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Inspira Technologies Oxy BHN Ltd is a specialty medical device company focused on developing innovative respiratory support technology as an alternative to mechanical ventilation. By 2020, over 600,000 patients in the U.S. will need mechanical ventilation, with a significant portion requiring ICU admission, costing an estimated $64 billion annually. The company's OxyLink technology, an advanced nano vesicle device, introduces an intravascular oxygenation system to enhance blood oxygen levels and reduce carbon dioxide, enabling physicians to address primary ventilatory conditions effectively.
The company has recently received 510(k) class II clearance from the U.S. FDA for its INSPIRA ART100 Cardiopulmonary Bypass System. Inspira Technologies aims to revolutionize the respiratory care market with its innovative products, including the INSPIRA ART (Gen 2) system designed to elevate patient oxygen levels and potentially reduce the need for mechanical ventilation, providing new treatment alternatives and enhancing patient care.
Inspira Technologies has received approval from the Israeli Ministry of Health for its INSPIRA™ ART100 system, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This approval follows the FDA clearance announced on May 28, 2024.
Both approvals are critical milestones, enhancing the company's market opportunities in the U.S. and Israel. The INSPIRA™ ART100, equipped with Adaptive Blood Oxygenation technology, measures blood parameters in real-time to deliver oxygen directly into the blood.
CEO Dagi Ben-Noon and Dr. Dekel Stavi highlight the significance of these approvals for business expansion and local adoption. The company aims to revolutionize respiratory and life-support technologies with further product development, although some products like the INSPIRA™ ART (Gen 2) and HYLA™ blood sensor remain untested and unapproved by any regulatory bodies.
Inspira Technologies OXY B.H.N. (Nasdaq: IINN) announced its business plan targets on June 20, 2024, focusing on the promotion of the INSPIRA™ ART100 following FDA clearance and the acceleration of the INSPIRA™ ART (Gen2).
The company aims to capture a share of the $19 billion mechanical ventilation market by 2030, with plans to deploy INSPIRA ART100 in multiple sites and countries. The first purchase order from the U.S. distributor has been received, with the first shipment scheduled for Q4 2024.
Key goals include the submission of the HYLA™ blood sensor for FDA clearance and ongoing development of the VORTX™ blood delivery system. The company believes the success of INSPIRA ART100 will pave the way for future breakthroughs with INSPIRA ART (Gen2).
Inspira Technologies (Nasdaq: IINN) announced its participation at the annual iECOs Conference in Herzliya, Israel, on June 18, 2024.
The company will showcase the INSPIRA™ ART100 System, which recently received 510(k) clearance from the U.S. FDA and is pending approval from Israel's AMAR.
Inspira's R&D team will be available to discuss their advanced life support solutions and other technologies in development.
For meetings, attendees can contact the company via info@inspira02.com.
Inspira Technologies has announced its first purchase order for the INSPIRA ART100 systems from Glo-Med Networks. This order includes five units expected to ship in Q4 2024, with a potential for 20 additional units pending further agreements. This milestone follows the recent FDA clearance of the INSPIRA ART100 and marks a significant step in Inspira's growth strategy. The INSPIRA ART100, part of a new generation of devices targeting the $19 billion mechanical ventilator market, aims to reduce the need for traditional mechanical ventilation. The company also plans to offer hospitals special terms for the integrated HYLA Blood Sensor and INSPIRA ART (Gen 2) devices, pending regulatory approvals and product development.
Inspira Technologies (Nasdaq: IINN) announces plans to exhibit its FDA-cleared INSPIRA™ ART100 System at the ELSO conference in Detroit, Michigan, from September 29 to October 1, 2024. The event offers a platform to showcase the system to healthcare representatives and strategic partners. The INSPIRA™ ART100 is designed for cardiopulmonary bypass procedures, offering advanced software and portability. This system supports use with various disposables and will be demoed to potential buyers and partners, facilitating pre-scheduled meetings. The event will be discussed further in a conference call on June 20, 2024.
Inspira Technologies OXY B.H.N. (Nasdaq: IINN, IINNW) announced significant milestones, including FDA clearance for its INSPIRA™ ART100 system. The company will present its business targets and distribution agreements in a conference call on June 20, 2024, at 9:00 am Eastern Time. Company President and co-founder Joe Hayon will lead the discussion, providing insights into Inspira's future steps.
Inspira Technologies OXY announced that its INSPIRA™ ART100 Cardiopulmonary Bypass System has received 510(k) class II clearance from the FDA.
The FDA clearance is a significant milestone for the company, suggesting technological and innovative advancements.
CEO Dagi Ben Noon and Chairman Professor Benad Goldwasser expressed their appreciation for investors and partners and highlighted the strategic importance of this clearance.
Inspira™ Technologies OXY B.H.N. (Nasdaq: IINN, IINNW) has announced the start of production of the INSPIRA ART100 medical device. The device is being contract manufactured by a leading technology company and the first batch will be used in initial sites pending FDA approval.
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