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PESG Report: Inspira Technologies Strengthens its AI-Powered Blood Sensor with new Capabilities, Intends to Share Clinical Findings Soon

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Inspira Technologies (NASDAQ: IINN) has enhanced its AI-driven medical platform by integrating a next-generation oxygenation indicator into its HYLA blood sensor technology. This advancement enables rapid detection of oxygen-related conditions without requiring blood draws, targeting the $2.5 billion Arterial Blood Gas analyzer market.

The HYLA system, currently under clinical evaluation at Sheba Medical Center, uses optical sensors and machine learning for real-time blood parameter monitoring. The company plans 510(k) FDA submissions in the second half of 2025. The technology complements their FDA-cleared INSPIRA ART100 system, which received its first U.S. purchase order through Glo-Med Networks in June 2024.

This development comes amid strong medtech M&A activity, with Q3 2024 seeing 275 deals worth $34 billion, a 35% increase year-over-year. The company is targeting both the blood gas analysis market and the $19 billion mechanical ventilation market, addressing the needs of approximately 20 million patients requiring mechanical ventilation globally.

Inspira Technologies (NASDAQ: IINN) ha migliorato la sua piattaforma medica basata sull'IA integrando un indicatore di ossigenazione di nuova generazione nella sua tecnologia di sensori per il sangue HYLA. Questo progresso consente una rapida rilevazione delle condizioni correlate all'ossigeno senza necessità di prelievo di sangue, puntando al mercato degli analizzatori di gas arterioso da 2.5 miliardi di dollari.

Il sistema HYLA, attualmente in fase di valutazione clinica presso il Sheba Medical Center, utilizza sensori ottici e apprendimento automatico per il monitoraggio in tempo reale dei parametri ematici. L'azienda prevede di presentare le domande 510(k) alla FDA nella seconda metà del 2025. La tecnologia completa il loro sistema INSPIRA ART100, approvato dalla FDA, che ha ricevuto il suo primo ordine d'acquisto negli Stati Uniti tramite Glo-Med Networks a giugno 2024.

Questo sviluppo si inserisce in un contesto di attività intensa di fusioni e acquisizioni nel settore med-tech, con il terzo trimestre del 2024 che ha registrato 275 affari per un valore di 34 miliardi di dollari, un incremento del 35% rispetto all'anno precedente. L'azienda punta sia al mercato dell'analisi dei gas ematici sia al mercato della ventilazione meccanica da 19 miliardi di dollari, rispondendo alle esigenze di circa 20 milioni di pazienti che necessitano di ventilazione meccanica a livello globale.

Inspira Technologies (NASDAQ: IINN) ha mejorado su plataforma médica impulsada por IA al integrar un indicador de oxigenación de próxima generación en su tecnología de sensores de sangre HYLA. Este avance permite la detección rápida de condiciones relacionadas con el oxígeno sin necesidad de extracciones de sangre, apuntando al mercado de analizadores de gases arteriales de 2.5 mil millones de dólares.

El sistema HYLA, actualmente en evaluación clínica en el Sheba Medical Center, utiliza sensores ópticos y aprendizaje automático para el monitoreo en tiempo real de los parámetros sanguíneos. La empresa planea enviar las solicitudes 510(k) a la FDA en la segunda mitad de 2025. La tecnología complementa su sistema INSPIRA ART100 aprobado por la FDA, que recibió su primer pedido de compra en EE. UU. a través de Glo-Med Networks en junio de 2024.

Este desarrollo ocurre en medio de una fuerte actividad de fusiones y adquisiciones en el sector medtech, con el tercer trimestre de 2024 viendo 275 acuerdos por un valor de 34 mil millones de dólares, un aumento del 35% en comparación con el año anterior. La empresa está apuntando tanto al mercado de análisis de gases en sangre como al mercado de ventilación mecánica de 19 mil millones de dólares, atendiendo las necesidades de aproximadamente 20 millones de pacientes que requieren ventilación mecánica a nivel mundial.

Inspira Technologies (NASDAQ: IINN)는 차세대 산소 지표를 HYLA 혈액 센서 기술에 통합하여 AI 기반의 의료 플랫폼을 개선했습니다. 이러한 발전은 혈액 채취 없이도 산소 관련 상태를 신속하게 감지할 수 있게 하며, 25억 달러 규모의 동맥혈가스 분석기 시장을 목표로 하고 있습니다.

현재 Sheba Medical Center에서 임상 평가 중인 HYLA 시스템은 광학 센서와 머신 러닝을 사용하여 실시간으로 혈액 매개 변수를 모니터링합니다. 회사는 2025년 하반기 중으로 510(k) FDA 제출을 계획하고 있습니다. 이 기술은 FDA 승인을 받은 INSPIRA ART100 시스템을 보완하며, 이 시스템은 2024년 6월 Glo-Med Networks를 통해 미국에서 첫 번째 구매 주문을 받았습니다.

이번 발전은 강력한 의료 기술 M&A 활동 속에서 이루어지며, 2024년 3분기에는 275건의 거래가 340억 달러에 달하며, 전년 대비 35% 증가했습니다. 회사는 혈액 가스 분석 시장과 190억 달러 규모의 기계적 환기 시장을 목표로 하고 있으며, 전 세계 약 2000만 명의 기계적 환기를 필요로 하는 환자의 요구를 해결하고 있습니다.

Inspira Technologies (NASDAQ: IINN) a amélioré sa plateforme médicale basée sur l'IA en intégrant un indicateur d'oxygénation de nouvelle génération dans sa technologie de capteurs sanguins HYLA. Cette avancée permet une détection rapide des conditions liées à l'oxygène sans nécessiter de prélèvements sanguins, ciblant le marché des analyseurs de gaz artériel d'une valeur de 2,5 milliards de dollars.

Le système HYLA, actuellement évalué cliniquement au Sheba Medical Center, utilise des capteurs optiques et de l'apprentissage automatique pour le suivi en temps réel des paramètres sanguins. L'entreprise prévoit de soumettre des demandes 510(k) à la FDA dans la seconde moitié de 2025. La technologie complète leur système INSPIRA ART100, qui a été approuvé par la FDA et a reçu sa première commande d'achat aux États-Unis par le biais de Glo-Med Networks en juin 2024.

Ce développement s'inscrit dans un contexte d'activités intenses de fusions et d'acquisitions dans le secteur medtech, avec un 3ème trimestre 2024 ayant enregistré 275 transactions d'une valeur de 34 milliards de dollars, soit une augmentation de 35 % par rapport à l'année précédente. L'entreprise vise à la fois le marché de l'analyse des gaz sanguins et le marché de la ventilation mécanique d'une valeur de 19 milliards de dollars, répondant aux besoins d'environ 20 millions de patients nécessitant une ventilation mécanique dans le monde.

Inspira Technologies (NASDAQ: IINN) hat seine KI-gestützte medizinische Plattform verbessert, indem es einen Sauerstoffindikator der nächsten Generation in seine HYLA-Blutsensortechnologie integriert hat. Dieser Fortschritt ermöglicht eine schnelle Erkennung von sauerstoffbezogenen Zuständen, ohne dass Blutabnahmen erforderlich sind und zielt auf den Markt für arterielle Blutgasanalysegeräte im Wert von 2,5 Milliarden Dollar.

Das HYLA-System, das sich derzeit in klinischer Erprobung am Sheba Medical Center befindet, nutzt optische Sensoren und maschinelles Lernen zur Echtzeitüberwachung von Blutparametern. Das Unternehmen plant, im zweiten Halbjahr 2025 510(k)-Anträge bei der FDA einzureichen. Die Technologie ergänzt ihr von der FDA zugelassenes INSPIRA ART100-System, das im Juni 2024 seine erste Kaufbestellung in den USA über Glo-Med Networks erhalten hat.

Diese Entwicklung findet vor dem Hintergrund einer intensiven M&A-Aktivität im Medizintechniksektor statt, wobei das dritte Quartal 2024 275 Transaktionen im Wert von 34 Milliarden Dollar verzeichnete, was einem Anstieg von 35 % im Vergleich zum Vorjahr entspricht. Das Unternehmen zielt sowohl auf den Markt für Blutgasanalyse als auch auf den Markt für mechanische Belüftung im Wert von 19 Milliarden Dollar ab und adressiert die Bedürfnisse von rund 20 Millionen Patienten, die weltweit eine mechanische Belüftung benötigen.

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Inspira Technologies* advancement of its AI-powered blood monitoring technology comes amid robust growth in medical technology M&A, with Q3 2024 seeing 275 deals worth $34 billion - a 35% increase year-over-year. The integration of this new oxygenation indicator strengthens the Company's position in both the $2.5 billion blood gas analysis market and, through the FDA-cleared INSPIRA ART100 system, the $19 billion mechanical ventilation market. With clinical evaluations of the HYLA blood sensor underway at Sheba Medical Center and preliminary results reportedly expected in the near future, the Company continues to execute its strategy of combining AI-enhanced monitoring capabilities with innovative respiratory support solutions.

NEW YORK--(BUSINESS WIRE)-- Future Markets Research Releases an update following recent developments: Inspira Technologies* (NASDAQ: IINN) has announced a significant advancement in its AI-driven medical platform with the integration of a next-generation oxygenation indicator into its HYLA blood sensor technology. This enhancement enables rapid detection of critical oxygen-related conditions without requiring intermittent blood draws, representing a potential breakthrough in continuous patient monitoring.

The HYLA System: A New Paradigm in Blood Monitoring, powered by AI

The enhanced HYLA blood sensor system leverages sophisticated optical sensors and machine learning algorithms to provide real-time monitoring of vital blood parameters. This AI-powered technology is designed to detect and alert healthcare providers to changes in tissue oxygenation and early warning signs of respiratory complications, including hypoxia.

Currently undergoing clinical evaluation at Sheba Medical Center, ranked among the world's top 10 smartest hospitals by Newsweek, the system targets what the companies notes as the $2.5 billion Arterial Blood Gas analyzer market. The company has announced plans for 510(k) FDA submissions in the second half of 2025, marking a clear regulatory pathway for this innovative technology.

Notably, the product is intended for dual use – both as a standalone product, as well as an addon to Inspira’s ART100 system, which is already in commercialization phases after reviewing FDA clearance. The ART100 is designed to revolutionize extracorporeal blood circulation by integrating cutting-edge technology with intuitive design to optimize patient care during crucial times. As such, this enhancement of the HYLA also strengthens Inspira’s offering also in what the companies says is a $19 billion mechanical ventilation market.

Expansive Product line with FDA Cleared Products being Deployed

While HYLA advances through clinical evaluation, Inspira has already achieved significant business milestones with its INSPIRA ART100 system. Following FDA 510(k) clearance in May 2024 for Cardiopulmonary Bypass procedures and subsequent Israeli AMAR certification, the company secured its first U.S. purchase order through distribution partner Glo-Med Networks in June 2024. The ART100 system is now being prepared for deployment in U.S. hospitals, demonstrating Inspira's ability to navigate both regulatory requirements and its operational implementation.

Inspira's technology ecosystem extends beyond blood monitoring to address critical challenges in respiratory care. The company's proprietary VORTX technology represents a novel approach to blood oxygenation, designed to minimize blood trauma compared to traditional fiber membrane technologies. This innovation supports their flagship INSPIRA ART (Gen 2) system, which targets the $19 billion mechanical ventilation market by offering an alternative to conventional ventilation methods that often require medically induced coma and intubation.

Market Context and Importance

Inspira's technological advances is particularly relevant given current healthcare challenges. With approximately 20 million patients annually requiring mechanical ventilation globally and mortality rates exceeding 50% under current protocols according to recent reports the company has highlighted, the need for innovative solutions is clear. Inspira's approach of enabling conscious patient treatment while maintaining continuous monitoring represents a potential paradigm shift in critical care management.

From a financial perspective, deal activity in medical technology presents a compelling backdrop for innovative AI-focused companies like Inspira. Overall medical device M&A showed robust growth in Q3 2024, with GlobalData reporting 275 deals worth $34 billion - marking a 35% increase in volume and 25% increase in value compared to Q3 2023. Venture investment activity has been particularly strong, with medtech seeing $16.1 billion across 554 funding rounds through Q3 2024. Notably, Inspira holds a market capitlization of just of $20 Million.

What to look out for

Several key developments seem to be expected in the coming months, including the deployment of INSPIRA ART100 systems in leading U.S. hospitals which the company is preparing for according to a recent press release. Additionally, according to this latest release, preliminary clinical results from the HYLA blood sensor evaluation program are expected to be reported in the near future. If the preliminary clinical results are positive, specifically, if they are indeed inline with the performance of the standard sensors in the market, that would be a significant validation of Inspira’s HYLA and could be a strong boost in their positioning.

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* Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This report is published by PESG Research, a brand affiliated with the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This report contains paid promotional content related to Inspira Technologies and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by Inspira prior to publication Please review the full disclaimers and compensation disclosures here: redditwire.com/terms.

PESG Editorial Desk

ronald@futuremarketsresearch.com

Source: PESG

FAQ

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

The enhanced HYLA blood sensor uses AI-powered optical sensors and machine learning algorithms to provide real-time monitoring of vital blood parameters, detecting oxygen-related conditions without requiring blood draws.

When is Inspira Technologies (IINN) planning to submit its HYLA system for FDA approval?

Inspira Technologies plans to submit its HYLA system for 510(k) FDA approval in the second half of 2025.

What is the market size potential for Inspira's HYLA and ART100 systems?

The HYLA system targets the $2.5 billion Arterial Blood Gas analyzer market, while the ART100 system addresses the $19 billion mechanical ventilation market.

Where is the HYLA blood sensor currently being clinically evaluated?

The HYLA blood sensor is currently undergoing clinical evaluation at Sheba Medical Center, ranked among the world's top 10 smartest hospitals by Newsweek.

What recent milestones has IINN achieved with its ART100 system?

IINN received FDA 510(k) clearance for the ART100 system in May 2024, obtained Israeli AMAR certification, and secured its first U.S. purchase order through Glo-Med Networks in June 2024.

How does the current medtech M&A environment impact IINN's market position?

The medtech sector saw robust M&A activity in Q3 2024 with 275 deals worth $34 billion, representing a 35% increase year-over-year, creating a favorable environment for innovative AI-focused companies like IINN.
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