Inspira™ Preparing Production in Response to Spread of Respiratory Virus in China

Rhea-AI Summary

Inspira Technologies (Nasdaq: IINN) announced preparations for potential production ramp-up of its INSPIRA™ ART100 device in response to the human metapneumovirus (hMPV) outbreak in China. The company is engaging with leading providers in affected regions and securing raw materials to meet possible demand increases.

The INSPIRA ART100 device, which received FDA 510(k) clearance and Israeli AMAR certification in June and July 2024 for CBP procedures, offers an alternative to traditional mechanical ventilators. The technology aims to stabilize decreasing oxygen saturation levels without requiring ventilation, while patients remain awake during treatment.

The company's innovative system targets the $19 billion mechanical ventilation market, addressing the needs of 20 million ICU patients with acute respiratory failure annually. The device includes a HYLA™ blood sensor for real-time continuous monitoring without requiring blood samples.

Positive

• FDA 510(k) clearance obtained for INSPIRA ART100 in June 2024
• Israeli AMAR certification received in July 2024
• Company targeting $19B mechanical ventilation market
• Production capacity ready to scale for potential market demand

Negative

• Core products including INSPIRA ART500, Cardi-ART, VORTX, and HYLA not yet tested in humans
• Key technologies still pending regulatory approvals

Insights

Medical Technology Analyst

The strategic preparation for production ramp-up of the INSPIRA™ ART100 device represents a calculated response to China's hMPV outbreak. The device's FDA 510(k) clearance and Israeli AMAR certification obtained in mid-2024 position Inspira favorably to capitalize on potential demand. However, several critical factors warrant consideration:

The $19 billion mechanical ventilation market opportunity seems promising, but Inspira's $22.4 million market cap suggests significant execution risks. Their technology's differentiation - allowing patients to remain awake during treatment and stabilizing oxygen levels without traditional ventilation - could provide a competitive edge, particularly in acute respiratory failure cases.

Supply chain readiness and discussions with regional providers demonstrate proactive management, but the company's ability to scale production significantly remains untested. The HYLA™ blood sensor integration adds value through continuous monitoring capabilities, though this component is still in development.

Market Research Analyst

The timing of this announcement aligns with heightened global health concerns, but several market dynamics require examination:

• The company's positioning in the respiratory care market comes during increased attention to respiratory viruses, potentially elevating investor interest
• While the strategic timing is noteworthy, the actual revenue impact remains speculative without concrete orders or partnerships
• The company's small market capitalization suggests production capacity, which could constrain ability to meet sudden demand surges

For context, this preparedness announcement, while positive for market positioning, represents more of a strategic communication than a material business development. Investors should note that the company's core products beyond the ART100 remain in development phases, indicating a need for substantial capital to bring their full product pipeline to market.

RA'ANANA, Israel, Jan. 10, 2025 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, announced today that it is preparing for a potential production ramp-up of its INSPIRA™ ART100 device. This strategic readiness comes in light of the recent outbreak of human metapneumovirus (hMPV) in China, which has highlighted the growing need for advanced respiratory care technologies globally.

Inspira is already in discussions with leading providers in affected regions to evaluate demand for advance respiratory solutions and deployment of the INSPIRA™ ART100 device, ensuring rapid response capabilities in case of increased demand.

As global health authorities monitor the hMPV outbreak, Inspira™ believes that it is well-positioned to meet potential increased demand for advanced respiratory support systems. Inspira is working closely with suppliers to secure necessary raw materials and components to meet potential demand spikes. The Company is following the hMPV situation globally and working to adjust production plans as needed.

"While hMPV is not a new virus, and experts indicate the current outbreak is part of normal seasonal patterns, Inspira believes in being prepared," said Dagi Ben-Noon, CEO of Inspira. "Our increased production capacity will help ensure healthcare providers have access to vital respiratory care equipment should the need arise."

Inspira emphasizes that its preparedness measures are precautionary and align with the Company's commitment to global health readiness. The Company will work closely with health authorities in affected regions and adjust its plans based on the evolving situation.

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 growing need for advanced respiratory care technologies and its ability to adjust its plans to rapidly respond in case of increased demand. 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

MRK-ARS-113

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 the INSPIRA ART100 device?

IINN received FDA 510(k) clearance in June 2024 and Israeli AMAR certification in July 2024 for use in CBP procedures.

How is IINN responding to the hMPV outbreak in China?

IINN is preparing to ramp up production of the INSPIRA ART100 device and is in discussions with providers in affected regions to evaluate demand for advanced respiratory solutions.

What is the market size IINN is targeting with its respiratory technology?

IINN is targeting the $19 billion mechanical ventilation market, which serves 20 million ICU patients with acute respiratory failure annually.

What distinguishes IINN's INSPIRA ART technology from traditional ventilators?

The INSPIRA ART technology can stabilize decreasing oxygen saturation levels in minutes without a ventilator, allowing patients to remain awake during treatment.

Which IINN products are currently pending human testing and regulatory approval?

The INSPIRA ART500 (Gen 2), INSPIRA Cardi-ART, VORTX Oxygen Delivery System, and HYLA blood sensor are still in development and haven't been tested in humans or received regulatory approval.