×

New US FDA 510(k) clearance for expanded system including automated centrifuge

BIRKEROD, Denmark, April 27, 2017 (GLOBE NEWSWIRE) -- Reapplix today announced that it has received US FDA 510(k) clearance for its 3C Patch System® including the 3C Patch Centrifuge.

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.

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, Chief Executive Officer 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.

- Notes to editors -

Reapplix have developed a unique device technology for regenerative medicine. In Europe, this technology is currently known as the LeucoPatch® System, which is undergoing both clinical evaluation and commercial market testing. In the LeucoPatch® System, blood is collected from the patient in a single use LeucoPatch® Device, which is effectively a precision engineered mini cell processor. The LeucoPatch® Device, in combination with the LeucoPatch 3CP® Centrifuge, uses the patent protected 3CP® Technology to produce each autologous LeucoPatch® on demand using a simple to use process, with no reagents, which fits in well with existing clinical work flow.

LeucoPatch® is currently being used at selected centres across Europe to treat a variety of hard to heal wounds. In addition to this, LeucoPatch® is being evaluated for the treatment of diabetic foot ulcers in a randomized controlled clinical study that is expected to be completed in 2017. Diabetic foot ulcers are associated with high morbidity and substantial health care costs as up to 40% of diabetic foot ulcer wounds remain unhealed after one year using current standards of care. Given these market dynamics, there is a clear need for a cost-effective and efficacious treatment option.

Reapplix’s unique technology - a single use medical device used to prepare an autologous platelet-rich plasma (PRP) gel from the patient’s peripheral blood by centrifugation, without the addition of any reagents – first achieved US FDA 510(k) clearance in February 2016. The further clearance achieved in April 2017 includes Reapplix’s automated 3C Patch Centrifuge in the system.

Reapplix ApS is a privately-held wound care company backed by three leading Danish investors, SEED Capital Denmark, Novo Seeds and Vækstfonden (The Danish Growth Fund).

www.reapplix.com


For further information, please contact: Graeme Brookes, Reapplix ApS, +45 53777447 or email gnb@reapplix.com Tony Stephenson, Exitus Communications, +44 7899 796655 or email tony@exituscommunications.co.uk

Source: Reapplix