RA'ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ: IINN), a medical technology firm, anticipates FDA clearance for its INSPIRA ART100 (Gen 1) device in the first half of 2024, aiming to tap into the $1.16 billion perfusion systems market. The company's President, Joe Hayon, revealed plans to announce primary results for a core blood oxygenation technology, INSPIRA ART (Gen 2), which is expected to enhance oxygen delivery directly into the blood.
The INSPIRA ART (Gen 2) leverages the company's proprietary HYLA blood Sensor and VORTX Orbiting Blood Oxygenation to potentially replace current medical devices. The technology has been undergoing various tests, with results indicating 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 significance of the INSPIRA ART100 (Gen 1), which functions as a cardio-pulmonary bypass device. He shared a personal story highlighting the challenges associated with traditional ventilation methods and the need for Inspira's technology.
The INSPIRA ART100 is expected to integrate with the HYLA blood monitoring technologies following FDA clearance, while the INSPIRA ART (Gen 2) is being developed to perform adaptive blood oxygenation with real-time detection 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 clearance of the INSPIRA ART100 will be a significant milestone reinforcing its position in the medical field.
This report is based on a press release statement..
InvestingPro Insights
In light of Inspira Technologies' anticipation for FDA clearance 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) holds a market capitalization of $23.39 million, showcasing the scale of the company in the competitive medical technology space.
An InvestingPro Tip 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 stock has experienced a significant return over the last month, with a price total return of 95.4%, reflecting investor optimism around its technological advancements and market potential.
Despite these positive indicators, the company is not yet profitable, with a negative P/E ratio of -1.99 for the last twelve months as of Q1 2023, and an operating income adjusted to a loss of $12.13 million in the same period. These figures underscore the high-stakes nature of Inspira's push for FDA clearance and market entry.
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