AVITA Medical (ASX: AVH, OTCQX: AVMXY) is a global regenerative medicine company. Today the company announced that it has commenced the U.S. national market launch of the RECELL® Autologous Cell Harvesting Device (RECELL® System) for the treatment of acute thermal burns in patients 18 years and older. The U.S. sales team of Regenerative Tissue Specialists and Clinical Training Specialists that joined AVITA Medical in November 2018 has been trained and fully deployed across the U.S. in support of the nationwide launch of the RECELL System.

In advance of the national launch, AVITA Medical has been actively fulfilling orders in response to strong market demand. Clinical evidence, years of successful patient outcomes and favorable health economic results have created ideal market conditions for the RECELL System. AVITA’s new commercial team is now in active discussions with nearly half of the total number of burn centers across the U.S.  The Company also announced the successful commercial results that have been achieved in advance of the national market launch:

  • 36 burns centers have begun the purchase authorization process with their hospital administration.
  • 25 burn centers have been trained and certified in the use of the RECELL System.
  • 12 accounts have already placed orders and have received commercial shipments.

“We are pleased that in advance of our market launch and without any direct promotional effort the clinical and economic benefits of the RECELL System have generated strong interest and sales orders,” said Erin Liberto, Chief Commercial Officer. “Based on the pre-promotion demand, we are excited to see the response now that our full sales team of 20 has been deployed.”

AVITA Medical’s U.S. commercial team brings extensive surgical and operating room experience to support the RECELL market adoption. Each member of the sales team has burn care experience with an average of 16 years of experience in the field, and 100 percent of the team members have previously launched a new product. The team’s Clinical Training Specialists are all credentialed clinicians with first-hand burn experience, and the Regenerative Tissue Specialists are adept at effectively navigating hospital approval processes. With the continued scientific and clinical support of a distinguished Medical Affairs staff, the AVITA team is well positioned to drive the market success of the RECELL System.

“I could not be more pleased with the quality of individuals and the collective focus they have all devoted to the RECELL System launch,” said Terry Bromley, Vice President of Commercial Operations. “We are very delighted with the enthusiasm our highly experienced sales team has expressed for the RECELL System, and how quickly this team of professionals has prepared for the U.S. launch.”

Key commercial achievements after the U.S. Food and Drug Administration (FDA) approved the RECELL System in September 2018 include:

  • American Burn Association (ABA) issued reimbursement coding guidelines within one week of approval.
  • Commercial product availability within two weeks of approval.
  • First commercial sale within two days of product availability.
  • Entire U.S. sales team in place within eight weeks of approval.
  • National sales launch commenced in January 2019.

Healthcare professionals should read the INSTRUCTIONS FOR USE – RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of important safety information including contraindications, warnings and precautions.