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RA’ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), a medical device company with a market capitalization of $11 million, has announced a strategic shift toward accelerating the commercialization of its FDA-cleared INSPIRA™ ART100 system. According to InvestingPro data, the company maintains a current ratio of 2.02, indicating adequate short-term liquidity despite challenging market conditions. This move follows the system’s successful clinical use in U.S. medical centers and is part of the company’s broader focus on advancing its respiratory support and diagnostic technology portfolio.
The ART100, used in critical care settings, has transitioned from concept to clinical application, according to Inspira’s CEO Dagi Ben Noon. The company is actively engaged in sales discussions in various locations, with several negotiations in advanced stages. However, InvestingPro analysis reveals the company is quickly burning through cash, with negative EBITDA of $11.1 million in the last twelve months. These discussions are aimed at structuring rollouts that meet national and regional clinical needs. Inspira anticipates beginning deliveries in the second half of 2025, contingent upon regulatory approval and finalizing commercial terms.
Inspira’s ART100 system is approved for cardiopulmonary bypass procedures in the U.S. and for ECMO (Extracorporeal Membrane Oxygenation) outside the U.S. The company’s strategy aims to capitalize on the growing demand for alternative respiratory solutions and to generate near-term revenue, while continuing to develop its innovation pipeline, including the next-generation INSPIRA™ ART500 system and the HYLA™ blood sensor.
This strategic pivot is set against a backdrop of increasing global attention to scalable respiratory solutions and may position Inspira as a key player in public health initiatives and cross-sector collaborations.
The company’s recent internal shifts align with long-term industry trends, which include consolidation and potential strategic partnerships. Inspira Technologies also maintains a focus on its intellectual property portfolio and the development of its advanced respiratory support systems.
This announcement is based on a press release statement and contains forward-looking statements regarding Inspira’s commercialization plans, expected product deliveries, and potential market positioning. These statements are subject to various risks and uncertainties that could cause actual results to differ materially from those projected. With a beta of 2.15, the stock shows significant volatility compared to the market. Unlock comprehensive financial analysis and 12 additional key insights about Inspira Technologies with InvestingPro.
In other recent news, Inspira Technologies has reported its first revenue from the installation of its FDA-cleared INSPIRA ART100 life support systems at a leading U.S. academic medical center, amounting to the low hundreds of thousands of dollars. This milestone marks a significant step as the company establishes its presence in the U.S. medical market. Additionally, Inspira Technologies announced that its INSPIRA ART100 system will undergo clinical validation for use in organ transplant procedures at a major Israeli medical center, following its FDA approval for cardiopulmonary bypass procedures. In terms of corporate restructuring, the company has undergone a significant executive change with Co-Founder and President Joe Hayon stepping down from his operational role to focus on strategic vision as a Board member.
Inspira Technologies is also advancing its product line with the development of the INSPIRA ART500 system, which aims to provide oxygenation for patients with acute respiratory failure without mechanical ventilation. The company plans to submit this system for FDA approval within the next 18 months. In another development, Inspira Technologies received a notice from Nasdaq regarding non-compliance with the minimum bid price rule, requiring the company to meet specific criteria by September 2025 to avoid delisting. The company is actively exploring solutions to address this issue, including the possibility of a reverse share split. These developments highlight Inspira Technologies’ ongoing efforts to expand its market presence and navigate regulatory challenges.
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