Inspira™ Preparing Production in Response to Spread of Respiratory Virus in China

Regulatory Approvals and Certifications - The INSPIRA™ ART100 system received FDA 510(k) clearance for use in CBP procedures in June and July 2024 [1] - The system also obtained Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures [1] Production and Market Readiness - The company is preparing for a potential production ramp-up of the INSPIRA™ ART100 device due to the recent hMPV outbreak in China [2] - Discussions are ongoing with leading providers in affected regions to evaluate demand for advanced respiratory solutions [3] - The company is working closely with suppliers to secure raw materials and components to meet potential demand spikes [4] - Production plans are being adjusted based on the evolving hMPV situation globally [4] Company Preparedness and Strategy - The company believes it is well-positioned to meet potential increased demand for advanced respiratory support systems [4] - Increased production capacity is aimed at ensuring healthcare providers have access to vital respiratory care equipment [5] - Preparedness measures are precautionary and align with the company's commitment to global health readiness [5] Product Development and Innovation - The company is developing other products and technologies, including the INSPIRA ART (INSPIRA™ ART500 or Gen 2), INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor [6] - These products are currently in the design and development phase and have not yet been tested or used in humans nor approved by any regulatory entity [6] Market Potential and Technology Impact - The INSPIRA™ ART is a groundbreaking device aimed at revolutionizing the $19 billion mechanical ventilation market [7] - The technology offers a potential alternative to mechanical ventilators by elevating and stabilizing decreasing oxygen saturation levels in minutes without a ventilator, with patients being awake during treatment [7] - The INSPIRA ART is equipped with a clip-on HYLA™ blood sensor, a real-time continuous blood monitoring technology, aiming to alert physicians of changes in a patient's condition without the need for intermittent actual blood samples [7]