Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory Submission
Inspira Technologies (NASDAQ: IINN) completed the clinical study for its HYLA non-invasive blood sensor on Nov. 13, 2025 and is progressing toward regulatory submission.
Company-reported results and ongoing lab tests show 95%–99% accuracy across measured parameters. Inspira said it will enter final validation and verification before submitting for approval and is integrating machine-learning to expand HYLA’s physiological parameter set beyond current non-invasive monitoring capabilities.
Inspira Technologies (NASDAQ: IINN) ha completato lo studio clinico per il suo sensore ematico non invasivo HYLA il 13 novembre 2025 e avanza verso la sottomissione regolamentare.
I risultati riportati dall'azienda e i test di laboratorio in corso mostrano una precisione dal 95% al 99% sui parametri misurati. Inspira ha detto che entrerà nella validazione e verifica finali prima di presentare la domanda di approvazione e sta integrando l'apprendimento automatico per espandere l'insieme di parametri fisiologici di HYLA oltre le attuali capacità di monitoraggio non invasivo.
Inspira Technologies (NASDAQ: IINN) completó el estudio clínico de su sensor de sangre no invasivo HYLA el 13 de noviembre de 2025 y avanza hacia la presentación regulatoria.
Los resultados reportados por la empresa y las pruebas de laboratorio en curso muestran una precisión del 95% al 99% en los parámetros medidos. Inspira dijo que ingresará a la validación y verificación finales antes de presentar la solicitud de aprobación y está integrando aprendizaje automático para ampliar el conjunto de parámetros fisiológicos de HYLA más allá de las capacidades actuales de monitoreo no invasivo.
Inspira Technologies (NASDAQ: IINN)가 2025년 11월 13일 HYLA 비침습 혈액 센서에 대한 임상 연구를 완료했으며 규제 제출을 향해 진행 중입니다.
회사 보고 결과와 진행 중인 실험실 테스트는 측정된 매개변수에서 95%에서 99%의 정확도를 보여줍니다. Inspira는 승인을 위한 최종 검증 및 확인 단계로 들어가 규제 승인을 제출하고, HYLA의 생리학적 매개변수 세트를 현재의 비침습 모니터링 능력을 넘어 확장하기 위해 머신러닝을 통합할 것이라고 밝혔습니다.
Inspira Technologies (NASDAQ : IINN) a achevé l'étude clinique de son capteur sanguin non invasif HYLA le 13 novembre 2025 et progresse vers la soumission réglementaire.
Les résultats rapportés par l'entreprise et les tests en laboratoire en cours montrent une précision de 95% à 99% pour les paramètres mesurés. Inspira a déclaré qu'elle entamerait la validation et la vérification finales avant de déposer la demande d'approbation et intègre l'apprentissage automatique pour étendre l'ensemble des paramètres physiologiques de HYLA au-delà des capacités actuelles de surveillance non invasive.
Inspira Technologies (NASDAQ: IINN) hat die klinische Studie für den nicht-invasiven Blut-Sensor HYLA am 13. November 2025 abgeschlossen und unternimmt Schritte in Richtung regulatorischer Einreichung.
Von dem Unternehmen gemeldete Ergebnisse und laufende Labortests zeigen eine Genauigkeit von 95% bis 99% über die gemessenen Parameter. Inspira sagte, dass sie in die abschließende Validierung und Verifikation eintreten wird, bevor sie den Antrag auf Zulassung stellt, und integriert maschinelles Lernen, um HYLA's Parameter-Set über die derzeitigen nicht-invasiven Überwachungsmöglichkeiten hinaus zu erweitern.
Inspira Technologies (بورصة ناسداك: IINN) أكملت الدراسة السريرية لجهاز HYLA لقياس الدم غير التدخلي في 13 نوفمبر 2025 وتتقدم نحو التقديم التنظيمي.
تُظهر النتائج التي أبلغت عنها الشركة والاختبارات المخبرية الجارية دقة بنسبة 95% إلى 99% عبر المعلمات المقاسة. قالت Inspira إنها ستدخل في التحقق والاعتماد النهائيين قبل تقديم طلب الموافقة وتدمج التعلم الآلي لتوسيع مجموعة المعلمات الفسيولوجية لـ HYLA بما يتجاوز قدرات الرصد غير التدخلي الحالية.
- Clinical accuracy reported at 95%–99% across measured parameters
- Final validation stage reached ahead of regulatory submission
- Machine learning integration to expand measurable physiological parameters
- Regulatory approval not yet obtained; submission still planned
- Reported accuracy is from trials and ongoing lab tests, not regulatory review
RA'ANANA, Israel, Nov. 13, 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 the completion of the clinical study for its HYLA, non-invasive blood sensor, toward regulatory submission and future commercialization.
Based on the clinical trial results and ongoing lab tests, showing between
Inspira is leveraging its proprietary non-invasive platform and integrating advanced Machine Learning algorithms to further extend the HYLA sensor's capabilities beyond its core parameters. This development focuses on adding critical physiological parameters currently unavailable through existing non-invasive monitoring systems.
Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated: “The system is performing at exceptional accuracy levels in our testing - between 95 and 99 percent across the board. These results reinforce HYLA’s position as a disruptive, non-invasive solution for real-time blood monitoring. We are now entering the final phase before submitting for regulatory approval.”
About the HYLA Blood Sensor
The HYLA is a smart, non-invasive blood sensor designed to deliver continuous, real-time blood data without the need for blood draws. Developed for use in operating rooms, ICUs, ECMO/CRRT/dialysis settings, and cardiac care units, HYLA provides clinicians with immediate access to critical physiological information. By enabling seamless, real-time monitoring, the system is engineered to enhance patient safety, improve workflow efficiency, and support more informed decision-making in demanding critical-care environments.
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 U.S. Food and Drug Administration-cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) 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 regulatory submission for HYLA and potential future commercialization, that the Company is soon entering the final validation and verification stage ahead of planned regulatory submission, HYLA’s benefits and advantages and that the Company is adding critical physiological parameters currently unavailable through existing non-invasive monitoring systems, and that results reinforce HYLA’s position as a breakthrough, non-invasive solution for real-time blood monitoring . 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
FAQ
What did Inspira announce about the HYLA clinical study on Nov. 13, 2025 for IINN?
What accuracy did Inspira report for the HYLA blood sensor (IINN)?
Does Inspira (IINN) have regulatory approval for HYLA after the Nov. 13, 2025 update?
How is Inspira enhancing HYLA’s capabilities according to the Nov. 13, 2025 release?
What are the next steps for HYLA after the clinical study completion for IINN?
