Inspira™ Releases New Data Demonstrating Superiority of its Core Technology, Across Key Endpoints of HMSS Indicator

Rhea-AI Summary

Inspira Technologies achieves a breakthrough with their VORTX™ device, meeting 100% of regulatory blood oxygenation requirements with zero pressure gradient, potentially revolutionizing medical device technology. The company's U.S. patent with novel claims further enhances its innovative position in the market.

Positive

• VORTX™ device meets 100% of blood oxygenation requirements at various flow rates with zero pressure gradient
• U.S. patent with 94% novel claims enhances company's innovative position
• Technology aims to reduce patient risk and improve clinical outcomes

Negative

• None.

Insights

Biomedical Engineer

The recent advancements in the VORTX™ device, which achieves zero pressure gradient during blood oxygenation, represent a substantial innovation in medical device technology. In traditional membrane-based blood oxygenation systems, a significant issue is the pressure differential, which can lead to high mechanical shear stress (HMSS). HMSS is known to cause damage to blood components, such as hemolysis, where red blood cells are destroyed and can increase the risk of complications like inflammation and thrombosis. The zero pressure gradient reported is indicative of a potentially gentler treatment option that could mitigate these risks.

From a biomedical engineering perspective, the implications of this technology could be far-reaching. For instance, reducing the need for fiber membranes in oxygenators could lead to lower manufacturing costs, as well as decrease the reliance on specific raw materials, which are often sourced from limited suppliers. This could ultimately lead to more accessible and affordable treatments for patients requiring oxygenation support. Additionally, the scalability of the VORTX™ system suggests that it could accommodate various patient sizes and conditions without compromising safety or efficacy.

Healthcare Economist

The economic impact of Inspira Technologies' VORTX™ system could be significant for the healthcare industry. By potentially reducing the incidence of complications associated with mechanical ventilators, such as bleeding and blood clots, the overall cost of patient care could decrease. This is due to the reduction in additional treatments, extended hospital stays and the need for more intensive care that such complications often necessitate.

Furthermore, the ability of the VORTX™ system to allow patients to remain awake during treatment could revolutionize the standard of care in respiratory treatment. This aspect could reduce the psychological impact on patients, shorten recovery times and lessen the burden on healthcare staff. In the long term, this could lead to a shift in clinical practices and resource allocation within hospitals, emphasizing the importance of cost-effective and patient-friendly technologies in healthcare.

Medical Research Analyst

The clinical implications of the VORTX™ device's ability to meet 100% of blood oxygenation requirements at various flow rates are profound. The zero pressure gradient achievement is a clear indicator of the potential for improved clinical outcomes. If these results can be replicated in human trials, it would mark a significant step forward in the treatment of patients requiring respiratory support.

It is important to note, however, that despite the promising results, Inspira Technologies' products have not yet undergone human testing or regulatory approval. The journey from a successful patent and preclinical results to widespread clinical adoption is complex and fraught with challenges. Rigorous clinical trials will be necessary to validate the efficacy and safety of the VORTX™ system in real-world settings. The novelty of the claims associated with the U.S. patent suggests strong intellectual property positioning, which could be advantageous in attracting investment and partnerships necessary for further development.

• An unprecedented achievement of a zero pressure gradient measured when using the VORTX™ device, directly correlating with a decrease in markers of blood damage.
• The performance of the VORTX™, tested according to a regulatory guideline, was found to meet 100% of blood oxygenation requirements at various blood flow rates.
• A significant leap forward in the development of safer, more effective medical devices designed to minimize patient risk and improve clinical outcomes.
• U.S. Patent with 94% of claims found to be novel.

RA'ANANA, Israel, March 12, 2024 /PRNewswire/ -- Inspira™Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company targeting to supersede mechanical ventilators, today announced that the Company's U.S. patent backed technology, the orbiting blood oxygenation technology (VORTX™) has broken through a significant technological barrier, meeting 100% of regulatory guideline requirements for blood oxygenation and carbon dioxide removal, at various blood flow rates with the pressure gradient on the blood across the device remaining at zero level. Pressure gradient is associated with high mechanical shear stress (HMSS), which plays a dominant role in damaging blood components such as red blood cells, immune cells, thrombocytes and more.  These primary results for the key endpoints of a new blood oxygenation technology without the need for fiber membranes and with zero levels of pressure gradient mark a huge milestone for the Company and for the INSPIRA™ ART (Gen 2) device.

The Chief Technology Officer of Inspira Technologies, Dr. Daniella Yeheskely-Hayon, stated: "Our team achieved this technological breakthrough with the Company's proprietary orbiting oxygenation technology designed to promote less damaging blood flow regime and eliminate the need to use the current membrane fibers-based devices that are associated with increased pressure differential and high shear stress across the blood oxygenators, which leads to severe critical clinical complications such as hemolysis, bleeding, inflammation and blood clots. For me, this is a very significant day in my career as a scientist."

The advanced experiments demonstrated the primary performance of the VORTX™ by collecting data on oxygenation, carbon dioxide removal, and pressures across the device during blood use. The unique design of the VORTX™ system suggests that scaling up may result in negligible to zero pressure, even at higher flow rates. This stands in stark contrast to membrane-based devices, which typically experience significant pressure drops, leading to potential damage to the patient's blood.

We firmly believe that Inspira technology will facilitate a shift away from fiber membrane-based devices towards a technology that offers excellent gas exchange (i.e., oxygenation and carbon dioxide removal) without the critical complications associated with long-term use. Furthermore, transitioning from fiber membrane to alternative materials will significantly reduce manufacturing costs and eliminate the global dependence on a single raw material supplier.

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 significance of the VORTX™ and data collected, its belief relating to the superiority of its technology to membrane-based devices in terms of sustaining zero to negligible pressure at high flow rates, that the unique design of the VORTX™ suggests that scaling up may result in negligible to zero pressure, the belief that the Company's technology will facilitate a shift away from fiber membrane-based devices towards gas exchange facilitation technologies and that transitioning from fiber membrane to alternative materials will significantly reduce manufacturing costs and eliminate the global dependence on a single raw material supplier. 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 zero pressure gradient achieved by the VORTX™ device?

The zero pressure gradient achieved by the VORTX™ device correlates with a decrease in blood damage markers and meets 100% of regulatory blood oxygenation requirements.

How does the VORTX™ device aim to minimize patient risk?

The VORTX™ device is designed to promote less damaging blood flow regime, eliminating the need for membrane-based devices that can lead to severe clinical complications.

What is the status of Inspira Technologies' U.S. patent?

Inspira Technologies holds a U.S. patent with 94% of claims found to be novel, enhancing the company's position in the market.

What is the primary focus of Inspira Technologies' medical technology?

Inspira Technologies focuses on developing Augmented Respiration Technology (INSPIRA™ ART) to rebalance patient oxygen levels and potentially reduce the need for mechanical ventilation systems.

Has Inspira Technologies' products been tested in humans?

No, the company's products have not yet been tested in humans or approved by regulatory entities.

What is the potential impact of transitioning from fiber membrane-based devices?

Transitioning to alternative materials may reduce manufacturing costs and decrease global dependence on a single raw material supplier.