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Inspira Technologies Delivers Systems to Leading Distributor for U.S. Deployment RA'ANANA, Israel

Key Takeaway: Inspira Technologies has successfully delivered its INSPIRA ART100 systems to Glo-Med Networks Inc, a U.S. distributor, to enhance cardiopulmonary care in leading hospitals. The deployment is part of the company's strategy to introduce innovative respiratory support technology to U.S. healthcare providers. The INSPIRA ART100, which has FDA clearance for cardiopulmonary bypass procedures, is set to be integrated with the HYLA blood monitoring system to improve patient monitoring. The systems are intended for use in high-ranking hospitals, supporting the company's goal of revolutionizing respiratory care.

Market Sentiment Analysis

POSITIVE FACTORS

  • Delivery of INSPIRA ART100 systems marks significant progress in U.S. market deployment.
  • The technology is designed in collaboration with leading U.S. clinicians, enhancing its credibility.
  • Integration of HYLA technology aims to provide real-time monitoring, improving patient care.
  • The company has received FDA clearance for the INSPIRA ART100, facilitating its entry into the healthcare market.

Full Press Release Details

Inspira Technologies Delivers
Systems to Leading Distributor for U.S. Deployment
RA'ANANA, Israel- December 16, 2024 - Inspira Technologies
Oxy B.H.N. Ltd. (NASDAQ: IINN, IINNW), ("Inspira Technologies," "Inspira" or the "Company"), a
groundbreaking respiratory support technology company, announced the delivery of INSPIRA
ART100 systems to its U.S. distributor, Glo-Med Networks Inc ("Glo-Med"). The systems were shipped in fulfilment of a purchase
order issued by Glo-Med to Inspira.
The delivered INSPIRA
ART100 systems will be distributed to sales targets across hospitals on the U.S. east coast and distributed to a cardiothoracic surgery
division at a leading New York hospital, ranked among the top 15 percent of cardiothoracic programs in the U.S., with a view
to collaborating with such hospital. The Company believes that the delivery of the INSPIRA
ART100 to the U.S. market serves the Company's goal well to introduce physicians and perfusionists to Inspira's technologies and brand
via initial deployments at leading hospitals.
Designed in collaboration with leading U.S. clinicians, the INSPIRA
ART100 cardiopulmonary bypass system revolutionizes extracorporeal blood circulation by combining cutting-edge technology with intuitive
design to optimize patient care during crucial times. The INSPIRA
ART100 is planned to be integrated with the HYLA , a continuous
blood monitoring technology designed to potentially detect real-time changes in patient condition. The HYLA
is undergoing clinical evaluations at Sheba Hospital, ranked the 9th in the world by Newsweek , in patients undergoing
open-heart procedures, in preparation of the Company's planned U.S. Food and Drug Administration ("FDA") submission of the first
configuration of the HYLA in 2025.
Dagi Ben-Noon, CEO of Inspira Technologies stated: "We
see this as merely the first deployment step in Inspira's quest to revolutionize acute respiratory care with our groundbreaking technology
and superior products that we believe will follow this initial distribution."
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 the HYLA blood sensor technology, 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 Statements
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 prospective distribution lines for the INSPIRA
ART100 systems, the belief that the delivery of the INSPIRA
ART100 to the U.S. market serves the Company's goal well to introduce physicians and perfusionists to Inspira's technologies and brand
via initial deployments at leading hospitals, the benefits of the INSPIRA ART100 , its plan to combine the INSPIRA
ART100 with the HYLA , the expected timing of the planned
FDA submission of the first configuration of the HYLA , and that
its sees these distribution lines as the first deployment step in Inspira's quest to revolutionize acute respiratory care with its groundbreaking technology
and superior products that may follow. 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.
For more information, contact:
Inspira Technologies - Media Relations
Phone: +972-9-9664485
Copyright 2018-2024 Inspira Technologies OXY B.H.N. LTD., All

Frequently Asked Questions

What did Inspira Technologies deliver recently?

Inspira Technologies delivered INSPIRA ART100 systems to U.S. distributor Glo-Med Networks.

Where will the INSPIRA ART100 systems be used?

The systems will be distributed to hospitals on the U.S. east coast, including a New York hospital.

What technology does the INSPIRA ART100 incorporate?

The INSPIRA ART100 features cutting-edge design alongside a continuous blood monitoring system.

Is the INSPIRA ART100 FDA approved?

Yes, the INSPIRA ART100 has received FDA 510(k) clearance for cardiopulmonary bypass procedures.

When is the HYLA technology expected for FDA submission?

The planned FDA submission for the HYLA technology is scheduled for 2025.

Last updated: Dec 16, 2024