Inspira Announces 97.3% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance
Inspira Technologies (NASDAQ: IINN) announced breakthrough performance results for its HYLA™ blood sensor, achieving 97.35% accuracy in its latest testing phase ahead of FDA submission. The HYLA sensor provides continuous, non-invasive blood monitoring through optical measurement technology.
The device offers second-by-second monitoring capabilities and is compatible with various medical procedures including cardiopulmonary bypass and dialysis. Targeting the two-million annual open-heart surgery patients globally, HYLA is designed both as a standalone device and for integration with Inspira's ART device line, implementing a razor-and-blade revenue model.
Inspira Technologies (NASDAQ: IINN) ha annunciato risultati rivoluzionari per il sensore ematico HYLA™, raggiungendo una precisione del 97,35% nella fase di test più recente, in vista della presentazione alla FDA. Il sensore HYLA consente il monitoraggio continuo e non invasivo del sangue tramite tecnologia di misura ottica.
Il dispositivo offre monitoraggio secondo per secondo ed è compatibile con varie procedure mediche, tra cui bypass cardiopolmonare e dialisi. Rivolgendosi ai due milioni di pazienti che ogni anno subiscono interventi di cardiochirurgia a cuore aperto nel mondo, HYLA è progettato sia come dispositivo autonomo sia per l'integrazione con la linea di dispositivi ART di Inspira, adottando un modello di ricavi razor-and-blade.
Inspira Technologies (NASDAQ: IINN) anunció resultados revolucionarios para su sensor sanguíneo HYLA™, alcanzando una precisión del 97,35% en su fase de pruebas más reciente, antes de la presentación a la FDA. El sensor HYLA proporciona monitoreo sanguíneo continuo y no invasivo mediante tecnología de medición óptica.
El dispositivo ofrece monitorización segundo a segundo y es compatible con diversos procedimientos médicos, incluidos el bypass cardiopulmonar y la diálisis. Dirigido a los dos millones de pacientes anuales sometidos a cirugía cardíaca abierta a nivel mundial, HYLA está diseñado tanto como dispositivo independiente como para integrarse con la línea de dispositivos ART de Inspira, implementando un modelo de ingresos razor-and-blade.
Inspira Technologies (NASDAQ: IINN)는 HYLA™ 혈액 센서에 대해 획기적인 성능 결과를 발표했으며, FDA 제출을 앞둔 최근 시험에서 97.35% 정확도를 달성했습니다. HYLA 센서는 광학 측정 기술을 통해 연속적이고 비침습적인 혈액 모니터링을 제공합니다.
이 장치는 초단위 모니터링을 제공하며 심폐우회술 및 투석을 포함한 다양한 의료 절차와 호환됩니다. 전 세계 연간 200만 명의 개심 수술 환자을 목표로 하는 HYLA는 독립형 장치로도, Inspira의 ART 장비 라인과 통합되는 형태로도 설계되었으며, razor-and-blade 수익 모델을 적용합니다.
Inspira Technologies (NASDAQ: IINN) a annoncé des résultats majeurs pour son capteur sanguin HYLA™, atteignant une précision de 97,35% lors de sa dernière phase de tests, avant le dépôt auprès de la FDA. Le capteur HYLA offre une surveillance sanguine continue et non invasive grâce à une technologie de mesure optique.
Le dispositif permet une surveillance seconde par seconde et est compatible avec diverses procédures médicales, notamment la circulation extracorporelle et la dialyse. Ciblant les deux millions de patients opérés à cœur ouvert chaque année dans le monde, HYLA est conçu à la fois comme appareil autonome et pour une intégration à la gamme d'appareils ART d'Inspira, en adoptant un modèle de revenus razor-and-blade.
Inspira Technologies (NASDAQ: IINN) gab bahnbrechende Leistungsdaten für seinen HYLA™-Blutsensor bekannt und erreichte in der jüngsten Testphase vor der FDA-Einreichung eine Genauigkeit von 97,35%. Der HYLA-Sensor ermöglicht eine kontinuierliche, nicht-invasive Blutüberwachung mittels optischer Messtechnik.
Das Gerät bietet Sekunde-für-Sekunde-Überwachung und ist mit verschiedenen medizinischen Verfahren kompatibel, darunter kardiopulmonaler Bypass und Dialyse. Mit Blick auf die weltweit zwei Millionen jährlich durchgeführten offenen Herzoperationen ist HYLA sowohl als eigenständiges Gerät als auch zur Integration in Inspiras ART-Gerätelinie konzipiert und verfolgt ein razor-and-blade-Umsatzmodell.
- Achieved high accuracy rate of 97.35% in latest performance testing
- Non-invasive continuous monitoring eliminates need for blood draws
- Versatile compatibility with multiple medical procedures
- Large market potential with 2 million annual open-heart surgeries
- Dual revenue potential as standalone device and integrated solution
- FDA approval still pending
- Product not yet commercialized
Insights
Inspira's HYLA blood sensor achieves 97.35% accuracy in testing, signaling readiness for FDA submission with strong commercial potential.
Inspira Technologies has achieved a critical regulatory milestone with its HYLA blood sensor demonstrating 97.35% accuracy compared to standard blood gas analyzers in performance testing. This represents a significant advancement following their March 2025 clinical validation study at a top-ranked medical center.
The reported accuracy level is particularly impressive for a continuous monitoring device. Typical blood gas analyzers require discrete blood samples and provide only periodic snapshots of patient status, while HYLA offers second-by-second monitoring without blood draws – addressing a genuine clinical need in critical care settings.
From a regulatory perspective, this performance testing phase is strategically timed to support Inspira's upcoming FDA submission. The company is pursuing a dual-market approach: integrating HYLA with their proprietary ART device line while simultaneously developing it as a standalone product – a sound strategy to maximize market penetration.
The technology's compatibility with multiple clinical applications (cardiopulmonary bypass, ECMO, CRRT, and dialysis) significantly expands its potential market, particularly targeting the two million annual open-heart surgery patients globally. The planned razor-and-blade revenue model with disposable components should generate recurring revenue if adoption targets are met.
These results suggest Inspira is well-positioned on its regulatory pathway for both U.S. and European markets. The non-invasive optical measurement technology addresses meaningful clinical pain points around the limitations of intermittent blood monitoring in critical care settings where rapid physiological changes can occur.
RA'ANANA, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced pivotal results for its HYLA blood sensor, achieving
The clinical study from March, conducted at a medical center ranked among the world’s leading hospitals, provided validation for HYLA’s performance, while these latest test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe.
Key features of the HYLA Blood Sensor include:
- High Accuracy: Achieves
97.35% accuracy relative to standard blood gas analyzers. - Continuous Monitoring: Provides second-by-second data, eliminating the need for intermittent blood draws.
- Non-invasive Technology: Utilizes optical measurement, operating without drawing blood from the patient.
- Versatility: Compatible with various medical procedures, including cardiopulmonary bypass, extracorporeal membrane oxygenation, continuous renal replacement therapy, and dialysis.
- Modular Design: Engineered to complement existing medical devices, targeting the two-million annual open-heart surgery patients globally.
While primarily designed for integration with Inspira's ART device line, the HYLA sensor is also being developed as a standalone device. This positions the HYLA platform to penetrate the broader disposables market, leveraging a planned razor-and-blade recurring revenue model.
Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated: “HYLA was designed to solve one of the most urgent problems in operating rooms and critical care. A patient’s condition can change in seconds, yet current blood tests provide delayed results. HYLA changes this reality by delivering continuous, second-by-second monitoring of key blood parameters, alerting medical teams instantly and enabling life-saving decisions in real time. Years of focused development across optics, software, hardware, and mechanics, supported by strong clinical results, have brought us to this point. The sensor's unique combination of simplicity and precision is already attracting significant interest from leading global medtech companies.”
About Inspira Technologies
Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company’s FDA -cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S and serves as a foundation for the development of the INSPIRA ART500, a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the life-support and MedTech landscape. The Company’s recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. For more information, visit: https://inspira-technologies.com
Forward-Looking Statement Disclaimer
This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses: its belief that the test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe; the prospective size of the target demographic for the HYLA; the other prospective development uses for the HYLA sensor; the belief that the test results position the HYLA platform to penetrate the broader disposables market, leveraging a planned razor-and-blade recurring revenue model; the belief that the HYLA changes delivers continuous, second-by-second monitoring of key blood parameters, alerting medical teams instantly and enabling life-saving decisions in real time; and that the HYLA’s features are attracting significant interest from leading global medtech companies. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website at www.sec.gov.
Company Contact
Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485
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