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AVITA Medical (ASX: AVH) has achieved a "breakthrough approval" with the US Food and Drug Administration (FDA) by gaining pre-market approval for its RECELL system to treat vitiligo, an autoimmune disease that causes discoloration of the skin and affects around 2 per cent of the global population.
This means that RECELL is the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care for the repigmentation of stable depigmented vitiligo lesions.
Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.
"RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells," says AVITA Medical's Los Angeles-based chief executive officer Jim Corbett, who took on the role in September last year and last week was joined by the company's new chief financial officer, David O’Toole.
"This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care.
"We look forward to offering a meaningful one-time treatment option for patients with stable vitiligo across the US."
The pre-market approval was based on a pivotal safety and effectiveness trial for the product's application, which showed 36 per cent of RECELL treatments resulted in a repigmentation of at least 80 per cent of the treated area at six months, compared to zero per cent for control treatments.
At the same six-month point, treating physicians reported RECELL treatment as a success for 68 per cent of patients, while 80 per cent of patients self-reported RECELL treatment as a success.
The news comes within two weeks of AVITA receiving pre-market approval from the FDA for the same product's use in treating full-thickness skin defects, such as wounds and soft tissue infections after surgery.
"The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings," Corbett said on 8 June.
AVITA operates on a calendar year, and last month reported its first-quarter results with commercial revenue of US$10.5 million ($15.3 million), up 40 per cent year-on-year, although the group still ran at a net loss of US$9.2 million ($13.4 million). Gross margin was up by eight percentage points at 84 per cent.
"With a solid first quarter, we are on track to deliver a year of significant growth revenue," Corbett said on 12 May.
AVH shares are down 5 per cent today at $4.74, giving the company a market capitalisation of $595 million. This price level is up 261.83 per cent over the past 12 months, representing significant recovery to levels not seen since September 2021 but still well below the $16.30 share price traded before the pandemic in early 2020.
Formerly known as Clinical Cell Culture, AVITA is dual listed on the NASDAQ and is now headquartered in California, but its cornerstone RECELL product was was developed by Perth surgeon Fiona Wood and used to treat victims of the Bali bombings in 2002. The company's share registry is listed in Perth.
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