A clinical-stage biotechnology company that has been developing a proprietary patented high-energy plasma device that generates nitric oxide (“NO”) in the form of a plasma/NO stream and delivers it to targeted locations of the body. The stream can potentially be used for various therapeutic purposes, including as an anti-infective, anti-inflammatory and tissue-regenerative therapy for chronic wounds and skin and soft tissue infections (“SSTIs”). The U.S. Food and Drug Administration (the “FDA”) previously determined that our product will be a Class III medical device reviewed under a premarket approval (“PMA”) application with the FDA’s Center for Devices and Radiological Health (“CDRH”) consulting with the Center for Drug Evaluation and Research (“CDER”) as necessary.
