RA'ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) (NASDAQ:IINNW), known for its medical technology innovations, announced today that it has gained 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System.
The clearance represents a significant milestone for the company, which specializes in life support technologies. The INSPIRA™ ART100 is designed to elevate patient oxygen saturation levels quickly, potentially allowing patients to remain conscious during treatment. This feature is expected to enable treatment in various care settings, potentially reducing the reliance on mechanical ventilation that requires intubation and medically induced coma.
Dagi Ben Noon, CEO of Inspira, expressed gratitude to investors and partners for their support in reaching this pivotal moment. Professor Benad Goldwasser, Chairman of the Board, highlighted the FDA clearance as a testament to the company's commitment to technological and innovative advancements.
While the INSPIRA™ ART100 has now been cleared by the FDA, Inspira Technologies' other products, including the INSPIRA ART (Gen 2) and HYLA™ blood sensor, are still in the development phase and have not yet been tested on humans nor received regulatory approval.
The company's statement also included a standard forward-looking disclaimer, noting that the expressed expectations are subject to various factors and uncertainties that could cause actual results to differ from those projected.
The announcement is based on a press release statement from Inspira Technologies. For more information about the company and its technologies, interested parties can visit the corporate website. However, it should be noted that the company's forward-looking statements are based on current expectations and are subject to risks and uncertainties that could affect future results.
InvestingPro Insights
In light of Inspira Technologies OXY B.H.N. Ltd.'s recent FDA clearance for its INSPIRA™ ART100, a deeper look into the company's financial health and market performance provides additional context for investors. According to real-time data from InvestingPro, Inspira Technologies holds a market capitalization of $37.87 million. The company's financial metrics indicate that it is not profitable over the last twelve months, with an adjusted P/E ratio for the same period standing at -3.36. Despite these challenges, the company's stock price has seen significant growth, with a six-month price total return of 114.71%.
Two key InvestingPro Tips shed further light on the company's financial position. Inspira Technologies currently holds more cash than debt on its balance sheet, which may provide some financial flexibility in its operations and development efforts. However, the company is quickly burning through cash, which is a concern for sustainability and long-term growth. Additionally, the company does not pay a dividend to shareholders, which is typical for firms focused on reinvesting earnings into research and development.
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