Full Press Release Details
Inspira Technologies Announces FDA Listing and Market Readiness
Ra'anana, Israel, August 22, 2024 - Inspira Technologies
OXY B.H.N. Ltd. (Nasdaq: IINN, 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
Public Relations Manager
Inspira Technologies
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