RAANA, Israel – Inspira Technologies OXY BHN Ltd. (NASDAQ: IINN), a medical technology company, expects to receive FDA clearance for its INSPIRA ART100 (Gen 1) device in the first half of 2024, aiming to leverage $1.16 billion in perfusion resources. system market. Company President Joe Hayon announced plans to announce initial results from INSPIRA ART’s core blood oxygenation technology (Gen 2), which is expected to improve the delivery of oxygen directly to the blood.
INSPIRA ART (Gen 2) uses the patented HYLA blood sensor and VORTX orbital blood oxygenation to potentially replace existing medical devices. The technology has undergone various trials, the results of which have shown its suitability for medical markets, which are currently dominated by leading device manufacturers.
Hayon expressed the company’s ambition to revolutionize the mechanical ventilation market, highlighting the importance of the INSPIRA ART100 (Gen 1), which functions as a cardiopulmonary bypass device. He shared a personal story highlighting the challenges associated with traditional ventilation methods and the need for Inspira technology.
INSPIRA ART100 is expected to be integrated with HYLA’s blood monitoring technologies once FDA clearance is received, and INSPIRA ART (Gen 2) is being developed to perform adaptive blood oxygenation with real-time detection capabilities.
Inspira technology allows patients to remain awake during treatment, reducing the need for invasive mechanical ventilation systems. Although the company’s products have not yet been tested in humans or approved by any regulatory agency, Inspira expects that the receipt of FDA approval for INSPIRA ART100 will be a significant milestone in strengthening its position in the medical field.
This report is based on a press statement.
InvestingAbout Insights
In light of Inspira Technologies’ expectations of FDA clearance and its potential impact on the perfusion system market, investors are closely monitoring the company’s financial health and stock performance. Inspira Technologies (NASDAQ: IINN) has a market capitalization of $23.39 million, according to InvestingPro, demonstrating the company’s scale in the competitive medtech space.
InvestingPro’s advice emphasizes that Inspira Technologies has more cash than debt on its balance sheet, which can provide the financial flexibility needed to navigate the regulatory process and invest in product development. Additionally, the company’s shares have posted strong returns over the past month, with a total return of 95.4%, reflecting investor optimism about its technology advancements and market potential.
Despite these positive metrics, the company is not yet profitable, with a negative P/E ratio of -1.99 for the trailing twelve months as of the first quarter of 2023, and an operating profit adjusted to reflect a loss of $12.13 million in that year. same period. These numbers underscore just how high the stakes are in Inspira’s efforts to gain FDA approval and enter the market.
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