We are a clinical-stage biotechnology company that has been developing the Ionojet, a proprietary patented 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”). (Incorporated in Delaware)
We are re-engineering the prototype of our device in preparation for our pivotal clinical trial, which will focus on diabetic foot ulcers.
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.
When used in this prospectus, the term “pivotal” trial is the clinical investigation intended to gather additional information about the safety and effectiveness of the Ionojet device that we believe will be the final clinical trial that will be required to support approval of a PMA for the device by the FDA for the treatment of diabetic foot ulcers. However, if the FDA should determine that such clinical trial (that we refer to as the pivotal trial) has not demonstrated reasonable assurance of the safety and effectiveness of the device, we may be required to conduct a further clinical trial to support approval of a PMA. Reference in this prospectus to the term “feasibility” trial refers to all clinical studies that precede the pivotal trial. Prior to commencing our pivotal trial in diabetic foot ulcers, we will need to submit, and receive approval of, a new Investigational Device Exemption (“IDE”) filing, permitting the use of the reengineered design of the Ionojet in a new clinical study. We anticipate that we will be able to submit the new IDE approximately six months after consummation of this offering and that it will take approximately three months after submission of the IDE to receive approval thereof from the FDA. After receiving approval of the new IDE, we expect that it will take approximately three months to commence the pivotal trial, which will require Institutional Review Board (“IRB”) approval of the study, identification and initiation of clinical trial sites and patient recruitment activities. We do not believe that the modifications to the device or the requirement to submit, and receive approval of, a new IDE has had, or will have, an effect on our expected timeline for commencement of the pivotal trial.
We plan to seek premarket approval of the Ionojet from the FDA as a Class III medical device, assuming we are able to complete our pivotal trial and the data are favorable. If we are unable to complete our pivotal trial or, upon completion of the trial, the outcomes of the trial design are not met, we may not be able to seek premarket approval of the Ionojet. We expect to submit our PMA application in the second quarter of 2024 and the FDA’s review of the PMA can range from 6 to 15 months depending on whether the FDA raises significant issues during its interactive review. If we receive premarket approval from the FDA of our technology for the treatment of diabetic foot ulcers, our goal is to market our technology to hospitals, wound clinics and private podiatrist offices to treat diabetic foot ulcers and to generate revenue by charging for the device on a usage basis. We do not intend to generate revenue from the sale of the Ionojet device, of which we intend to retain ownership. In addition to wound healing, we believe that our technology has application in many additional indications, including dermatology, infection control, podiatry, dentistry, pain and inflammation and cosmetics, as well as potentially in certain respiratory infections, both viral and bacterial, oral infections, dental indications, ophthalmic and facial applications and in topical indications, although to date the only pre-clinical and clinical studies we have conducted with our Ionojet device have been with regard to wound healing, and our pivotal clinical trial will focus solely on diabetic foot ulcers.
**Note: Net loss is for the year ended Dec. 31, 2022. The company has generated only minimal revenue to date.
(Origin Life Sciences, Inc. filed its S-1 on March 13, 2023, and disclosed terms: 3.0 million shares at $4.00 to $6.00 to raise $15.0 million. The company filed confidential IPO documents on Nov. 14, 2022.)
(Note: In addition, the Selling Stockholders (as defined in the accompanying resale prospectus) are offering 775,900 shares of common stock to be sold pursuant to a separate resale prospectus, which shares will be issuable upon conversion of convertible promissory notes (the “Convertible Notes”) held by the Selling Stockholders pursuant to a prospectus to be used in connection with the potential distribution of such shares by such Selling Stockholders (the “Resale Prospectus”), which Convertible Notes will automatically convert into common stock at a conversion price of $2.50 per share, which is 50% of the assumed initial public offering price of $5.00 per share, the midpoint of the price range set forth above, upon the effectiveness of the registration statement of which this prospectus is a part. We will not receive any proceeds from the sale of the common stock to be sold by the Selling Stockholders. The Selling Stockholders have represented to us that they will not offer or sell shares prior to the closing of this offering.)