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Technology and Product Assessment
Product Type: Platelet-Rich Plasma
Other related products
Unbiased information for educational purposes only. WoundReference does not produce, market, advertise, re-sell or distribute healthcare goods or services consumed by, or used on patients. For information about specific products, please contact the manufacturer directly.

ActiGraft® is an autologous blood clot product 

CLAIMED FEATURES: ActiGraft® is an FDA-cleared regenerative wound care solution that enables health care providers to produce—in real time—in vitro blood clots from a patient’s whole blood. Once applied, the blood clot tissue serves as a protective covering, biologic scaffold and wound microenvironment to promote the natural wound healing processes of the body.

INTENDED USE: ActiGraft is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.

Clot size: 6sq cm

Manufacturer: RedDress
Information retrieved from manufacturer and/or FDA-approved labels
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Composition: Viable (living) cells May apply on full-thickness wounds May apply over exposed tendon/ bone/ muscle May apply over infected tissue Processing: Fresh (limited shelf life) Processing: Minimally manipulated
CPT CodeDescription Physician Reimbursement - Office Physician Reimbursement - Facility Facility Reimbursement
G0460Autolog prp not diab ulcer $0.00 $0.00 $1,749.26
G0465Autolog prp diab wound ulcer $0.00 $0.00
  • Based on national averages
  • Medicare payments for participating qualified health professionals (QHP) for services performed in their Offices (*) or at a Facility (** i.e., hospital outpatient department or ambulatory service center). Payments are nationally unadjusted average amounts, and do not account for differences in payment due to geographic variation. The allowed rate for non-participating physicians is set at 95% of the allowable for participating physicians. Non-participating physicians are subject to the limiting charge rules. The coinsurance is limited to 20% of the allowable fee.
  • When covered by the Medicare contractor, this manufacturer product is separately payable in a QHP office based on the Average Sales Price (ASP) as reported by the manufacturer on a quarterly basis.
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  • The information provided on this website is informational only. This is not a guarantee of Reimbursement Rates, nor is it intended to make recommendations regarding clinical practices. Information on this website is subject to change with out notice due to changes in reimbursement laws, regulations, rules and policies. The ultimate responsibility for correct coding lies with the provider of services. Please contact the appropriate payer for their interpretation of the appropriate code to use for the procedure.
  • CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2018, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced on Wound Reference are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the American Medical Association prior to the submission of claims for reimbursement of covered services.
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ActiGraft (formerly RD1 System) contains 3 sets of components for drawing and handling autologous blood and allowing it to clot in a controlled manner in order to form the provisional wound matrix (preparation kit) [1]:

  1. Blood withdrawal kit
  2. Coagulation initiator and accelerator component
  3. Clotting trays

All ActiGraft kit components are single-use.

Mechanism of action

This autologous blood clot tissue appears to meet the requirements as a living cell biologic. Although the central component of this therapy is blood, the autologous clot tissue creates a scaffold that performs  as a biologic delivery system that functions to control the release of growth factors and cytokines over several days. The matrix contains viable cells that are autologous, biocompatible, biological and consistent with a metabolically  active scaffold. It is proposed that this stroma may replace the extracellular matrix and facilitate the movement of cells such as keratinocytes, fibroblasts and endothelial cells among others.[2][3]


  • ActiGraft is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the whole blood clot gel produced by the ActiGraft System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.[1] 


  • The ActiGraft System is contraindicated in patients with wounds due to malignancy or wounds with active clinically diagnosed infection.


In 2018, ActiGraft received U.S. Food and Drug Administration (FDA) 510(k) clearance, under 21CFR 864.9245 (Automated blood cell separator).[1]

Evidence and Recommendations

Please refer to section 'Cellular and/or Tissue Products' in topic "Diabetic Foot Ulcers - Treatment" for other recommendations, rationales and summary of evidence supporting the recommendation below:

  • 2COther CTPs: For more superficial, non-infected, nonischemic DFUs (Texas 1A or 2A) that failed 4 weeks of standard therapy, clinicians might consider autologous blood clot product in addition to standard care, if other CTPs are not available (Grade 2C).
  • The FDA determined that ActiGraft is substantially equivalent to the predicate 3C Patch System. The ActiGraft System has the same intended use and very similar indications for use, technological characteristics, and principles of operation as its predicate device.[1] 

Instructions for use 

  • To use the kit, 10ml of blood is drawn into a sterile syringe containing CPDA1 anticoagulant. The citrated blood is then gently mixed with a suspension of calcium gluconate and kaolin powder, and the coagulating blood is placed in a sterile clotting tray, containing cotton gauze, to coagulate for 12 minutes. After 12 minutes, the whole blood clot is placed on a wound and dressed with a secondary sterile non-adherent dressing.
  • All kit elements and reagents are disposed of after a single use of the kit. The procedure may be repeated with a new kit after a few days.


This section currently focuses primarily on Medicare. It may be expanded in the future to include information on private insurers as well. 

Actigraft is eligible for reimbursement nationally from Medicare and Medicare Advantage via NCD 270.3 and G-0465 & G-0460 CTP codes.[4]

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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.


  1. FDA. 510(K) SUMMARY RedDress Ltd.’s RD1 System . 2018;.
  2. Snyder RJ, Schultz G, Wachuku C, Rashid AM, Ead JKK et al. Proposed Mechanism of Action of Topically Applied Autologous Blood Clot Tissue: A Quintessential Cellular and Tissue Based Therapy. Journal of the American Podiatric Medical Association. 2020;.
  3. Snyder RJ, Kasper MA, Patel K, Carter MJ, Kushnir I, Kushnir A, Serena TE et al. Safety and Efficacy of an Autologous Blood Clot Product in the Management of Texas 1A or 2A Neuropathic Diabetic Foot Ulcers: A Prospective, Multicenter, Open Label Pilot Study. Wounds : a compendium of clinical research and practice. 2018;volume 30(7):84-89.
  4. CMS . National Coverage Determination (NCD) for Blood-Derived Products for Chronic Non-Healing Wounds (270.3) . 2021;.
Topic 1579 Version 1.0