Inspira™ Technologies Unveils Modular Configuration for Revolutionary VORTX™ Blood Oxygenation Delivery Technology

Rhea-AI Summary

Inspira Technologies has unveiled a modular configuration for its VORTX blood oxygenation delivery technology, targeting the $19 billion mechanical ventilation market. The VORTX system, protected by 32 novel patent claims, is designed to maintain more natural blood flow compared to traditional fiber-based oxygenators.

The company's flagship INSPIRA ART system aims to stabilize declining oxygen saturation levels in awake patients without requiring a ventilator, potentially benefiting approximately 20 million ICU patients with respiratory failure annually. In mid-2024, the INSPIRA ART100 system received both FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

The modular VORTX configuration is expected to extend the INSPIRA ART's capabilities in blood oxygen enrichment and carbon dioxide removal, enhancing its versatility across various medical scenarios.

Positive

• FDA 510(k) clearance obtained for INSPIRA ART100 system
• Israeli AMAR certification received for multiple procedures
• 32 novel patent claims protecting VORTX technology
• Targeting large $19 billion mechanical ventilation market

Negative

• Core products including INSPIRA ART500, Cardi-ART, VORTX, and HYLA not yet tested in humans
• No regulatory approvals for main product line
• Products still in development phase

Insights

Medical Device Expert

The modular VORTX configuration represents a notable technical advancement in extracorporeal oxygenation technology. The system's design philosophy of maintaining natural blood flow patterns could potentially reduce hemolysis and platelet activation compared to traditional fiber-based oxygenators. The 32 patent claims provide robust IP protection, though market success will ultimately depend on clinical validation.

The recent FDA 510(k) clearance for the INSPIRA ART100 system specifically for CPB procedures, combined with Israeli AMAR certification, establishes initial regulatory pathway momentum. However, the broader INSPIRA ART500 platform still requires extensive clinical testing and regulatory approvals before commercialization. The $19 billion mechanical ventilation market opportunity is substantial, but penetration will require compelling clinical evidence demonstrating superiority over established ventilation approaches.

The HYLA blood sensor integration could provide valuable continuous monitoring capabilities, potentially reducing the need for repeated blood draws and enabling faster clinical interventions. However, the technology remains in development phase without human testing or regulatory approval.

Market Research Analyst

This development targets a critical market opportunity with 20 million ICU patients annually suffering from respiratory failure. The modular approach could enhance market adoption by offering flexibility in clinical applications and potentially reducing implementation barriers. Key competitive advantages include the unique awake-patient treatment capability and continuous blood monitoring features.

The regulatory clearances for the ART100 system represent initial market validation, though revenue impact remains uncertain given the approved use cases. The broader product portfolio's development status suggests a multi-year commercialization timeline before significant market penetration. The $19 billion market size indicates substantial revenue potential, but success will require establishing clinical efficacy and economic benefits versus current standard of care.

The technology has the potential to provide life-saving support for the approximately 20 million ICU patients with respiratory failure annually

RA'ANANA, Israel, Jan. 14, 2025 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, is proud to announce the development of a modular configuration for its groundbreaking VORTX blood oxygenation delivery technology. We believe that this innovative approach represents a significant advancement in the field of extracorporeal oxygenation and has the potential to transform critical care practices worldwide.

The unique modular configuration of the VORTX blood oxygenation delivery system is expected to extend the INSPIRA ART's range of blood oxygen enrichment and carbon dioxide removal, potentially expanding the versatility of the INSPIRA ART. The flagship INSPIRA ART system targets to revolutionize the $19 Billion Mechanical ventilation market, and is being designed to elevate and stabilize declining oxygen saturation levels in patients while they are awake, and without a ventilator.

Inspira's VORTX system represents a potential paradigm shift in blood oxygenation technology. Unlike traditional fiber-based oxygenators, the VORTX is designed to maintain a more natural blood flow, potentially reducing harmful effects on blood components. This novel approach has garnered significant attention, with the technology now protected by 32 novel patent claims.

As Inspira continues to develop and refine the modular VORTX blood oxygenation delivery technology, the Company remains committed to advancing respiratory care and improving patient outcomes. The modular configuration is expected to enhance the versatility and applicability of the VORTX technology across various medical scenarios.

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 ventilator, with patients being awake during treatment. The INSPIRA ART is being equipped with a clip-on HYLA™ blood sensor, 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, aiming to support physicians in making informed decisions.

In June and July 2024, respectively, the Company's INSPIRA^™ ART100 system has obtained FDA 510(k) clearance for use in CBP 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™ Oxygen Delivery System, and HYLA™ blood sensor, are currently being designed and developed, and have not yet been tested or used in humans nor approved by any regulatory entity.

For more information, please visit our corporate website at 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 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 benefits of its technology, its believe that its innovative approach represents a significant advancement in the field of extracorporeal oxygenation and has the potential to transform critical care practices worldwide, and that its technology has the potential to provide life-saving support for the approximately 20 million ICU patients with respiratory failure annually. 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 at www.sec.gov.

Contact: Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485

Copyright © 2018-2025 Inspira Technologies OXY B.H.N. LTD., All rights reserved.

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SOURCE Inspira Technologies

FAQ

What regulatory approvals has IINN received for its INSPIRA ART100 system?

IINN received FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in June and July 2024.

How many patent claims protect IINN's VORTX technology?

IINN's VORTX technology is protected by 32 novel patent claims.

What is the target market size for IINN's INSPIRA ART system?

IINN is targeting the $19 billion mechanical ventilation market with its INSPIRA ART system.

How many ICU patients could potentially benefit from IINN's technology annually?

Approximately 20 million ICU patients with respiratory failure annually could potentially benefit from IINN's technology.

Which IINN products are still in development and not yet approved?

The INSPIRA ART500 (Gen 2), INSPIRA Cardi-ART portable modular device, VORTX Oxygen Delivery System, and HYLA blood sensor are still in development and have not been tested in humans or received regulatory approval.