Inspira™ Announces Plans to Launch and Target Single-Use Disposable Blood Oxygenation Kit for a New Disposable Perfusion Market Opportunity

Rhea-AI Summary

Inspira Technologies OXY B.H.N Ltd. (Nasdaq: IINN) announces the development of a single-use disposable blood oxygenation kit for its INSPIRA ART medical device series, targeting FDA authorization in 2025. The kit is designed to be compatible with various life support machines, potentially reducing hospital costs. CEO Dagi Ben-Noon anticipates revenue streams based on the disposable razorblade business model, along with the FDA clearance of the INSPIRA™ ART100 device in 2024.

Positive

• Development of a disposable blood oxygenation kit for the INSPIRA ART medical device series
• Potential FDA authorization in 2025
• Compatibility with various life support machines
• Anticipated revenue streams based on the disposable razorblade business model
• Anticipated FDA clearance of the INSPIRA™ ART100 device in the first half of 2024

Negative

• None.

Medical Device Industry Analyst

The announcement of Inspira Technologies' single-use disposable blood oxygenation kit development for the INSPIRA™ ART device series presents a strategic maneuver in the medical device market. The move to create a product that is anticipated to be compatible with various life support machines addresses a growing demand for interoperable and cost-effective medical supplies. The focus on disposable kits aligns with the increasing trend towards single-use devices in healthcare, which are favored for their ability to reduce the risk of cross-contamination and streamline hospital operations.

From a financial perspective, the adoption of the 'disposable razorblade business model' has historically proven to be lucrative for companies by driving recurring revenue streams. The market for disposable perfusion systems is expanding and Inspira's entry could disrupt the competitive landscape, potentially increasing the company's market share and impacting its stock valuation positively. However, the actual financial impact will depend on the product's market acceptance, pricing strategy and the ability to scale production efficiently.

Healthcare Financial Analyst

Investor interest in Inspira Technologies may be heightened due to the potential FDA clearance of the INSPIRA™ ART100 device, which is expected in the first half of 2024. Regulatory approval is a critical milestone for medical device companies and can significantly influence stock performance. The announcement of the Kit's anticipated submission for FDA authorization in 2025 further underscores the company's commitment to expanding its product portfolio and enhancing its competitive edge in the life support technology sector.

However, investors should consider the inherent risks associated with the regulatory approval process, as any delays or denials can adversely affect the company's financial projections and stock price. Additionally, the long-term success of the Kit will hinge on its ability to deliver cost savings to hospitals, which is a key value proposition mentioned by the CEO. If Inspira can demonstrate a tangible reduction in hospital budget spending, it may secure a favorable market position and drive shareholder value.

Healthcare Regulatory Expert

The regulatory pathway for medical devices, such as the blood oxygenation kit being developed by Inspira Technologies, is complex and requires rigorous evaluation of safety and efficacy. The FDA's premarket approval process is designed to ensure that medical devices are safe for human use and perform as intended. The company's strategic focus on FDA authorization indicates an understanding of the critical role regulatory compliance plays in the commercial success of medical technologies.

While the submission for FDA authorization is planned for 2025, stakeholders should be aware of the potential for regulatory hurdles that could impact the timeline. The interoperability of the Kit with other life support machines could be a significant factor in the FDA's assessment, as it must meet stringent standards for compatibility and safety. Successful authorization could lead to a favorable market reception and validate Inspira's technology, potentially leading to increased investor confidence and market capitalization.

The kit is being designed for the INSPIRA™ ART device series and is intended to be compatible with various life support machines sold in the market 

RA'ANANA, Israel, Jan. 9, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, today announced its plan to launch a single-use disposable blood oxygenation kit (the "Kit"), currently in development, for its INSPIRA ART medical device series. The Kit is also intended to be compatible with various other life support machines, tapping into the disposable perfusion systems market.

The Kit, anticipated to be submitted for US Food & Drug Administration (FDA) authorization in 2025, is a single-use product designed for efficient blood oxygenation and carbon dioxide removal. The Kit represents a strategic move to enhance hospital budget spending by potentially reducing costs. The Company is focusing on making the Kit compatible with other medical devices such as certain types of cardio-pulmonary bypass machines.

Dagi Ben-Noon, CEO of Inspira Technologies, commented: "Introducing the Kit marks the potential expansion of our market presence and fast-tracks our goal to deploy our blood oxygenation devices, with potential revenue streams based on the disposable razorblade business model. We believe that this development, along with the anticipated FDA clearance of our INSPIRA™ ART100 device in the first half of 2024, solidifies our commitment to providing comprehensive and affordable solutions in life support technology."

Inspira Technologies OXY B.H.N Ltd.

Inspira Technologies is leading the way in transforming life-support care. Its innovative solutions are paving the way for direct blood oxygenation, bypassing the lungs, and potentially reducing the need for traditional mechanical ventilation. Beyond this, the Company is committed to advancing blood circulation technology and incorporating AI-driven monitoring systems. These advancements are part of its strategy to offer more patient-focused, data-informed care. The integration of these technologies signifies the potential to enhance patient outcomes and streamline hospital operations, marking a new era in respiratory care.

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 under U.S. Federal securities laws. These forward-looking statements and their implications are based only on the current expectations of the management of the Company. They are subject to several factors and uncertainties that could cause results to differ materially from those described in the forward-looking statements. For example, the Company uses forward-looking statements when it discusses the prospective compatibility of the Kit with other life support machines, the anticipated FDA submission of the Kit in 2025, that the Kit represents a strategic move to potentially reduce costs, that the Kit fast-tracks the Company's goal to deploy its blood oxygenation devices, and the belief that the Kits, along with the anticipated FDA clearance of its INSPIRA ART device in the first half of 2024, solidifies its commitment to providing comprehensive and affordable solutions in life support technology. 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 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 SEC, which is available on the SEC's website, http://www.sec.gov.

For more details:

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

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

 

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SOURCE Inspira Technologies

FAQ

What is the new development announced by Inspira Technologies OXY B.H.N Ltd. (Nasdaq: IINN)?

Inspira Technologies has announced the development of a single-use disposable blood oxygenation kit for its INSPIRA ART medical device series.

What is the expected timeline for FDA authorization of the new kit?

The new kit is anticipated to be submitted for US Food & Drug Administration (FDA) authorization in 2025.

How does the company aim to reduce hospital costs with the new kit?

The company is focusing on making the kit compatible with other life support machines, potentially reducing hospital costs.

What is the CEO's anticipation regarding revenue streams?

CEO Dagi Ben-Noon anticipates revenue streams based on the disposable razorblade business model, along with the FDA clearance of the INSPIRA™ ART100 device in the first half of 2024.