Prognose

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NeuroPace increases core RNS revenue and files SIR request after 'not approvable' FDA decision

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. » Mere på de.investing.com
NeuroPace faces pivotal FDA review for IGE approval and confirms revenue and margin targets

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. » Mere på de.investing.com
FDA initially rejects expanded approval for NeuroPace epilepsy system

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. » Mere på de.investing.com

Virksomhedstal

I det seneste kvartal havde NEUROPACE INC. DL-,001 en omsætning på 20 mio. € og et nettoresultat på -5,43 mio. €

(EUR)	juni 2026	YoY
Omsætning	20 mio.	0,23 %
Bruttofortjeneste	16,57 mio.	7,68 %
Nettoresultat	-5,43 mio.	25,98 %
EBITDA	-4 mio.	22,97 %

Fundamentale data

Nøgletal	Værdi
Markedsværdi	431,17 mio. €
Antal aktier	34,09 mio.
Højeste/laveste i 52 uger	16,99 € - 7,99 €
Udbytte	Nej
Beta	1,95
P/E (PE Ratio)	-25,52
PEG (PEG Ratio)	-0,62
K/I (PB Ratio)	41,87
P/S (PS Ratio)	5,03

Virksomhedsprofil

NeuroPace, Inc. ist als Medizintechnikunternehmen in den Vereinigten Staaten tätig. Es entwickelt und vertreibt das RNS-System, ein auf das Gehirn reagierendes Neuromodulationssystem zur Behandlung von medizinisch refraktärer fokaler Epilepsie durch eine personalisierte Echtzeitbehandlung an der Anfallsquelle. Das RNS-System des Unternehmens zeichnet außerdem kontinuierlich Hirnaktivitätsdaten auf und ermöglicht es Klinikern, Patienten persönlich und aus der Ferne zu überwachen. Das Unternehmen verkauft seine Produkte an Krankenhäuser für die Erstimplantation von RNS-Systemen und für Ersatzverfahren. Das Unternehmen wurde 1997 gegründet und hat seinen Hauptsitz in Mountain View, Kalifornien.

Navn	NEUROPACE INC. DL-,001
CEO	Joel D. Becker
Hjemsted	Mountain View, ca USA
Websted	neuropace.com
Sektor	Cykliske forbrugsvarer
Branche	Forbrugsgoder
Børsnotering	22.04.2021
Medarbejdere	220