Avita’s Spray-On Skin Cells RECELL approved by US FDA. Picture Getty
Health & Biotech
Regenerative medicine company focusing on skin restoration, Avita Medical (ASX:AVH), said the US FDA has approved the application for Premarket Approval (PMA) of its RECELL System for the treatment of vitiligo.
RECELL has now become the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care. 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 result is a loss of pigmentation in patches of skin, and affects up to 2% of the population worldwide.
“This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care,” said Jim Corbett, AVITA’s CEO.
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 the RECELL treatment in areas of skin resurfaced using ablative laser, versus standard of care treatment in another area.
Results showed that 36% of RECELL treatments (versus 0% of control treatments) resulted in repigmentation of at least 80% of the treated area at six months, establishing super-superiority for the primary endpoint.
At the same six-month point, physicians reported RECELL treatment as a success for 68% of patients, and 80% 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.
The Spray-On Skin Cells contain a combination of single living cells that stimulate healing and repigmentation throughout the wound bed.
Living Cell Technologies (ASX:LCT) fell 7% this morning after providing an update on its NTCELL clinical trial program for Parkinson’s disease.
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.
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 3,000 to 5,000 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.
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