Inspira™ Secures a Second U.S. Patent Approval for Orbiting Blood Oxygenation Delivery System

Rhea-AI Summary

Inspira™ Technologies (Nasdaq: IINN) has secured a second U.S. Patent approval for its VORTX™ orbiting blood oxygenation delivery system, a core technology of the INSPIRA™ ART device. This brings the total novel claims for the core technology to 32. The VORTX™ system aims to oxygenate blood without fiber membranes, potentially reducing blood damage and costs compared to current technologies.

The INSPIRA™ ART device targets the $19 billion mechanical ventilation market, offering a potential alternative for the 20 million ICU patients with respiratory failure annually. It aims to maintain stable oxygen saturation levels without ventilators, allowing patients to remain awake during treatment.

Inspira™ Technologies has developed Augmented Respiration Technology (INSPIRA™ ART) with adaptive blood monitoring. The INSPIRA™ ART100 system has obtained FDA 510(k) clearance for Cardiopulmonary Bypass procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

Positive

• Secured second U.S. Patent approval for VORTX™ orbiting blood oxygenation delivery system
• Total of 32 novel claims for core technology of INSPIRA™ ART device
• Targeting $19 billion mechanical ventilation market
• INSPIRA™ ART100 system obtained FDA 510(k) clearance for Cardiopulmonary Bypass procedures
• INSPIRA™ ART100 system received Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures

Negative

• INSPIRA™ ART500 (Gen 2), INSPIRA™ Cardi-ART, and HYLA™ blood sensor are still in development and not yet approved or tested in humans

Insights

Medical Technology Analyst

Inspira's second U.S. patent approval for the VORTX™ orbiting blood oxygenation delivery system marks a significant advancement in respiratory care technology. This innovation aims to address critical limitations in current fiber-based oxygenators, potentially reducing blood damage and costs. The technology's 32 novel claims underscore its uniqueness in the field.

The INSPIRA™ ART device, incorporating this patented technology, could be a game-changer in the $19 billion mechanical ventilation market. By potentially allowing patients to remain awake during treatment and reducing the need for invasive ventilation, it addresses a important gap in current treatment options for the 20 million ICU patients with respiratory failure annually.

However, investors should note that while the INSPIRA™ ART100 has FDA 510(k) clearance for specific procedures, the INSPIRA™ ART500 and other products are still in development and not yet approved. This presents both opportunity and risk, as regulatory hurdles remain before full market penetration.

Market Research Analyst

Inspira's patent approval strengthens its position in the respiratory care market, potentially disrupting the $19 billion mechanical ventilation industry. The company's focus on the 20 million annual ICU patients with respiratory failure represents a substantial addressable market.

The VORTX™ technology's potential to reduce blood damage and costs could be a significant value proposition for healthcare providers, potentially driving adoption if clinical efficacy is proven. However, market penetration will depend on factors such as clinical trial results, regulatory approvals and healthcare system acceptance.

Investors should consider the long-term potential balanced against the risks associated with bringing novel medical technologies to market, including regulatory hurdles and competition from established players in the respiratory care space.

Financial Analyst

While Inspira's patent approval is promising, its financial impact remains speculative. The company's focus on a $19 billion market presents significant revenue potential, but realizing this depends on successful product development, regulatory approvals and market adoption.

Investors should note that only the INSPIRA™ ART100 has FDA clearance, while other products are still in development. This suggests a potentially long runway to significant revenue generation. The company's ability to fund ongoing R&D and navigate the regulatory landscape will be crucial.

Given the early stage of most products, financial metrics like revenue growth and profitability are likely to be in the near term. Investors should focus on milestones such as clinical trial progress, additional regulatory approvals and strategic partnerships as indicators of long-term value creation potential.

To date, a combined total of 32 claims have been deemed novel for the core technology of the INSPIRA™ ART device

Targeting treatment for 20 million ICU patients with respiratory failure annually, with many relying on mechanical ventilators, in a $19 billion industry

RA'ANANA, Israel, Sept. 13, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company targeting to supersede mechanical ventilators, has secured an additional U.S. Patent approval for the VORTX™ orbiting blood oxygenation delivery system, a core technology of the revolutionary INSPIRA™ ART device, bringing the combined total of claims deemed novel relating to the core technology of the INSPIRA™ ART device, to 32.

 

 

The VORTX™ system aims to oxygenate blood without fiber membranes, potentially transforming the medical field as this technology is expected to reduce both blood damage and costs. Today's fiber technologies for blood oxygenation significantly harm the patient's blood cells, since existing fiber oxygenators force blood to flow through multiple fiber layers, causing harmful turbulence, friction, and shear forces. Due to the fiber fabric's high resistance to blood flow, it creates pressure differences that can severely damage blood components, potentially causing hemolysis, white blood cell damage, inflammatory and immune system activation, and blood clotting.

Dagi Ben-Noon, CEO of Inspira Technologies, remarked, "We view this as another major leap forward in blood oxygenation technologies, representing another crucial milestone highlighting the core technological capabilities of the INSPIRA™ ART."

We believe the INSPIRA™ ART is a groundbreaking device poised to revolutionize the $19 billion mechanical ventilation market. Designed to support the 20 million intensive care unit patients with respiratory failure each year, many of whom rely on mechanical ventilators, the INSPIRA™ ART offers a potential alternative by maintaining stable oxygen saturation levels without the need for ventilators while patients can remain awake during treatment.

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), with adaptive blood monitoring and blood oxygenation technology 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. Equipped with HYLA™ real-time continuous blood monitoring technology, the system instantly detects changes in patient conditions, empowering 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, including the INSPIRA™ ART also known as the INSPIRA™ ART500 or Gen 2, the INSPIRA™ Cardi-ART portable modular device 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 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 intended benefits and uses of its technology, the number of potential patients, and potential market size, that may utilize its technology and products, the belief that the patent is a major leap forward in blood oxygenation technologies, representing another crucial milestone highlighting the core technological capabilities of the INSPIRA and the belief that the INSPIRA ART is an innovative device set to transform the $19 billion mechanical ventilation industry. 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.

MRK-ARS-116

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Phone: +972-9-9664485

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SOURCE Inspira Technologies

FAQ

What is the significance of Inspira Technologies' second U.S. Patent approval for IINN stock?

The second U.S. Patent approval for Inspira Technologies' VORTX™ system strengthens the company's intellectual property portfolio, potentially increasing the value of IINN stock. It demonstrates the innovative nature of their technology in the competitive medical device market.

How large is the market that Inspira Technologies (IINN) is targeting with its INSPIRA™ ART device?

Inspira Technologies (IINN) is targeting the $19 billion mechanical ventilation market with its INSPIRA™ ART device, aiming to serve approximately 20 million ICU patients with respiratory failure annually.

What regulatory approvals has Inspira Technologies (IINN) received for its INSPIRA™ ART100 system?

Inspira Technologies (IINN) has received FDA 510(k) clearance for the INSPIRA™ ART100 system for use in Cardiopulmonary Bypass procedures. It has also obtained Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

What is the current development status of Inspira Technologies' (IINN) INSPIRA™ ART500 and other products?

The INSPIRA™ ART500 (Gen 2), INSPIRA™ Cardi-ART portable modular device, and HYLA™ blood sensor are currently in the design and development phase. They have not yet been tested in humans or received regulatory approval from any entity.