Inspira Technologies Oxy B.H.N. Ltd. reports developments in Additively Manufactured Electronics, quantum connectivity and its medical technology portfolio. Company updates focus on AME system orders and deployments, QTREX-branded cryogenic interconnect work for superconducting quantum systems, customer activity with research, defense and technology organizations, and leadership or strategic-direction announcements.
The company's medical technology context includes respiratory support and blood monitoring platforms, including INSPIRA ART, INSPIRA ART100 and the HYLA Blood Sensor, while recent communications emphasize a dedicated medical business unit alongside the AME and quantum connectivity strategy.
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.
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.