ART100 Becomes Inspira’s First System to Complete Clinical Evaluation and Enters Budgeted Procurement at Top U.S. Medical Center
Rhea-AI Summary
Inspira Technologies (NASDAQ: IINN) announced its FDA-cleared INSPIRA ART100 completed full clinical evaluation and moved from pilot use to routine workflow at a top U.S. academic medical center.
Approximately 30 patients were treated across multiple indications and the hospital has begun a budgeted procurement process for multiple ART100 systems.
Positive
- FDA-cleared ART100 completed full clinical evaluation at top U.S. center
- ART100 moved from pilot use to routine clinical workflow
- Approximately 30 patients treated across multiple medical indications
- Medical center initiated budgeted procurement for multiple ART100 systems
Negative
- Procurement remains conditional on procedural budget release, not guaranteed
- No signed purchase contract or delivery schedule disclosed yet
- Clinical experience reported covers only about 30 patients
Key Figures
Market Reality Check
Peers on Argus
Several medical device peers were down sharply, with MYO -7.76%, RBOT -8.58%, ECOR -8.81%, and MODD -6.43%. IINN was modestly lower at -1.24%, suggesting broader sector pressure rather than company-specific weakness.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 21 | Government PO validation | Positive | -4.6% | Large binding purchase orders advanced to final budget validation and fund allocation. |
| Jan 08 | Strategic expansion vision | Positive | -0.2% | Outlined expansion into liquid biopsy diagnostics and CVR-based value allocation framework. |
| Jan 05 | Acquisition term sheet | Positive | +7.8% | Non-binding term sheet for liquid biopsy acquisition plus $15M equity investment. |
| Jan 05 | Acquisition term sheet | Positive | +7.8% | All-share liquid biopsy acquisition and $15M strategic investment at $180M valuation. |
| Dec 23 | PO reaffirmation | Positive | -5.0% | Reaffirmed $49.5M binding purchase orders aligned with 2026 deployment milestones. |
Recent positive corporate and commercial updates have often been met with mixed or negative next-day price reactions.
Over the last months, Inspira reported $49.5M in binding purchase orders and later detailed two orders of $22.5M and $27M moving into final governmental budget validation for expected 2026 recognition. It also signed a term sheet for a liquid biopsy acquisition with a $15M equity investment at a $180M valuation and outlined a strategic expansion vision. Despite these seemingly constructive milestones, several prior news days saw negative or muted price moves, framing today’s ART100 clinical-workflow milestone against a backdrop of cautious trading reactions.
Regulatory & Risk Context
The company has a Form F-3 shelf filed to offer up to $75,000,000 of ordinary shares, warrants and units. Shelf usage to date includes at least one 424B5 prospectus supplement for a registered direct offering of 1,565,217 shares at $1.15 per share, with expected net proceeds of approximately $1.7 million.
Market Pulse Summary
This announcement highlights that the FDA-cleared ART100 completed full clinical evaluation at a top U.S. academic medical center and moved from pilot use into standard clinical workflow after treating about 30 patients. The center has begun an internal process to procure multiple systems, adding a tangible commercialization signal to prior binding purchase orders totaling $49.5M. Investors may track execution of governmental budget processes, progress on the liquid biopsy expansion, and future use of the $75,000,000 Form F-3 shelf.
AI-generated analysis. Not financial advice.
RA'ANANA, Israel, Jan. 29, 2026 (GLOBE NEWSWIRE) -- 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
FAQ
What does Inspira's (IINN) announcement on Jan 29, 2026 say about ART100 clinical evaluation?
Does the Jan 29, 2026 news mean Inspira (IINN) has sold ART100 systems to the hospital?
How many patients were treated with ART100 during the clinical evaluation mentioned by Inspira (IINN)?
What commercial impact does the ART100 milestone have for Inspira (IINN)?
What are the remaining steps before the hospital acquires ART100 systems from Inspira (IINN)?
