UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of December 2024
Commission File Number: 001-40303
Inspira Technologies Oxy B.H.N. Ltd.
(Translation of registrant’s name into
English)
2 Ha-Tidhar St.
Ra’anana 4366504, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form
40-F
CONTENTS
On December 4, 2024, Inspira
Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira™ Collaborates with New York’s
Westchester Medical Center to Evaluate the Inspira™ ART100 Functionality and Performance in Clinical Scenarios,” a copy of
which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.
The first two paragraphs and
the section titled “Forward-Looking Statements” in the press release are incorporated by
reference into the Registrant’s Registration Statements on Form F-3 (Registration No. 333-266748) and Form S-8 (Registration
Nos. 333-259057 and 333-277980), filed with the Securities and Exchange Commission, to be a part thereof from the date on
which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently
filed or furnished.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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Inspira Technologies Oxy B.H.N. Ltd. |
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Date: December 4, 2024 |
By: |
/s/ Dagi Ben-Noon |
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Name: |
Dagi Ben-Noon |
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Title: |
Chief Executive Officer |
2
Exhibit
99.1
Inspira™
Collaborates with New York’s Westchester Medical Center to Evaluate the INSPIRA™ ART100 Functionality and Performance in
Clinical Scenarios
Ra’anana, Israel, December 4, 2024 – Inspira Technologies
OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (“Inspira Technologies”, “Inspira” or the “Company”), a groundbreaking
life support technology company, entered into a strategic collaboration with Westchester Medical Center in Valhalla, New York. Westchester
Medical Center, the flagship hospital in the Westchester Medical Center Health Network, will evaluate the performance and effectiveness
of the new U.S. Food and Drug Administration (FDA) cleared INSPIRA ART100 systems in various real-world clinical scenarios, exposing Inspira’s
products and technologies to leading physicians and medical institutions.
The strategic collaboration allows for Westchester Medical Center,
a premier provider of advanced medical care, and Inspira Technologies, a pioneer of breakthrough technologies, to advance critical patient
care with the deployment of Inspira’s proprietary INSPIRA ART100 systems. The parties have entered the strategic collaboration with
the intention to mutually explore a long-term collaboration towards the future deployment of Inspira’s next-generation flagship
technology, its INSPIRA™ ART system, which is currently in development and which is being designed to treat acute respiratory failure
by elevating declining oxygen saturation levels in minutes without mechanical ventilators.
“We are thrilled to supply Westchester Medical Center with our
FDA-cleared INSPIRA ART100 systems,” Joe Hayon, co-founder and President of Inspira Technologies. “We believe that this
collaboration validates the growing interest in our innovative technology and also provides us with an opportunity to demonstrate its
capabilities in one of New York’s premier medical networks.”
David Spielvogel, MD, Section Chief of Cardiothoracic Surgery, Westchester
Medical Center, said: “This partnership exemplifies Westchester Medical Center’s commitment to investing in innovative
technologies to provide the highest, safest, and most effective care. By integrating this technology we aim to enhance our treatment of
acute respiratory failure and improve patient outcomes. As one of the few centers in New York State performing Cardiopulmonary Bypass
(CPB) and Extracorporeal Membrane Oxygenation (ECMO), we are uniquely positioned to leverage this advanced technology for the benefit
of our patients.”
About
Westchester Medical Center Health Network
The Westchester
Medical Center Health Network (WMCHealth) is a 1,700-bed healthcare system headquartered in Valhalla, New York, with nine hospitals on
seven campuses spanning 6,200 square miles of the Hudson Valley. WMCHealth employs more than 12,000 people and has nearly 3,000 attending
physicians. The Network has Level I (adult and pediatric), Level II and Level III trauma centers, the region’s only acute care
children’s hospital, an academic medical center, several community hospitals, dozens of specialized institutes and centers, Comprehensive
and Primary Stroke Centers, skilled nursing facilities, home-care services and one of the largest mental health systems in New York State.
Today, WMCHealth is the pre-eminent provider of integrated health care in the Hudson Valley. For more information about WMCHealth, visit
WMCHealth.org or follow WMCHealth on Facebook, Instagram, LinkedIn, YouTube, and X.
About 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 potential of the collaboration to enable the advancement of critical patient care, the prospective long-term collaboration
in deploying the INSPIRA™ ART System, the belief that this collaboration validates the growing interest in the Company’s innovative
technology and provides the Company with an opportunity to demonstrate its capabilities in one of New York’s premier medical networks,
the belief that this collaboration exemplifies Westchester Medical Center’s commitment to investing in innovative technologies,
that Westchester Medical Center aims to enhance its treatment of acute respiratory failure and improve patient outcomes through the integration
of this technology and the belief that Westchester Medical Center is uniquely positioned to leverage this advanced technology for the
benefit of its patients. 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
MRK-ARS-120
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All
rights reserved.
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