Full Press Release Details
Technologies Reveals Next Generation Liby ECMO, an Extracorporeal Membrane Oxygenation System, Targeting a $531 Million Global
Israel, July 11, 2022 - Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira
Technologies") introduces today the "Liby " System, an advanced form of life support better known by the medical
industry as extracorporeal membrane oxygenation (ECMO), used to treat patients with life-threatening heart and lung failure. The Liby
System is intended to target the $531million global ECMO market. The Inspira Technologies Liby system currently under development,
is expected to be submitted to the U.S. Food and Drug Administration (FDA) for approval, during the first half of 2023.
Inspira Technologies Liby system is designed to be a new generation ECMO system, with potential advantages that may improve usability
and patient care. The Liby system is also expected to be the first system designed for integration with the Company's recently
revealed non-invasive HYLA blood sensor technology. The addition of the HYLA to patients treated with the Liby system,
would potentially allow for the real-time and continuous monitoring of patient condition to alert physicians of immediate signs of changes
in a patient's clinical condition
Liby system includes several Inspira Technologies developed features and capabilities as well as a new approach to medical device
designs, including a large touchscreen and novel colorful graphical representation that increases the visibility, scope and functionality
of data displayed to the medical staff. With its small footprint and lightweight characteristics, the Liby system is being designed
with a rapid style aerospace-grade aluminum structure to be both lightweight and highly durable, and will be equipped with long battery
life, a contributing factor to making the Liby system suitable for patient mobility within hospitals and for transportation of
patients to hospitals in ambulances.
Liby system is expected to be submitted to the FDA for approval during the first half of 2023. Subject to FDA approval, the Liby
system's expected regulatory pathway is intended to be designated as a Class II 510 (K), meaning it may not require human trials.
Model - Recurring Revenue
to the Company's flagship ART system, the Liby system is being designed to generate recurring revenues based upon
consumable sales of its single use disposable kit, which is an important part of the system's unique design, aimed at reducing
setup time and associated medical-care costs.
Ben-Noon, Inspira Technologies' Chief Executive Officer, stated:
Liby system is intended to target one of three market segments within Inspira Technologies product scope. The Liby system
is expected to introduce the next generation of ECMO within Intensive Care Units (ICUs), due to its practical advantages, designed to
improve durability, patient mobility both within the hospital or via ambulance, and ease of use. I believe that these are important advantages
for medical teams within over-crowded ICUs, targeting to improve patient outcomes."
systems are designed to directly oxygenate and remove carbon dioxide from a patient's blood, replacing the entire lung function
by circulating all of the patient's blood (5-7 liters) every minute. As a last resort procedure, it requires the patient to be
confined to ICUs and is associated with a high level of medical risks.
Technologies OXY B.H.N. Ltd.
Technologies is an innovative medical technology Company in the respiratory treatment arena. The Company has developed a breakthrough
Augmented Respiration Technology (ART), designed to rebalance patient oxygen saturation levels. The Company's ART technology
potentially allows patients to remain awake during treatment while minimizing 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.
more information, please visit our corporate website: https://inspirao2.com
Statement Disclaimer
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 benefits to be derived from the use of the
Liby system, once developed, the expected timing of FDA submission for approval, that the Liby system is expected to be
designated as a Class II 510(K), meaning it may not require human trials, and that the Liby system is being designed to generate
recurring revenues based upon consumable sales of its single use disposable kit. 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, 2021 filed with the U.S. Securities and Exchange Commission (the "SEC"),
which is available on the SEC's website, www.sec.gov