RA'ANANA, Israel, Dec. 26,
2023 /PRNewswire/ -- Inspira Technologies
OXY BHN Ltd. (NASDAQ: IINN) (NASDAQ: IINNW)
(the "Company" or "Inspira"), a pioneer in life support
technology with a vision to supersede traditional mechanical
ventilators, today announced a significant advancement in its
sensor technology by its team of experts. This breakthrough, in
achieving 95% accuracy compared to standard blood gas analyzers,
brings continuous and real-time blood monitoring capabilities
compared to traditional blood gas analyzer systems used in
hospitals that typically require intermittent blood draws. This
advancement signals Inspira's potential entry into the disposables
market.
The development of the first
HYLA™ variant, key to this advancement,
marks a significant step towards its submission under a 510(k)
pathway with the U.S. Food & Drug Administration ("FDA"), which
is expected in the second half of 2024. This sensor technology is
designed to be integrated with the Company's INSPIRA ART100 and was
submitted to the FDA in September
2023, with clearance anticipated in the first half of
2024.
The HYLA™ Blood Sensor line
(the "Blood Sensor") is set to transform intensive care unit (ICU)
operations, offering continuous, real-time blood data collection
and analysis. This enhances patient care with critical insights and
alerts, with the aim to improve medical procedures and device
efficiency.
Key features of the Blood Sensor include:
- High Accuracy: Achieves 95% accuracy relative to standard
blood gas analyzers;
- Non-invasive: Eliminates the need for blood
draws;
- Durability: Built to handle ICU and operating room
environments;
- Versatility: Compatible with various medical procedures,
including: the cardio pulmonary bypass, extracorporeal membrane
oxygenation, continuous renal replacement therapy, and dialysis;
and
- Modular Design: Engineered to complement existing medical
devices, targeting the two-million annual open-heart surgery
patients globally.
In developing the HYLA™ Blood Sensor
line, Inspira utilizes in-house lab testing as well as hospital
collaborations for the purpose of clinical research and
development. This approach has enabled to define the Blood Sensor's
disposable materials and methods, with HYLA's planned razor blade
business model. While primarily designed for INSPIRA ART devices,
plans are underway also to offer a variant of the Blood Sensor as a
standalone device.
Dagi Ben-Noon, CEO of Inspira Technologies,
commented: "With our sensor technology, we are not
only enriching our INSPIRA ART device line but also forging a path
into the disposables market, setting the stage for groundbreaking
developments in healthcare."
Inspira Technologies OXY BHN Ltd.
Inspira Technologies is leading the way in transforming
life-support care. Its innovative solutions are paving the way for
direct blood oxygenation, bypassing the lungs, and potentially
reducing the need for traditional mechanical ventilation. Beyond
this, the Company is committed to advancing blood circulation
technology and incorporating AI-driven monitoring systems. These
advancements are part of its strategy to offer more
patient-focused, data-informed care. The integration of these
technologies signifies the potential to enhance patient outcomes
and streamline hospital operations, marking a new era in
respiratory care.
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 under US Federal securities laws. These forward-looking
statements and their implications are based only on the current
expectations of the management of the Company. They are subject to
several factors and uncertainties that could cause results to
differ materially from those described in the forward-looking
statements. For example, the Company uses forward-looking
statements when it discusses the Company's vision to supersede
traditional mechanical ventilators, the expected timeline for FDA
submissions and potential FDA approvals of its devices, the
expected benefits and accuracy of its devices and the belief that
with this new sensor technology, it is not only enriching its ART
device lineup but also forging a path into the disposables market,
setting the stage for groundbreaking developments in healthcare.
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 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
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 © 2018-2023 Inspira Technologies OXY B.H.N. LTD., All
rights reserved.
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SOURCE Inspira Technologies