The UK’s National Institute for Health and Care Excellence is seeking additional information on Avita Medical’s ReCell Spray-On Skin System after an assessment panel expressed doubts about the device.
The novel technology uses a piece of patient skin to create a suspension of skin cell components that are sprayed onto the side of a burn. The cells multiply quickly, embedding themselves in the base of the wound and encouraging growth of healthy skin.
According to Avita, the result is shorter healing time, fewer dressing changes, earlier discharge, better skin color matching, less scarring and a smaller skin graft donor site.
In a draft recommendation calling for further research, NICE said the system shows promise, but lacks sufficient evidence of clinical and cost benefits. The National Health Service watchdog said Avita also needs to identify which patients might benefit from its use.
Avita’s interim CEO, Tim Rooney, said the company is pleased with NICE’s response and looks forward “to further demonstrate evidence to support the case for adoption.”
NICE is accepting comments on its recommendation through May 19 at http://guidance.nice.org.uk/MT/205/Consultation/DraftGuidance. Comments should address whether all of the relevant evidence has been taken into account, whether the summaries of clinical effectiveness and resource savings are reasonable interpretations of evidence, and whether provisional recommendations are sound and a suitable basis for NHS guidance.
View the draft recommendation and supporting documents at www.fdanews.com/ext/resources/files/04/04-16-14-ReCell.pdf. — Lena Freund