Investors: Press Release
First Patient Enrolled in AVITA Therapeutic’s Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo
“The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutic’s pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications,” said Dr.
Vitiligo is an autoimmune disease that attacks the epidermis layer of skin resulting in loss of color or pigmentation. This serious skin condition affects up to 2% of the population worldwide, including an estimated 6.5 million Americans.i Vitiligo has a comparable market size & psychosocial impact to other major dermatology diseases including psoriasis (thick, scaly skin) and atopic dermatitis (red, cracked skin). IV-VI Like these diseases, patients with vitiligo may suffer from poor body image along with low self-esteem, leading to an impaired quality of life.ii There is currently no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.iii
“While often considered a cosmetic issue, vitiligo can greatly impact the quality of life of those living with the disease, and treatment options are limited,” said
The multi-center pivotal study will assess the safety and effectiveness of the RECELL System in treatment of depigmented vitiligo lesions at 24 weeks in patients whose vitiligo is stable, meaning they have not had new vitiligo lesions or lesions that have expanded for at least one year. Clinicians will obtain a small amount of the study participant’s own healthy skin at the point-of-care to prepare a suspension of Spray-On Skin™ Cells using the RECELL System that will then be applied to the vitiligo lesion. Additional long-term safety and effectiveness data, including sustained repigmentation of the vitiligo lesion, will be collected over the course of the study.
In parallel with the clinical study,
Of note: Use of the RECELL System in patients undergoing reconstruction of skin defects not associated with a burn injury is limited by the Federal law to investigational use.
Authorized for release by the Chief Executive Officer of
AVITA Therapeutics’ first
In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in
To learn more, visit www.avitamedical.com.
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This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
i Advances in Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon, et al. J Clin Aesth Derm. 2017
ii Willingness-to-pay and quality of life in patients with vitiligo. Radtke, et al. BJD. 2009
V The burden of vitiligo: Patient characteristics associated with quality of life. Homan, et al. JAAD. 2009
VI Comparison of the Psychological Impacts of Asymptomatic and Symptomatic Cutaneous Diseases: Vitiligo and Atopic Dermtitis. Noh, et al. Annals of Derm. 2013
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