Inspira™ Technologies Collaborates With Zriha Medical To Launch Cutting-Edge Production Line

Rhea-AI Summary

Inspira Technologies (Nasdaq: IINN) has partnered with Zriha Medical to establish a dedicated production line for a important flow mechanism component of its respiratory support system. Zriha Medical, with over 50 years of experience and ISO 13485 certification, will manufacture components for extracorporeal blood circulation during oxygenation.

The company's flagship product, the INSPIRA ART, aims to revolutionize the $19 billion mechanical ventilation market by providing an alternative to traditional ventilators. The system recently received FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in May and July 2024.

Positive

• FDA 510(k) clearance obtained for INSPIRA ART100 system
• Israeli AMAR certification received for multiple procedures
• Strategic manufacturing partnership with established medical device manufacturer
• Targeting $19 billion mechanical ventilation market

Negative

• Multiple key products still in development phase without regulatory approval
• Core products not yet tested in humans

Insights

Manufacturing Operations Expert

This manufacturing collaboration marks a strategic operational milestone for Inspira. The partnership with Zriha Medical, leveraging their 50+ years of manufacturing expertise and ISO 13485 certification, significantly de-risks the production scale-up of Inspira's respiratory support systems. The clean room facilities and precision assembly capabilities are important for maintaining product quality and regulatory compliance.

The focus on the flow mechanism component - essential for extracorporeal blood circulation - demonstrates a methodical approach to production scaling. This specialized manufacturing arrangement could potentially reduce production costs and accelerate time-to-market, particularly important given the recent FDA 510(k) clearance for the INSPIRA™ ART100 system.

In simpler terms: Think of this as Inspira hiring a highly experienced chef with a state-of-the-art kitchen to make a important ingredient for their recipe, rather than trying to make everything themselves. This usually means better quality, faster production and fewer mistakes.

Medical Device Market Analyst

This collaboration positions Inspira strategically in the $19 billion mechanical ventilation market. With their innovative INSPIRA ART technology targeting a massive addressable market of 20 million ICU patients annually, establishing reliable production capabilities is crucial. The timing is particularly favorable following their recent regulatory approvals in the US and Israel.

The partnership with Zriha Medical addresses a critical aspect of scaling medical device production - maintaining consistent quality while increasing volume. This is especially important for devices handling extracorporeal blood circulation, where reliability and precision are paramount. For investors, this represents a concrete step toward commercialization, though revenue impact will depend on successful market penetration and adoption rates.

To put it simply: Inspira has developed a potentially game-changing breathing support device and they've now partnered with a proven manufacturer to help bring it to market. This is like having a great recipe and finally finding the right commercial kitchen to produce it at scale.

RA'ANANA, ISRAEL, Jan. 17, 2025 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, has announced that the Company is establishing a dedicated production line for a crucial component of its innovative respiratory support system, in collaboration with Zriha Medical Ltd ("Zriha Medical"), a leading international manufacturer specializing in medical device production. The collaboration involves the manufacture of a flow mechanism that will be integrated into Inspira's products for use in the extracorporeal circulation of blood during the oxygenation process.

Zriha Medical's capabilities and precision assembly in clean room environments are particularly well-suited for this collaboration. The establishment of this production line at Zriha Medical's facilities represents a significant step forward in Inspira's strategy. It may enable the Company to scale up production of its innovative respiratory support technologies, potentially accelerating the path to market for its groundbreaking devices while benefiting from Zriha Medical's extensive experience in medical device manufacturing. Zriha Medical, with over 50 years of experience in advanced plastic and silicone injection and metal processing technologies, brings extensive expertise to this collaboration. Zriha Medical's state-of-the-art clean room facilities and adherence to stringent quality standards, as exhibited by its ISO 13485 certification, make it an ideal producer of critical medical components.

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 May 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 belief that Zriha Medical's capabilities and precision assembly in clean room environments are particularly well-suited for this collaboration, that the establishment of this production line at Zriha Medical's facilities represents a significant step forward in Inspira's strategy, that this collaboration may enable the Company to scale up production of its innovative respiratory support technologies, potentially accelerating the path to market for its groundbreaking devices while benefiting from Zriha Medical's extensive experience in medical device manufacturing. 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-129

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's INSPIRA ART100 system received in 2024?

In 2024, the INSPIRA ART100 system received FDA 510(k) clearance for CBP procedures in May and Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in July.

What is the market size that IINN's INSPIRA ART technology is targeting?

IINN's INSPIRA ART technology is targeting the mechanical ventilation market, valued at $19 billion, with potential applications for 20 million ICU patients with acute respiratory failure annually.

What is the significance of IINN's partnership with Zriha Medical?

The partnership enables IINN to establish a dedicated production line for important flow mechanism components, leveraging Zriha Medical's 50+ years of experience and ISO 13485 certified facilities to scale up production.

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

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