Inspira™ Announces Breakthrough Update: Nears First FDA 510(k) Approval, 3 U.S. Patents Approved, $546 million in Summary Distribution Agreements [Yahoo! Finance]
Inspira Technologies Oxy B.H.N. Ltd. - Ordinary Shares (IINN)
Company Research
Source: Yahoo! Finance
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. Inspira has set out in its investor presentation ( link ) its plans to revolutionize the $19 billion mechanical ventilator market with the next generation INSPIRA™ ART device, equipped with adaptive blood oxygenation technology
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News
- Inspira™ Announces Start of Production of the INSPIRA™ ART100 [Yahoo! Finance]Yahoo! Finance
- Inspira™ Announces Start of Production of the INSPIRA™ ART100PR Newswire
- Inspira™ Receives CSA Certification of Compliance to U.S. Standards for the INSPIRA™ ART100 [Yahoo! Finance]Yahoo! Finance
- Inspira™ Receives CSA Certification of Compliance to U.S. Standards for the INSPIRA™ ART100PR Newswire
- Inspira™ Signs Term Sheet for Use of INSPIRA™ ART100 Device in Organ Transplant Procedures [Yahoo! Finance]Yahoo! Finance
IINN
Sec Filings
- 5/6/24 - Form 144
- 5/3/24 - Form 144
- 5/2/24 - Form 6-K
- IINN's page on the SEC website