OREANDA-NEWS. Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced approval from the U.S. Food and Drug Administration (FDA) for a second expansion of its Compassionate Use Investigational Device Exemption (IDE) program for ReCell®.

This IDE supplement allows Avita Medical to increase the total number of patients allowed for clinical evaluation of ReCell® by 50 percent, bringing the total number of patients from 24 to 36 patients who have insufficient healthy skin available for standard skin grafting of their injury. The IDE allows the application of ReCell® beyond burns and to larger, more serious defects than those studied in the U.S. pivotal trial. Under the compassionate use protocol, investigational use of ReCell® may be granted in cases where the patient's treating physician believes that there is no suitable alternative treatment.

"A second approval from the FDA to expand the number of compassionate use cases in our ReCell® IDE program is another mark of validation for the technology, particularly as we continue our pivotal U.S. trial for ReCell® in burns, for which we recently completed enrollment, " commented Adam Kelliher, CEO of Avita Medical. "This expansion allows for the opportunity to treat even more patients who have no other alternative treatment options with ReCell® for a catalyzed, effective regenerative healing effect that may lead to potentially life-saving outcomes."

The FDA approved the initial IDE for up to 12 subjects with life-threatening wounds in April 2014. Under the original IDE, 12 compassionate use cases using ReCell® have been conducted with success at several leading institutions, including Wake Forest Baptist Medical Center, Maricopa Medical Center, Walter Reed National Military Medical Center and MedStar Washington Hospital Center. In October 2015, the FDA doubled the number of patients permitted to be treated under the IDE from 12 to 24 patients. To date, 23 patients have been enrolled in the IDE program and treated successfully with ReCell® at additional leading institutions, including University of California San Diego Health System and Regional Medical Center / University of Tennessee.

Individual and case series results have been presented to the international medical community at various professional meetings over the past two years, such as the Southern Region Burn Conference, the 17th Biennial Congress of the International Society for Burn Injuries, the 47th Annual Meeting of the American Burn Association, Avita's Skin Regeneration Symposium, the Military Health System Research Symposium, and the Tissue Engineering and Regenerative Medicine International Society World Congress.