Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation First Quarter of Fiscal Year 2024 Financial Results Conference Call. Today's call will be conducted by the company's Chief Financial Officer, Ron McClurg. Before I turn the call over to Mr. McClurg, 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 as 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 or implied by such statements. See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, NeuroOne undertakes no obligation to update such forward-looking statements. With that, I will turn the call over to Mr. Ron McClurg, CFO of NeuroOne. Please go ahead, sir.

Thank you, operator. Before I begin, I wanted to mention that Dave Rosa, our CEO, had minor surgery, which prevented him from being able to present this afternoon, so I will be handling the call. During the first quarter of fiscal 2024, we continued to make significant progress on our objectives relating to commercialization and product development. First, I would like to remind the audience of our recent milestone achievement of receiving FDA clearance for our OneRF Ablation System, the first FDA cleared system with an intended use for both recording electrical activity and ablation of nervous tissue utilizing the same device. As previously noted, we submitted a 510(k) application to the FDA in June 2023 for the OneRF Ablation System and we received 510(k) clearance from the FDA in December of 2023 for the creation of radio frequency lesions and nervous tissue for functional neurosurgical procedures. We are very excited to be the first to market this novel technology in the United States and are preparing to initiate a limited commercial launch in the second quarter of calendar 2024. We will remain in discussions with potential, strategic partners regarding the licensing of the technology for brain ablation procedures and we expect to reach a decision in the near future regarding our commercialization strategy. We also remain open to commercializing the device directly if we believe it represents the best option for the company and we are working in parallel on a plan to launch the technology directly. In addition, our team is exploring other applications for the OneRF System to treat pain. We believe that there are additional market opportunities for the OneRF System that we may be able to address and we will provide further updates in the future. I would now like to provide an update regarding…

Absolutely. Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] The first question comes from Alex Nowak with Craig-Hallum. Please proceed.

Hey, good afternoon. This is Connor on for Alex. Thanks for taking my questions. Could you maybe speak on the RF generator parts? I know last quarter you mentioned that was one of the hold ups in getting some of these systems placed. Any update on that would be great.

One of the – I think what we may have mentioned in the past was that there were some long lead time components and that was the gating factor for us in terms of when we could launch a limited release of the device and we’ve got those components on order. We are expecting to receive our first units of the hardware, the RF generator itself by the end of March. And so we’re looking at beginning a very limited launch of the product in the second calendar quarter of this year.

Got you. And then, maybe can you speak on any initial impact on Evo sEEG sales following the OneRF approval? I know you mentioned a step-up and then maybe when can we start seeing Zimmer to fully start launching Evo? Or is there any barriers preventing this full launch?

There are no barriers at this time that are preventing the full launch. The other than – when we initiated the limited launch, we only trained a portion of their sales force. So as I mentioned during the call, in January, so just last month, we attended their national sales meeting and trained their full distribution network, including distributors and direct employees. And one of the things that is kind of gating the rollout is their approval by the value analysis committee at each of the hospitals. So that is underway right now. They've got a targeted launch. They're trying to do this in a methodical manner and continue to add new accounts as we go forward.

Great. And then one more here. Could you speak towards the progress on maybe a potential partnership? Could this be within the year time span, less or more? I know you mentioned direct as well.

Well, we are in discussions right now with a couple of potential strategic partners and we would – if those come to fruition, we will then distribute the RF ablation – the OneRF Ablation System through that distributor. If we do not get terms that are favorable or acceptable to the company, we are prepared to go and start distribution on our own. And that's what I meant when I said we are kind of – we have a dual path right now that we are operating under so that we don't delay regardless of which direction we go. We do want to – yes, we do want to make that decision before we proceed with the limited launch. So we should have that decision made here in the near-term.

Gotcha, great. Thank you.

Thank you, Connor.

Okay. We have no further questions in queue. I will now turn the call back over to management for any closing remarks.

Yes. Thank you, operator. I would just like to say that the company is making great progress toward our goals for fiscal 2024. We're excited by the FDA clearance of the OneRF Ablation System and pleased with the expansion of Zimmer Biomet's launch of the Evo sEEG electrode and the related increase in revenue. We continue to make progress on our Drug Delivery program and our Spinal Cord Stimulation program intended to treat chronic back pain. Altogether, we believe NeuroOne has the potential to add revenue in 2024 and beyond just sEEG sales, with contributions coming from the OneRF commercial launch and potential drug delivery partnerships. We hope you will continue to follow our exciting progress. Thank you.

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.