NEUROPACE INC. DL-,001

NeuroPace reported 21% revenue growth in its core RNS business, driven by record numbers of prescribing physicians and a growing patient pipeline. After a 'not approvable' FDA letter, the company plans to use the Submission Issue Request (SIR) process and cites 24‑month data from the NAUTILUS study showing a median seizure reduction of 100%. Management expects cash-flow break‑even by the end of 2027 and reports gross margins in the low 80% range, but notes that reimbursement processes could delay market penetration after a potential IGE approval. NeuroPace emphasizes a strategic data advantage (over 27 million ECoG recordings) and introduced the ECoG Assistant tool to improve physician efficiency. » Więcej na de.investing.com

NeuroPace said at the Wells Fargo Health Care Conference that its approval submission for idiopathic generalized epilepsy (IGE) is in an open review process with the FDA and that a meeting with the agency is expected in early to mid‑Q4 2024. The NAUTILUS study missed its primary endpoint but showed strong secondary efficacy signals (median seizure reduction up to 100% at 24 months) and met safety requirements. The company confirmed its 2024 revenue guidance for the RNS System of +21–23% and non‑GAAP gross margins of 82–83%, and reiterated its goal to reach cash‑flow break‑even by the end of 2027 regardless of IGE approval. NeuroPace highlighted substantial market potential in drug‑resistant epilepsy and is preparing commercial and remote‑care tools for a possible IGE launch. » Więcej na de.investing.com

The FDA deems the application for an expanded approval (PMA supplement) for NeuroPace’s RNS system to treat idiopathic generalized epilepsy not approvable in its current form and requests additional clinical evidence from the NAUTILUS study plus supporting literature. NeuroPace discussed the feedback with the agency and will submit a Submission Issue Request and provide further data on the patient groups studied. NAUTILUS data show substantial seizure reductions at 18–24 months, but the company’s forecast currently does not assume revenue from the expanded indication; Q2 results will be released on August 11. » Więcej na de.investing.com