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RA’ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) announced Thursday it has completed the clinical study for its HYLA non-invasive blood sensor, moving the device closer to regulatory submission. The micro-cap company, with a market capitalization of approximately $28 million, is preparing for its next earnings release on November 19.
According to the company’s press release, clinical trial results and ongoing lab tests showed the device achieved between 95% to 99% accuracy across measured parameters. Inspira is now preparing to enter the final validation and verification stage before planned regulatory submission. InvestingPro data shows the stock has experienced significant volatility, with a beta of 2.27 and a 75% price return over the past six months despite not being profitable over the last twelve months.
The HYLA is designed to provide continuous, real-time blood data without requiring blood draws. The company states the device is being developed for use in operating rooms, intensive care units, and cardiac care settings.
"The system is performing at exceptional accuracy levels in our testing - between 95 and 99 percent across the board," said Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, in the statement.
Inspira reports it is integrating machine learning algorithms to extend the sensor’s capabilities beyond core parameters, focusing on adding physiological measurements that the company claims are currently unavailable through existing non-invasive monitoring systems.
The medical device company, which has its FDA-cleared INSPIRA ART100 system approved for cardiopulmonary bypass in the U.S., is also developing the INSPIRA ART500 system for oxygenation while patients remain awake.
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 completed the regulatory submission of its FDA-cleared INSPIRA ART100 system to the United Arab Emirates Ministry of Health and Prevention. The company anticipates final approval soon, which could facilitate its entry into the Gulf region market. In another development, Inspira Technologies has announced a strategic partnership with Bites Learning Ltd. to integrate AI-powered training capabilities into its medical device ecosystem. This collaboration will enhance future versions of the INSPIRA ART100 system and the HYLA blood sensor with Bites’ AI learning platform. Additionally, Inspira Technologies has received U.S. patent approval for its ART500 core technology, a low flow rates extracorporeal oxygenation system. The patent, which is valid until at least 2043, includes 16 novel claims that ensure patient safety and treatment efficiency. These recent developments highlight Inspira Technologies’ efforts to expand its market presence and technological capabilities.
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