Commercialization of this unique, breakthrough treatment for diabetic foot ulcers to be accelerated in the United States
(Birkerod, Denmark) – Reapplix announces that a final National Coverage Determination (NCD) from the Centers for Medicare and Medicaid Services (CMS) has secured coverage for the company’s 3C Patch® system. The NCD describes the coverage of autologous platelet-rich plasma for the treatment of chronic, non-healing diabetic wounds for up to 20 weeks. CMS specifies that coverage only applies to FDA-cleared devices with relevant wound indications, of which 3C Patch® is currently the only actively marketed product available in the United States.
Reapplix Chairman of the Board, Richard Twomey commented:
“We’ve been looking forward to the publication of the final NCD for a long time as it removes a lot of uncertainty on the US market. This is the best-case scenario we have been working towards and it is now up to us to deliver. We are in the midst of preparing our US commercialization efforts to ensure that we will be able to roll-out our 3C Patch® system to clinics as soon as possible. People with diabetes and chronic foot ulcers are a patient group for which there is still no adequate treatment and we are therefore eager to provide our effective and proven 3C Patch® solution to the benefit of patients and health care providers.”
The NCD will go into effect immediately, but specific coding details and reimbursement levels are beyond the scope of the published decision memo. Reapplix is confident that a reasonable level of payment will be ascribed to the procedure in the coming months. Under the current, temporary coding regime, a 3C Patch® application is reimbursed at a national average reimbursement rate of USD 1,715.
CMS has a period of up to 12 months to advise Medicare Administrative Contractors (MACs) on the conditions under which an item or service is covered. MACs serve as the primary operational contact between CMS and health care providers. The transmittal period may be shorter than 12 months, and therefore, Reapplix is now focusing all its commercialization efforts on the US market.
Rasmus Lundquist, Chief Scientific Officer and Founder
+45 26 71 74 47
Founded in 2008, Reapplix specializes in the biological treatment and management of diabetic foot ulcers. The patented 3CPatch® System is an innovative, evidence-based biological wound therapy made entirely from the patient’s own blood – nothing else. Headquartered in Denmark, with a dedicated sales and distribution team in the US, Reapplix is poised for commercial launch with particular focus on the US market.
Every wound is personal.