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 July 2024 (Report No. 2)
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 July 30, 2024, Inspira
Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira Technologies Introduces the INSPIRA Cardi-ART,
Aiming to Provide Oxygen to the Brain During Cardiac Arrest,” a copy of which is furnished as Exhibit 99.1 with this report of foreign
private issuer on Form 6-K.
The first, third, fourth,
fifth and sixth 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
is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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.
|
Inspira Technologies Oxy B.H.N. Ltd. |
|
|
|
Date: July 30, 2024 |
By: |
/s/ Dagi Ben-Noon |
|
|
Name: |
Dagi Ben-Noon |
|
|
Title: |
Chief Executive Officer |
2
Exhibit 99.1
Inspira™
Technologies Introduces the INSPIRA Cardi-ART, Aiming to Provide Oxygen to the Brain During Cardiac Arrest
Inspira’s innovation targets life-saving intervention
for patients with cardiac arrest, of which there are approximately 550,000 annual cardiac arrest events in the U.S., including 350,000
outside hospitals, where the survival rate is less than 10%.
The INSPIRA Cardi-ART provides the Company a new
market opportunity to target the $39.8 billion global cardiac arrest market.*
Ra’anana, Israel, July 30, 2024 –
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company”, “Inspira”, or “Inspira Technologies”),
a trailblazer in life-support technology, proudly introduces the INSPIRA Cardi-ART, a portable modular device, currently in development,
to provide oxygen to the brain during cardiac arrest (the “Device” or “INSPIRA Cardi-ART”).
The device is expected to expand the next-generation
INSPIRA™ ART platform to a wider range of applications with a combined potential market of approximately $58.8 billion ($19 billion
global mechanical ventilation market and $39.8 billion global cardiac arrest market).
The INSPIRA Cardi-ART is being designed to support
vital organ oxygenation during cardiac arrest to treat patients both in and outside of hospitals. The Company plans the regulatory submission
of the Device to the U.S. Food and Drug Administration for as early as 2026, pending the final regulatory pathway.
Today, nearly 70% of cardiac arrests occur outside
of the hospital, of which there is a mortality rate of approximately 90%. The Device aims to improve survival rates of cardiac arrest
patients with the Company’s core blood oxygenation and monitoring technologies, targeting new applications in the global cardiac
arrest market.
The INSPIRA Cardi-ART portable modular unit is being
designed for fast emergency response during CPR (cardio pulmonary resuscitations) in and outside of hospitals, allowing for rapid cannulation
and the delivery of oxygenated blood throughout the body to reduce damage to the heart and brain during cardiac arrest. The Device is
being designed to monitor key vital parameters using the groundbreaking HYLA blood sensor technology.
The INSPIRA Cardi-ART is being designed to provide
quick hemodynamic support in the case of cardiac failure as it drains blood, exchanges gases, and then returns the blood to the arterial
system to maintain systemic perfusion. The technique has been used in other procedures that have been recommended in medical guidelines
as set out by the American Heart Association (AHA).
Dr. Dekel Stavi, Inspira Technologies’
Medical Director, stated: “The INSPIRA Cardi-ART may become the difference between life and death during a cardiac arrest event,
where the medical team sometimes has only minutes to provide critical life-saving care.”
About Cardiac Arrest
In the United States, both in-hospital cardiac arrests
(IHCA) and out-of-hospital cardiac arrests (OHCA) are common, with estimated incidences of 200,000 and 350,000 per year, respectively.
Survival rates for these patients are low, with survival from IHCA ranging from 6% to 26% and survival from OHCA less than 10%.
Cardiac arrest results in the onset of coma within
10–20 seconds due to the lack of oxygen delivery to the brain and loss of neuronal function. Unless the circulation is quickly restored,
the lack of oxygen delivery to the brain leads to the death of neurons over 5–40 minutes.
As part of a global endeavor to enhance patient outcomes,
medical centers worldwide have began to adopt extracorporeal techniques to restore oxygenation and circulation for patients having both
IHCA and OHCA. In such critical scenarios, if administered early enough, it provides healthcare professionals with valuable time to stabilize
the patient and identify the underlying cause of cardiac arrest.
Inspira Technologies OXY B.H.N. Ltd.
Inspira™ Technologies targets to reshape
the respiratory and life-support landscape. We are developing novel expanding life support technologies with Inspira blood oxygenation
and blood monitoring technologies. Inspira is on a quest to become the leading ground-breaking medical device company in our field with
business alliances around the world.
The INSPIRA™ ART (Gen 2), also known as the
INSPIRA™ ART500, will include the Company’s Adaptive Blood Oxygenation technology and is being designed to continuously measure
the patient’s blood parameters in real-time, delivering needed oxygen volume straight into the blood. By elevating patient oxygen saturation
levels in minutes, this technology potentially allows patients to remain awake during treatment and therefore may enable patients to be
treated in and beyond intensive care units, reducing the need for mechanical ventilation systems that require intubation and medically
induced coma.
The Company’s INSPIRA™ ART100 system received
FDA 510(k) clearance for Cardiopulmonary Bypass procedures and AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary
Bypass procedures.
The Company’s other products, including the INSPIRA™
ART (Gen 2) including the INSPIRA Cardi-ART portable modular device 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 that it expects the development to expand the next-generation INSPIRA™ ART platform, the prospective design of
and the ways in which its Device targets life-saving intervention for patients with cardiac arrest, the actual and expected expansion
of the size of its combined potential addressable market for its devices, the potential U.S. Food and Drug Administration submission for
the Device and its expected timing, and that the Device could make a significant difference in patient outcomes. 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
* https://www.maximizemarketresearch.com/market-report/global-cardiac-arrest-treatment-market/36103/
For more details:
Public Relations Manager
Adi Shmueli
Inspira Technologies
info@inspirao2.com
+972-9-9664485
MRK-ARS-109
Copyright © 2018-2024 Inspira Technologies OXY
B.H.N. LTD., All rights reserved.
3
Inspira Technologies Oxy... (NASDAQ:IINN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Inspira Technologies Oxy... (NASDAQ:IINN)
Historical Stock Chart
From Sep 2023 to Sep 2024