RA'ANANA, Israel, Oct. 9, 2024
/PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd.
(Nasdaq: IINN) (Nasdaq: IINNW) ("Inspira Technologies",
"Inspira" or the "Company"), a groundbreaking respiratory support
technology company, is pleased to announce the development of a new
disposable kit for the perfusion market. This strategic move is
central to Inspira's business strategy of generating recurring
revenues for products to be deployed in conjunction with the
INSPIRA ART100 and that are also intended to be compatible with
other life support machines, thus potentially tapping into the
$1 billion perfusion systems
market.
The innovative disposable kit is being developed as a single-use
product designed to identify and alert users on changes in the
performance of the disposable during operation and treatment. The
unique design and features of the disposable are expected to
provide a smart, compatible, and adjustable experience for medical
teams. This is intended to enhance product safety and improve
patient protection.
The disposable kit will be the subject of a planned application
for U.S. Food and Drug Administration (FDA) clearance for
marketing. Once cleared for marketing, the disposable is expected
to be offered to hospitals that use the INSPIRA ART100 system. The
INSPIRA ART100 system received FDA 510(k) clearance in May 2024 for Cardiopulmonary Bypass (CPB)
procedures and in July 2024 received
Israeli medical device and accessory certification for
extra-corporeal membrane oxygenation and cardiopulmonary bypass
procedures. The first manufactured devices are expected to be
deployed in the U.S. by the end of 2024.
Mr. Dagi Ben-Noon, co-founder, and CEO of Inspira
Technologies, stated: "This new innovation and capability,
being integrated into our disposable kit, is expected to be an
additional step by Inspira to provide new technologies and user
experiences for the purpose of supporting improved safety and
patient care."
Inspira Technologies OXY B.H.N. Ltd.
Inspira™ Technologies is an innovative medical technology
company in the life support and respiratory treatment arena. The
Company has developed a breakthrough Augmented Respiration
Technology (INSPIRA™ ART), a groundbreaking device poised to
revolutionize the $19 billion mechanical ventilation
market. With 20 million intensive care unit patients with acute
respiratory failure each year, many of whom rely on mechanical
ventilators, the INSPIRA™ ART offers a potential alternative by
elevating and stabilizing decreasing oxygen saturation levels in
minutes without a ventilators, with patient being awake during
treatment. The INSPIRA ART is being equipped with clip-on HYLA™
blood sensor, a real-time continuous blood monitoring technology,
aiming to alert physicians of changes in a patient's condition
without the need for intermittent actual blood samples, and
potentially supporting physicians in making informed decisions.
The Company's INSPIRA™ ART100 system has
obtained FDA 510(k) clearance for use in Cardiopulmonary Bypass
procedures, along with the Israeli AMAR certification for both
Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass
procedures.
The Company's other products and technologies, including the
INSPIRA™ ART also known as the INSPIRA™ ART500 or Gen 2, the
INSPIRA™ Cardi-ART portable modular device, VORTX orbiting Oxygen
Delivery System 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. 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 Company's belief
that the development of a new disposable kit is central to
Inspira's business strategy of generating recurring revenues for
products to be deployed in conjunction with the INSPIRA ART100, the
potential size of the perfusion systems market, that the design and
features of the disposable are expected to provide a smart,
compatible, and adjustable experience for medical teams which may
potentially enhance product safety and improve patient protection,
prospective FDA applications and approval of the disposable kit,
that the first manufactured devices are expected to be deployed in
the U.S. by the end of 2024, and the belief that this disposable
kit is expected to be an additional step by Inspira to provide new
technologies and user experiences for the purpose of supporting
improved safety and patient care. 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.
Contact:
Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All
rights reserved
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SOURCE Inspira Technologies