RA'ANANA, Israel, Feb. 27,
2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N.
Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira
Technologies"), a breakthrough medical technology company, has
announced that the Company is progressing towards 510(k) clearance
from the U.S. Food & Drug Administration ("FDA") for its
INSPIRA™ ART100 in the first half of 2024. The Company plans
additional FDA 510(k) submissions for the HYLA blood sensor in 2024
and for INSPIRA ART disposables in 2025, as part of a scalable
razor-blade business model. Three breakthrough patents have been
approved by the United States Patent and Trademark Office ("USPTO")
and an additional three patent applications are pending at the
USPTO for certain core technologies. To date, the Company has
signed $546 million in
pre-conditioned summary distribution agreements, subject to
regulatory approvals and authorizing authorities.
Inspira has set out in its investor presentation (link) its
plans to revolutionize the $19
billion mechanical ventilator market with the next
generation INSPIRA™ ART device, equipped with adaptive blood
oxygenation technology. The INSPIRA ART device is the first INSPIRA
device of its kind to be embedded with our proprietary HYLA blood
sensor and VORTX™, an orbiting blood oxygenation delivery system.
The INSPIRA ART device is designed to continuously scan blood
parameters in real-time to deliver the needed oxygen volume
straight into the blood, elevating patient oxygen levels within
minutes.
Joe Hayon, President and
Co-founder, stated: "The blood holds insights and valuable
information needed when treating patients, so we believe that the
HYLA blood sensor has a vital role to play while the INSPIRA ART
delivers the needed oxygen straight into the blood. We vision the
INSPIRA ART is expected to changing the medical landscape, with the
VORTX orbiting blood oxygenation delivery system. This is the first
patent of its kind, recently approved by the USPTO."
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 expected timing of
its 510(k) clearance from the FDA, that it intends to submit
additional 510(k) submissions, the value and potential of its
summary distribution agreements, each subject to regulatory
approvals and authorizing authorities, the belief that the HYLA
blood sensor has a vital role to play while the INSPIRA ART
delivers the needed oxygen straight into the blood, the belief that
the INSPIRA ART is expected to change the medical landscape, and
the potential benefits of its products. 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.
MRK-ARS-088
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD. All
rights reserved.
Logo:
https://mma.prnewswire.com/media/1668495/Inspira_Technologies_Logo.jpg
For more details:
Adi Shmueli
Public Relations Manager
Inspira Technologies
info@inspirao2.com
+972-9-9664485
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SOURCE Inspira Technologies