Reapplix today announced that it has received US FDA 510(k) clearance for its 3C Patch System® including the 3C Patch Centrifuge, currently being used at selected centres across Europe to treat a variety of hard to heal wounds.
This new 510(k) clearance expands the 3C Patch System® to include Reapplix’s new 3C Patch Centrifuge, which features optical sensors and automates the process of producing a 3C Patch®. This further improves usability as health care professionals now need just a few minutes’ hands on time to prepare the 3C Patch – which is an autologous platelet-rich plasma (PRP) gel from the patient’s peripheral blood to be placed in the wound to facilitate healing.
The proprietary 3C Patch Centrifuge further enhances the simple-to-use 3C Patch® device technology and 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 funding 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 this is expected to close recruitment in the first half of 2017, which will then enable data analysis in late 2017. Additionally, as the technology already has CE Mark approval, Reapplix is undertaking market acceptance testing in selected European markets and with Key Opinion Leaders to assess the pre-reimbursement commercial potential and over 5,000 devices have been used so far, treating over 500 patients.
With this 510(k) clearance now in place, Reapplix intends to begin the introduction of 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.
Founder Niels Erik Holm, COO commented on the news:
“Designing, building and testing our own dedicated 3C Patch Centrifuge has been a significant challenge but rewarding as this new centrifuge will reduce intervention time for users. With the new centrifuge the health care professionals just need to draw the blood and then focus on patient treatment. We expect that this new centrifuge will make it possible for more patients to use their own blood cells to heal their wounds.”
Graeme Brookes, CEO at Reapplix, added:
“Achieving this clearance unlocks our plans to initiate our first US users and we will now extend our market acceptance testing to selected US sites in 2017. The new 3C Patch® centrifuge further optimises our already simple to use technology. We are looking forward to helping patients in the key US market achieve better outcomes.”
Graeme Brookes, CEO
+45 53 77 74 47
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.