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Inspira Technologies Generates First Revenues from Deployment of INSPIRA ART100 Systems

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Inspira Technologies (NASDAQ: IINN) has achieved a significant milestone by generating its first revenues from the deployment of FDA-cleared INSPIRA ART100 systems at a premier U.S. academic medical center. The revenue, in the low hundreds of thousands of dollars, comes from U.S. distributor Glo-Med Networks for the recently installed systems.

Additional systems are planned for installation at a second leading academic medical center. The INSPIRA ART100, designed for cardiopulmonary bypass procedures, circulates and oxygenates blood outside the body during cardiac surgeries. This technology serves as the foundation for their flagship INSPIRA ART500 system under development, which aims to provide direct blood oxygenation for respiratory failure patients without mechanical ventilation, targeting the $19 billion mechanical ventilation market.

Inspira Technologies (NASDAQ: IINN) ha raggiunto un traguardo importante generando i primi ricavi dalla distribuzione dei sistemi INSPIRA ART100, approvati dalla FDA, presso un prestigioso centro medico accademico negli Stati Uniti. I ricavi, nell'ordine di qualche centinaio di migliaia di dollari, provengono dal distributore statunitense Glo-Med Networks per i sistemi recentemente installati.

Altri sistemi sono previsti per l'installazione in un secondo importante centro medico accademico. Il INSPIRA ART100, progettato per le procedure di bypass cardiopolmonare, circola e ossigena il sangue fuori dal corpo durante gli interventi cardiaci. Questa tecnologia costituisce la base per il loro sistema di punta in fase di sviluppo, il INSPIRA ART500, che mira a fornire ossigenazione diretta del sangue per pazienti con insufficienza respiratoria senza ventilazione meccanica, rivolgendosi al mercato da 19 miliardi di dollari della ventilazione meccanica.

Inspira Technologies (NASDAQ: IINN) ha alcanzado un hito importante al generar sus primeros ingresos por la implementación de los sistemas INSPIRA ART100, aprobados por la FDA, en un prestigioso centro médico académico de Estados Unidos. Los ingresos, que ascienden a unos cientos de miles de dólares, provienen del distribuidor estadounidense Glo-Med Networks por los sistemas recientemente instalados.

Se planea la instalación de sistemas adicionales en un segundo centro médico académico líder. El INSPIRA ART100, diseñado para procedimientos de bypass cardiopulmonar, circula y oxigena la sangre fuera del cuerpo durante cirugías cardíacas. Esta tecnología es la base para su sistema principal en desarrollo, el INSPIRA ART500, que busca proporcionar oxigenación directa de la sangre para pacientes con insuficiencia respiratoria sin ventilación mecánica, apuntando al mercado de ventilación mecánica de 19 mil millones de dólares.

Inspira Technologies (NASDAQ: IINN)는 미국의 주요 학술 의료센터에서 FDA 승인 INSPIRA ART100 시스템을 배치하여 첫 매출을 달성하는 중요한 이정표를 세웠습니다. 수익은 수십만 달러 규모로, 최근 설치된 시스템에 대해 미국 유통업체 Glo-Med Networks로부터 발생했습니다.

추가 시스템은 두 번째 주요 학술 의료센터에 설치될 예정입니다. INSPIRA ART100는 심폐 우회 수술 중 체외에서 혈액을 순환시키고 산소를 공급하도록 설계되었습니다. 이 기술은 현재 개발 중인 주력 제품 INSPIRA ART500의 기반이 되며, 기계적 인공호흡 없이 호흡부전 환자에게 직접 혈액 산소 공급을 제공하는 것을 목표로 하며, 190억 달러 규모의 인공호흡기 시장을 겨냥하고 있습니다.

Inspira Technologies (NASDAQ : IINN) a franchi une étape importante en générant ses premiers revenus grâce au déploiement des systèmes INSPIRA ART100, approuvés par la FDA, dans un centre médical universitaire de premier plan aux États-Unis. Les revenus, s’élevant à plusieurs centaines de milliers de dollars, proviennent du distributeur américain Glo-Med Networks pour les systèmes récemment installés.

D’autres systèmes sont prévus pour une installation dans un second centre médical universitaire majeur. Le INSPIRA ART100, conçu pour les procédures de dérivation cardiopulmonaire, fait circuler et oxygéne le sang hors du corps lors des interventions cardiaques. Cette technologie constitue la base de leur système phare en développement, le INSPIRA ART500, qui vise à fournir une oxygénation directe du sang pour les patients en insuffisance respiratoire sans ventilation mécanique, ciblant le marché de la ventilation mécanique estimé à 19 milliards de dollars.

Inspira Technologies (NASDAQ: IINN) hat einen bedeutenden Meilenstein erreicht, indem es erste Umsätze durch den Einsatz der von der FDA zugelassenen INSPIRA ART100-Systeme an einem führenden akademischen US-Medizinzentrum erzielte. Die Umsätze, die im niedrigen sechsstelligen Bereich liegen, stammen vom US-Distributor Glo-Med Networks für die kürzlich installierten Systeme.

Weitere Systeme sind für die Installation an einem zweiten führenden akademischen Medizinzentrum geplant. Das INSPIRA ART100, entwickelt für kardiopulmonale Bypass-Verfahren, zirkuliert und oxygeniert Blut außerhalb des Körpers während Herzoperationen. Diese Technologie bildet die Grundlage für ihr Flaggschiff-System INSPIRA ART500, das sich in der Entwicklung befindet und darauf abzielt, Patienten mit Atemversagen ohne mechanische Beatmung direkt mit Sauerstoff im Blut zu versorgen. Dabei wird der 19-Milliarden-Dollar-Markt für mechanische Beatmungsgeräte adressiert.

Positive
  • First revenue generation from FDA-cleared INSPIRA ART100 systems
  • Successful deployment in a premier U.S. academic medical center
  • Planned expansion to a second leading academic medical center
  • Revenue in low hundreds of thousands of dollars from initial deployment
Negative
  • Revenue generation still in early stages with deployment
  • Flagship INSPIRA ART500 system still under development, not yet commercialized

Insights

Inspira's announcement marks a critical commercialization milestone with first revenue generation from their FDA-cleared INSPIRA ART100 system. The successful deployment at a premier U.S. academic medical center provides crucial clinical validation for their extracorporeal oxygenation technology, addressing a high-credibility market segment that typically has rigorous technology assessment processes.

The company's strategic approach deserves attention - they're establishing real-world usage in academic centers, creating valuable reference sites that can accelerate broader market adoption. The planned expansion to a second facility indicates positive initial clinical reception and demonstrates execution capability in their commercialization strategy.

What's particularly notable is how the ART100 serves as both a revenue-generating product and a platform validation for their more ambitious INSPIRA ART500 system under development. By targeting the $19 billion mechanical ventilation market with their next-generation product, Inspira is establishing a beachhead in extracorporeal oxygenation while building toward a much larger opportunity that could potentially transform respiratory care protocols.

The key differentiator appears to be their approach allowing patients to remain awake during treatment, avoiding mechanical ventilation complications that have gained increased attention during recent respiratory health crises. This initial revenue generation, while modest, represents an essential validation point for both their core technology and commercial pathway.

This revenue milestone, while modest at "low hundreds of thousands of dollars," represents a fundamental inflection point for Inspira. For micro-cap medical technology companies, transitioning from pre-revenue development to initial commercialization significantly reduces investment risk by validating both market acceptance and operational execution capability.

With a market capitalization of approximately $15.7 million, Inspira has been valued primarily on technological promise until now. This revenue event transforms their investment profile from purely speculative to early commercial stage, potentially enabling re-rating toward revenue-based valuation metrics as deployment expands.

The sequential expansion to a second medical center suggests early commercial momentum rather than a one-off placement. This pattern of adoption, particularly in prestigious academic centers, typically precedes broader commercial traction in medical technology rollouts. The announced revenue likely represents only the initial systems, with potential recurring revenue from consumables and maintenance not yet materialized.

The company's strategy of leveraging their FDA-cleared ART100 platform while developing the potentially more disruptive ART500 creates a dual-horizon growth narrative - immediate revenue generation coupled with longer-term market disruption potential. For investors, this reduces near-term cash burn concerns while maintaining significant upside optionality. As clinical data accumulates from these initial deployments, we'll gain better visibility into potential adoption trajectories and revenue scaling potential.

The Company achieves significant milestone with initial revenues generated from FDA-cleared life support technology deployed in a leading U.S. healthcare facility; additional systems currently planned for second hospital facility

RA'ANANA, Israel, April 15, 2025 (GLOBE NEWSWIRE) -- RA'ANANA, Israel, April 15, 2025 -- 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 received payment from its U.S. distributor, Glo-Med Networks Inc. (“Glo-Med”), for a delivery of its INSPIRA™ ART100 systems, which are cleared by the U.S. Food & Drug Administration (“FDA”).

The revenue, in the range of the low hundreds of thousands of dollars, relates to the delivery of the INSPIRA ART100 systems, which have been recently installed at a premier U.S. academic medical center, as previously announced. In addition, additional systems are planned for installation at a second leading academic medical center. This revenue milestone represents a significant achievement in the Company's deployment strategy, as it continues to expand its footprint in the U.S. healthcare market.

"Generating our first revenues represents a transformative milestone for Inspira as we establish our presence in the U.S. medical landscape," said Dagi Ben-Noon, Chief Executive Officer of Inspira. "This achievement, coupled with our successful system installation at a premier medical institution, validates both our innovative technology and our ability to work with top tier medical institutions. As we expand our clinical footprint and generate valuable real-world data, we look forward to advancing the adoption of our life-support systems among leading healthcare facilities across the United States, generating initial revenues in the process."

The Company's broader expansion strategy includes collaborating with additional leading medical experts and institutions to further validate its innovative approach to extracorporeal life support. The FDA-cleared INSPIRA ART100, intended for cardiopulmonary bypass procedures, circulates and oxygenates blood outside the body during cardiac surgeries. This same core technology serves as a foundational technology of the Company’s flagship INSPIRA™ ART500 system which is currently under development and is being designed to provide direct blood oxygenation for respiratory failure patients without mechanical ventilation. The INSPIRA ART500 aims to revolutionize the $19 billion mechanical ventilation market by offering a safer alternative that allows patients to remain awake during treatment.

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

About Glo-Med Networks, Inc.
Glo-Med, known for delivering unique healthcare solutions, collaborates with top medical device and biomedical companies worldwide to meet the growing demand for innovative medical devices and related products in domestic and international markets. Glo-Med maintains extensive access to next-generation medical products globally via long-term partnerships and relationships with medical providers and through its sister company focused on medical device servicing with a focus on hospital beds and medical mattresses, Med-Stat Consulting Services, Inc. (est. 2003). Along with larger and prominent healthcare organizations in New York and Florida as clients, Glo-Med has offices and partner companies in the U.S., Latin America, Europe, the Middle East, and Africa, providing extensive access to the global medical network.

For more information, please visit the corporate website: www.glomednet.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 planned installation of additional ART100 systems at a second leading academic medical center, that the achievement of its initial revenues, coupled with its successful system installation at a premier medical institution, validates both its innovative technology and its ability to work with top tier medical institutions and its broader expansion strategy, its anticipated advancement of adoption of its life-support systems across leading healthcare facilities, the potential advantages of the INSPIRA ART100, and its aim to revolutionize the mechanical ventilation market.. 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


FAQ

How much revenue did Inspira Technologies (IINN) generate from its first INSPIRA ART100 deployment?

Inspira generated revenue in the low hundreds of thousands of dollars from the deployment of INSPIRA ART100 systems at a U.S. academic medical center.

What is the primary function of Inspira Technologies' ART100 system?

The INSPIRA ART100 is designed for cardiopulmonary bypass procedures, circulating and oxygenating blood outside the body during cardiac surgeries.

How many medical centers are currently implementing Inspira's ART100 technology?

One premier U.S. academic medical center has installed the system, with planned installation at a second leading academic medical center.

What market is Inspira Technologies targeting with its upcoming ART500 system?

The INSPIRA ART500 targets the $19 billion mechanical ventilation market, aiming to provide direct blood oxygenation without mechanical ventilation.

What distinguishes Inspira's ART500 system from traditional mechanical ventilation?

The ART500 is designed to allow patients to remain awake during treatment while providing direct blood oxygenation, offering a potentially safer alternative to mechanical ventilation.
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