Inspira Technologies is an Israeli pre-commercial medical device company developing a blood oxygenation system designed to replace mechanical ventilation in critically ill patients. Its flagship product, the INSPIRA ART, circulates blood outside the body to add oxygen and remove carbon dioxide directly — bypassing the lungs entirely. Inspira argues the key advantage is that patients remain awake, avoiding the complications of intubation and induced coma associated with conventional ventilators. The INSPIRA ART has not yet been tested in humans and does not have FDA clearance. Inspira's only commercially available product is the ART100, a cardiopulmonary bypass pump cleared by the FDA in 2024 for short procedures up to 6 hours, used in open-heart surgeries and transplants. Inspira uses the ART100 as a beachhead to introduce its technology to hospitals and physicians ahead of the INSPIRA ART's eventual launch. Inspira intends to operate on a razor-and-blades model, selling capital equipment systems to hospitals and generating recurring revenue from single-use disposable kits consumed per procedure. The company is nearly pre-revenue, with its first ART100 sales occurring in 2025. Inspira sells through regional distributors rather than a direct sales force, with agreements covering the U.S., Europe, the Middle East, Central America, and Israel. The company is also developing ancillary products including the HYLA blood gas sensor, a dual lumen cannula, and the VORTX oxygenation technology. Manufacturing is outsourced to contract manufacturers, and R&D represents the primary cost.
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