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AVITA Medical Achieves Positive Topline Pivotal Trial Results for Treatment of Stable Vitiligo Using the RECELL System

The study achieved its primary effectiveness endpoint of super-superiority.

AVITA Medical continues to plan for submission to FDA by the end of 2022

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AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced positive topline results from a pivotal randomized, controlled trial evaluating the safety and effectiveness of the RECELL® System for repigmentation of stable vitiligo lesions.

The study compared repigmentation success rates, in a design where each patient randomly received RECELL treatment in one portion of depigmented area and treatment with the study control in another portion of depigmented area. The study control treatment was the standard of care narrowband ultraviolet-B phototherapy, which is typical first-line treatment for vitiligo. Repigmentation was evaluated 6 months after treatment by an expert central review committee (CRC).

The CRC reported the following:

  • Fifty-six percent (56%) of RECELL treatments (versus 12% of control treatments) resulted in repigmentation of more than 50% of the treated area
  • Thirty-six percent (36%) of RECELL treatments (versus 0% of control treatments) resulted in repigmentation of at least 80% of the treated area, establishing supersuperiority for the primary endpoint (p<0.025)

RECELL’s compelling safety profile to date is reflected in preliminary review of adverse events in this study.

These are the first results from a U.S. randomized, controlled trial of the RECELL System in treating patients with segmental and nonsegmental stable vitiligo and provide a foundation for communicating favorable clinical benefit in pursuit of FDA approval via submission of a PMA supplement for this indication later this year.

Dr. Mike Perry, Chief Executive Officer of AVITA Medical said,

“Vitiligo often has a severe impact on quality of life and is a therapeutic area within which there have been very limited treatment options. We are excited by our topline data, as we are now closer to our goal of providing patients with a durable, clinically meaningful, one-time treatment for repigmentation.”

He added, “RECELL has the potential to address the unmet medical need for an estimated 1.3 million people in the U.S. who suffer from stable vitiligo, and further, we envision a potential opportunity for RECELL as part of a multi-modal treatment plan for patients achieving stability with JAK inhibitor treatment.”

“Repigmentation is challenging to manage and burdensome for patients with vitiligo,” said Iltefat Hamzavi, MD, of Henry Ford Hospital (Detroit, MI), lead investigator of the trial. “These are encouraging results that underscore the potential for RECELL to address repigmentation in patients with stable vitiligo in a rapid and sustained fashion which is distinct from existing therapies.”

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. Vitiligo affects up to 2% of the population worldwide,i including up to 6.5 million Americans, ii with an estimated 1.3 million suffering from stable vitiligo. Vitiligo has a comparable psychosocial impact to other major dermatology diseases including psoriasis (thick, scaly skin) and atopic dermatitis (red, cracked skin).iii, iv, v Like these diseases, those living with vitiligo may suffer from poor body image along with low self-esteem, leading to an impaired quality of life.

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