The expanded indication covers wound injuries after surgical excision, resection and traumatic avulsion. Credit: anatoliy_gleb / Shutterstock.com.

Avita Medical has received approval from the US Food and Drug Administration (FDA) for its Recell system for the treatment of full-thickness skin defects.

The regulator has approved the company’s premarket approval supplement application for the system.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Avita Medical CEO Jim Corbett said: “This is a landmark approval representing an inflection point for Avita Medical.

“The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”

The indication has been expanded to cover a wide range of full-thickness skin defects, including wound injuries after surgical excision, resection and traumatic avulsion.

This move is expected to help the company significantly expand its market potential at least five times.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In 2018, the company first received approval from the FDA for the Recell system to treat severe burns.

It is an autologous cell-harvesting device that uses a small amount of a patient’s skin to prepare, produce and deliver a regenerative cell suspension called Spray-On Skin cells.

The Spray-On Skin cells comprise a combination of single living cells, which stimulate healing and re-pigmentation throughout the wound bed to enable a definitive closure.

According to the findings of the pivotal trial conducted by the company, Recell showcased good healing rates for soft tissue repair and reconstruction.

Corbett added: “In anticipation of the expanded indication, we more than doubled our field sales organisation in the first few months of the year.

“Our sales team is now ready, trained and fully prepared for the commercial launch, which will commence on 1 July 2023.”