The AVITA Medical Inc (ASX: AVH) share price is set to finish higher today. This comes after the company announced an update from the United States Food and Drug Administration in regards to its Recell System.
At the time of writing, the regenerative medicine company's shares are fetching for $2.64, up 6.02%.
What did Avita announce?
In today's statement, Avita advised it has received approval from the FDA for its Recell Autologous Cell Harvesting Device.
This has led investors to bid up the Avita share price following the positive news from the company.
According to the release, Avita can now begin to supply and market the enhanced Recell system to the United States market.
The Recell System is a device that is used to treat a patient's acute thermal burns. Healthcare professionals produce a suspension of 'Spray-On Skin' cells using a small sample of the patient's own skin. In turn, this reduces the amount of the donor skin required to heal the burn injury.
The new Recell System has been modified to reduce set-up steps by around one-third and can be operated with reduced support personnel.
This follows the company's first United States product, the original Recell System, which received FDA approval in September 2018. With the new ease-of-use design now approved, Avita will launch the product in the second quarter of 2022.
Avita CEO, Dr Mike Perry commented:
To ensure Recell continues to meet the needs of our customers, we initiated a program to explore how we could improve the device, and then addressed those matters with this new system.
Based upon research and human factors testing, we are confident that the new Recell System will be positively received by the burn community. The enhancements will provide a range of benefits to clinicians using the device and in turn, patients will benefit as the procedure becomes more efficient.
Avita share price snapshot
The Avita share price has been on a trending decline the past 12 months, reaching a multi-year low of $2.46 last month. Over the period, its shares have lost almost 60%, with year to date down 22%.
Avita commands a market capitalisation of roughly $186.88 million and has approximately 70.89 million shares on its registry.
