RA'ANANA, Israel, May 28, 2024
/PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd.
(Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or
"Inspira Technologies"), a breakthrough medical technology
company, today announced that it has received notification of
510(k) class II clearance from the U.S. Food and Drug
Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary
Bypass System.
Dagi Ben Noon, CEO of Inspira, said "This is a proud
moment for all of us at Inspira Technologies. We would like to
thank all our investors and partners who have been with us on this
journey to get here."
Professor Benad Goldwasser, the Chairman of the Board of
Inspira, stated: "We believe that the FDA clearance marks a
clear example of the Company's technological and innovative
advancements."
About Inspira Technologies OXY B.H.N. Ltd.
Inspira™ Technologies is an innovative medical technology
company in the life support arena. The INSPIRA™ ART (Gen 2), also
known as the INSPIRA™ ART500, includes the Company's Adaptive Blood
Oxygenation technology and 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,
reducing the need for mechanical ventilation systems that requires
intubation and medically induced coma.
The Company received FDA 510(k) clearance for its INSPIRA
ART100, a Cardiopulmonary Bypass System.
The Company's other products, including the INSPIRA ART (Gen 2)
and HYLA™ blood sensor, 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. These
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 that the Company
believes the FDA clearance is an example of its technological and
innovative advancements and the potential benefits of its products
and technologies. 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, http://www.sec.gov
For more details:
Public Relations Manager
Adi Shmueli
Inspira Technologies
info@inspirao2.com
+972-9-9664485
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All
rights reserved.
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SOURCE Inspira Technologies