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Inspira Technologies Announces Successful Installation of INSPIRA ART100 Systems in Premier U.S. Hospital

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Inspira Technologies (NASDAQ: IINN) has successfully completed the installation and training program for its FDA-cleared INSPIRA ART100 system at a premier New York hospital. The system, designed for cardiopulmonary bypass procedures, is now ready for clinical use, marking a significant milestone in the company's deployment strategy.

The installation serves as a precursor to implementing core technologies of the flagship INSPIRA ART500 system, which aims to transform the $19 billion mechanical ventilation market. Inspira's goal is to replace a substantial portion of the estimated 100,000 ventilators in the U.S. with their innovative alternative.

This deployment follows the FDA 510(k) clearance for the INSPIRA ART100 system and aligns with the company's expansion strategy of collaborating with leading medical opinion leaders and institutions. The company expects to receive clinical feedback in the coming weeks.

Inspira Technologies (NASDAQ: IINN) ha completato con successo l'installazione e il programma di formazione per il suo sistema INSPIRA ART100, approvato dalla FDA, presso un prestigioso ospedale di New York. Il sistema, progettato per procedure di bypass cardiopolmonare, è ora pronto per l'uso clinico, segnando un traguardo significativo nella strategia di distribuzione dell'azienda.

L'installazione funge da precursore per l'implementazione delle tecnologie fondamentali del sistema di punta INSPIRA ART500, che mira a trasformare il mercato della ventilazione meccanica da 19 miliardi di dollari. L'obiettivo di Inspira è sostituire una parte sostanziale dei circa 100.000 ventilatori negli Stati Uniti con la loro alternativa innovativa.

Questa distribuzione segue l'approvazione FDA 510(k) per il sistema INSPIRA ART100 e si allinea con la strategia di espansione dell'azienda di collaborare con leader di opinione medica e istituzioni di spicco. L'azienda prevede di ricevere feedback clinici nelle prossime settimane.

Inspira Technologies (NASDAQ: IINN) ha completado con éxito la instalación y el programa de capacitación para su sistema INSPIRA ART100, aprobado por la FDA, en un hospital de prestigio en Nueva York. El sistema, diseñado para procedimientos de bypass cardiopulmonar, ya está listo para su uso clínico, marcando un hito significativo en la estrategia de implementación de la empresa.

La instalación sirve como precursor para la implementación de las tecnologías centrales del sistema insignia INSPIRA ART500, que busca transformar el mercado de ventilación mecánica de 19 mil millones de dólares. El objetivo de Inspira es reemplazar una parte sustancial de los aproximadamente 100,000 ventiladores en los EE. UU. con su alternativa innovadora.

Este despliegue sigue la aprobación FDA 510(k) para el sistema INSPIRA ART100 y se alinea con la estrategia de expansión de la empresa de colaborar con líderes de opinión médica e instituciones destacadas. La empresa espera recibir comentarios clínicos en las próximas semanas.

Inspira Technologies (NASDAQ: IINN)은 FDA 승인을 받은 INSPIRA ART100 시스템의 설치 및 교육 프로그램을 뉴욕의 유명 병원에서 성공적으로 완료했습니다. 이 시스템은 심폐 우회 수술을 위해 설계되었으며, 이제 임상 사용을 위한 준비가 완료되어 회사의 배포 전략에 있어 중요한 이정표가 되었습니다.

이번 설치는 주력 제품인 INSPIRA ART500 시스템의 핵심 기술 구현을 위한 전초전 역할을 하며, 190억 달러 규모의 기계 환기 시장을 혁신할 것을 목표로 하고 있습니다. Inspira의 목표는 미국 내 약 100,000개의 인공호흡기 중 상당 부분을 혁신적인 대체품으로 교체하는 것입니다.

이번 배포는 INSPIRA ART100 시스템에 대한 FDA 510(k) 승인을 따르며, 주요 의료 의견 리더 및 기관과 협력하는 회사의 확장 전략과 일치합니다. 회사는 향후 몇 주 내에 임상 피드백을 받을 것으로 기대하고 있습니다.

Inspira Technologies (NASDAQ: IINN) a réussi à terminer l'installation et le programme de formation pour son système INSPIRA ART100, approuvé par la FDA, dans un hôpital de premier plan à New York. Le système, conçu pour les procédures de pontage cardiopulmonaire, est maintenant prêt pour une utilisation clinique, marquant une étape importante dans la stratégie de déploiement de l'entreprise.

L'installation sert de précurseur à la mise en œuvre des technologies de base du système phare INSPIRA ART500, qui vise à transformer le marché de la ventilation mécanique de 19 milliards de dollars. L'objectif d'Inspira est de remplacer une partie substantielle des 100 000 ventilateurs estimés aux États-Unis par leur alternative innovante.

Ce déploiement fait suite à l'approbation 510(k) de la FDA pour le système INSPIRA ART100 et s'inscrit dans la stratégie d'expansion de l'entreprise, qui consiste à collaborer avec des leaders d'opinion médicale et des institutions de premier plan. L'entreprise s'attend à recevoir des retours cliniques dans les semaines à venir.

Inspira Technologies (NASDAQ: IINN) hat erfolgreich die Installation und das Schulungsprogramm für sein von der FDA zugelassenes INSPIRA ART100 System in einem renommierten Krankenhaus in New York abgeschlossen. Das System, das für kardiopulmonale Bypass-Verfahren konzipiert wurde, ist nun bereit für den klinischen Einsatz, was einen bedeutenden Meilenstein in der Einsatzstrategie des Unternehmens darstellt.

Die Installation dient als Vorläufer für die Implementierung der Kerntechnologien des Flaggschiff-Systems INSPIRA ART500, das den 19 Milliarden Dollar schweren Markt für mechanische Beatmung revolutionieren soll. Inspiras Ziel ist es, einen erheblichen Teil der geschätzten 100.000 Beatmungsgeräte in den USA durch ihre innovative Alternative zu ersetzen.

Dieser Einsatz folgt auf die FDA 510(k) Genehmigung für das INSPIRA ART100 System und steht im Einklang mit der Expansionsstrategie des Unternehmens, mit führenden medizinischen Meinungsführern und Institutionen zusammenzuarbeiten. Das Unternehmen erwartet in den kommenden Wochen klinisches Feedback.

Positive
  • FDA-cleared INSPIRA ART100 system successfully installed and ready for clinical use
  • Strategic installation in premier New York hospital validates technology
  • Targeting large $19B mechanical ventilation market opportunity
  • System prepared for immediate clinical deployment with completed training program
Negative
  • No immediate revenue generation reported from the installation
  • Clinical feedback and actual performance data still pending
  • Market penetration and adoption rates remain uncertain

Insights

Inspira Technologies' announcement represents a significant commercialization milestone with the successful installation of its FDA-cleared INSPIRA ART100 system at a premier New York hospital. This development marks the transition from regulatory approval to real-world implementation, positioning the company for the first human clinical use of their technology.

The deployment encompasses both physical installation and completion of the training program, creating operational readiness for cardiopulmonary bypass procedures. While the systems are now in place, it's important to note that actual clinical use with patients hasn't yet begun but is anticipated in the "near future" with feedback expected "in the coming weeks."

This installation serves dual strategic purposes: establishing initial commercial presence in the U.S. healthcare market and validating the core technologies that will also power their flagship INSPIRA ART500 system. The successful implementation at a prestigious institution could provide valuable clinical validation if the technology performs as expected.

Inspira's longer-term strategy targets the $19 billion mechanical ventilation market, aiming to displace traditional ventilators with their technology. However, investors should recognize that this installation represents an early commercialization step rather than immediate significant revenue. The current milestone relates specifically to the ART100 for cardiopulmonary bypass, while the company's broader ventilator market aspirations depend on future products.

This announcement demonstrates tangible progress in Inspira's commercialization pathway, with a prestigious first customer potentially providing credibility for future market expansion.

Inspira's innovative FDA-cleared INSPIRA ART100 system was successfully deployed at premier U.S. hospital, with systems in place for clinical use

RA'ANANA, Israel, March 25, 2025 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced that it has successfully completed the installation, training program and operational readiness for its INSPIRA ART100 system for cardiopulmonary bypass procedures at one of New York's premier hospitals.

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We believe that this installation represents a significant milestone in the Company's deployment plan, as the Company nears the first human clinical use of the system. The newly installed INSPIRA ART100 systems are expected to be used for clinical use in the near future by the hospital's team of experts on patients undergoing procedures. The Company expects to receive feedback in the coming weeks from such use.

"We believe that this successful installation and training program represents a transformative moment for Inspira," said Dagi Ben-Noon, Chief Executive Officer of Inspira. "The adoption of our technology by one of the nation's premier hospitals is expected to provide validation for the clinical value of our innovative approach to extracorporeal life support and to establish our commercial presence in the U.S. healthcare market. The enthusiastic initial response from the hospital's world-class team reinforces the transformative potential of our technology in revolutionizing respiratory care standards."

The Company's proprietary hardware and software platform is already embedded in the INSPIRA ART100, with this installation expected to serve as the precursor to the clinical use of one of the core technologies of the flagship INSPIRA™ ART500 system. Inspira aims to revolutionize the $19 billion mechanical ventilation market with its INSPIRA ART500 novel technology, with the goal of replacing a significant portion of the estimated 100,000 ventilators in the U.S. with a safer, more human-centered alternative.

The deployment is part of the Company's broader expansion strategy, which includes collaborating with leading medical opinion leaders and successfully supplying leading institutions with its next-generation technology for clinical use. This achievement follows the receipt of FDA 510(k) clearance for the INSPIRA ART100 system.

About Inspira Technologies

Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART500 system aims to revolutionize critical care by enabling patients to remain awake during treatment while stabilizing oxygen levels without mechanical ventilation. The FDA-cleared INSPIRA ART100 system has received regulatory approvals for Cardiopulmonary Bypass procedures in the U.S. and for Cardiopulmonary Bypass procedures and Extra Corporeal Membrane Oxygenation in Israel. The Company's HYLA blood sensor technology is designed to provide continuous, real-time blood monitoring without the need for blood draws. The Company's pipeline products, including the INSPIRA ART500, HYLA blood sensor, and Single-use patient kit are currently in development and have not yet received regulatory approval.

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 belief that the installation represents a significant milestone in the Company's deployment plan, the prospective first clinical use cases of the system, the belief that this successful installation and training program represents a transformative moment for the Company, the expectation that the installation may provide validation for the clinical value of the Company's system, thereby establishing its commercial presence in the U.S. healthcare market, the expectation that this installation is expected to serve as the precursor to the clinical use of one of the core technologies of the flagship INSPIRA™ ART500 system, and that the Company aims to revolutionize the $19 billion mechanical ventilation market with its INSPIRA ART500 novel technology. 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

Capital Markets & Investor Contact

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

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SOURCE Inspira Technologies

FAQ

What is the significance of INSPIRA ART100's installation at the New York hospital for IINN?

It marks a important milestone for clinical deployment and validates their technology in a premier healthcare setting, potentially establishing their commercial presence in the U.S. market.

How large is the market opportunity that Inspira Technologies (IINN) is targeting?

IINN is targeting the $19 billion mechanical ventilation market, aiming to replace a significant portion of 100,000 U.S. ventilators.

What regulatory approvals has the INSPIRA ART100 system received?

The INSPIRA ART100 system has received FDA 510(k) clearance.

When will the INSPIRA ART100 begin clinical use at the New York hospital?

The system is expected to begin clinical use in the near future, with feedback anticipated in the coming weeks.
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