Inspira™ Technologies Strategically Plans to Actualize Hundreds of Millions in Conditional Distribution Agreements

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Israel-based medical device company Inspira Technologies OXY B.H.N Ltd. IINN reported setting some milestone targets for 2023.

Among the milestone targets is the initiation of the U.S. Food and Drug Administration (FDA) approval process for its patented ART™ system, which is designed to offer patients an alternative to undergoing mechanical ventilation to aid breathing. The ART system works by directly oxygenating the blood for patients in respiratory distress while removing carbon dioxide and avoiding the need for mechanical ventilation that requires placing the patient in an induced medical coma.

The company is simultaneously pushing ahead with another of its goals – its strategic distribution agreements, subject to regulatory approvals in the United States, Europe and Israel, jointly targeting $401 million in sales over 7 years.

In January 2022, Inspira announced it had secured a preliminary agreement for a seven-year distribution of the ART devices and systems in six states: Texas, New Jersey, New York, Florida, South Carolina and North Carolina.

The agreement with Florida-based Glo-Med Networks Inc targets $212 million in sales subject to regulatory approvals and includes a minimum purchase of 2,121 ART systems and 131,413 disposable units by Glo-Med for use at medical centers and hospitals in the six states. It follows similar subject-to-regulatory-approval agreements in Israel and Europe signed by Inspira in the last quarter of 2021, targeting $189 million of business in Spain, Portugal, Czech Republic, Slovakia and Poland.

A Growing Market?

The company believes the agreements and ongoing regulatory approval process reflect a growing need for innovative and relatively easy to administer respiratory aid products.

This is driven by the proven treatment gap in acute respiratory care, propelled by the growth in chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS) patients as well as the global elderly population — people older than 60 — which itself is expected to grow to 2 billion by 2050¹. 

At the same time, the market for global mechanical ventilation is estimated at $7.24 billion in 2020 with consistent yearly growth anticipated¹. The ART device and therapy system will allow respiratory aid to be administered ahead of the mechanical ventilation stage — potentially avoiding the need for it at all — and requires less experienced personnel to use.

“So many patients rely on mechanical ventilation, and the ART system will potentially shorten the period for potential treatment with ventilation,” Inspira’s Chairman Benad Goldwasser told Benzinga. “This really could be a game changer both for the patient and from an economic point of view.” 

Just one patient on a ventilator in the ICU can cost up to $10,000 a day, Mr.Goldwasser stated.

Strategic Step-By-Step Approach

Inspira’s approach to the FDA approval is to start with the company’s extracorporeal life support (ECLS) product. ECLS is the company’s version of the well-established extracorporeal membrane oxygenation (ECMO) system, a last resort when patients in respiratory distress cannot function on a mechanical ventilator.

Major producers of the ECMO machine, which similarly to the ART, focuses on adding oxygen and removing carbon dioxide, include Medtronic plc MDT and Fresenius Medical Care AG & Co. FMS. 

The reason for focusing on the ECLS product which mirrors the established model in ECMO, is to begin to introduce and provide the market with elements of Inspira’s core technological features in advance of the approval of the ART therapy line. 

“Upon approval by relevant regulatory authorities, the U.S. market size can provide Inspira with a potential for the deployment of the ART system,” Joe Hayon, co-founder of Inspira and the company’s Chief Financial Officer, stated at the time of the Glo-Med agreement signing. “The company is developing further infrastructure to penetrate the remaining U.S. states to adopt our ART system.”

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¹Grand View Research Invasive Mechanical Ventilation Market Analysis and Segment Forecast to 2028

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