Full Press Release Details
Technologies Begins Manufacturing of the ALICETM CPB Device, ahead of planned 2023 FDA submission
ALICE device is an important part of Inspira's market penetration strategy.
Israel, December 20, 2022 - Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company"
or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that it has begun
the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the "ALICE device") to undergo the Verification
and Validation phase prior to its planned 2023 submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. If FDA
clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important
operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Additional units are expected
to be assembled for the targeted future first deployments of the ALICE devices in the U.S. and Israel.
ALICE device is being contract manufactured by an end-to-end solution provider that offers New Product Introduction (NPI) services to
mass production capabilities for leading medical electronic device companies. This includes full turn-key manufacturing, full system
integration, including PCB(Printed Circuit Board) manufacturing, assembly services, testing and packaging in facilities that meet Good
Manufacturing Practices (GMP) compliance.
ALICE device is intended to provide potential advantages in medical device design, including a large touchscreen and novel colorful graphical
presentation, that increases the visibility and functionality of data displayed to the medical staff. The ALICE device is being designed
to be both lightweight and highly durable and is designed to be equipped with long battery life. The ALICE device is intended to be indicated
for use in clinical settings requiring CPB support. Inspira plans for the ALICE to be the first device to Integrate the HYLATM
Blood Sensor designed to be non-invasive, perform continuous measurements and alert physicians at real time of sudden changes in a patient's
specific key blood indicators.
Technologies' goal is to set a new standard in various aspects of patient care, targeting intensive care units (ICUs), general
medical units, operating theaters, emergency medical services and small urban and rural hospitals, with the focus of increasing accessibility
to medical care for millions of patients worldwide. As part of our strategy to reach these goals, and in parallel to pursuing regulatory
approvals, we are actively working to establish collaborations with strategic partners and globally ranked health centers to provide
endorsement and clinical adoption for regional deployments of our respiratory support, CPB, and blood measuring products and technologies.
we believe that we have achieved a very important milestone in line with our strategy towards the production and delivery of Inspira
Technologies' products to the market," stated Avi Shabtai, Inspira Technologies' Chief Operating Officer.
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 (INSPIRA ART), designed to rebalance patient oxygen saturation levels. This 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://Inspira-Technologies.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 its regulatory strategy, the timing of the expected submission
of the ALICE device for 510k clearance, the extension of indications and uses for its ALICE product following FDA clearance, its intended
manufacturing plans and intended first targeted markets for the ALICE device, the potential advantages, and benefits to be derived by
its products, its goal is to set a new standard in various aspects of patient care and increase accessibility to medical care for millions
of patients worldwide, its pursuit of collaborations with strategic partners and globally ranked health centers and its belief that it
has achieved a very important milestone in line with its strategy towards the production and delivery of its products to the market.
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
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