INSPIRA ART100 System Approved by Israel's Largest Healthcare Provider for Use in Organ Transplant Patients
Rhea-AI Summary
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.
Positive
- 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
Negative
- ART500 flagship system still under development with no clear timeline for completion
- Clinical validation phase indicates early stage of market penetration
News Market Reaction – IINN
On the day this news was published, IINN declined 8.10%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
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
What approvals has the INSPIRA ART100 system received?
How will IINN's ART100 system be used in organ transplants?
What is the difference between INSPIRA's ART100 and ART500 systems?
Which healthcare provider approved IINN's ART100 system in Israel?
What is the current development status of INSPIRA's ART500 system?
