INSPIRA ART100 System Approved by Israel's Largest Healthcare Provider for Use in Organ Transplant Patients
Inspira Technologies (NASDAQ: IINN) announced that its INSPIRA ART100 system has been approved by Israel's largest healthcare provider for clinical validation in organ transplant procedures. The FDA-approved system will be deployed at a renowned Israeli medical center, where transplant specialists will evaluate its potential for maintaining organ viability through blood oxygenation during transplants and post-operative recovery.
The ART100 system received FDA 510(k) clearance in May 2024 for cardiopulmonary bypass procedures and Israeli AMAR certification in July 2024 for both bypass and ECMO procedures. This technology serves as the foundation for Inspira's flagship INSPIRA ART500 system, currently under development, which aims to provide direct blood oxygenation without mechanical ventilation for respiratory care.
Inspira Technologies (NASDAQ: IINN) ha annunciato che il suo sistema INSPIRA ART100 è stato approvato dal più grande ente sanitario israeliano per la validazione clinica nelle procedure di trapianto d'organo. Il sistema, approvato dalla FDA, sarà utilizzato in un rinomato centro medico israeliano, dove gli specialisti in trapianti valuteranno il suo potenziale nel mantenimento della vitalità degli organi attraverso l'ossigenazione del sangue durante i trapianti e il recupero post-operatorio.
Il sistema ART100 ha ottenuto l'autorizzazione FDA 510(k) a maggio 2024 per le procedure di bypass cardiopolmonare e la certificazione AMAR israeliana a luglio 2024 per le procedure di bypass e ECMO. Questa tecnologia costituisce la base per il sistema di punta di Inspira, il INSPIRA ART500, attualmente in sviluppo, che mira a fornire ossigenazione diretta del sangue senza ventilazione meccanica per la cura respiratoria.
Inspira Technologies (NASDAQ: IINN) anunció que su sistema INSPIRA ART100 ha sido aprobado por el mayor proveedor de salud de Israel para la validación clínica en procedimientos de trasplante de órganos. El sistema aprobado por la FDA será implementado en un prestigioso centro médico israelí, donde especialistas en trasplantes evaluarán su potencial para mantener la viabilidad de los órganos mediante la oxigenación de la sangre durante los trasplantes y la recuperación postoperatoria.
El sistema ART100 recibió la autorización FDA 510(k) en mayo de 2024 para procedimientos de bypass cardiopulmonar y la certificación AMAR israelí en julio de 2024 para procedimientos de bypass y ECMO. Esta tecnología es la base para el sistema principal de Inspira, el INSPIRA ART500, actualmente en desarrollo, que busca proporcionar oxigenación directa de la sangre sin ventilación mecánica para el cuidado respiratorio.
Inspira Technologies (NASDAQ: IINN)는 자사의 INSPIRA ART100 시스템이 이스라엘 최대 의료 제공자로부터 장기 이식 절차 임상 검증 승인을 받았다고 발표했습니다. FDA 승인을 받은 이 시스템은 이스라엘의 유명 의료 센터에 배치되어, 이식 전문의들이 이식 중 및 수술 후 회복 과정에서 혈액 산소 공급을 통해 장기 생존 가능성을 평가할 예정입니다.
ART100 시스템은 2024년 5월 심폐 우회술 절차에 대해 FDA 510(k) 승인을 받았으며, 2024년 7월에는 우회술 및 ECMO 절차에 대해 이스라엘 AMAR 인증을 획득했습니다. 이 기술은 현재 개발 중인 Inspira의 주력 시스템인 INSPIRA ART500의 기반으로, 기계적 인공호흡 없이 직접 혈액 산소 공급을 제공하여 호흡 치료를 목표로 합니다.
Inspira Technologies (NASDAQ : IINN) a annoncé que son système INSPIRA ART100 a été approuvé par le plus grand fournisseur de soins de santé d'Israël pour une validation clinique dans les procédures de transplantation d'organes. Ce système approuvé par la FDA sera déployé dans un centre médical israélien renommé, où des spécialistes de la transplantation évalueront son potentiel à maintenir la viabilité des organes grâce à l'oxygénation du sang pendant les transplantations et la récupération postopératoire.
Le système ART100 a obtenu l'autorisation 510(k) de la FDA en mai 2024 pour les procédures de pontage cardiopulmonaire et la certification AMAR israélienne en juillet 2024 pour les procédures de pontage et ECMO. Cette technologie constitue la base du système phare d'Inspira, le INSPIRA ART500, actuellement en développement, qui vise à fournir une oxygénation sanguine directe sans ventilation mécanique pour les soins respiratoires.
Inspira Technologies (NASDAQ: IINN) gab bekannt, dass sein INSPIRA ART100-System von Israels größtem Gesundheitsanbieter für die klinische Validierung bei Organtransplantationen zugelassen wurde. Das von der FDA zugelassene System wird in einem renommierten israelischen medizinischen Zentrum eingesetzt, wo Transplantationsspezialisten dessen Potenzial zur Erhaltung der Organfunktion durch Blutsauerstoffversorgung während Transplantationen und der postoperativen Erholung bewerten werden.
Das ART100-System erhielt im Mai 2024 die FDA 510(k)-Freigabe für kardiopulmonale Bypass-Verfahren und im Juli 2024 die israelische AMAR-Zertifizierung für Bypass- und ECMO-Verfahren. Diese Technologie bildet die Grundlage für das Flaggschiff-System von Inspira, das INSPIRA ART500, das sich derzeit in der Entwicklung befindet und darauf abzielt, eine direkte Blutsauerstoffversorgung ohne mechanische Beatmung für die Atemwegspflege bereitzustellen.
- FDA 510(k) clearance obtained for ART100 system in May 2024
- Israeli AMAR certification received for cardiopulmonary bypass and ECMO procedures
- Expansion into new clinical application (organ transplantation) could broaden market opportunities
- Partnership with Israel's largest healthcare provider validates technology potential
- ART500 flagship system still under development with no clear timeline for completion
- Clinical validation phase indicates early stage of market penetration
Insights
Inspira's ART100 approval for transplant validation signals expanded applications and clinical credibility, potentially accelerating flagship product development.
This approval represents a strategic advancement for Inspira Technologies as Israel's largest healthcare provider has authorized clinical validation of their FDA-cleared ART100 system specifically for organ transplant procedures. This development is particularly significant as it expands the potential applications of their technology beyond its current regulatory clearances.
The validation process will occur at a renowned Israeli medical center where transplant specialists will evaluate the ART100's capability to provide out-of-body blood oxygenation during complex organ transplant procedures and post-surgical recovery. This represents a novel application that could potentially address critical needs in transplantation medicine, where maintaining organ viability is paramount.
From a technical perspective, this clinical validation creates a dual opportunity for Inspira. First, it allows testing of their current FDA-approved system in high-stakes surgical environments, potentially expanding its market applications. Second, and perhaps more strategically valuable, the data collected will support the development program for their flagship INSPIRA ART500 system, which aims to revolutionize respiratory care through direct blood oxygenation without mechanical ventilation.
This approval builds upon the ART100's existing regulatory foundation, having received FDA 510(k) clearance in May 2024 for cardiopulmonary bypass and Israeli AMAR certification in July 2024 for both cardiopulmonary bypass and ECMO procedures. The company is effectively leveraging these approvals to gather valuable clinical insights while potentially opening new market segments.
The endorsement from Israel's largest healthcare provider adds significant credibility to Inspira's technology platform and demonstrates growing clinical interest in their approach to blood oxygenation and life support. While this validation doesn't guarantee commercial success, it represents meaningful progress in building clinical evidence and institutional relationships that could accelerate their development roadmap.
RA'ANANA, Israel, May 07, 2025 (GLOBE NEWSWIRE) -- 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 the INSPIRA™ ART100 has been approved by Israel's largest healthcare provider to undergo a clinical validation by leading physicians who intend to use the innovative life-support and diagnostic device during organ transplant procedures. As part of this advancement, Inspira will deploy the U.S. Food and Drug Administration (“FDA”) approved INSPIRA ART100 system at one of Israel’s renowned medical centers affiliated with the largest health care provider.
A team of pioneering physicians at a renowned medical center has requested to validate the INSPIRA ART100 system for application in highly complex organ transplant procedures. This deployment will allow leading Israeli transplant specialists to gain hands-on experience with Inspira's innovative technology, specifically exploring its potential to maintain organ viability through advanced blood oxygenation. The INSPIRA ART100 system may serve a unique role by providing out of body blood oxygenation to keep the patient alive during the organ transplant procedure as well as for several hours in the recovery room.
This validation process represents a new clinical application for the innovative INSPIRA ART100 system, offering the Company a unique opportunity to gather valuable insights from leading medical specialists as they evaluate the system's performance in demanding transplantation environments. The clinical data collected during these procedures will be strategically used to support the ongoing development program of Inspira's flagship INSPIRA ART500 system designed to oxygenate a patient’s blood and support vital organs during acute respiratory failure.
"Being approved by Israel's largest and prestigious healthcare provider showcases the significant interest our technology is garnering from leading medical institutions, including in our local market, as well as abroad, as previously reported," said Dagi Ben-Noon, Chief Executive Officer of Inspira. "We look forward to working closely with the provider’s medical professionals to explore new applications of our technologies."
The INSPIRA ART100 system was granted FDA 510(k) clearance on May 2024, for cardiopulmonary bypass procedures and in July 2024 received the Israeli AMAR certification for cardiopulmonary bypass and extra-corporeal membrane oxygenation (ECMO) procedures. The system's proprietary hardware and software platform serves as the foundation for the Company's flagship INSPIRA ART500 system, which is currently under development and aims to revolutionize respiratory care by providing direct blood oxygenation without mechanical ventilation.
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 collaboration with Israel’s largest healthcare provider, the planned evaluation of the INSPIRA ART100 system in organ transplant procedures, the potential of the Company's technology to address critical needs in advanced pulmonary care, that the clinical data collected during the procedures will be used to support the ongoing development program of the INSPIRA ART500 system, and the expected benefits and uses of its products. 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
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Email: info@inspirao2.com
Phone: +972-9-9664485
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FAQ
What approvals has the INSPIRA ART100 system received?
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What is the difference between INSPIRA's ART100 and ART500 systems?
Which healthcare provider approved IINN's ART100 system in Israel?
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