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RA'ANANA, Israel – Inspira Technologies OXY BHN Ltd. (NASDAQ: IINN), a medical technology company, anticipates FDA approval for its INSPIRA ART100 (Gen 1) device in the first half of 2024, with the goal of take advantage of the 1.16 billion dollars of perfusion. systems market. Company President Joe Hayon revealed plans to announce primary results of a core blood oxygenation technology, INSPIRA ART (Gen 2), which is expected to improve the delivery of oxygen directly to the blood.
INSPIRA ART (Gen 2) leverages the company's patented HYLA blood sensor and VORTX in-orbit blood oxygenation to potentially replace current medical devices. The technology has undergone several tests, and the results indicate its suitability for medical markets currently dominated by leading device companies.
Hayon expressed the company's ambition to revolutionize the mechanical ventilation market, underlining the importance of the INSPIRA ART100 (Gen 1), which functions as a cardiopulmonary bypass device. He shared a personal story that highlights the challenges associated with traditional ventilation methods and the need for Inspira's technology.
INSPIRA ART100 is expected to be integrated with HYLA's blood monitoring technologies following FDA approval, while INSPIRA ART (Gen 2) is being developed to perform adaptive blood oxygenation with real-time sensing capabilities.
Inspira's technology is designed to allow patients to remain awake during treatment, reducing the need for invasive mechanical ventilation systems. Although the company's products have not yet been tested on humans or approved by any regulatory entity, Inspira anticipates that the FDA approval of INSPIRA ART100 will be an important milestone that will strengthen its position in the medical field.
This report is based on a press release.
InvestingPro Insights
In light of Inspira Technologies' anticipation for FDA approval and its potential impact on the perfusion systems market, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro, Inspira Technologies (NASDAQ: IINN) has a market capitalization of $23.39 million, demonstrating the company's scale in the competitive medical technology space.
A tip from InvestingPro highlights that Inspira Technologies has more cash than debt on its balance sheet, which could provide the financial flexibility needed to navigate the regulatory process and invest in product development. Additionally, the company's shares have seen significant performance over the past month, with a total price return of 95.4%, reflecting investor optimism around its technological advancements and market potential.
Despite these positive indicators, the company is still not profitable, with a negative P/E ratio of -1.99 for the trailing twelve months to the first quarter of 2023, and operating income adjusted to a loss of $12.13 million in the same period. These numbers underscore the high-risk nature of Inspira's push for FDA clearance and market entry.
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