Regenerative medicine firm Avita Medical has temporarily stopped the sales of Recell device in the Europe Union region.
Image: Recell system will be used to treat burns and other wounds. Photo: courtesy of zole4 / FreeDigitalPhotos.net.
The sales of the Recell device has been interrupted after the notified body responsible for EU certificates reported open items related to administrative and procedural non-conformities
Avita said that the open items are limited to product supplied within the EU and are not related to product quality, performance or safety. The current action has no effect on the sale of products outside of the EU.
The firm is not active in the promotion of products in the EU, and its activity in the region is restricted to filling purchase requests as they are received.
In September 2018, the company secured approval from the US Food and Drug Administration (FDA) for its Recell autologous cell harvesting device (Recell system) to treat acute thermal burns in patients 18 years and older in September 2018.
Avita Medical CEO Dr Mike Perry said: “We will work closely with the authorities to close this administrative request as soon as possible, and no later than the 3rd 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.”
Separately, Avita Medical has collaborated M3 Group firm Cosmotec to market and distribute the Recell system to treat burns and other wounds in Japan.
In February this year, Cosmotec has filed an application with Japan’s Pharmaceuticals and Medical Devices Act (JPMDA) for the Recell system. The JPMDA has accepted the application, and the assessment is expected to be completed in a year.
Cosmotec president Kiyoshi Takei said: “The number of patients suffering from chronic wounds and decubitus ulcers is increasing in Japan due to aging. Japan is also planning for the Tokyo Olympic Games in 2020 and must be prepared for major disasters such as a large earthquake. We are very proud to add the RECELL System to our product lineup.”
Avita’s patented and proprietary collection and application technology offers advanced treatment solutions derived from the regenerative properties of a patient’s own skin.