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RA'ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), a company focused on life-support technology innovation, announced today that their INSPIRA™ CART, designed for use with the INSPIRA™ ART100 system, has been listed by the U.S. Food and Drug Administration (FDA). The medical cart is intended for use in operating rooms during Cardiopulmonary Bypass procedures in the United States.
The INSPIRA™ CART, now classified as a Class I Medical Device and exempt from 510(K) premarket notification, complies with the FDA's safety and efficacy standards, paving the way for its U.S. market introduction. This development is part of Inspira's broader strategy to deploy the FDA-cleared INSPIRA™ ART100 system in leading hospitals in the U.S. and Israel.
Dagi Ben-Noon, CEO of Inspira, expressed optimism about the company's growth prospects, citing a first order of INSPIRA™ CARTs from Glo-Med Networks, Inc. and the potential for future recognition from strategic partners and investors.
Inspira is also developing other products in its pipeline, such as the HYLA™ blood sensor for real-time blood parameter monitoring and the INSPIRA™ Cardi-ART, a portable device aimed at oxygenating the brain during cardiac arrest. Additionally, the INSPIRA™ ART (Gen 2) or ART500 is being designed to enhance patient oxygen saturation levels potentially without the need for mechanical ventilation systems.
However, it is important to note that the INSPIRA™ ART (Gen 2), the INSPIRA™ Cardi-ART, and the HYLA™ blood sensor are still in the design and development phase and have not yet been tested in humans or approved by any regulatory body.
The company's announcement contained forward-looking statements about the potential benefits and uses of its products, which are subject to various risks and uncertainties that could cause actual results to differ materially from those projected.
This news is based on a press release statement from Inspira Technologies.
In other recent news, Inspira Technologies has made significant strides in the medical technology space, with the FDA clearance of its INSPIRA ART100 device marking its entry into the mechanical ventilation market. The company has also secured an initial purchase order for five INSPIRA ART100 systems from Glo-Med Networks, indicating a promising start in this new market sector. This development is part of the company's strategy to capture a portion of the mechanical ventilation market, which is projected to reach $19 billion by 2030.
The ART100, a cardiopulmonary support system, is expected to be distributed in the U.S. by Q4 2024. Inspira Technologies is also making progress with its next-generation INSPIRA ART (Gen 2) technology and HYLA blood sensor, both currently awaiting regulatory approval. The company has also partnered with Beilinson Hospital in Israel to evaluate the potential application of the INSPIRA ART100 device in organ transplant procedures.
In addition, Inspira Technologies secured a direct share offering, resulting in expected proceeds of $1.65 million, which will be used for working capital and general corporate purposes. The company is also collaborating with Ennocure MedTech Ltd. on a new bio-electronic treatment aimed at preventing bloodstream infections. These recent developments underscore Inspira's commitment to advancing medical technology and enhancing patient care.
InvestingPro Insights
Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), despite its recent FDA listing success, faces financial challenges as reflected in its real-time metrics. The company's market capitalization stands at a modest 19.51 million USD, indicating a relatively small enterprise value in the medical device sector. Additionally, the InvestingPro Data suggests that Inspira Technologies is not currently profitable, with an adjusted price-to-earnings (P/E) ratio for the last twelve months ending in Q4 2023 at -1.73. This negative P/E ratio is a clear indicator of the company's lack of profitability during this period.
Moreover, InvestingPro Tips highlight that while Inspira Technologies holds more cash than debt, ensuring a stable financial cushion, it is also quickly burning through cash. This rapid cash burn could be a concern for investors looking for sustainable financial health. Furthermore, the company's stock price has experienced a significant drop of 51.14% over the last three months, underscoring the volatility noted in another InvestingPro Tip.
For readers interested in a deeper dive into the financial health and stock performance of Inspira Technologies, InvestingPro offers additional tips. There are currently 7 more InvestingPro Tips available, which can provide further insights into the company's financials and market position. These tips can be accessed by visiting the InvestingPro platform for IINN at https://www.investing.com/pro/IINN.
As Inspira continues to innovate with products like the INSPIRA™ ART100 system and the INSPIRA™ CART, investors and potential partners will likely keep an eye on both the company's technological advancements and its financial stability. The real-time data and InvestingPro Tips serve as valuable tools for stakeholders to stay informed and make educated decisions regarding their interest in Inspira Technologies.
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