Inspira™ Announces AMAR Regulatory Submission of the INSPIRA™ ART100, to Enter the Southeast Asia and South American Markets

Rhea-AI Summary

Inspira Technologies OXY B.H.N. announces AMAR submission for approval of the INSPIRA™ ART100, a breakthrough medical device. The company aims to redefine life support with innovative technology, potentially targeting new markets in Southeast Asia and South America.

Insights

Medical Research Analyst

The submission of the INSPIRA™ ART100 device for AMAR approval represents a pivotal step for Inspira Technologies in expanding its market presence. The device's innovative approach to oxygenation, which allows for real-time blood parameter monitoring and targeted oxygen delivery, could indeed disrupt traditional ventilation methods. If approved, this technology could reduce hospitalization time and complications associated with mechanical ventilation, which is a significant consideration for healthcare providers.

From a research perspective, the potential to offer a non-invasive treatment that allows patients to remain conscious could greatly improve patient comfort and outcomes. This is especially relevant in the context of the COVID-19 pandemic, which has seen a surge in demand for respiratory support devices. However, it's important to note that the products have not yet been tested in humans, which is a critical phase in determining the safety and efficacy of any medical device.

Healthcare Industry Analyst

The announcement by Inspira Technologies could have notable implications for the respiratory treatment market. The INSPIRA™ ART (Gen 2) device's approach to patient treatment without mechanical ventilation could meet a significant unmet need in the market. If the technology proves successful, it could lead to a shift in standard care practices and create a new niche in the respiratory care market.

Investors should be aware that the medical device approval process is lengthy and uncertain and the company's success hinges on obtaining regulatory clearances. Additionally, the adoption rate of new technologies in healthcare is often gradual, influenced by clinical trial results, physician endorsement and cost-effectiveness studies. The market potential in Southeast Asia and South America, mentioned in the announcement, suggests a strategic move to tap into emerging markets where healthcare infrastructure may be evolving and more receptive to innovative technologies.

Financial Analyst

For investors, the key factors to consider include the timeline for regulatory approval, the potential market size and the competitive landscape. Inspira Technologies' focus on Southeast Asia and South America indicates an intention to penetrate less saturated markets with high growth potential. However, financials will be affected by the costs associated with the regulatory process, potential need for further R&D and marketing efforts required to gain traction in new territories.

The company's stock could see volatility based on the outcomes of the regulatory review and subsequent market acceptance. Long-term investors may look at the company's pipeline and technology platform as indicators of future growth, while short-term investors may focus on the immediate impacts of regulatory news. It's essential to monitor the company's progress and any partnerships or collaborations that could influence its path to market.

RA'ANANA, Israel, March 18, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, is excited to announce the AMAR submission for approval of the INSPIRA™ ART100, marking a significant milestone in Inspira's venture into new markets.

AMAR - the Israeli Ministry of Health's medical device regulation unit, is the authority responsible for controlling medical device licenses and approvals including the issuance of certificates of free sale which are necessary for marketing regulatory approvals in the Southeast Asia and South American markets, potentially propelling the Company towards targeting exceptional growth opportunities.

"We are immensely proud to submit our initial blood oxygenation device, the INSPIRA™ ART100 for AMAR approval, ahead of our INSPIRA™ ART (Gen 2) device designed to treat patients while awake without the need for mechanical ventilation, marking a pivotal moment in our mission to redefine life support on a global scale," said Dagi Ben-Noon, CEO of Inspira Technologies. "The enthusiastic support from local key-opinion leaders highlights the excitement surrounding our technology, setting the stage for its global journey. Our team has blended advanced engineering, technology, and design to push the boundaries."

The INSPIRA™ ART (Gen 2) utilizes adaptive blood oxygenation technology to continuously measure the patient's blood parameters in real-time to deliver needed oxygen volume straight into the blood. The unique technology is designed to allow for the targeted control of oxygenation levels, thereby adapting to the individual needs of each patient. This method is expected to significantly reduce complications associated with traditional ventilation methods, shorten hospital stays and potentially save lives.

The INSPIRA™ ART (Gen 2) device is the culmination of extensive research and development efforts by the team at Inspira. It is designed to offer an alternative to traditional mechanical ventilation, providing patients with a less invasive, more comfortable, and potentially more effective treatment option. The device is intended to integrate cutting-edge technologies to enhance oxygenation, reduce the need for intubation, and improve overall patient outcomes.

Inspira Technologies OXY B.H.N. Ltd.

Inspira™ 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 reducing 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.

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 marketing of its products in the Southeast Asia and South American markets, that approval by AMAR might propel the Company towards targeting exceptional growth opportunities, its prospective INSPIRA™ ART (Gen 2) device, and the benefits of the Company's products and potential products. 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, 2022 filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website, www.sec.gov

For more details:
Public Relations Manager
Adi Shmueli
Inspira Technologies
info@inspirao2.com
+972-9-9664485

Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All rights reserved.

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SOURCE Inspira Technologies

FAQ

What is the significance of the AMAR submission for the INSPIRA™ ART100?

The AMAR submission marks a significant milestone for Inspira Technologies as it paves the way for regulatory approvals in new markets, potentially leading to exceptional growth opportunities.

How does the INSPIRA™ ART (Gen 2) device differ from traditional ventilation methods?

The INSPIRA™ ART (Gen 2) device utilizes adaptive blood oxygenation technology to deliver oxygen volume directly into the blood, reducing complications associated with traditional ventilation methods and potentially saving lives.

What is the goal of the INSPIRA™ ART (Gen 2) device?

The device aims to provide patients with a less invasive, more comfortable, and potentially more effective treatment option by integrating cutting-edge technologies to enhance oxygenation and improve overall patient outcomes.

What is the focus of Inspira Technologies OXY B.H.N. ?

Inspira Technologies focuses on developing Augmented Respiration Technology (INSPIRA ART) to rebalance patient oxygen saturation levels, potentially allowing patients to remain awake during treatment and reducing the need for highly invasive mechanical ventilation systems.