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.”