RA'ANANA, Israel, April 25,
2024 /PRNewswire/ -- Inspira™ Technologies OXY
B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the
"Company" or "Inspira"), a breakthrough medical technology
company, announced that it has received the Canadian Standards
Association (CSA) Certification of Compliance to U.S. standards for
the INSPIRA ART100 device.
This is a positive recognition of our product's quality and
safety standards. We believe, subject to U.S. Food and Drug
Administration (FDA) regulatory clearance, that this is an
important milestone on the path towards attaining market access for
our medical device, with the INSPIRA ART100 having undergone
advanced testing and certification to evaluate compliance with
safety and performance requirements defined by the CSA.
The Certification of Compliance allows for the INSPIRA ART100
System to bear the CSA Mark; C878081 MEDICAL ELECTRICAL
EQUIPMENT/SYSTEMS - Certified to U.S. Standards.
Inspira Chief Operations Officer Mr. Avi Shabtay
stated: "This certification is more than just a mark of
compliance. It is a sign of our unwavering commitment to the
highest standards of product quality and safety."
About CSA
CSA Group is an independent, not-for-profit and impartial
organization that develops standards and codes serving industry,
government, consumers and other interested parties in Canada and the global marketplace. CSA Group
works to develop standards that address real needs, such as
enhancing public safety and health, advancing the quality of life,
helping to preserve the environment and facilitating trade.
Accredited by the Standards Council of Canada, CSA Group has developed more than
3,000 standards, codes and related products for the safety, design
or performance of a wide range of products and services.
About 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 states that the receipt of the
CSA mark is an important milestone on the path towards attaining
market access for the INSPIRA ART100 , subject to FDA regulatory
clearance or when it states that the receipt of the mark is a sign
of its unwavering commitment to the highest standards of product
quality and safety. 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, https://www.sec.gov.
MRK-ARS-100
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