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American Diabetes Association Meeting, Orlando
Friday, 22 June 2018

We look forward to attending this conference, where the results of the large scale Randomised Controlled trial with our technology will be presented in public for the first time by the Principle Investigators in the study.

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Reapplix announces new US FDA 510(k) clearance for expanded system, including automated centrifuge, a further advancement of its regenerative wound care technology

by Rasmus Lundquist

Reapplix today announced that it has received US FDA 510(k) clearance for its 3C Patch System® including the 3CP Centrifuge.

This new 510(k) clearance expands the 3C Patch System® to include Reapplix’s new 3CP 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.

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 Press release - 510(k) for expanded System April 2017

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