Inspira Technologies OXY B.H.N. Ltd. 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. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA ART), designed to rebalance patient oxygen saturation levels.

For example, the Company is using forward-looking statements when it discusses the expected timing of its 510(k) clearance from The FDA, that it intends to submit additional 510(k) submissions, the value and potential of its summary distribution agreements, each subject to regulatory approvals and authorizing authorities, the belief that the HYLA blood sensor has a vital role to play while the INSPIRA ART delivers the needed oxygen straight into the blood, the belief that the INSPIRA ART is expected to change the medical landscape, and the potential benefits of its products. The Company has developed a Breakmented Respiration Technology (IN SPIRA ART), designed to resalance patient oxygen saturation levels". For example, the Company is use forward - looking statements when it discusses the projected size of and the Mechanical ventilation Market and Perfusion Systems Market, the potential outcome that its technology can eliminate complications associated with Mechanical Ventilation, its aim to replace the use of Mechanical Ventilators, the intended uses and potential benefits of its products and technology, its prospective targeting of current procedural terminology codes that the Company could potentially use for charging and reimbursement of its products, potential revenues models, revenue sources and streams that may be realized pursuant to various distribution agreements, strategic opportunities and based on software licensing, its prospective target consumers and end - users for its products, its projected milestone timelines for each of its products, its strategy for market penetration and market share gain, its go - to - market strategy, its regulatory strategy and anticipation of software licensing and U. S Food and Drug Administration (FDA) clearance, its potential commercialization of its products, and its prospective and ongoing regulatory approval processes in various jurisdictions.

The products have not been cleared or approved by the U. S. Food and Drug Administration (F FDA) or any other regulatory or authorizing authority. Approval or clearance by the FDA, CE or any other authorizing entity may not be granted or may require different study parameters or data or validation from those that are intended or were included in the submission.