Inspira Technologies boosts production of FDA-cleared system

Published 05/06/2025, 14:26
Inspira Technologies boosts production of FDA-cleared system

RA’ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), a medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, has announced a scale-up of its production capabilities for its INSPIRA ART100 system. The company, currently valued at $15.35 million in market capitalization, has seen its stock surge nearly 11% over the past week, according to InvestingPro data. This increase in production is in anticipation of demand from a European governmental authority, with whom the company is in the final stages of procurement negotiations.

The ART100 system, which is FDA-cleared for cardiopulmonary bypass procedures in the U.S. and for Extracorporeal Membrane Oxygenation (ECMO) outside the U.S., has been adopted in clinical settings across the United States. The system is part of Inspira’s strategy to become a key supplier in critical care and emergency preparedness programs. While the company maintains a healthy current ratio of 2.02, InvestingPro analysis indicates rapid cash utilization, suggesting careful monitoring of its expansion strategy is warranted.

Dagi Ben Noon, CEO of Inspira Technologies, stated that the company’s dialogue with the European government body has progressed to a point where increasing production capacity is crucial for meeting the expected deployment needs efficiently.

The move to expand production follows Inspira’s recent announcement of its global rollout strategy for the ART100 system and reflects its commitment to accelerate revenue generation. With current EBITDA at -$11.1 million, the company faces challenges in achieving profitability. Furthermore, the company is developing next-generation platforms, including the ART500 and the HYLA blood sensor, which are designed to provide oxygenation to awake patients and offer continuous, non-invasive blood monitoring, respectively. InvestingPro subscribers can access additional insights, including 5 more ProTips and detailed financial metrics that help evaluate the company’s growth potential.

Inspira Technologies aims to establish itself as a strategic public health supplier in both governmental and private sectors, leveraging the growing global focus on scalable respiratory solutions. The company’s efforts to streamline operations and its growing intellectual property portfolio position it favorably within the MedTech landscape.

This expansion is part of Inspira’s long-term strategy, which includes potential cross-sector collaborations and strategic partnerships. The company’s forward-looking statements are based on current management expectations and are subject to uncertainties that could affect future results.

The information in this article is based on a press release statement from Inspira Technologies.

In other recent news, Inspira Technologies has reported the generation of its initial revenue from the delivery and installation of the INSPIRA ART100 life support systems at a leading U.S. academic medical center. The revenue is described as being in the low hundreds of thousands of dollars, marking a significant milestone for the company. The ART100 system, which has received FDA clearance for cardiopulmonary bypass procedures, is also set for clinical validation in organ transplant procedures at a major Israeli medical center. This initiative aims to explore its capability in enhancing organ viability during transplant surgeries. Additionally, Inspira Technologies is accelerating the commercialization of its ART100 system, with plans to begin deliveries in the second half of 2025, contingent on regulatory approval. The company is also advancing its INSPIRA ART500 system, which is designed to provide a safer alternative to mechanical ventilation. In a recent executive restructuring, Co-Founder and President Joe Hayon will resign from his operational role but remain on the Board of Directors. These developments reflect Inspira’s strategic focus on expanding its respiratory support and diagnostic technology portfolio.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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