NeuroPace (NPCE) investor relations material

Regulatory and clinical progress

• Pursuing FDA approval for expanded indication into idiopathic generalized epilepsy (IGE), which could open up 20% more of the epilepsy market.

• Currently engaged in the Submission Issue Request (SIR) process with the FDA after receiving a not approvable letter; meeting expected in early to mid Q4.

• Breakthrough Device designation allows for collaborative FDA interactions; approval could occur as early as Q2 next year if a major amendment is required.

• Clinical data shows 77% median seizure reduction at 18 months and 100% at 24 months for IGE patients.

• Confident in existing data supporting broad IGE population, though limited representation in patients under 12 may require future amendments.

Core business performance and growth drivers

• Core RNS business grew 21% in the most recent quarter, with strong prescriber and patient pipeline growth.

• Adult focal epilepsy market remains under-penetrated; only a fraction of eligible patients receive intervention.

• Investments in sales, marketing, and patient navigators aim to deepen utilization at comprehensive epilepsy centers and expand into community settings.

• Clinical adoption is broadening as physicians become more comfortable with network stimulation and hybrid approaches.

• Adoption dynamics for IGE are compelling due to easier procedures and potential for community-based treatment.

Data, AI, and digital initiatives

• Over 27 million intracranial EEG recordings create a unique, longitudinal data set that serves as a competitive moat.

• Recently launched ECoG Assistant (AI tool) to help physicians quickly identify relevant brainwave data, reducing analysis time by up to 10 minutes per patient.

• Remote monitoring and programming capabilities are planned for FDA submission by year-end, aiming to reduce friction for patients outside major centers.

• Data collaborations with pharmaceutical companies support drug trials and personalized treatment adjustments.

• Monetization focus remains on device sales, with high ASP and gross margins over 80%; SaaS monetization not prioritized due to under-penetration.