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Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN) is at the forefront of developing innovative respiratory support technology as an alternative to invasive mechanical ventilation. The company's flagship product, INSPIRA ART100, is a breakthrough in Augmented Respiration Technology designed to maintain optimal oxygen levels in patients without the need for intubation and sedation. This technology is particularly significant in the treatment of respiratory failure and offers a less invasive option compared to traditional mechanical ventilation.
Inspira Technologies operates in various regions, including North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa. The company is involved in the research, development, manufacture, and marketing of proprietary respiratory care devices, aiming to transform the landscape of acute and neonatal care.
Recently, Inspira Technologies has announced several key developments:
- April 3, 2024: Commencement of a program to explore the use of the INSPIRA ART100 Device for an artificial womb for neonates requiring vital respiratory support.
- April 10, 2024: Collaborative development with Ennocure MedTech Ltd. on bio-electronic treatment to prevent bloodstream infections in ICU patients, showcasing a 100% reduction in bacterial growth within 24 hours in an in vitro study.
- April 16, 2024: Signing of a collaboration term sheet with Beilinson Hospital for the evaluation of the INSPIRA ART100 device in organ transplant procedures.
- April 25, 2024: Receiving CSA Certification of Compliance to U.S. standards for the INSPIRA ART100 device.
- May 2, 2024: Initiation of the production of the INSPIRA ART100 medical device by a leading technology company.
- May 28, 2024: Notification of 510(k) class II clearance from the U.S. FDA for the INSPIRA ART100.
Inspira's products are designed not only to enhance patient outcomes but also to reduce the costs and complications associated with traditional respiratory support methods. The INSPIRA ART100 system has received FDA clearance, marking a pivotal moment in the company's history. Other products in the pipeline, including the INSPIRA ART (Gen 2) and HYLA™ blood sensor, are poised to further revolutionize respiratory care once approved.
Inspira Technologies (Nasdaq: IINN) announced positive initial results from its collaboration with Ennocure MedTech to develop a novel bio-electronic treatment for preventing bloodstream infections. The ex-vivo testing on porcine skin model demonstrated a 95% reduction in bacterial presence within 4 hours, maintaining effectiveness over 24 hours.
The innovative technology uses physical electric stimulation instead of chemical agents to prevent pathogen growth. This development addresses an estimated 250,000 annual bloodstream infections related to intravenous lines worldwide. The bio-electronic technology aims to overcome traditional IV dressing challenges through bacterial growth prevention, extended wear time, applicability to both skin surface and cannula areas, and real-time monitoring capabilities.
Testing followed adjusted standardized protocols, including the AATCC TM100 standard for antimicrobial performance, showing consistent bacterial reduction under active patches versus controls.
Inspira Technologies (NASDAQ: IINN) has enhanced its AI-driven medical platform by integrating a next-generation oxygenation indicator into its HYLA blood sensor technology. This advancement enables rapid detection of oxygen-related conditions without requiring blood draws, targeting the $2.5 billion Arterial Blood Gas analyzer market.
The HYLA system, currently under clinical evaluation at Sheba Medical Center, uses optical sensors and machine learning for real-time blood parameter monitoring. The company plans 510(k) FDA submissions in the second half of 2025. The technology complements their FDA-cleared INSPIRA ART100 system, which received its first U.S. purchase order through Glo-Med Networks in June 2024.
This development comes amid strong medtech M&A activity, with Q3 2024 seeing 275 deals worth $34 billion, a 35% increase year-over-year. The company is targeting both the blood gas analysis market and the $19 billion mechanical ventilation market, addressing the needs of approximately 20 million patients requiring mechanical ventilation globally.
Inspira Technologies (NASDAQ: IINN) has announced the integration of a next-generation oxygenation indicator into its AI-powered HYLA blood sensor technology. This enhancement enables continuous monitoring of tissue oxygenation and early hypoxia detection without requiring intermittent blood draws.
The technology is currently undergoing clinical validation at Sheba Medical Center, with preliminary results expected soon. The non-invasive system uses optical sensors and machine-learning algorithms for continuous blood parameter monitoring, targeting the $2.5 billion point-of-care testing and arterial blood gas analyzer market. FDA submission is planned for the second half of 2025.
When combined with the FDA-cleared INSPIRA ART100 system, HYLA aims to provide comprehensive patient care through continuous, non-invasive monitoring while maintaining consciousness during treatment.
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.