NeuroPace (NPCE) Q2 FY26 earnings call: guidance and Q&A

When is the specific date for the SIR meeting, what are the next steps, and is a resubmission still expected before year-end without a full 180-day clock reset?

The specific SIR meeting date is not yet set, but preparation is on track for the next few weeks. Management expects to submit the amendment timely after the SIR meeting and anticipates an interactive review without a full 180-day clock reset, based on prior FDA interactions.

“Our current expectation based on the way that the agency has interacted with us when we have amended this submission a couple of other times during the review is to stay interactive.”

asked by Anthony Petrone · answered by Joel Becker

Will NeuroPace push into community centers ahead of IGE label expansion, or wait for the label?

NeuroPace is already increasing its footprint in the community, establishing relationships with referring physicians and community-based programs for the adult focal indication. This strategy also lays groundwork for future IGE expansion, as it's beneficial for the current business and prepares for indication expansion.

“So we absolutely are and have been increasing our footprint from a community perspective, which has the advantage of laying a bunch of track, if you will, in anticipation of an indication expansion as well.”

asked by Anthony Petrone · answered by Joel Becker

How did the clinical community react to the FDA's 'not approvable' letter for IGE? Were they surprised or understanding?

The clinical community reacted with appreciation for the update, maintained confidence in the clinical data, and offered support. They recognize the significant unmet need for drug-resistant IGE patients who lack neurostimulation options and are not surgical candidates.

“One, thanks for letting us know and for keeping everybody up to date here real time. Two, just as we do, they remain very confident in the clinical data that was generated from the study. And three, let us know how we can help.”

asked by Ross Osborn · answered by Joel Becker

What is the development timeline and key improvements for the next-generation platform?

The next-generation platform (hardware) is in active development ('D' phase, not 'R'). Key improvements include expanded capability for additional lead configurations and Bluetooth low-energy communication. Specific timelines are available in Investor Day materials, but it will buttress AI and remote care initiatives.

“But it will expand the capability and capacity of the system from the management of the potential for additional lead configurations is one. Bluetooth low-energy communication is another.”

asked by Ross Osborn · answered by Joel Becker

How will AI initiatives be monetized? Through increased RNS unit volume or separate AI-specific revenue streams?

The primary monetization strategy for AI tools like ECOG Assistant is to enable increased RNS unit volume by making patient management more efficient and potentially improving outcomes. While other downstream opportunities like diagnostic capabilities or partnerships exist, the current focus is on driving RNS system sales.

“But in particular, if you think about the diagnostic capability associated with the system, if you think about what those algorithms can do by way of helping us predict the appropriate detection and therapy settings and you think about things like some of the partnership work that we've done, we think there are other potential business models to help create -- recognize rather the value that the capability and underlying assets that we have are, but those are further downstream.”

asked by Frank Takkinen · answered by Joel Becker

How long does it take for new accounts to become meaningful contributors and patients to move through the pipeline? How does this inform the outlook, especially with IGE?

For existing Level 4 centers, the focus is on increasing adoption among more epileptologists and utilization. For new centers, it varies from quick ramp-up to longer depending on infrastructure. The focal patient pipeline can take 6 months to over a year due to multiple evaluation steps. IGE is expected to have faster patient pipeline dynamics due to not requiring invasive localization, reducing friction.

“So if you think about the steps in the process, a patient with a regional or focal disease will undergo an initial SEEG evaluation where scalp EEG rather, a scalp and video EEG is kind of a Phase I evaluation. Then they move from there to a Phase II evaluation, which is an inpatient procedure, where SEEG electrodes are used to localize the specific spot or spots of origination of the seizure. And then those patients are adjudicated to either resection or neurostimulation.”

asked by Sam · answered by Joel Becker