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RA’ANANA, Israel - Medical device company Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), currently valued at $31.4 million, announced Thursday it has filed a shelf registration statement on Form F-3 with the U.S. Securities and Exchange Commission. The stock, trading at $1.21, has shown significant volatility with a beta of 2.3.
The filing, submitted on August 6, represents a routine renewal process conducted every three years and will replace the company’s previous shelf registration statement expiring on August 18, 2025.
Inspira Technologies specializes in respiratory support and blood monitoring solutions. The company’s FDA-cleared INSPIRA ART100 system is approved for cardiopulmonary bypass procedures in the U.S. and for ECMO (Extracorporeal Membrane Oxygenation) procedures in markets outside the United States.
The company is also developing the INSPIRA ART500, a next-generation system designed to deliver oxygenation while patients remain awake and breathing spontaneously, along with HYLA, a continuous non-invasive blood sensor platform.
The shelf registration statement, filed under File No. 333-289324, is part of standard financial procedures that allow publicly traded companies to register securities for potential future offerings.
This information is based on a press release statement issued by the company.
In other recent news, Inspira Technologies OXY B.H.N. Ltd. has secured a binding $22.5 million purchase order for its FDA-cleared ART100 system. This order comes from a privately held company with established commercial ties to government entities and institutional healthcare customers, with full payment expected in 2025. The company is also in discussions with a foreign government about potentially integrating the ART100 system into its national emergency infrastructure. Additionally, Inspira has announced a scale-up in production capabilities for the ART100 system to meet anticipated demand from a European governmental authority. To support its strategic expansion efforts, Inspira has hired a specialized consulting firm to assist with structuring strategic transactions and accelerating commercial growth. The company is actively working on advancing the commercialization of the ART100 system, which has already seen successful clinical use in U.S. medical centers. Inspira is in the final stages of procurement negotiations with various entities and anticipates beginning deliveries in the second half of 2025, pending regulatory approval and finalizing commercial terms.
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