Reapplix has received Medicare reimbursement coding instructions from the Centers for Medicare and Medicaid Services (CMS) with a national average payment rate of US$1,622.74. The rate covers each patient visit to hospital outpatient departments to receive 3C Patch therapy for hard-to-heal diabetic foot ulcers.
Reapplix also announces that it has successfully closed a US$22.6M equity financing round, primarily to accelerate the US commercialisation of 3C Patch.
Reapplix president, James G Wetrich, comments: “We are delighted that the Reapplix US team can offer our unique, autologous wound care technology with an appropriate reimbursement rate to allow health care professionals to help patients with diabetic foot ulcers who are still in need of novel therapies. Reapplix has invested in a substantial body of evidence supporting the use of 3C Patch, including a randomised controlled trial published in The Lancet, which led to the International Working Group on the Diabetic Foot (IWGDF) recommending the use of our technology.”
The reimbursement coding instructions received from CMS were provided under the Coverage with Evidence Development (CED) framework. Access to the procedure is granted nationally via a CMS-approved claims-based programme.
In parallel, CMS has re-opened its National Coverage Analysis (NCA) process for autologous blood-derived products for chronic non-healing wounds with a stated, expected NCA completion date of January 2021. Reapplix expects that the CED framework arrangement will be replaced by a positive National Coverage Determination decision with a permanent future coding and reimbursement rate at the beginning of 2021.
The equity financing round was completed with new investors, including North East Health Care, Lauxera Capital Partners, and MK Ventures, private life science investors Bo Jesper Hansen and Jan Struve, as well as existing investors, including Novo Holdings and Vækstfonden (The Danish Growth Fund).
Chief executive officer Graeme Brookes says: “We are very pleased to have obtained sufficient capital to drive revenue growth and strengthen our value proposition in the fast-growing US advanced biologic wound care market. Now that we also have the US reimbursement rate and coding confirmed, we can execute on our plans to provide our proven and effective technology to address the unmet medical need for diabetic foot ulcer patients and to help healthcare professionals achieve their treatment goals. Finally, I would like to welcome our new investors, who further strengthen the knowledge base and commitment already in place with our highly supportive existing investor group.”
Samuel Levy, founding partner at Lauxera Capital, adds: “Approximately every 20 seconds, a limb is lost as a consequence of diabetes. Lauxera Capital is delighted to partner with Reapplix to transform the treatment of diabetic foot ulcers with our 3C Patch therapy. Reapplix’s US commercial organisation is extremely talented and is poised to launch a true innovation in the fast-growing 1.4-billion-dollar advanced biologic wound care market.”