Inspira’s ART100 in Use at Tier-1 U.S. Hospitals, Generating Strong Clinical Interest and Accelerating Sales Discussions

Rhea-AI Summary

Inspira Technologies (NASDAQ: IINN) reports successful integration of its FDA-cleared ART100 life-support system at leading tier-one U.S. hospitals. The system's real-world clinical implementation over several months has generated significant commercial interest from U.S. and international healthcare institutions, as well as governmental authorities. While specific hospital details remain confidential, the deployment at Tier-1 facilities demonstrates growing trust in the technology's capability to support critical condition patients. CEO Dagi Ben-Noon emphasizes that the clinical adoption validates their technology and is driving commercial demand. The company is scaling up operations to meet anticipated demand and is in advanced negotiations with a European government authority, with additional strategic deployments expected soon.

Positive

• FDA-cleared ART100 system successfully deployed and used in Tier-1 U.S. hospitals
• Growing commercial interest from U.S. and international healthcare institutions
• Advanced negotiations ongoing with European government authority
• Company scaling up operational capabilities to meet anticipated demand

Negative

• Specific hospital deployment details remain confidential, limiting transparency
• Commercial revenue impact and specific sales figures not disclosed

Insights

Medical Technology Analyst

Inspira's ART100 system gaining traction at top US hospitals signals early commercial validation, but specific revenue impacts remain unclear.

Inspira Technologies has reached a significant milestone with its FDA-cleared ART100 life-support system now being used in actual clinical settings at leading U.S. hospitals. This real-world adoption represents crucial clinical validation that typically accelerates the commercialization curve for medical devices.

While the press release is light on specifics - notably omitting the exact number of installations, patient outcomes, or revenue figures - the mention of "tier-one" hospital adoption suggests the company has successfully penetrated premium healthcare institutions, which often serve as reference customers that influence broader market adoption.

The company's statement about "scaling up operational capabilities" indicates they're preparing for increased production demand, which aligns with their reported commercial discussions across multiple regions. This suggests management anticipates meaningful unit sales in upcoming quarters.

This development follows Inspira's previously announced expansion of manufacturing capacity and negotiations with a European government authority, showing systematic execution of their commercialization strategy. For medical device companies, this progression from regulatory approval to clinical adoption to commercial scaling represents the critical path to revenue generation.

The market for advanced life-support technologies is highly competitive but also offers substantial opportunities, particularly for innovative systems that can demonstrate clinical advantages. The ART100's ability to gain traction at prestigious institutions provides an important market signal, though the lack of disclosed deployment numbers makes it difficult to quantify the near-term revenue impact.

RA'ANANA, Israel, June 11, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the "Company"), a pioneer in innovative life-support and diagnostic technologies, announced today that its FDA-cleared ART100 system adoption has begun to positively impact commercialization interest and efforts, representing a key milestone and significantly contributes to the Company's commercial validation.

The ART100 system has been successfully integrated into real-world clinical workflows at leading tier-one U.S. hospitals over the past several months. Details of specific hospital deployments are subject to confidentiality, but reflect Tier-1 facilities in the U.S. This clinical use reflects growing confidence in the system’s potential to support patients in critical condition and positions Inspira at the forefront of a rapidly evolving market of life-saving technologies.

The consistent use of the ART100 has prompted a wave of interest from additional U.S. and international healthcare institutions, as well as governmental authorities. The Company is currently engaged in commercial discussions with various stakeholders across multiple regions and is scaling up operational capabilities to support the anticipated adoption of the ART100.

"Over the past several months, the ART100 has been used in real-world settings at leading U.S. hospitals, supporting patients. This clinical use sends a strong message to the global market – that our technology is trusted by physicians, integrated into workflows, and is now driving commercial demand."
— Dagi Ben-Noon, CEO, Inspira Technologies

This announcement builds on Inspira’s global rollout strategy, expanded manufacturing capacity and advanced negotiations with a European government authority. The Company anticipates announcing additional strategic deployments and commercial milestones in the near term.

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 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 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. The Company’s 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 the adoption of the ART100 has begun to positively impact commercialization interest and efforts, representing a key milestone and which it believes significantly contributes to its commercial validation,  the belief that this clinical use reflects growing confidence in the ART100’s potential to support patients in critical condition and positions the Company at the forefront of a rapidly evolving market of life-saving technologies, that the consistent use of the ART100 has prompted a wave of interest from additional U.S. and international healthcare institutions, as well as governmental authorities, that it is currently engaged in commercial discussions with various stakeholders across multiple regions and is scaling up operational capabilities to support the anticipated adoption of the ART100 and the belief that the clinical use of the ART100 sends a strong message to the global market – that the Company’s technology is trusted by physicians, integrated into workflows, and is now potentially driving commercial demand.. 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

FAQ

What is the current status of Inspira's ART100 system deployment in hospitals?

The ART100 system is currently being used in multiple tier-one U.S. hospitals, successfully integrated into real-world clinical workflows over the past several months.

What regulatory approvals has IINN's ART100 system received?

The ART100 system has received FDA clearance, allowing for its deployment in U.S. hospitals.

What are Inspira Technologies' (IINN) expansion plans for the ART100?

Inspira is scaling up operations, engaging in commercial discussions across multiple regions, and is in advanced negotiations with a European government authority.

How is the market responding to IINN's ART100 system?

The system is generating strong commercial interest from U.S. and international healthcare institutions, with growing confidence from healthcare providers in its potential to support critical condition patients.

What is the revenue impact of ART100 deployments for IINN stock?

While the company reports growing commercial interest and ongoing sales discussions, specific revenue figures from ART100 deployments have not been disclosed.