Inspira Technologies Announces Successful Treatment of First Patient with INSPIRA ART100 at Westchester Medical Center
Inspira Technologies (Nasdaq: IINN) has announced the successful completion of the first human treatment using its FDA-cleared INSPIRA ART100 system at Westchester Medical Center in New York State. The life-support procedure demonstrated effective heart and lung support through blood oxygenation and circulation, with the patient safely transitioning off the system afterward.
Dr. David Spielvogel, Section Chief of Cardiothoracic Surgery at Westchester Medical Center, praised the system's reliability and responsiveness, highlighting the seamless transition during connection and disconnection phases. The procedure's success validates the technology's performance in a real-world clinical environment.
The installation, training, and professional services were managed by Glo-Med Networks Inc., Inspira's U.S. distributor, as they prepare for broader hospital adoption.
Inspira Technologies (Nasdaq: IINN) ha annunciato il completamento con successo del primo trattamento umano utilizzando il suo sistema INSPIRA ART100 approvato dalla FDA presso il Westchester Medical Center nello Stato di New York. La procedura di supporto vitale ha dimostrato un'efficace assistenza per cuore e polmoni attraverso l'ossigenazione e la circolazione del sangue, con il paziente che ha potuto interrompere in sicurezza l'uso del sistema successivamente.
Il Dr. David Spielvogel, Capo Sezione di Chirurgia Cardiotoracica presso il Westchester Medical Center, ha lodato l'affidabilità e la reattività del sistema, evidenziando la transizione fluida durante le fasi di connessione e disconnessione. Il successo della procedura convalida le prestazioni della tecnologia in un ambiente clinico reale.
L'installazione, la formazione e i servizi professionali sono stati gestiti da Glo-Med Networks Inc., distributore statunitense di Inspira, mentre si preparano per una più ampia adozione negli ospedali.
Inspira Technologies (Nasdaq: IINN) ha anunciado la finalización exitosa del primer tratamiento humano utilizando su sistema INSPIRA ART100 aprobado por la FDA en el Westchester Medical Center en el Estado de Nueva York. El procedimiento de soporte vital demostró un apoyo efectivo para el corazón y los pulmones a través de la oxigenación y circulación de la sangre, con el paciente que pudo desconectarse del sistema de manera segura después.
El Dr. David Spielvogel, Jefe de la Sección de Cirugía Cardiotorácica en el Westchester Medical Center, elogió la fiabilidad y la capacidad de respuesta del sistema, destacando la transición sin problemas durante las fases de conexión y desconexión. El éxito del procedimiento valida el rendimiento de la tecnología en un entorno clínico real.
La instalación, capacitación y servicios profesionales fueron gestionados por Glo-Med Networks Inc., distribuidor de Inspira en EE. UU., mientras se preparan para una adopción más amplia en los hospitales.
Inspira Technologies (Nasdaq: IINN)는 뉴욕주 웨스트체스터 메디컬 센터에서 FDA 승인된 INSPIRA ART100 시스템을 사용한 첫 번째 인간 치료의 성공적인 완료를 발표했습니다. 이 생명 유지 절차는 혈액 산소화 및 순환을 통해 심장과 폐에 효과적인 지원을 보여주었으며, 환자는 이후 안전하게 시스템에서 전환되었습니다.
웨스트체스터 메디컬 센터의 심장흉부외과 섹션 책임자인 David Spielvogel 박사는 시스템의 신뢰성과 반응성을 칭찬하며 연결 및 분리 단계에서의 원활한 전환을 강조했습니다. 이 절차의 성공은 실제 임상 환경에서 기술 성능을 검증합니다.
설치, 교육 및 전문 서비스는 Inspira의 미국 유통업체인 Glo-Med Networks Inc.에 의해 관리되었으며, 그들은 더 넓은 병원 채택을 준비하고 있습니다.
Inspira Technologies (Nasdaq: IINN) a annoncé l'achèvement réussi du premier traitement humain utilisant son système INSPIRA ART100 approuvé par la FDA au Westchester Medical Center dans l'État de New York. La procédure de soutien vital a démontré un soutien efficace du cœur et des poumons grâce à l'oxygénation et à la circulation sanguine, le patient ayant pu se déconnecter en toute sécurité du système par la suite.
Le Dr David Spielvogel, Chef de la section de chirurgie cardiaque et thoracique au Westchester Medical Center, a salué la fiabilité et la réactivité du système, soulignant la transition fluide lors des phases de connexion et de déconnexion. Le succès de la procédure valide les performances de la technologie dans un environnement clinique réel.
L'installation, la formation et les services professionnels ont été gérés par Glo-Med Networks Inc., le distributeur américain d'Inspira, alors qu'ils se préparent à une adoption plus large dans les hôpitaux.
Inspira Technologies (Nasdaq: IINN) hat den erfolgreichen Abschluss der ersten menschlichen Behandlung mit seinem von der FDA zugelassenen INSPIRA ART100 System im Westchester Medical Center im Bundesstaat New York bekannt gegeben. Das lebenserhaltende Verfahren zeigte eine effektive Unterstützung von Herz und Lunge durch Blutoxygenierung und -zirkulation, wobei der Patient anschließend sicher vom System abgeleitet wurde.
Dr. David Spielvogel, Abteilungsleiter für Herz-Thorax-Chirurgie im Westchester Medical Center, lobte die Zuverlässigkeit und Reaktionsfähigkeit des Systems und hob die nahtlose Übergangsphase während der Verbindungs- und Trennungsphasen hervor. Der Erfolg des Verfahrens validiert die Leistungsfähigkeit der Technologie in einer realen klinischen Umgebung.
Die Installation, Schulung und professionellen Dienstleistungen wurden von Glo-Med Networks Inc., dem US-Distributor von Inspira, verwaltet, während sie sich auf eine breitere Akzeptanz in den Krankenhäusern vorbereiten.
- First successful human treatment validates INSPIRA ART100's clinical effectiveness
- FDA clearance already obtained for the INSPIRA ART100 system
- Established distribution partnership with Glo-Med Networks for U.S. market penetration
- Positive feedback from leading medical institution supports potential broader adoption
- Early stage of commercial deployment with only one patient treated so far
- Market penetration and adoption rates yet to be demonstrated
Insights
The successful first clinical use of INSPIRA ART100 represents a critical validation milestone in the medical device commercialization journey. After receiving FDA clearance, this real-world implementation at Westchester Medical Center demonstrates the system's ability to perform its core function of providing heart and lung support in an actual clinical setting - the true test of any medical technology.
Particularly noteworthy is Dr. Spielvogel's feedback highlighting the system's reliability during connection and disconnection phases, traditionally high-risk transition points in extracorporeal support technologies. These moments can present significant complications, and successful management indicates robust engineering and thoughtful user interface design.
The endorsement from Westchester Medical Center provides valuable clinical credibility that typically accelerates adoption curves. This prestigious institution's willingness to be the first implementation site suggests confidence in the technology's safety profile and potential clinical utility.
However, this represents just the first step in broader clinical validation. The extracorporeal support market includes established competitors with extensive clinical data and entrenched hospital relationships. Inspira must now execute a careful commercial strategy through their distributor Glo-Med Networks to build on this initial success.
This milestone effectively transitions Inspira from a development-stage company to one with commercial-stage technology - a fundamental inflection point that transforms how the company operates and is perceived by healthcare providers, partners, and investors.
This successful first patient treatment represents a pivotal milestone for Inspira Technologies, transitioning the company from regulatory approval to actual clinical implementation. For a micro-cap company with just
The positive feedback from Westchester Medical Center's Section Chief of Cardiothoracic Surgery provides crucial clinical validation that can accelerate institutional adoption - traditionally a lengthy process for medical devices. This first real-world implementation establishes credibility that will likely facilitate conversations with other potential hospital customers.
Significantly, the news mentions Glo-Med Networks as Inspira's U.S. distributor leading installation, training, and professional services. This partnership will be critical to monitor as distribution execution often determines commercial success for medical devices.
While this news validates the technology's potential, investors should recognize that medical device commercialization typically follows an extended timeline from first clinical use to meaningful revenue generation. The company must now execute a careful strategy to leverage this initial success into broader market adoption.
For context, this single successful case represents validation of Inspira's core technology and business model but must be followed by consistent implementation at additional institutions to demonstrate commercial viability. The company's small market capitalization suggests significant upside potential if execution continues successfully, but also indicates inherent risks in the commercialization journey ahead.
First Clinical Use of INSPIRA ART100 System Successfully Completes Full Treatment Cycle, Validating the Technology’s Performance in a Real-World Clinical Environment and Garnering Overwhelmingly Positive Feedback
RA'ANANA, Israel, April 07, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced the successful completion of the first human treatment using its U.S. Food and Drug Administration-cleared INSPIRA™ ART100 system in a critical life-support procedure.
The procedure was successfully performed by expert physicians at Westchester Medical Center in New York State, marking the first real-world implementation of Inspira's innovative technology. During the life-support procedure, the INSPIRA ART100 effectively provided comprehensive heart and lung support by oxygenating and circulating the patient's blood. Following the procedure, the patient was safely transitioned off the system, demonstrating its effective support.
Dr. David Spielvogel, MD, Section Chief of Cardiothoracic Surgery at Westchester Medical Center commented: "The INSPIRA ART100 system performed exceptionally well during this critical procedure. We were particularly impressed with the system's reliability and responsiveness throughout the procedure. I believe that the seamless transition during both the connection and disconnection phases demonstrated the technology's sophistication and clinical readiness. This successful first case represents a promising advancement in extracorporeal support technology that could benefit numerous patients requiring this level of care. We look forward to continuing and expanding our relationship with Inspira."
Joe Hayon, President of Inspira, added: "This first successful patient use of INSPIRA ART100 is a pivotal milestone for Inspira, validating the real-world potential of the INSPIRA ART100. We believe that the positive outcome at Westchester Medical Center sets the stage for broader adoption across leading hospitals, with Glo-Med Networks Inc. (“Glo-Med”), our U.S. distributor. We remain committed to expanding clinical use and advancing critical care solutions for patients worldwide."
The installation, training program and professional services relating to the clinical use of the INSPIRA ART100 was led by Glo-Med.
About Inspira Technologies
Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART500 system also known as the INSPIRA ART 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 both 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, and HYLA blood sensor, are currently in development and have not yet received regulatory approval.
For more information, please visit our corporate website at 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 the largest and most 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 that the INSPIRA ART100 represents a promising advancement in extracorporeal support technology that could benefit numerous patients, the prospective future collaboration between Westchester Medical Center and Inspira, the belief that the seamless transition during both the connection and disconnection phases of the patient treatment demonstrated the technology's sophistication and clinical readiness, the belief that the successful patient treatment with the INSPIRA ART100 represents a huge milestone for the Company and validates its technology's potential to transform critical care, the belief that the positive outcome at Westchester Medical Center sets the stage for broader adoption across leading hospitals, led by Glo-Med, and the belief that the successful deployment of its system in a leading cardiopulmonary facility demonstrates the readiness of its technology for real-world clinical applications. 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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