Avita Medical has hit a hiccup with its Recell Device sales in Europe. The Melbourne, Australia-based company said the sales of the technology had been interrupted after the notified body responsible for EU certificates reported open items related to administrative and procedural non-conformities.
The company said these open items are limited to product distributed within the EU and are not related to product quality, performance or safety. In addition, this action has no impact on the sale of products outside of the EU.
“It is important to note that this interruption is unrelated to the performance and safety of our products and does not impact the U.S. market,” Dr. Mike Perry, CEO of Avita Medical said in a release. “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.”
Avita Medical received FDA approval of the Recell Autologous Cell Harvesting Device for the treatment of acute thermal burns in patients 18 years and older in September 2018. Avita was one of the first companies to qualify for FDA's Expedited Access Pathway designation.
The company’s competitors include Canton, MA-based Organogenesis and Scottsdale AZ-based RenovaCare.