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RA’ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) has completed the regulatory submission of its FDA-cleared INSPIRA ART100 system to the United Arab Emirates Ministry of Health and Prevention (MOHAP), according to a company press release Thursday. The micro-cap medical device company, with a market capitalization of just $26 million, is making strategic moves despite facing financial challenges.
The medical device company, which specializes in respiratory support technologies, expects final approval "within days," potentially opening access to the Gulf region market. This submission follows discussions with UAE government officials regarding potential deployment of the system following regulatory approval. The company’s stock has shown significant volatility, with InvestingPro data showing a 55% price gain over the past six months despite recent weakness.
The ART100 system is currently cleared by the U.S. Food and Drug Administration for cardiopulmonary bypass procedures in the United States and for ECMO (Extracorporeal Membrane Oxygenation) procedures in other markets.
"We are executing decisively on our global commercialization strategy for the ART100 system," said Dagi Ben-Noon, Chief Executive Officer of Inspira. "The UAE’s regulatory progress marks a defining step forward in Inspira’s expansion across one of the world’s fastest-growing healthcare markets."
The company stated it is prepared commercially, operationally, and clinically to proceed once authorization is granted. Inspira also noted that the UAE is known for its efficient regulatory framework for medical innovations. According to InvestingPro analysis, Inspira faces significant financial challenges with a weak financial health score and is quickly burning through cash, factors investors should consider as the company pursues expansion.
In addition to the ART100, the company is developing the INSPIRA ART500, described as a next-generation system designed for oxygenation while patients remain awake and breathing spontaneously, as well as HYLA, a blood sensor platform for continuous monitoring.
The information in this article is based on a company press release statement.
In other recent news, Inspira Technologies OXY B.H.N. Ltd. has secured a $27 million purchase order from a national health ministry in Africa for its ART100 systems, marking a significant milestone for the company. The order will see an immediate deployment across the nation, with full payment expected by 2025. Additionally, the company has received U.S. patent approval for its ART500 technology, which offers low flow rates extracorporeal oxygenation. This patent, providing protection until at least 2043, includes 16 novel claims aimed at enhancing patient safety and treatment efficiency. Inspira Technologies has also announced a strategic collaboration with Bites Learning Ltd. to integrate AI-powered training into its medical devices, enhancing the functionality of products like the INSPIRA ART100 and HYLA blood sensor. Furthermore, the company has filed a routine shelf registration renewal with the U.S. Securities and Exchange Commission, ensuring continued compliance and operational flexibility. These developments reflect Inspira Technologies’ ongoing efforts to innovate and expand its market presence.
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