NeuroPace (NPCE) Wells Fargo 21st Annual Healthcare Conference summary

Market opportunity and barriers

• Drug-resistant epilepsy remains highly under-penetrated, with only a small fraction of patients receiving advanced interventions.

• Major barriers include limited awareness among patients and physicians, and access to specialized Level 4 epilepsy centers.

• Project CARE aims to increase awareness and access in community settings, especially for those far from major centers.

• Expansion into new indications, such as idiopathic generalized epilepsy (IGE), could improve adoption by simplifying patient pathways.

Product differentiation and competitive landscape

• The RNS system offers personalized, closed-loop neurostimulation with continuous EEG monitoring and tailored therapy.

• Competing devices include VNS (vagus nerve stimulation) and DBS (deep brain stimulation), but RNS is positioned as a cranial implant with longer battery life and initial implant-driven revenue.

• Replacement revenue is expected to become a tailwind as more RNS devices are implanted.

NAUTILUS trial and IGE indication

• NAUTILUS trial targeted IGE, representing about 20% of the epilepsy market, with both adult and pediatric submissions.

• The trial missed its primary efficacy endpoint but achieved robust secondary efficacy and safety results, including a 100% median seizure reduction at 24 months.

• FDA requested more data on underrepresented populations and subpopulations; a Submission Issue Request (SIR) has been filed to address these.

• Approval for IGE could be narrowed to adults or specific seizure frequencies, but any approval would be a significant market opportunity.

• Potential FDA approval could occur between Q1 and Q2 2027, depending on regulatory timelines.