CORRECTION - Inspira Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority
- Advanced-stage procurement negotiations with European government authority indicate potential significant contract
- FDA clearance already obtained for ART100 system
- Successful implementation in US clinical settings demonstrates market validation
- Strategic expansion of production capacity shows operational readiness
- Development of next-generation platforms (ART500 and HYLA blood sensor) indicates pipeline growth
- Production scale-up costs may impact financial resources
- No guaranteed outcome from ongoing negotiations
- Competition in respiratory solutions market could affect market share
Insights
Inspira scaling production for FDA-cleared ART100 amid advanced negotiations with European government, indicating potential revenue acceleration.
Inspira's announcement about scaling up production for their FDA-cleared INSPIRA ART100 system represents a significant operational milestone that typically precedes major commercial contracts. The company has moved beyond just marketing to actually preparing manufacturing infrastructure for anticipated demand from a European governmental authority.
What makes this particularly notable is the characterization of these discussions as "advanced-stage procurement negotiations" - language that suggests the talks have progressed beyond preliminary interest to specific terms and quantities. Government procurement contracts, especially for medical devices, typically involve substantial volumes and multi-year commitments that could provide Inspira with stable, predictable revenue streams.
The ART100 system's prior implementation in U.S. clinical settings provides validation that enhances the company's negotiating position. For medical technology companies, especially smaller innovators like Inspira, government contracts represent both revenue certainty and credibility that can catalyze additional market opportunities.
This development appears to align with Inspira's previously announced global rollout strategy, suggesting systematic execution rather than opportunistic sales efforts. The company maintains dual focus on commercializing the FDA-cleared ART100 while continuing development of next-generation technologies (ART500 and HYLA blood sensor), indicating a balanced approach to near-term revenue and long-term innovation.
RA'ANANA, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- RA'ANANA, Israel, June 5, 2025 -- Inspira鈩� Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," 鈥淚nspira Technologies,鈥� or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced preparations for scaled-up its production capabilities for its U.S. Food and Drug Administration (FDA)-cleared INSPIRA鈩� ART100 system (the 鈥�ART100 system鈥�), in response to expected demand from a European governmental authority with which the Company is currently in advanced-stage procurement negotiations.
this ramp up strategic production aims to meet near-term delivery needs as Inspira expects these negotiations move toward finalization. The ART100 system, already implemented in clinical settings in the United States, is gaining traction as a reliable device for a critical care and emergency preparedness programs.
鈥淲e are preparing for commercial execution,鈥� said Dagi Ben Noon, Chief Executive Officer of Inspira Technologies. 鈥淥ur dialogue with a European government body has advanced to a stage where operational readiness is essential. Expanding our production capacity will enable us to meet projected deployment needs quickly and efficiently.鈥�
This move follows Inspira鈥檚 recent announcement of its global rollout strategy and reflects the Company鈥檚 commitment to fast-track revenue generation from the ART100 system, while continuing its development of its next-generation platforms, the ART500 and the HYLA鈩� blood sensor.
The Company believes the current momentum鈥攃ombined with a growing global focus on scalable respiratory solutions鈥攎ay accelerate the Company鈥檚 emergence as a strategic public health supplier across both governmental and private sectors.
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鈥檚 U.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 technological 聽foundation for the development of the INSPIRA ART500 鈥� a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA鈩�, 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 critical care and MedTech landscape. The Company鈥檚 recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. 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 that it expects demand for its ART100 system from a European governmental authority, that it has ramped up its production in order to meet expected near term delivery needs, , the benefits and advantages of the ART100, that the ART100 system is gaining traction as a reliable device for a critical care and emergency preparedness programs, the potential outcome of its procurement negotiations with a European government authority, its belief that expanding its production capacity enables the Company to meet projected deployment needs quickly and efficiently, and its belief that current momentum may accelerate the Company鈥檚 emergence as a strategic public health supplier across both governmental and private sectors. 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 .
Company Contact
Inspira Technologies 鈥� Media Relations
Email: [email protected]
Phone: +972-9-9664485
FAQ
What is the status of Inspira Technologies' ART100 system production scale-up?
Where is the IINN ART100 system currently being used?
What other products is Inspira Technologies developing?
Who is the CEO of Inspira Technologies (IINN)?
What regulatory approvals does the Inspira ART100 system have?
