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Inspira Technologies Integrates New Oxygenation Indicator into AI-Powered HYLA Blood Sensor

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Inspira Technologies (NASDAQ: IINN) has announced the integration of a next-generation oxygenation indicator into its AI-powered HYLA blood sensor technology. This enhancement enables continuous monitoring of tissue oxygenation and early hypoxia detection without requiring intermittent blood draws.

The technology is currently undergoing clinical validation at Sheba Medical Center, with preliminary results expected soon. The non-invasive system uses optical sensors and machine-learning algorithms for continuous blood parameter monitoring, targeting the $2.5 billion point-of-care testing and arterial blood gas analyzer market. FDA submission is planned for the second half of 2025.

When combined with the FDA-cleared INSPIRA ART100 system, HYLA aims to provide comprehensive patient care through continuous, non-invasive monitoring while maintaining consciousness during treatment.

Inspira Technologies (NASDAQ: IINN) ha annunciato l'integrazione di un indicatore di ossigenazione di ultima generazione nella sua tecnologia per sensori di sangue HYLA basata sull'IA. Questo miglioramento consente un monitoraggio continuo dell'ossigenazione dei tessuti e una rilevazione precoce dell'ipossia senza la necessità di prelievi di sangue intermittenti.

La tecnologia è attualmente in fase di validazione clinica presso il Sheba Medical Center, con risultati preliminari attesi a breve. Il sistema non invasivo utilizza sensori ottici e algoritmi di apprendimento automatico per il monitoraggio continuo dei parametri ematici, mirando al mercato dei test presso il punto di cura e degli analizzatori di gas ematici, valutato a 2,5 miliardi di dollari. La presentazione alla FDA è prevista per la seconda metà del 2025.

Quando combinato con il sistema INSPIRA ART100 approvato dalla FDA, HYLA mira a fornire una cura completa del paziente attraverso un monitoraggio continuo e non invasivo, mantenendo la coscienza durante il trattamento.

Inspira Technologies (NASDAQ: IINN) ha anunciado la integración de un indicador de oxigenación de nueva generación en su tecnología de sensor de sangre HYLA impulsada por IA. Esta mejora permite el monitoreo continuo de la oxigenación de los tejidos y la detección temprana de hipoxia sin necesidad de extracciones de sangre intermitentes.

La tecnología se encuentra actualmente en validación clínica en el Sheba Medical Center, con resultados preliminares que se esperan pronto. El sistema no invasivo utiliza sensores ópticos y algoritmos de aprendizaje automático para el monitoreo continuo de parámetros sanguíneos, enfocándose en el mercado de pruebas en el punto de atención y analizadores de gases arteriales, valorado en 2.5 mil millones de dólares. Se planea la presentación a la FDA para la segunda mitad de 2025.

Cuando se combina con el sistema INSPIRA ART100 aprobado por la FDA, HYLA pretende proporcionar atención integral al paciente mediante monitoreo continuo y no invasivo, manteniendo la conciencia durante el tratamiento.

Inspira Technologies (NASDAQ: IINN)는 AI 기반 HYLA 혈액 센서 기술에 차세대 산소화 지표를 통합했다고 발표했습니다. 이 개선을 통해 조직 산소화의 지속적인 모니터링과 조기 저산소증 감지가 간헐적인 혈액 추출 없이 가능합니다.

현재 이 기술은 셰바 의료 센터에서 임상 검증 중이며, 조만간 예비 결과가 발표될 예정입니다. 비침습적인 시스템은 지속적인 혈액 매개변수 모니터링을 위해 광센서와 기계 학습 알고리즘을 사용하며, 25억 달러 규모의 포인트 오브 케어 테스트 및 동맥혈가스 분석기 시장을 목표로 하고 있습니다. FDA 제출은 2025년 하반기로 예정되어 있습니다.

FDA 승인을 받은 INSPIRA ART100 시스템과 결합하면 HYLA는 치료 중 의식을 유지하면서 지속적이고 비침습적인 모니터링을 통해 포괄적인 환자 관리를 제공하는 것을 목표로 합니다.

Inspira Technologies (NASDAQ: IINN) a annoncé l'intégration d'un indicateur d'oxygénation de nouvelle génération dans sa technologie de capteur sanguin HYLA alimentée par IA. Cette amélioration permet une surveillance continue de l'oxygénation des tissus et une détection précoce de l'hypoxie sans nécessiter de prélèvements de sang intermittents.

La technologie est actuellement en phase de validation clinique au Sheba Medical Center, avec des résultats préliminaires attendus prochainement. Le système non invasif utilise des capteurs optiques et des algorithmes d'apprentissage automatique pour le suivi continu des paramètres sanguins, ciblant le marché des tests au point de soin et des analyseurs de gaz artériel, évalué à 2,5 milliards de dollars. Une soumission à la FDA est prévue pour la seconde moitié de 2025.

Lorsqu'il est associé au système INSPIRA ART100, approuvé par la FDA, HYLA vise à fournir des soins complets aux patients grâce à une surveillance continue et non invasive tout en maintenant la conscience durant le traitement.

Inspira Technologies (NASDAQ: IINN) hat die Integration eines modernen Sauerstoffindikators in seine KI-gestützte HYLA Blut-Sensor-Technologie angekündigt. Diese Verbesserung ermöglicht eine kontinuierliche Überwachung der Gewebeoxygenierung und eine frühzeitige Erkennung von Hypoxie, ohne dass intermittierende Blutentnahmen erforderlich sind.

Die Technologie befindet sich derzeit in der klinischen Validierung im Sheba Medical Center, und erste Ergebnisse werden bald erwartet. Das nicht-invasive System nutzt optische Sensoren und maschinelles Lernen für die kontinuierliche Überwachung von Blutparametern und zielt auf den 2,5 Milliarden Dollar schweren Markt für Point-of-Care-Tests und arterielle Blutgasanalysegeräte ab. Die Einreichung bei der FDA ist für die zweite Hälfte des Jahres 2025 geplant.

In Kombination mit dem von der FDA zugelassenen INSPIRA ART100-System soll HYLA eine umfassende Patientenversorgung durch kontinuierliches, nicht-invasives Monitoring bieten, während die Bewusstheit während der Behandlung erhalten bleibt.

Positive
  • Targeting a substantial $2.5 billion market opportunity
  • Clinical validation ongoing at top-ranked Sheba Medical Center
  • FDA submission planned for H2 2025
  • Integration with existing FDA-cleared INSPIRA ART100 system
Negative
  • Product still in development phase without FDA approval
  • Clinical results not yet available
  • Market entry timeline extends to late 2025

Insights

The integration of advanced oxygenation monitoring into Inspira's HYLA blood sensor represents a significant technological leap in critical care monitoring. This development targets the $2.5 billion point-of-care testing market with several key competitive advantages:

  • Continuous, non-invasive monitoring eliminates the need for repeated blood draws, potentially reducing infection risks and improving patient comfort while delivering real-time data
  • Integration with the FDA-cleared INSPIRA ART100 system creates a comprehensive monitoring solution, potentially increasing the company's market penetration
  • AI-powered analytics enable early detection of respiratory complications, addressing a important need in critical care settings

The ongoing validation at Sheba Medical Center, ranked among the world's top 10 smart hospitals, adds significant credibility to the technology. This partnership could accelerate market adoption, particularly among leading healthcare institutions. The planned FDA submission in H2 2025 suggests a well-defined regulatory pathway, though investors should note that success is not guaranteed.

From a market perspective, the technology's ability to provide continuous monitoring represents a potential paradigm shift in critical care. The elimination of intermittent blood draws could lead to substantial cost savings for healthcare providers while improving patient outcomes. This positions Inspira to potentially capture a meaningful share of the point-of-care testing market, although the company's small market cap suggests careful consideration of execution risks.

Inspira Technologies develops its innovative AI-powered HYLA technology with advanced blood testing capability, enabling continuous monitoring of tissue oxygenation and early hypoxia detection; Company expects to release preliminary clinical results for the sensor in the near future

RA'ANANA, Israel, Feb. 5, 2025 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) ("Inspira" or the "Company"), a pioneer in breakthrough life-support technology, today announced the integration of a next-generation oxygenation indicator into its AI-powered HYLA™ blood sensor technology, designed to enable the rapid detection of critical oxygen-related conditions without the need for intermittent blood draws.

Inspira Technologies Logo

We believe that the integration of this advanced indicator represents a significant enhancement in critical care monitoring. The technology is designed to provide data through real-time and continuous monitoring of oxygenation therapy, enabling the rapid detection of tissue hypoxia and the early warning of respiratory complications. The advanced AI-powered system is designed to indicate the level of lung function and to monitor vital blood parameters, positioning HYLA as a potential game-changer in the $2.5 billion point-of-care testing and arterial blood gas analyzer market.

Clinical validation of the enhanced HYLA blood sensor, with its new oxygenation indicator, is currently underway at Sheba Medical Center, ranked among the world's top 10 smart hospitals by Newsweek. The Company is optimistic about the ongoing evaluations and expects to share preliminary clinical results in the near future. The non-invasive technology utilizes sophisticated optical sensors and machine-learning algorithms to deliver continuous monitoring of blood parameters and oxygen levels, with a U.S. Food and Drug Administration ("FDA") submission for regulatory clearance anticipated for the second half of 2025.

"This advancement marks an important step in transforming critical care monitoring," said Dagi Ben-Noon, chief executive officer of Inspira. "The integration of this new oxygenation indicator into HYLA will enable healthcare providers to monitor and respond to changes in tissue oxygenation in real-time. We continue to advance in our clinical evaluation program and look forward to sharing preliminary clinical results with the public in the near future, which we hope will further validate the HYLA's unique technological offering and superiority over traditional blood sensors in the market."

The addition of advanced oxygenation monitoring capabilities further strengthens HYLA's position as a comprehensive blood monitoring solution. When combined with the FDA-cleared INSPIRA ART100 system, this technology aims to provide a more complete approach to patient care by enabling continuous, non-invasive monitoring while maintaining consciousness during treatment.

About Inspira Technologies

Inspira Technologies is an innovative medical technology company in the life support and respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA™ ART), a groundbreaking device poised to revolutionize the $19 billion mechanical ventilation market. With 20 million intensive care unit patients with acute respiratory failure each year, many of whom rely on mechanical ventilators, the INSPIRA ART offers a potential alternative by elevating and stabilizing decreasing oxygen saturation levels in minutes without a ventilator, with patients being awake during treatment. The INSPIRA ART is being equipped with a clip-on HYLA™ blood sensor, a real-time continuous blood monitoring technology, aiming to alert physicians of changes in a patient's condition without the need for intermittent actual blood samples, aiming to support physicians in making informed decisions.

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 the prospective benefits and function of the HYLA blood sensor, the belief that the integration of this advanced indicator represents a significant enhancement in critical care monitoring, the prospective FDA regulatory clearance submission, the belief that this development marks an important step in transforming critical care monitoring, the expected release of preliminary clinical results, the belief that the integration of this new oxygenation indicator into HYLA enables healthcare providers to monitor and respond to changes in tissue oxygenation in real-time, and the belief that the addition of advanced oxygenation monitoring capabilities further strengthens HYLA's position as a comprehensive blood monitoring solution. 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, 2023, 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

Capital Markets & Investor Contact
Arx | Capital Markets Advisors
North American Equities Desk
inspira@arxadvisory.com

Logo: https://mma.prnewswire.com/media/1668495/Inspira_Technologies_Logo.jpg

Cision View original content:https://www.prnewswire.com/news-releases/inspira-technologies-integrates-new-oxygenation-indicator-into-ai-powered-hyla-blood-sensor-302368820.html

SOURCE Inspira Technologies

FAQ

When is Inspira Technologies (IINN) planning FDA submission for the HYLA blood sensor?

Inspira Technologies plans to submit the HYLA blood sensor for FDA regulatory clearance in the second half of 2025.

What is the market size for Inspira's (IINN) HYLA blood sensor technology?

The HYLA blood sensor targets the point-of-care testing and arterial blood gas analyzer market, valued at $2.5 billion.

Where is IINN conducting clinical validation for the HYLA blood sensor?

Clinical validation is being conducted at Sheba Medical Center, ranked among the world's top 10 smart hospitals by Newsweek.

What are the key features of IINN's enhanced HYLA blood sensor?

The HYLA blood sensor features AI-powered technology, non-invasive optical sensors, and machine-learning algorithms for continuous monitoring of blood parameters and oxygen levels without blood draws.

How does the new oxygenation indicator enhance IINN's HYLA technology?

The oxygenation indicator enables real-time monitoring of tissue oxygenation, rapid detection of hypoxia, and early warning of respiratory complications without requiring intermittent blood draws.
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