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RA’ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), a developer of life-support technology with a market capitalization of $15 million, has announced that its INSPIRA ART100 system will undergo clinical validation for use in organ transplant procedures at a major Israeli medical center. According to InvestingPro data, the company faces significant financial challenges with negative EBITDA of $11.1 million in the last twelve months. This initiative follows the system’s FDA approval for cardiopulmonary bypass procedures and its Israeli AMAR certification.
The validation will be conducted by leading transplant specialists in Israel, aiming to explore the ART100’s capability to enhance organ viability through advanced blood oxygenation during and after transplant surgeries. The ART100 provides out-of-body blood oxygenation, which could be critical in maintaining patients’ lives during the transplant process. Despite the promising technology, InvestingPro analysis shows the stock has experienced significant volatility, with a beta of 2.15 and a 73.5% decline over the past year.
This new application could expand the clinical use of the INSPIRA ART100 system, and the data gathered from these procedures is expected to support the development of the company’s flagship INSPIRA ART500 system. The ART500 is designed to oxygenate patients’ blood and support vital organs in cases of acute respiratory failure, potentially allowing patients to remain awake without mechanical ventilation.
Inspira’s CEO, Dagi Ben-Noon, expressed optimism about the collaboration with Israel’s largest healthcare provider, highlighting the interest in their technology both locally and internationally. The INSPIRA ART100 system’s proprietary hardware and software are also foundational for the ART500 system, which is still under development.
The ART100 system received FDA 510(k) clearance in May 2024 and Israeli certification in July 2024 for both cardiopulmonary bypass and extra-corporeal membrane oxygenation (ECMO) procedures. Inspira also develops the HYLA blood sensor technology for real-time blood monitoring without the need for blood draws, which is part of their product pipeline along with the ART500 system and a single-use patient kit, none of which have yet obtained regulatory approval.
This press release contains forward-looking statements regarding the expected benefits and applications of Inspira’s products, including the INSPIRA ART100 and ART500 systems. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. While the company maintains a healthy current ratio of 2.02, InvestingPro analysis reveals several additional financial metrics and insights that could be crucial for investors. Get access to over 10 additional ProTips and comprehensive financial analysis by subscribing to InvestingPro. The company has no obligation to update any forward-looking statements. More detailed information on these risks is available in the Company’s annual report filed with the U.S. Securities and Exchange Commission. The information in this article is based on a press release statement from Inspira Technologies.
In other recent news, Inspira Technologies OXY B.H.N. Ltd. has reported its first revenue from the delivery and installation of its FDA-cleared INSPIRA ART100 life support systems at a U.S. academic medical center, amounting to the low hundreds of thousands of dollars. This marks a significant step for the company as it establishes its presence in the U.S. medical market. Additionally, Inspira is developing the INSPIRA ART500 system, targeting the $19 billion mechanical ventilation market, with plans for FDA submission within 18 months. The company has also received a Nasdaq notification for non-compliance with the minimum bid price rule, with a deadline set for September 2025 to meet the requirement. Inspira is exploring options, including a reverse share split, to address this issue. In another development, Inspira announced positive initial results from its collaboration with Ennocure MedTech Ltd. on a bio-electronic patch that showed a 95% reduction in bacterial presence. These advancements highlight Inspira’s ongoing efforts to innovate in respiratory care and infection prevention technologies.
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