We are 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. The cornerstone of the plasma/NO therapy is our patented delivery platform named “Ionojet” which allows us to turn atmospheric air into a plasma/NO stream that has been shown in investigations: (i) to be non-toxic, (ii) to generate NO activity up to 3 cm below the skin, and (iii) to stimulate sustained biological activity in tissue for up to an hour after delivery of the therapy. To date, our clinical activities have been focused on the clinical trials described below, including our dose-ranging feasibility clinical trial for the treatment of diabetic foot ulcers completed in 2018 using the plasma/NO stream generated from our Ionojet, and the preparation for our planned pivotal clinical trial, including finalization of the prototype of the Ionojet that we intend to use in our pivotal trial.