Replies to post #4541 on Avita Medical Ltd (RCEL)

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AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of
Clinical Feasibility Study to Evaluate RECELL System for Vitiligo
Study expected to commence in first half of 2020
Valencia, Calif., USA, and Melbourne, Australia, 30 December 2019 — AVITA Medical Limited (ASX:
AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to
address unmet medical needs in therapeutic skin restoration, announced today that the U.S. Food and
Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE)
application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL®
Autologous Cell Harvesting Device (RECELL® System) for repigmentation of depigmented lesions
associated with stable vitiligo.
“Vitiligo affects approximately 6.5 million people in the United States(i)
, rivalling the prevalence of
psoriasis(ii)
; however, there are limited treatment options available to patients to permanently restore
skin pigmentation,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We’re pleased with
the FDA’s decision which allows us to begin our vitiligo study in the first half of 2020. Based on the
outcomes of the feasibility study, we anticipate proceeding with a pivotal clinical trial to pursue FDA
approval of the RECELL System as a cell-based repigmentation treatment option for stable vitiligo.”
Vitiligo is a disease resulting in loss of color, or pigmentation, in patches of skin that impacts the quality
of life for those living with the condition.
(iii) 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.
(iv)
“This study expands on peer-reviewed, published effectiveness outcomes to confirm the feasibility of
RECELL as a treatment for repigmentation in cases of stable vitiligo,” said Andy Quick, AVITA Medical’s
Chief Technology Officer. “Given the RECELL System’s broad approval outside of the U.S., more than
1,000 vitiligo patients have already been treated globally and reported repigmentation.”
AVITA Medical will collaborate with a leading medical center to conduct a pilot study with 10 patients
who have vitiligo lesions that have been stable for at least one year. Areas of the vitiligo lesion will be
randomly treated with slightly varying cell suspensions prepared using RECELL to confirm response
rates and optimal suspension parameters.
The randomized controlled study’s primary effectiveness measure is the percent area of repigmented
skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment.
Additional effectiveness data collected over the course of the 24-week study will include degree of
repigmentation achieved and patient rating of repigmentation.