AVITA Shares Climb Following Positive Results From RECELL System Study In Stable Vitiligo Lesions

AVITA Medical RCEL reveals positive top-line results from a pivotal trial evaluating the safety and effectiveness of the RECELL System for repigmentation of stable vitiligo lesions.

The clinical trial 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. The pivotal trial achieved its primary effectiveness endpoint of super-superiority.

Dr. Mike Perry, Chief Executive Officer, commented: "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.”

These positive top-line results facilitate the company to submit a supplement pre-marketing application for this indication later this year.

Vitiligo is a disease that attacks pigment-producing cells, called melanocytes, resulting in their destruction or malfunction, the loss of pigmentation in patches of skin.

Price action : AVITA shares are trading around 5 percent higher at $6.50 on Monday during after-hour session.