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Drug news

3C Patch System gets 510(k) approval for wound healing- Reapplix

Read time: 1 mins

Last updated:4th Mar 2016

Published:4th Mar 2016

Source: Pharmawand

Reapplix announced that it has received US FDA 510(k) clearance for its 3C Patch System. LeucoPatch is a triple layer patch produced from the patient’s own blood without the addition of reagents or additives. LeucoPatch is produced on demand in a disposable LeucoPatch Device using a three step process over 20 minutes. The patch then delivers active cells and growth factors key to wound healing.

Comment: 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.

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