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Actualités Accéder au fil d'actualités
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. » Plus sur de.investing.com
NeuroPace receives FDA approval for ECoG Assistant AI feature
NeuroPace said the U.S. FDA approved ECoG Assistant, its first AI-driven clinician-enabled feature for epilepsy care, on May 29. The tool, trained on 124,450 epileptologist-labeled records, flags "ECoGs of Interest" and provides integrated reports to review trends and timing patterns across months to speed data review and treatment decisions. CEO Joel Becker and CMO Martha Morrell said the feature converts the company's data advantage into practical clinician tools. NeuroPace also debuted the technology at the ASSFN meeting and has submitted a next-generation patient data platform for FDA review targeting approval in Q2 2026. » Plus sur finance.yahoo.com
NeuroPace receives FDA clearance for AI-powered ECoG Assistant
NeuroPace has received FDA clearance for the ECoG Assistant, an AI tool to support clinical decision-making in epilepsy treatment. Trained on 124,450 iEEG recordings classified by epileptologists, the system identifies relevant ECoG patterns and provides a trends report and a circadian pattern chart for analyzing temporal patterns. NeuroPace plans to present the tool on May 30 and has also submitted its new cloud-based patient data management system for FDA review, with approval expected in Q2 2026. The stock traded at $17.39 (market capitalization $593 million); revenue recently grew 18%, gross margin is 78%, but the company is not yet profitable and analysts have recently raised earnings estimates. » Plus sur de.investing.com
Données financières de l'entreprise
| (EUR) | juin 2026 | |
|---|---|---|
| Chiffre d'affaires | 20 M | 0,23 % |
| Bénéfice brut | 16,57 M | 7,68 % |
| Bénéfice net | -5,43 M | 25,98 % |
| EBITDA | -4 M | 22,97 % |
Données fondamentales
| Indicateur | Valeur |
|---|---|
Capitalisation boursière | 424,04 M € |
Nombre d'actions | 34,09 M |
Plus haut/bas sur 52 semaines | 16,92 € - 7,67 € |
| Dividendes | Non |
Bêta | 1,94 |
Ratio P/E | -25,21 |
Ratio PEG | -0,61 |
Ratio P/B | 41,36 |
Ratio P/S | 4,97 |
Profil de l'entreprise
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.
| Nom | NEUROPACE INC. DL-,001 |
| PDG | Joel D. Becker |
| Siège social | Mountain View,
ca États-Unis |
| Site web | |
| Secteur | Consommation discrétionnaire |
| Industrie | Biens de consommation durables |
| Introduction en bourse | 22/04/2021 |
| Employés | 220 |
Symboles boursiers
| Bourse | Symbole |
|---|---|
NASDAQ | NPCE |
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