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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 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.
Inspira Technologies OXY B.H.N. (IINN) has announced the FDA listing of its INSPIRA™ CART, a medical cart designed for use with the INSPIRA™ ART100 system. This Class I Medical Device, 510(K) Exempt, is intended for use in operating rooms during Cardiopulmonary Bypass procedures. The company aims to streamline healthcare delivery and transform the ART100 system into a mobile workstation.
Inspira is developing novel life support-extending technologies, targeting a combined market opportunity of approximately $59 billion annually. The company's product pipeline includes the HYLA™ blood sensor, INSPIRA™ Cardi-ART, and INSPIRA™ ART (Gen 2). These technologies are designed to monitor blood parameters, support cardiac arrest patients, and provide adaptive blood oxygenation, respectively.
Inspira Technologies (Nasdaq: IINN) has announced that a leading medical technology company approached them to evaluate the operation of their key product in combination with the INSPIRA™ ART100 system. The evaluation, conducted by Inspira researchers, showed that test results exceeded 100% of the standard value for gas transfer at maximum flow when integrated with the ART100 system.
The tests were performed in Inspira's advanced laboratory, simulating oxygen-deficient and carbon dioxide-rich blood conditions. The successful results demonstrate the power and versatility of the INSPIRA™ ART100 system in various technology settings. Inspira believes this validates the system's compatibility and performance with key products of a leading medical technology company, potentially leading to meaningful business development activities.
Inspira Technologies (Nasdaq: IINN) has introduced the INSPIRA Cardi-ART, a portable modular device designed to provide oxygen to the brain during cardiac arrest. This innovation targets the $39.8 billion global cardiac arrest market, expanding Inspira's potential market to approximately $58.8 billion. The device aims to improve survival rates for cardiac arrest patients, particularly outside hospitals where the mortality rate is about 90%.
Key features of the INSPIRA Cardi-ART include:
- Fast emergency response during CPR
- Rapid cannulation and oxygenated blood delivery
- Monitoring of vital parameters using HYLA blood sensor technology
- Hemodynamic support in case of cardiac failure
Inspira plans to submit the device for FDA regulatory approval as early as 2026, pending the final regulatory pathway.
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.
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