Regenerative medicine company Avita Medical has temporarily halted sales of Recell system in the European Union (EU) amid reports of certain non-conformities.
The agency responsible for EU certificates reported open items associated with administrative and procedural non-conformities.
These items are limited to product distributed within the EU region and not related to product quality, performance or safety, noted Avita Medical.
The company is not active in the product promotion in the EU and its activity in the region is limited to filling purchase requests. As a result, the company expects this temporary interruption to be financially immaterial.
Approved by the US Food and Drug Administration (FDA) in September last year, Recell device is developed to treat acute thermal burns by preparing spray-on skin cells with a small amount of a patient’s own skin.
Indicated for patients aged 18 years and older, the device is suitable for point of care use alone or along with autografts, based on the burn injury depth.
Across various markets, the system is marketed to promote skin healing in burns, acute wounds, scars and vitiligo, among others.
Sales of the device in ex-EU markets are not impacted.
Avita Medical CEO Mike Perry said: “It is important to note that this interruption is unrelated to the performance and safety of our products and does not impact the US market.
“We will work closely with the authorities to close this administrative request as soon as possible, and no later than the third quarter of calendar 2019.
“We do not actively promote in the EU at this time but do want to ensure that our products are available as soon as possible to those institutions who request it and to patients who can benefit from their use.”
Avita Medical further announced the partnership with M3 Group company COSMOTEC to market and distribute the Recell system for the treatment of burns and other wounds in Japan.