- The major milestone refers to Inspira's proprietary
technology to oxygenate blood for the INSPIRA™ ART (Gen 2). This
patented tech is considered by Inspira to be a game-changer and
also aims to replace technologies used today by current medical
device companies.
- Anticipated U.S. Food and Drug Administration (FDA) Clearance
for INSPIRA™ ART100 (Gen 1) in the first half of 2024, to
address the $1.16 Billion perfusion
systems market.
RA'ANANA, Israel, March 4,
2024 /PRNewswire/ -- Inspira™ Technologies
OXY B.H.N. Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the
"Company" or "Inspira"), a breakthrough medical technology company,
announced today that the Company's President, and co-founder, Mr.
Joe Hayon, presented key highlights
included in the Company's Investor Presentation and announced the
Company's next major milestone of a core blood oxygenation
technology of the INSPIRA ART (Gen 2). The INSPIRA ART (Gen 2) is
designed to utilize adaptive oxygenation technology, leveraging the
proprietary HYLA™ blood Sensor and VORTX™ Orbiting Blood
Oxygenation, to delivery oxygen straight into the blood. The
proprietary core technology has undergone a series of testing in a
variety of settings, with the results being collected and analyzed.
The results refer to the INSPIRA ART (Gen 2), with the new core
technology potentially being suitable for replacing current
solutions in medical markets dominated by leading medical device
companies. The Company plans to announce the primary results around
the core blood oxygenation technology of the INSPIRA ART (Gen 2)
within days.
Mr. Hayon shared "We have an appetite to revolutionize the huge
life-support mechanical ventilation market. In addition, it's
important to emphasize that we believe INSPIRA ART100 (Gen 1)
itself addresses $1B market." Key
highlights from the conference call included:
- The current healthcare challenge and a personal story.
- The solution – Inspira's oxygen delivery straight into the
blood.
- INSPIRA™ART (Gen 2), Adaptive Blood Oxygenation and expected
major milestone.
- INSPIRA™ ART Gen 1 and Gen 2 product overview.
- Anticipated FDA Clearance for INSPIRA™ ART100 (Gen
1).
Mr. Hayon shared a heartfelt personal story and the profound
impact of Inspira beyond technological innovation. He recounted his
father's prolonged reliance on mechanical ventilation, painting a
vivid picture of the challenges and complications associated with
traditional ventilation methods. Through conversations with
critical care physicians, the necessity for Inspira's technology
became clear – a sentiment echoed by medical professionals eager to
integrate INSPIRA ART into clinical practice.
Emphasizing the Company's core mission, Mr. Hayon continued to
share how Inspira is focused on delivering oxygen straight into the
blood. The Company is advancing two generations of blood
oxygenation solutions. INSPIRA ART100 (Gen 1), designed to perform
blood oxygenation as a cardio-pulmonary bypass device, is
anticipated to be cleared by the FDA in the first half of 2024.
With the planned FDA submission and clearance of the HYLA, the
INSPIRA ART100 is then intended to be integrated with blood
monitoring technologies from the HYLA. In parallel, the Company is
rapidly developing the INSPIRA ART (Gen 2), designed to perform
adaptive blood oxygenation, embedded with the HYLA advanced
continuous blood monitoring, to provide real-time detection of
changes and provide decision-making assistance data and the VORTX
orbiting blood oxygenation delivery system.
We believe that since the blood holds so many secrets about
patient condition and response to treatment, the collection,
aggregation and analysis of data by the INSPIRA ART will
potentially open a huge market opportunity for the Company, as we
aim to revolutionize the treatment of patients while they are awake
and without the need for mechanical ventilation. The forthcoming
expected FDA clearance of the INSPIRA ART100 will mark a pivotal
achievement, which we believe will reinforce Inspira's position as
a disruptive force in the medical landscape.
Inspira Technologies OXY B.H.N. Ltd.
Inspira™ Technologies is an innovative medical technology
company in the respiratory treatment arena. The Company has
developed a breakthrough Augmented Respiration Technology (INSPIRA
ART), designed to rebalance patient oxygen saturation levels. This
technology potentially allows patients to remain awake during
treatment while reducing the need for highly invasive, risky, and
costly mechanical ventilation systems that require intubation and
medically induced coma. The Company's products have not yet been
tested or used in humans and has 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 the potential benefits
of the Company's products and potential products, the potential
addressable market for its products, that it intends to announce
the primary results for its core blood oxygenation technology
within days, the expected timing of FDA approval and the intended
future submission of products for FDA approval, the belief that the
INSPIRA ART will potentially open a huge market opportunity and
that the expected FDA clearance of the INSPIRA ART100 will mark a
pivotal achievement, which it believes will reinforce its position
as a disruptive force in the medical landscape. 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, 2022
filed with the U.S. Securities and Exchange Commission (the "SEC"),
which is available on the SEC's website, 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