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| Statement |
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| 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 |
| I would just like to say that the company is making great progress toward our goals for fiscal 2024 |
| Customer feedback remains positive regarding device performance and we are seeing usage picking up in recent months |
| We believe the launch of the OneRF system will also have a positive impact on customer demand for the Evo sEEG electrode product line |
| We are excited with the prospects of this technology and how it may assist the biopharma industry in their drug or gene therapy delivery development and also, its value clinically in current neurosurgical procedures |
| 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 |
| Spinal cord stimulation and pain management remain a priority, given the size of the market opportunity and the potential competitive advantages of our technology |
| We hope you will continue to follow our exciting progress |
| We completed full salesforce training for Zimmer in January 2024 and we expect to see an increase in Evo sEEG sales and revenue as the launch expands |
| Development efforts with our Spinal Cord Stimulation Program to treat chronic back pain continued in our first quarter as members of our Physician Advisory Board, successfully placed a 9-millimeter paddle electrode, utilizing a percutaneous placement approach in a cadaver model |
| If we are able to reach an agreement in our current contract negotiations, the technology has the potential to add revenue later in calendar year 2024 |
| We continue to make progress on our Drug Delivery program and our Spinal Cord Stimulation program intended to treat chronic back pain |
| 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 |
| 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 |
| During the first quarter of fiscal 2024, we continued to make significant progress on our objectives relating to commercialization and product development |
| 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 |
| During the past quarter, we completed feasibility benchtop testing and an animal study demonstrating the ability to deliver a therapy and provide recording capabilities using the sEEG drug delivery system |
| 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 |
| Unidentified Analyst Great |
| Thank you |
| Thank you |
| Thank you |
| Statement |
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| The net loss was $3.3 million for the first quarter of fiscal 2024, compared to a net loss of $1.7 million in the first quarter of fiscal 2023 |
| 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 |
| See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ |
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