Reapplix today announced that it has received US FDA 510(k) clearance for its 3C Patch System™.
Reapplix’s proprietary simple-to-use device technology has been cleared for the following indications for use: “The 3C Patch System™ is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System™ is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.” Reapplix is currently conducting a large scale Randomized Controlled Trial of its technology in ~250 Diabetic Foot Ulcer patients in up to 35 centres in UK, Sweden and Denmark and expects to report the data from this in 2017. Additionally, given that the technology already has CE Mark approval, Reapplix is undertaking market tests in selected European markets to assess the pre-reimbursement commercial potential. This 510(k) clearance opens the way for Reapplix to introduce its unique device technology to the US market, where it will be marketed as the 3C Patch System™ for the indications for use cited above.
Founders Niels Erik Holm (COO) and Rasmus Lundquist (CSO) jointly commented on the news: “We are delighted to have achieved this milestone that will allow US patients to use their own blood to assist in the management of their wounds in US wound care clinics. Our ongoing CMS approved CED/IDE study is expected to further support our access to the world’s largest advanced wound care market.”
Graeme Brookes, Chief Executive Officer at Reapplix, added: “Achieving this clearance enables us to build out our plans to bring our technology to the key US market. We are well positioned to continue to build value whilst achieving our goal of providing effective solutions to healthcare providers to help patients achieve better outcomes.”