ASX Health Stocks: FDA approval for AVITA’s spray-on skin cells device RECELL

AVITA Medical’s quest to aid people with an unsightly skin disease has taken a big step forward, with its RECELL device winning a key FDA approval.

Avita's RECELL spray-on cells device may be a fair bit more sophisticated than this, but it's similarly helpful for the skin. Picture: Getty Images

AVITA Medical (ASX:AVH), a regenerative medicine company focusing on skin restoration, says it has Premarket Approval (PMA) from the US Food and Drug Authority for its spray-on vitiligo treatment RECELL.

RECELL has now become the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care.

---

For the latest health news, sign up here for free Stockhead daily newsletters

---

Using the device, a clinician can deliver autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.

Vitiligo is a disease that attacks pigment-producing cells, called melanocytes, resulting in their destruction or malfunction.

The condition, which affects up to 2 per cent of the global population, results in a loss of pigmentation in patches of skin.

“This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care,” said CEO Jim Corbett.

The PMA approval was given following results from the company’s pivotal trial evaluating the safety and effectiveness of the RECELL System.

The study had compared repigmentation success rates with RECELL in areas of skin resurfaced using ablative laser, versus standard of care treatment in another area.

Results showed that 36 per cent of RECELL treatments (versus 0 per cent of control treatments) resulted in repigmentation of at least 80 per cent of the treated area at six months, establishing super-superiority for the primary endpoint.

---

MORE FROM STOCKHEAD: ASX biotechs guarding against next pandemic | Austco nabs $7.4m contract | Small cap health stocks that pay dividends

---

At the same six-month point, physicians reported RECELL treatment as a success for 68 per cent of patients, and 80 per cent of patients self-reported RECELL treatment as a success.

The RECELL System is an autologous cell harvesting device that is used to prepare and deliver a regenerative cell suspension, Spray-On Skin Cells, using a small amount of a patient’s own skin.

Spray-On Skin Cells contain a combination of single living cells that stimulate healing and repigmentation throughout the wound bed.

Living Cell tumbles after update

Living Cell Technologies (ASX:LCT) fell 7 per cent on Monday morning after providing an update on its NTCELL clinical trial program for Parkinson’s disease.

But it recovered to be up more than 8 per cent for the day by 2.30pm (AEST).

LCT says it has now stepped back and commenced a scientific review of the clinical trial protocol in order to assess the recommendations proposed by Professor Carolyn Sue, a world expert in the field of Parkinson’s disease.

During this review period, LCT has enacted a temporary pause to the maintenance of the porcine herd to minimise unnecessary ongoing costs.

Since 2021, LCT has engaged NZeno to breed and maintain pigs to provide porcine choroid plexus tissue for the manufacture of NTCELL to be used in the company’s clinical trial.

The pig herd facility is based at NZeno’s location in Invercargill, New Zealand, and was built exclusively for LCT, entitling the company to maintain and manage its own source of pigs required for the manufacture of GMP grade NTCELL.

LCT says the herd will be built up again in 2024 when the scientific review has been completed.

---

Visit Stockhead, where ASX small caps are big deals

---

Oneview deal with NYSE-listed company

Oneview Healthcare (ASX:ONE) has entered into a reselling agreement with NYSE-listed Baxter International, one of the leading care communications providers in the world.

Under the deal, Baxter will resell Oneview’s Care Experience Platform (CXP) in the US market, including the CXP Cloud Enterprise.

Oneview had earlier advised the market that it was in advanced stages of signing an agreement with a major North American supplier of equipment to hospitals, which if signed may lead to additional sales of 3000 to 5000 beds per annum.

ONE says the deal with Baxter today is the agreement to which that update referred, and is considered material in the context of Oneview’s currently contracted book of approximately 15,000 beds.

This content first appeared on stockhead.com.au

SUBSCRIBE

Get the latest Stockhead news delivered free to your inbox. Click here

Originally published as ASX Health Stocks: FDA approval for AVITA’s spray-on skin cells device RECELL