NeuroOne Medical Technologies Corporation

Good day, ladies and gentlemen. Thank you for standing by and welcome to the NeuroOne Medical Technologies Corporation third quarter fiscal year 2023 financial results conference call. Today's call will be conducted by the company's chief executive officer, Dave Rosa, and the 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 laws with respect to future operations, financial results, events, trends, and performance, which are based on management's beliefs and assumptions of today's call or other specified date. Forward-looking statements may involve known and unknown risks, uncertainties, and other factors which may cause actual results to differ materially from those expressed and are implied or implied by such statements. See Neural One's corporate update press 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, I will turn the call over to Mr. Dave Rosa, CEO of Neural One. Please go ahead, sir.

Thanks, operator. During our fiscal third quarter and through today, The company continued to make significant progress across a number of commercial, development, and financing objectives. Let's first cover progress with the company's EVO SCEG electrode limited launch. I'm pleased that we have completed the number of cases we were targeting for a limited launch and have begun to train the remaining Zimmer Biomet field sales personnel in an effort to expand the launch. Those efforts began in August. All the centers that participated in the limited launch, with the exception of one, placed the EVO-SEG electrode with Zimmer Biomet's ROSA-1 brain, a robotic platform that assists surgeons in planning and performing complex yet minimally invasive neurosurgical procedures. We solicited feedback on the performance of the system from physicians and staff during and after these cases and were pleased with the feedback received. We have also received our first order for calendar year 2024 product supply from Zimmer Biomet. With regards to our 1RF ablation system, we submitted a 510K application to FDA on June the 8th. The FDA recently responded to the application with questions regarding some of the labeling as well as requests for additional information on some of the testing we performed. We expect to discuss the request with the FDA at the end of this week in an effort to address them efficiently. At this time, we remain confident in our projections on commercialization of the system in the first half of 2024. Last quarter that we mentioned that we held discussions with two strategic organizations regarding their interest in licensing the technology, and we expect to continue those conversations during our fiscal fourth quarter. At this time, we are also evaluating commercializing the device directly. In our next fiscal quarter, we expect to place initial orders for the system components in order to prepare for future commercialization. The company also continued to make progress in the development of our spinal cord stimulation program to treat chronic back pain. We successfully completed a 28-day animal implant utilizing a novel, flexible, thin-film material without experiencing any adverse events or neurological complications. We also filed a non-provisional patent for a novel conformable thin-film paddle that could be placed percutaneously on the spinal cord. In the fourth fiscal quarter, we have scheduled a study for the percutaneous placement of the paddle design in a spinal cord cadaver model by members of our advisory board. During our last quarterly call, I also discussed the potential for our electro technology to offer the ability to deliver genes or drugs to the brain, as well as record the agent's impact to the patient. As planned, we successfully completed feasibility testing in a small animal model at the Mayo Clinic in Rochester, Minnesota. We've received enthusiastic feedback from neurologists and neurosurgeons on the clinical applications as well as potential for use in pharmacologic trials. We are currently in discussions with a biotech company regarding their interest in using our device in research studies and product development efforts and expect to expand our efforts to discuss the technology with other potential partners. On the financial side, the company made progress with respect to revenue gains and improving our cash position. Moving forward, we also expect to see a reduction in operating cash burn from the current fiscal year as the cost for the development of our 1RF ablation system decrease. In addition, we increased product revenue based on our sales to Zimmer Biomed for the EVO product lines, and we improved our balance sheet through the use of an ATM facility and the recent capital raise, which Ron will take you through. Thank you for your time and attention. I would now like to turn it over to Ron for a more in-depth review of our fiscal second quarter financial results. Ron?

Mr. McClurg, this is the conference operator. Is your line unmuted?