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