Inspira™ Technologies Announces FDA Listing and Market Readiness of New Product

Rhea-AI Summary

Inspira Technologies OXY B.H.N. (IINN) has announced the FDA listing of its INSPIRA™ CART, a medical cart designed for use with the INSPIRA™ ART100 system. This Class I Medical Device, 510(K) Exempt, is intended for use in operating rooms during Cardiopulmonary Bypass procedures. The company aims to streamline healthcare delivery and transform the ART100 system into a mobile workstation.

Inspira is developing novel life support-extending technologies, targeting a combined market opportunity of approximately $59 billion annually. The company's product pipeline includes the HYLA™ blood sensor, INSPIRA™ Cardi-ART, and INSPIRA™ ART (Gen 2). These technologies are designed to monitor blood parameters, support cardiac arrest patients, and provide adaptive blood oxygenation, respectively.

Positive

• FDA listing of INSPIRA™ CART, enabling market entry in the US
• First order of INSPIRA™ CARTs received from Glo-Med Networks, Inc.
• INSPIRA™ ART100 system received FDA 510(k) clearance for Cardiopulmonary Bypass procedures
• Targeting a combined market opportunity of approximately $59 billion annually

Negative

• INSPIRA™ ART (Gen 2), INSPIRA™ Cardi-ART, and HYLA™ blood sensor are still in development and not yet approved

Medical Device Regulatory Expert

The FDA listing of Inspira's medical cart as a Class I Medical Device and 510(k) Exempt is a positive development for the company. This classification indicates that the device poses minimal risk and doesn't require extensive pre-market review, facilitating quicker market entry. However, it's important to note that this is for an accessory product, not the core INSPIRA™ ART100 system.

The company's pipeline, including the HYLA™ blood sensor and INSPIRA™ Cardi-ART, shows potential for innovation in critical care. Yet, these products are still in development and haven't undergone human trials or regulatory approval. Investors should be aware that the path from concept to market can be long and uncertain in the medical device industry.

Healthcare Technology Analyst

Inspira's focus on developing advanced respiratory and life-support technologies positions them in a substantial market, estimated at $59 billion annually. The FDA clearance for the ART100 system and the recent listing of the INSPIRA™ CART are positive steps towards commercialization. However, the company's revenue generation potential remains uncertain, with only a first order mentioned for the CART from Glo-Med Networks.

The company's strategy to partner with hospitals and potential business development partners is prudent, but execution will be key. Investors should monitor the adoption rate of the ART100 system and any strategic partnerships formed, as these will be critical indicators of the company's market penetration and future growth prospects.

RA'ANANA, Israel, Aug. 22, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN)  (Nasdaq: IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, today announces the U.S. Food and Drug Administration ("FDA") listing of its medical cart (INSPIRA™ CART) which has been custom designed for use with the INSPIRA™ ART100 system. With this dynamic combination of cutting-edge technology and operational efficiency, Inspira aims to streamline healthcare delivery in a variety of clinical scenarios, transforming the INSPIRA™ ART100 system into a mobile workstation supporting medical personnel in administering medical care quickly.

The INSPIRA™ CART is intended for use by medical professionals in operating rooms in the United States during Cardiopulmonary Bypass procedures. Classified as a Class I Medical Device and 510(K) Exempt under the FDA code for cardiopulmonary bypass accessory equipment, this device's regulatory status underscores its compliance with safety and efficacy standards, facilitating its entry into the U.S. market.

Dagi Ben-Noon, CEO of Inspira, commented, "We believe that the ongoing progress and pipeline of products of the Company will potentially translate in the future into substantial recognition by strategic partners and investors, with the Company already receiving first order of INSPIRA™ CARTs from Glo-Med Networks, Inc."

Inspira™ business overview

Inspira aims to reshape the respiratory and life-support landscape. We are developing novel life support-extending technologies with Inspira blood oxygenation and blood monitoring technologies, collectively targeting an estimated combined market opportunity of approximately $59 billion a year.

Inspira is working to deploy the FDA cleared INSPIRA™ ART100 system in leading U.S and Israeli hospitals. The Company's overall strategy is to generate business development activities with potential partners who are aiming to expand their product portfolio in the industry.

Inspira continues to grow and pioneer the INSPIRA™ ART pipeline, including:

HYLA™ blood sensor- being designed to monitor blood parameters continuously and in real-time.

INSPIRA™ Cardi-ART- a portable unit, derived from the INSPIRA™ ART (Gen 2) product, is being designed to oxygenate the brain to support patients undergoing cardiac arrest.

INSPIRA™ ART (Gen 2)- also known as the INSPIRA™ ART500, will include the Company's Adaptive Blood Oxygenation technology with the HYLA™ blood sensor, which is being designed to continuously measure the patient's blood parameters in real-time, delivering needed oxygen volume straight into the blood. By elevating patient oxygen saturation levels in minutes, this technology potentially allows patients to remain awake during treatment and, therefore, may enable patients to be treated in and beyond intensive care units, potentially reducing the need for mechanical ventilation systems that require intubation and medically induced coma.

The Company's INSPIRA™ ART100 system received FDA 510(k) clearance for Cardiopulmonary Bypass procedures and AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

The Company's other products, including the INSPIRA™ ART (Gen 2), the INSPIRA™ Cardi-ART portable modular device and HYLA™ blood sensor, are currently being designed and developed, and have not yet been tested or used in humans and have not been approved by any regulatory entity.

For more information, please visit our corporate website: https://inspira-technologies.com

Forward-Looking Statement Disclaimer

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. Thes forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potential benefits and uses of its products; its aim for its technology to streamline healthcare delivery in a variety of clinical scenarios; the intended uses of the INSPIRA™ CART; facilitating the INSPIRA™ CART's entry into the U.S. market; its belief that its ongoing progress with its products will translate in the future into substantial recognition by strategic partners and investors; its vision to reshape the respiratory and life-support landscape; the deployment of the INSPIRA™ ART100 system in leading U.S and Israeli hospitals; and its business strategy. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website, www.sec.gov.

MRK-ARS-110

Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All rights reserved.

For more details: 
Public Relations Manager
Adi Shmueli
Inspira™ Technologies
info@inspirao2.com
+972-9-9664485

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SOURCE Inspira Technologies

FAQ

What is the FDA status of Inspira Technologies' INSPIRA™ CART?

The INSPIRA™ CART has received FDA listing as a Class I Medical Device, 510(K) Exempt, for use in operating rooms during Cardiopulmonary Bypass procedures in the United States.

What is the market potential for Inspira Technologies' (IINN) products?

Inspira Technologies is targeting a combined market opportunity of approximately $59 billion annually with its life support-extending technologies and blood oxygenation and monitoring products.

What are the key products in Inspira Technologies' (IINN) pipeline?

Inspira's product pipeline includes the HYLA™ blood sensor for continuous blood parameter monitoring, INSPIRA™ Cardi-ART for oxygenating the brain during cardiac arrest, and INSPIRA™ ART (Gen 2) for adaptive blood oxygenation with real-time blood parameter measurement.

Has Inspira Technologies (IINN) received any orders for its INSPIRA™ CART?

Yes, Inspira Technologies has received its first order of INSPIRA™ CARTs from Glo-Med Networks, Inc.