Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell

Avita Medical (ASX:AVH) said yesterday that sales of its Recell device in the European Union were temporarily interrupted due to an administrative issue with its notified body and announced a new Japanese marketing and distribution deal. The Valencia, Calif.-based company said that the sales interruption occurred after its EU-based notified body “reported open items related to administrative and procedural non-conformities,” but said that the action has no impact outside the EU and that issues are not related to product quality, safety or performance. Avita said that it does not actively promote the product in the region and that activity there is limited to filling purchase requests as they are received, with an average of $40,000 in sales per month. “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. 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 CEO Dr. Mike Perry said in a press release. In a separate release, Avita said that it inked a Japanese marketing and distribution deal with Cosmotec, who recently filed with the country’s Pharma...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Distribution Featured Regulatory/Compliance Wound Care avitamedical Source Type: news