Reapplix also announces that it has successfully closed a USD 22.6M (DKK 150M) equity financing round, primarily to accelerate the US commercialization of 3C Patch® (www.3cpatch.com).
Reapplix President, US, James G. Wetrich commented: “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 program.
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 said: “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 added: “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 organization is extremely talented and is poised to launch a true innovation in the fast-growing 1.4 billion dollar advanced biologic wound care market.”
GRAEME BROOKES, CEO
+45 53 77 74 47
Founded in 2008, with SEED Capital as its first institutional investor, Reapplix specializes in the biological treatment and management of diabetic foot ulcers.
Diabetic foot ulcers have a debilitating impact on patients. Despite numerous treatment options, about 60% of all patients experience a wound that does not heal. If the severity of the wound progresses to grade 4 or 5, the cost of treatment is eight times higher than a grade 1 or 2 wound. For about 20% of patients, treatment ends in amputation within one year.
Reapplix has established that one of the keys to successful wound treatment lies in the body’s capacity to heal – and each patient is central to that process. The patented 3CPatch® System is an innovative, evidence-based biological wound therapy made entirely from the patient’s own blood – nothing else. The 3C Patch® is thus personalized and targeted towards the treatment of the individual patient’s diabetic foot ulcer. Using just a small sample of the patient’s blood, the 3C Patch® System separates, coagulates and compacts the blood components into a solid patch comprising a concentration of proteins, active cells and growth factors.
Each 3C Patch® takes about 20 minutes to produce and is applied directly to the wound at point-of-care. One of few evidence-based wound treatments, the 3C Patch® is clinically proven to significantly accelerate wound healing, nearly doubling the chance of healing, and improve wound reduction of hard-to-heal diabetic foot ulcers (Randomized Controlled Trial data published in The Lancet in September 2018). The outcome is a personalized wound treatment that draws on each patient’s unique ability to help their own healing process.
Headquartered in Denmark with US subsidiary Reapplix Inc. established in Texas, Reapplix is poised for commercial launch, with particular focus on the US market.
Every wound is personal.