NeuroOne Medical Technologies Corporation

Good morning, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation fourth quarter 2021 earnings call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonera. Sir, the floor is yours.

Thank you, Operator. And once again, welcome to the NeuroOne Medical Technologies Corporation fourth quarter and full year fiscal 2021 earnings conference call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa, and its Chief Financial Officer, Ron McClurg. Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of U.S. federal securities law with respect to future operations, financial results, events, trends, and performance, which are based on management's beliefs and assumptions as of today's call or other specified date. Forward-looking statements may involve known and unknown risk. uncertainties, and other factors which may cause actual results to differ materially from those expressed or implied by such statements. Here are earnings release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, we undertake no obligation to update such forward-looking statements. With that said, I'll turn the call over to Dave Rosa, CEO of NORA1. Dave?

Thanks, Operator, and welcome, everyone. During our fiscal fourth quarter, we continue to make great strides in both our development efforts for our therapeutic technologies as well as progress towards commercializing our second diagnostic product, the Evo SCEG electrode product line. As a reminder from last quarter's call, we have FDA 510K clearance for our Evo cortical diagnostic electrode and currently are marketing the product line through Zimmer Biomet as our exclusive distributor. Our EVO cortical electrodes are a portfolio of high definition strip and grid thin film diagnostic electrodes for recording brain activity, stimulation, and monitoring for less than 30 days. Applications include identifying problematic areas of the brain during epilepsy surgery and intraoperative mapping for brain tumors. This product line represents our smallest opportunity as it relies on more invasive surgical procedures than SCEG electrode technology. I mentioned during last quarter's call that we were targeting commercialization of the SCEG electrodes by year-end, pending 510 clearance. We received clearance for implantation less than 24 hours from FDA in September 2021 for similar indications as our EVO cortical product line. At that time, we decided to conduct additional testing to submit to the FDA for extended use for recording brain activity, stimulation, and monitoring for less than 30 days. I'm pleased to confirm that we submitted this application at the end of November and hope to have clearance from FDA by the first calendar quarter of 2022. SCEG electrodes represent the bulk of diagnostic procedures performed today due to their less invasive placement. This product is expected to be used with Zimmer's ROSA robotic platform, as it also is included in our development and distribution agreement. Zimmer Biomet has already begun to place their initial orders for the product, and our manufacturing has begun. If and when FDA clearance for less than 30-day use has been received, the company will begin to fill the orders. As a reminder, the company has the opportunity to receive additional payments from Zimmer Biomet based on meeting certain performance milestones. Moving to our ablation therapeutic electrode system, we had previously reported we were targeting completion of animal feasibility studies in the fourth quarter with the potential to complete the project by the end of calendar year 2022. As a reminder, the system is being designed to both record brain activity and ablate brain tissue using the same electrode. Currently, two separate hospital visits and surgeries are required to treat these patients that have seizures due to epilepsy or brain tumors that contribute to the seizures. Combining both diagnostic and therapeutic functions in one device is intended to save time, money, and contribute potentially to improve patient outcomes. We also previously reported our intent to market both the electrode and radio frequency generator to offer a complete system to our customers. I'm pleased to report that we signed a partnership agreement with RBC Medical Innovations, a recognized leader in the development and manufacturing of electromechanical therapeutic therapies to both develop and manufacture our RF generator. We also successfully completed an animal feasibility study with the assistance of Dr. Robert Gross, a neurosurgeon at Emory University in Atlanta, Georgia. We also continue to make progress on the testing of our electrodes that would be used for chronic recording and or stimulation. This would apply for both or for indications such as mental health, that is OCD, depression, Parkinson's disease, epilepsy, back pain due to failed back surgeries, and other potential conditions requiring a permanently implanted electrode. Our initial focus is to target the spinal cord stimulation market, which currently represents over $3 billion in the U.S. market alone. The company initiated long-term durability testing in the third fiscal quarter and expects to report on the results next quarter. We also continued work on the development of higher definition electrodes that might be useful for current applications as well as artificial intelligence. We have sent devices for testing to the Mayo Clinic and Carnegie Mellon University and look forward to providing additional updates as we receive those results. Another area of focus for the company has been the effort to generate pre- and post-market clinical data to support our technologies. In the third and fourth fiscal quarters, the company presented at the Congress of Neurological Surgeons, the Society for Neuroscience, and the American Epilepsy Society conferences. In addition, we also successfully completed an equity financing with gross proceeds of $13.35 million after our fiscal year end. I would now like to turn the call over to Ron for a more in-depth review of our fiscal fourth quarter and full year financial results. Ron?