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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) 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.
Inspira Technologies has established a strategic collaboration with Westchester Medical Center in New York to evaluate the performance of its FDA-cleared INSPIRA ART100 systems in clinical scenarios. The partnership aims to expose Inspira's technology to leading physicians and medical institutions.
The collaboration includes plans to explore future deployment of Inspira's next-generation flagship technology, the INSPIRA ART system, currently in development. This system is designed to treat acute respiratory failure by elevating declining oxygen saturation levels without mechanical ventilators.
Westchester Medical Center, as one of few centers in New York State performing Cardiopulmonary Bypass and Extracorporeal Membrane Oxygenation, will integrate this technology to enhance treatment of acute respiratory failure.
Inspira Technologies (NASDAQ: IINN) announces an upcoming live investor webinar and Q&A session scheduled for November 11, 2024, at 4:15 p.m. EST. The event, hosted by RedChip Companies, will feature company President Joe Hayon discussing innovative life support technology developments. The presentation will focus on their technology designed to monitor and improve declining blood oxygen saturation levels without mechanical ventilation, potentially disrupting the $19 billion mechanical ventilation market. Investors can register for free and submit questions in advance or during the event.
Inspira Technologies (Nasdaq: IINN) has signed a distribution agreement with Glo-Med Networks to serve as its primary distributor in the United States. The agreement establishes a Florida-based distribution facility that will support the deployment of the INSPIRA ART100, which is FDA 510(k)-cleared for Cardiopulmonary Bypass procedures. The facility will provide customer support and after-market services through a partnership with Med-Stat Consulting Services. This strategic move aims to enhance operational efficiency for the planned 2024 deployment of the ART100 and future products. The company's flagship product, INSPIRA ART, targets a potential $19 billion market opportunity, aiming to serve 20 million acute respiratory failure patients annually.
Inspira Technologies (Nasdaq: IINN) has announced a partnership with Glo-Med Networks as its primary U.S. distributor for the INSPIRA ART100 device, which is FDA 510(k)-cleared for Cardiopulmonary Bypass procedures. The distribution facility, located in Florida, will support deployment and maintenance of the system, with Med-Stat Consulting Services providing certified after-market services.
The company's proprietary INSPIRA ART device aims to revolutionize life support for acute respiratory failure patients, targeting a potential $19 billion market opportunity with 20 million annual patients. The technology is designed to monitor and elevate declining blood saturation levels without requiring a mechanical ventilator, with planned deployment beginning in 2024.
Inspira Technologies (Nasdaq: IINN) has announced the development of a new disposable kit for the perfusion market. This innovation is part of Inspira's strategy to generate recurring revenues and potentially tap into the $1 billion perfusion systems market. The single-use kit is designed to identify and alert users on performance changes during operation and treatment, aiming to enhance product safety and patient protection.
The disposable kit will be subject to an FDA clearance application and is expected to be offered to hospitals using the INSPIRA ART100 system. The ART100 system received FDA 510(k) clearance for Cardiopulmonary Bypass procedures in May 2024 and Israeli certification for extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures in July 2024. The first manufactured devices are expected to be deployed in the U.S. by the end of 2024.
Inspira™ Technologies OXY B.H.N. (Nasdaq: IINN, IINNW) is set to showcase its latest innovations at the 34th Annual Extracorporeal Life Support Organization (ELSO) Conference in Detroit, Michigan, from September 29-30, 2024. The company will present its FDA-cleared INSPIRA™ ART100 system, which is ready for deployment in the U.S. market.
Attendees will have the opportunity to experience interactive demonstrations and presentations of Inspira's technologies. The company's U.S. sales team, led by chief distributor Glo-Med Networks Inc., will be present at booth #18 to discuss the potential impact of these innovations on patient care. Key personnel, including VP of Product Tomer Carmeli, Medical Director Dr. Dekel Stavi, and CTO Dr. Daniella Yeheskely-Hayon, will be available to address questions and showcase the INSPIRA™ ART100 system's features and advantages.
Inspira™ Technologies (Nasdaq: IINN) has secured a second U.S. Patent approval for its VORTX™ orbiting blood oxygenation delivery system, a core technology of the INSPIRA™ ART device. This brings the total novel claims for the core technology to 32. The VORTX™ system aims to oxygenate blood without fiber membranes, potentially reducing blood damage and costs compared to current technologies.
The INSPIRA™ ART device targets the $19 billion mechanical ventilation market, offering a potential alternative for the 20 million ICU patients with respiratory failure annually. It aims to maintain stable oxygen saturation levels without ventilators, allowing patients to remain awake during treatment.
Inspira™ Technologies has developed Augmented Respiration Technology (INSPIRA™ ART) with adaptive blood monitoring. The INSPIRA™ ART100 system has obtained 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 announced plans to report clinical results for its HYLA™ blood sensor in Q4 2024. The clip-on sensor aims to alert physicians of changes in a patient's condition without intermittent blood samples, targeting a potential $2.5 billion Point of Care testing and Arterial Blood Gas analyzer market. Inspira is expanding its blood testing facilities to accelerate HYLA™ development, with a 510(k) submission to the FDA planned for early 2025.
The company's broader strategy involves transforming respiratory and life-support sectors, addressing an estimated $59 billion annual market opportunity. Inspira plans to deploy its FDA-cleared INSPIRA™ ART100 system in top U.S. and Israeli hospitals. The company is also developing additional products, including the INSPIRA™ ART (Gen 2) and INSPIRA™ Cardi-ART, focusing on innovative oxygenation and blood monitoring technologies.
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