Avita Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System in Vitiligo

The study is slated to begin in the first half of 2020.

The U.S. Food and Drug Administration (FDA) approved AVITA Medical’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.

The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required at the point of care. It was approved by the FDA in September 2018 for use in the treatment of acute thermal burns in patients 18 years and older.

The vitiligo study is slated to begin in the first half of 2020. AVITA Medical will collaborate with a 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.  Of note: Use of the RECELL System in patients undergoing reconstruction of skin defects not associated with a burn injury is limited by Federal law to investigational use.

“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,” says Dr. Mike Perry, AVITA Medical Chief Executive Officer

“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,” adds 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.”