Inspira Technologies Initiates Global Commercial Rollout of FDA-Cleared ART100 System

Rhea-AI Summary

Inspira Technologies (NASDAQ: IINN) is launching the global commercial rollout of its FDA-cleared INSPIRA™ ART100 system following successful clinical implementations in U.S. medical centers. The company is actively engaged in sales discussions with governmental health departments and private organizations, with deliveries expected to begin in H2 2025. The ART100, designed as an alternative to mechanical ventilation, has demonstrated real-world effectiveness in critical care settings. While focusing on ART100 commercialization, Inspira continues developing its innovation pipeline, including the next-generation INSPIRA™ ART500 and HYLA™ blood sensor. The strategic shift aims to capitalize on growing demand for respiratory solutions while prioritizing near-term revenue generation.

Positive

• FDA clearance obtained for the ART100 system
• Successful clinical implementations already achieved in U.S. medical centers
• Active sales discussions in progress with multiple potential customers
• Deliveries expected to commence in H2 2025
• Growing market demand for alternatives to mechanical ventilation

Negative

• Commercial agreements still subject to logistical, regulatory, commercial and legal terms
• Revenue generation from ART100 yet to materialize

Following successful clinical implementations in the U.S., Inspira accelerates commercialization of its system. The Company is already engaged in discussions with governmental health departments and private organizations

RA'ANANA, Israel, May 29, 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 a strategic shift to accelerate the commercialization of its U.S. FDA (Food and Drug Administration)-cleared INSPIRA™ ART100 system (the “ART100”), while maintaining the development and regulatory pathways of its portfolio of products. The Company is currently engaged in active sales discussions in multiple locations.

This development follows the initial clinical implementation of the ART100 system in medical centers in the U.S., where the device has been used to treat patients in real-world clinical settings.

“The ART100 has moved beyond the conceptual phase – it is now a working tool in critical care environments,” said Dagi Ben Noon, CEO of Inspira Technologies. “Our team is working closely with prospective customers to structure rollouts that align with national and regional clinical priorities. We recognize the immediate market potential for our ART100 system. This approach seeks to maximize shareholder value in the near and long term."

Several of these discussions are in advanced stages and involve structured procurement frameworks. Based on the current ongoing discussions, deliveries are expected to begin in the second half of 2025, subject to logistical and regulatory alignment, and the finalization of commercial and legal terms.

By growing demand for alternatives to mechanical ventilation, Inspira continue to support its innovation pipeline, including the next-generation INSPIRA™ ART500 and the HYLA™ blood sensor, while prioritizing near-term revenue activities from ART100.

The Company’s expansion efforts come amid an increase in the global focus on scalable respiratory solutions, which may position the Company as a strategic platform for public health initiatives and cross-sector partnerships.

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 (Food and Drug Administration)-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 regulatory 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 critical care 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 Company [has initiated a strategic shift] to accelerate the commercialization of the ART100, prospective rollouts in additional markets, the expectation of further deliveries of the ART100 to other medical centers in the second half of 2025, subject to logistical and regulatory alignment and the finalization of commercial and legal terms, the Company’s pipeline development, the Company’s future revenue stream expectations, and the belief that a global focus on scalable respiratory solutions may position the Company as a strategic platform for public health initiatives and cross-sector partnerships. 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 IINN ART100 system and what FDA clearance did it receive?

The INSPIRA ART100 is a life-support system designed as an alternative to mechanical ventilation. It has received FDA clearance and has been successfully implemented in U.S. medical centers for treating patients in critical care environments.

When will Inspira Technologies begin delivering the ART100 system?

Inspira Technologies expects to begin deliveries of the ART100 system in the second half of 2025, subject to logistical and regulatory alignment, and finalization of commercial and legal terms.

What products are in Inspira Technologies' development pipeline?

Inspira Technologies is developing the next-generation INSPIRA ART500 system and the HYLA blood sensor while commercializing the ART100 system.

Who are the potential customers for Inspira's ART100 system?

The company is in discussions with governmental health departments and private organizations across multiple locations for the ART100 system implementation.

What is IINN's commercialization strategy for the ART100?

IINN is accelerating global commercialization following successful U.S. clinical implementations, prioritizing near-term revenue activities while maintaining development of other products in their portfolio.