Q1 2024 Summary
Published Jan 27, 2025, 9:41 PM UTC- NeuroOne expects to add revenue in 2024 beyond just sEEG sales, with contributions from the OneRF commercial launch and potential drug delivery partnerships.
- The company has received FDA clearance for the OneRF Ablation System and plans to initiate a limited commercial launch in the second quarter of calendar 2024, with components for the RF generator expected to be received by the end of March.
- The expanded launch of the Evo sEEG electrode product line with Zimmer Biomet is progressing, with full sales force training completed in January 2024 and the process of hospital approvals underway, potentially leading to increased sales and revenue.
- The company is facing uncertainty in its distribution strategy for the OneRF Ablation System, as it is still in discussions with potential strategic partners, and may have to distribute the product on its own if favorable terms are not reached.
- The full launch of the Evo sEEG product line is being gated by approval processes at hospitals' value analysis committees, potentially slowing down the revenue growth from this product.
- The company has experienced delays due to long lead-time components for the RF generator, affecting the timeline for the limited release of the device, with the first units expected by the end of March and a limited launch planned for the second calendar quarter.
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Potential Partnership
Q: Update on potential partnership and timing?
A: We're in discussions with potential strategic partners to distribute the OneRF Ablation System through a distributor if terms are favorable. If not, we're prepared to start distribution on our own. We expect to make a decision in the near term before proceeding with the limited launch. -
Evo sEEG Sales and Launch
Q: Impact on Evo sEEG sales after OneRF approval? Any barriers to full Zimmer launch?
A: There are no barriers preventing the full launch. In January, we trained Zimmer Biomet's entire distribution network. The rollout is gated by approval from hospitals' value analysis committees, which is underway. Zimmer is adding new accounts methodically as we move forward. -
RF Generator Parts and Launch Timeline
Q: Update on RF generator parts availability?
A: Long lead time components were a gating factor. We've ordered these parts and expect the first units by end of March. We're planning a very limited product launch in the second calendar quarter of this year.