Reapplix ApS (Reapplix), developers of the unique LeucoPatch® active wound therapy, have today announced that the Centers for Medicare and Medicaid Services (CMS) in the USA have approved Reapplix’s clinical research study protocol for Coverage with Evidence Development. After careful review of Reapplix’s clinical research study protocol (LeucoPatch System in the Management of Hard-To-Heal Diabetic Foot Ulcers) CMS have determined that the study fulfils the requirements of the National Coverage Determination for blood derived products for chronic non-healing wounds.
Commenting on this news, Niels Erik Holm, COO at Reapplix said:
“On behalf of the lead investigators and the sponsor, Nottingham University Hospitals NHS Trust, we are proud that CMS has approved the protocol as a reimbursement study. This approval is akey step towards obtaining reimbursement for the use of LeucoPatch® in the USA.”
Graeme Brookes, CEO, added:
“We are committed to research and to providing evidence of the efficacy of LeucoPatch®. As our randomised controlled trial continues to progress in Europe, this approval now means that we can widen our regulatory and reimbursement strategies and opens up the opportunity for us to develop our plans for accessing the world’s largest healthcare market”
Graeme Brookes, CEO
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Reapplix is a Danish medtech company, founded in 2008 by Niels Erik Holm and Rasmus Lundquist. Reapplix’s core technology is based on the development of blood-based treatments for patients. The company’s first patented product is LeucoPatch® for the treatment of diabetic foot ulcers. Reapplix is a privately-held company backed by three leading Danish investors, SEED Capital, Novo Seeds and Vækstfonden (The Danish Growth Fund), and has been supported by Markedsmodningsfonden.