Fibrinet® PRF Wound Matrix

From The Patient. For The Patient.

Prepared from autologous blood and applied at the point of care within the clinical setting.^1,6

Description and Intended Use

The PRF Wound Matrix Single Kit is a sterile, one-time use disposable kit used for preparing a PRP (Platelet Rich Plasma) Gel Membrane (PRFM) from a small sample of the patient’s blood at the point of care. The PRF Wound Matrix Single Kit is designed to be used for the management of chronic wounds for up to twelve weeks if the wound does not show improvement with 2 or more weeks of standard of care treatment as determined by a licensed health care practitioner.

The PRF Wound Matrix Single Kit should be used in conjunction with standard of care procedures for comprehensive wound management such as the removal of necrotic or infected tissue, cleansing the wound, maintenance of a moist wound environment, off-loading, management of infections of the wound, proper nutrition, blood glucose control for subjects with diabetic ulcers, and management of any underlying disease that may be contributing to the wound.

The PRF-Matrix system is intended to be used for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood at point-of-care. Under the supervision of a healthcare professional, the PRP gel produced is topically applied for the management of cutaneous wounds such as diabetic ulcers, venous leg ulcers, and mechanically or surgically debrided wounds.

Kit Components

Ready to use kit with all essential parts

The Fibrinet® PRF Wound Matrix System Single Kit Contents

(2) PRP tubes
(1) PRFM Membrane Vial
(2) Luer-Lok Transfer device (Red tip)
(2) Luer-Lok Access device (Blue tip)
(1) 20mm Vial Adapter
(1) Safety-wing blood collection set
(1) Latex-free Tourniquet

The Fibrinet® PRF Wound Matrix System Double Kit Contents

(4) PRP tubes
(2) PRFM Membrane Vial
(2) Luer-Lok Transfer device (Red tip)
(2) Luer-Lok Access device (Blue tip)
(1) 20mm Vial Adapter
(1) Safety-wing blood collection set
(1) Latex-free Tourniquet

Point-of-Care, Autologous System

Draw

Spin

Transfer

Spin

Apply

Clinical Evidence

Read our pre-clinical and clinical evidence to learn more about the clinical data supporting our portfolio.

A Prospective Study to Evaluate Efficacy and Safety of Autologous Platelet-Rich Fibrin Matrix for the Treatment of Chronic Diabetic Foot Ulcers

Image 1: 65-year-old male with history of ulcer submetatarsal right #1 for 6 months a) Screening Visit [SV1] b) Application Visit, 2 weeks post-screening [TV1], c) Treatment Visit #3 [TV3], d) Ulcer closed on Treatment Visit #5 [TV5] ¹

Reimbursement

Fibrinet® PRF Wound Matrix is 510k cleared for the management of cutaneous wounds such as diabetic ulcers, venous leg ulcers, and mechanically or surgically debrided wounds.

G0465 – Diabetic Chronic Wounds

National Coverage

Covered under the applicable Medicare NCD, subject to all coverage requirements and documentation guidelines.
For more information email: coding@royalbiologics.com

ORDERING INFORMATION

Part Number Description
PRF-01 Fibrinet PRF Wound Matrix, Single Kit Covers up to 6 cm²
PRF-02 Fibrinet PRF Wound Matrix, Double Kit Covers up to 12 cm²

REFERENCES

1. 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.
2. Lucarelli E, et al. A recently developed bifacial platelet-rich fibrin matrix. Eur Cells Materials 2010; 20:13-23.
3. Roy S, Sen CK, et al. Platelet-rich fibrin matrix improves wound angiogenesis via inducing endothelial cell proliferation. Wound Rep Regen. 2011;19(6):753-766.
4. Visser LC, Arnoczky SP, Caballero O, et al. Platelet-rich fibrin constructs elute higher concentrations of TGF-ß1 and increase tendon cell proliferation over time when compared to blood clots of similar volume: A comparative in vitro analysis. Vet Surg.2010c; 39(7):811-817.
5. Castillo TN, Pouliot MA, Kim HJ, Dragoo JL. Comparison of growth factor and platelet concentration from commercial PRP separa- tion systems. Am J Sports Med. ePub Nov 4, 2010.
6. O’Connell SM, Impeduglia T, Hessler K, Wang X-J, Carroll RJ, Dardik H.Autologous platelet-rich fibrin matrix as cell therapy in the healing of chronic lower-extremity ulcers. Wound Repair and Regeneration. 2008;16(6):749–756. doi:10.1111/j.1524-475X.2008.00426.x 
7. Johnson KE, Wilgus TA. Vascular Endothelial Growth Factor and Angiogenesis in the Regulation of Cutaneous Wound Repair. Adv Wound Care (New Rochelle). 2014 Oct 1;3(10):647-661. doi: 10.1089/wound.2013.0517. PMID: 25302139; PMCID: PMC418392

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About Royal

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.

At Royal, our mission is driven by patient-centered care, innovation and excellence, and integrity and compassion. Royal provides a comprehensive array of products tailored to meet the varied needs of the orthobiologic and wound care industry.

As a rapidly expanding force in the industry, Royal is continuously developing and launching new products and solutions that set benchmarks for quality, effectiveness, and patient outcomes. Royal’s commitment to research and innovation keeps it at the forefront of the industry, helping to shape the future of healthcare and improving lives.