied topically for the management of cutaneous wounds, including diabetic ulcers, venous ulcers, and mechanically or surgically debrided wounds.

Currently, the Centers for Medicare & Medicaid Services (CMS) maintains an active National Coverage Determination (NCD 270.3) governing the use of platelet-rich plasma (PRP) devices in wound care. This policy provides coverage for PRP when it is "prepared using devices with Food and Drug Administration (FDA)-cleared indications for the management of exuding cutaneous wounds, such as diabetic ulcers." Although numerous PRP devices are available on the market, the Fibrinet® PRF Wound Matrix is among a limited number of devices that have received FDA clearance specifically for wound management.

Salvatore Leo, CEO and founder of Royal Biologics stated, "We are very excited to announce the FDA approval of Fibrinet® PRF Wound Matrix. Unlike traditional platelet preparations, the Fibrinet® PRF Wound Matrix system concentrates intact platelets into a platelet-rich fibrin membrane without the use of exogenous activators such as bovine thrombin, enabling the delivery of autologous platelets and associated growth factors within a fibrin scaffold. Fibrinet® PRF Wound Matrix adds another great tool for providers in our already market leading autologous live cell technologies portfolio. We are seeing a market shift in the industry where there is an overabundance of commoditized skin substitute options for providers. Fibrinet® PRF Wound Matrix is a unique, patient specific solution, offering providers an advanced live cellular therapy, point of care."

Fibrinet® preclinical models evaluating PRFM have demonstrated sustained concentrations of key growth factors for up to seven days.¹

PRFM is designed to support the core elements of tissue repair through:

• Scaffold: A durable fibrin structure with enhanced mechanical properties, providing structural support within the wound environment and ability to be sutured.
• Signals: Sustained concentrations of platelet-derived growth factors that support angiogenesis, cellular recruitment, and tissue repair.
• Cells: High retention of intact, viable platelets within the fibrin matrix to maintain biological activity over time.

This easy-to-use system enables clinicians to prepare the matrix at the point of care through a simple workflow: draw, spin, transfer, spin, and apply; allowing integration into existing wound care practices.

Preclinical and clinical observational data associated with PRFM technology have demonstrated outcomes including 92% of wounds achieving ≥ 50% reduction in wound size and 57% complete closure at 12 weeks, with a mean time to heal of approximately 6.75 weeks.²

Fibrinet® PRF Wound Matrix is available in Single Kit and Double Kit configurations, designed to treat wounds up to 6 cm² and 12 cm², respectively.

Royal Biologics will debut the commercial launch of Fibrinet® PRF Wound Matrix at the upcoming National Symposium for Advanced Wound Care (SAWC) in Charlotte, NC. Visit Booth #1033 to experience the technology firsthand.

About Royal Biologics

Royal is a pioneering leader in orthobiologic and wound care research and development. Royal's commitment lies in delivering top-tier, innovative biologic solutions that enhance the healing process and improve patients' quality of life. Royal places patient well-being at the center of its mission, offering exceptional solutions to address a variety of complex needs.

For more information, visit www.royalbiologics.com.

References

1. Lucarelli E, et al. A recently developed bifacial platelet-rich fibrin matrix. Eur Cells Materials 2010; 20:13-23. 3. Roy
2. Fridman R, Wielgomas J. A Prospective Study to Evaluate Efficacy and Safety of Autologous Platelet-Rich Fibrin Matrix for the Treatment of Chronic Diabetic Foot Ulcers. Clin Res Foot Ankle. 2024;12:590. doi:10.4172/2329-910X.1000590.

Media Contact
Mary Jo Murino
[email protected]

SOURCE Royal Biologics