Inspira Nears First FDA 510(K) Approval, 3 US Patents Approved, $546M in Summary Distribution Agreements

Author: Benzinga Newsdesk | February 27, 2024 08:15am

Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) (NASDAQ:IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, has announced that the Company is progressing towards 510(k) clearance from the U.S. Food & Drug Administration ("FDA") for its INSPIRA™ ART100 in the first half of 2024. The Company plans additional FDA 510(k) submissions for the HYLA blood sensor in 2024 and for INSPIRA ART disposables in 2025, as part of a scalable razor-blade business model. Three breakthrough patents have been approved by the United States Patent and Trademark Office ("USPTO") and an additional three patent applications are pending at the USPTO for certain core technologies. To date, the Company has signed $546 million in pre-conditioned summary distribution agreements, subject to regulatory approvals and authorizing authorities.

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