Inspira ART100 clears evaluation at top U.S. hospital
Inspira Technologies reported that its FDA-cleared INSPIRA™ ART100 system has completed full clinical evaluation at a leading U.S. academic medical center ranked among the top hospitals in the country.
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Rhea-AI Filing Summary
Inspira Technologies reported that its FDA-cleared INSPIRA™ ART100 system has completed full clinical evaluation at a leading U.S. academic medical center ranked among the top hospitals in the country. The system treated approximately 30 patients across procedures such as life-saving interventions, surgeries and transplants.
Based on consistent performance and repeat use by medical staff, ART100 has moved from pilot use into the center’s standard clinical workflow, with no remaining open clinical evaluation phase. The hospital has started an internal, budgeted procurement process for multiple ART100 systems, subject to procedural budget release, which the company views as an important validation of ART100’s clinical value and commercial readiness.
Insights
ART100 moves from pilot to routine use at a top U.S. center, with a budgeted procurement process underway.
Inspira Technologies states that its FDA-cleared INSPIRA™ ART100 system has completed clinical evaluation at a leading U.S. academic medical center after use in approximately 30 patients. The system is now incorporated into the institution’s standard clinical workflow, indicating ongoing, routine utilization rather than limited pilot use.
The medical center has initiated an internal process for the budgeted procurement of multiple ART100 systems, with procurement described as subject to procedural budget release. This suggests a defined path toward commercial purchases, though timing and volumes are not detailed in the excerpt.
The company believes this milestone strengthens its U.S. commercial positioning and supports potential broader ART100 adoption across healthcare institutions. Actual commercial impact will depend on completion of the internal procurement process at this center and any subsequent decisions by additional hospitals.
FAQ
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What did Inspira Technologies (IINN) announce about the ART100 system in this 6-K?
How has the U.S. medical center integrated Inspira’s ART100 system into its clinical workflow?
What procurement steps has the U.S. medical center taken regarding Inspira’s ART100 systems?
Why does Inspira Technologies view this ART100 milestone as important for its U.S. strategy?
What is the INSPIRA ART100 system and where is it approved for use?
What forward-looking statements did Inspira Technologies include about the ART100 procurement?
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2026 (Report No. 4)
Commission File Number: 001-40303
Inspira Technologies Oxy B.H.N. Ltd.
(Translation of registrant’s name into English)
2 Ha-Tidhar St.
Ra’anana 4366504, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
CONTENTS
On January 29, 2026, Inspira Technologies Oxy B.H.N. Ltd. (the “Company”) issued a press release titled “ART100 Becomes Inspira’s First System to Complete Clinical Evaluation and Enters Budgeted Procurement at Top U.S. Medical Center,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.
The first four and the sixth paragraphs and the section titled “Forward-Looking Statements” of the press release attached hereto as Exhibit 99.1, is incorporated by reference into the Company’s Registration Statements on Form F-3 (Registration Nos. 333-284308 and 333-289324) and Form S-8 (Registration Nos. 333-259057, 333-277980, 333-285565, 333-290162 and 333-292592), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
| Exhibit No. | ||
| 99.1 | Press Release issued by Inspira Technologies Oxy B.H.N. Ltd. on January 29, 2026, titled “ART100 Becomes Inspira’s First System to Complete Clinical Evaluation and Enters Budgeted Procurement at Top U.S. Medical Center.” |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Inspira Technologies Oxy B.H.N. Ltd. | |||
| Date: January 29, 2026 | By: | /s/ Dagi Ben-Noon | |
| Name: | Dagi Ben-Noon | ||
| Title: | Chief Executive Officer | ||
2
Exhibit 99.1
ART100 Becomes Inspira’s First System to Complete Clinical Evaluation and Enters Budgeted Procurement at Top U.S. Medical Center
RA’ANANA, Israel, January 29, 2026 -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN, IINNW) (“Inspira,” “Inspira Technologies,” or the “Company”), a pioneer in innovative life-support and diagnostic technologies, today announced that its U.S. Food and Drug Administration (the “FDA”)-cleared INSPIRA™ ART100 system has completed its full clinical evaluation and advanced to a budgeted procurement execution process at a leading U.S. academic medical center, ranked among the top hospitals in the United States.
The ART100 becomes Inspira’s first system at this institution to complete a clinical evaluation and to transition from pilot use to standard clinical workflow, following the successful treatment of approximately 30 patients across multiple medical indications: life-saving procedures, surgeries and transplants. Based on consistent clinical performance and repeat utilization by medical staff, the ART100 systems have now been incorporated into that medical center’s routine workflow, with no remaining open clinical evaluation phase.
Following completion of the clinical phase, the medical center has initiated an internal procurement process for the acquisition of multiple ART100 systems. The procurement is now subject to procedural budget release, with the clinical decision-making phase fully concluded.
This marks the first instance at a major U.S. academic medical center where the ART100 has progressed from clinical evaluation to a formal, budgeted procurement pathway.
Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, commented: “We view reaching this milestone at one of the nation’s leading academic medical centers as a powerful validation of our technology’s clinical value and reliability. The ART100 has moved beyond pilot use to standard clinical workflow, driven by repeat utilization and positive physician feedback. With the clinical phase now complete, we are advancing through a defined procurement execution process and view this milestone as a strong validation of our ART100’s real-world clinical and commercial readiness.”
The Company believes this milestone significantly strengthens its U.S. commercial positioning and supports broader adoption of the ART100 platform across leading healthcare institutions.
About Inspira Technologies
Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company’s FDA-cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a foundation for the development of the INSPIRA ART500, a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the life-support and MedTech landscape. For more information, visit: https://inspira-technologies.com.
Forward-Looking Statements
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 procurement is now subject to procedural budget release, that reaching this milestone at one of the nation’s leading academic medical centers is a powerful validation of its technology’s clinical value and reliability and of the system’s real-world clinical and commercial readiness, and the its belief that this milestone significantly strengthens its U.S. commercial positioning and supports broader adoption of the ART100 platform across leading healthcare institutions. 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
Email: info@inspirao2.com
Phone: +972-9-9664485