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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 (Nasdaq: IINN) has announced new support features for its FDA-cleared INSPIRA™ ART100 system, enhancing medical team procedures and efficiency in extracorporeal life support technology. The updates include integration with hospital procedures, system-activated alarm troubleshooting, and advanced software display features for complex care situations.
The ART100 system adds oxygen to blood and removes carbon dioxide, functioning as a heart-lung support for critical care patients. Key features include a compact design, four-hour emergency uptime, and compatibility with various disposable equipment. The system 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.
Inspira Technologies (NASDAQ: IINN) has delivered its INSPIRA™ ART100 systems to Glo-Med Networks for deployment at a leading U.S. hospital. The systems will be distributed to hospitals on the U.S. east coast, including a top-ranking cardiothoracic surgery division in New York.
The INSPIRA™ ART100, which received FDA 510(k) clearance for cardiopulmonary bypass procedures in May 2024, will be integrated with the HYLA™ blood monitoring technology. The HYLA™ is currently undergoing clinical evaluations at Sheba Hospital in preparation for FDA submission in 2025.
The company is developing breakthrough respiratory support technologies, including the INSPIRA ART, aimed at potentially replacing the $19 billion mechanical ventilation market. This technology is designed to stabilize decreasing oxygen levels without requiring ventilation, allowing patients to remain awake during treatment.
Inspira Technologies (Nasdaq: IINN) has appointed Tal Parnes as the new chairman of the board, effective February 1, 2025. Parnes, who has served as an independent director since July 2021, brings over 30 years of experience in technology, particularly in medical technology and pharmaceuticals. He succeeds Prof. Benad Goldwasser, who resigned for personal reasons.
Parnes' background includes co-founding and serving as CEO of Zuta-Core and HQL Pharmaceuticals , along with executive roles at several technology companies. The appointment aims to enhance Inspira's leadership and market position.
The company recently achieved significant milestones with its INSPIRA ART100 system receiving FDA 510(k) clearance for CBP procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures in June and July 2024.
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.
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.
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.
Inspira Technologies (NASDAQ: IINN) has announced its participation in the Arab Health 2025 exhibition, where it will showcase its FDA-cleared INSPIRA™ ART100 cardiopulmonary bypass system. The event, scheduled for January 27-30, 2025, at the Dubai World Trade Center, is expected to attract over 3,800 exhibitors from more than 180 countries.
The INSPIRA ART100 system is designed to oxygenate blood and remove carbon dioxide, effectively taking over heart and lung functions in critical care patients. The system features proprietary software for setup guidance, advanced customization options, and built-in alarm management with troubleshooting solutions. It offers up to four hours of emergency uptime, maintains a small footprint, and is compatible with various market-available disposables.
Inspira Technologies (NASDAQ: IINN) has announced a $3.2M private placement offering, consisting of 4,608,715 ordinary shares (or pre-funded warrants) and warrants to purchase up to 4,608,715 ordinary shares at $0.70 per combined unit. The ordinary warrants have an eighteen-month term with a $1.10 exercise price.
The company, which develops respiratory support technology, plans to use the proceeds for working capital and general corporate purposes. The placement is expected to close around December 30, 2024, with Dawson James Securities acting as the exclusive placement agent.
Inspira's flagship product, the INSPIRA ART, has received FDA 510(k) clearance for Cardiopulmonary Bypass procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.
Inspira Technologies (NASDAQ: IINN) has delivered its INSPIRA™ ART100 systems to U.S. distributor Glo-Med Networks for deployment in east coast hospitals, including a leading New York cardiothoracic surgery division ranked in the top 15% nationally. The ART100, designed with U.S. clinicians, is FDA 510(k) cleared for Cardiopulmonary Bypass procedures and will be integrated with the HYLA™ blood monitoring technology, currently under clinical evaluation at Sheba Hospital.
The HYLA™ system is preparing for FDA submission in 2025, aiming to provide real-time patient condition monitoring without requiring blood samples. The company's broader technology portfolio includes the INSPIRA ART500, Cardi-ART portable device, and VORTX system, all still in development and pending regulatory approvals.
Inspira Technologies (NASDAQ: IINN) announced the expansion of its HYLA blood sensor technology into personalized Blood Lab Testing. The technology aims to provide real-time patient blood work for rapid detection of life-threatening conditions within minutes, potentially replacing traditional blood sampling methods in extracorporeal procedures.
The HYLA system is designed for use in ERs, ICUs, Medical Units, and operating rooms, with potential benefits including replacement of expensive equipment, elimination of blood cartridges, reduced dependency on central labs, and decreased hospital staff burden. The technology is currently undergoing clinical evaluations at Sheba Hospital in patients undergoing open-heart procedures, with FDA submission planned for 2025.
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