RenovaCare, Inc. announced that its investigational device exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This approval enables the company to conduct a clinical trial to evaluate the safety and feasibility of its SkinGun™ and CellMist™ System for the treatment of burn wounds using skin cells obtained directly from the burn patient. The clinical trial protocol is an open-label, single-arm clinical study that will enroll 14 adult burn subjects with partial-thickness second degree thermal burn wounds.

The company expects to conduct the clinical study at four U.S. burn centers over twelve months. Spraying Cells onto Burns and Wounds: to date, over 70 patients with various types of burns have been treated in investigator initiated clinical case studies utilizing the technology underlying the company's SkinGun™ and CellMist™ System, which the company has developed as a potential alternative to skin grafting and other treatment options, such as in vitro cultured skin epithelial cells that require a specialized and expensive external laboratory. Clinical outcomes of these early experimental studies have been peer-reviewed and published in several medical journals, including Burns and Annals of Plastic Surgery.

In late 2019, the company was issued a patent allowing the company's novel SkinGun™ spray device to spray a variety of tissues and cells, thus opening the door for its potential application in the regeneration of other tissues, beyond skin.