NewsIRRAS Provides Update on FDA 510(k) Application of IRRAflow™

– Requests for certain technical clarifications and labeling definition –
– Financial targets remain unchanged –

San Diego, CA, USA, Munich, Germany and Stockholm, Sweden March 12, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on designing, developing, and commercializing innovative solutions for various brain pathologies, announced that it received a response from the U.S. Food and Drug Administration (FDA) regarding the company’s 510(k) application for the approval of IRRAflow™, a CE-marked, fully integrated, closed-circuit medical device system that enables intelligent intracranial fluid management as well as accurate, real-time monitoring of intracranial pressure.

The FDA has asked for technical clarifications and updates of certain reports primarily relating to IRRAS’ third party contractors’ biocompatibility and sterility testing and software. Recommendations and clarifications of the proposed labeling have also been provided. The requests by the FDA are not unusual for a complex, software-driven surgical device like IRRAflow™ and will be addressed by IRRAS in a timely manner.

“The feedback from the FDA is both appreciated and addressable, and we believe this communication brings us closer to the approval of IRRAflow™ in the United States,” said Kleanthis G. Xanthopoulos, Ph.D, President and CEO of IRRAS. “With the completion of our dialog on labeling and the technical clarifications with the FDA, we anticipate a potential launch of IRRAflow™ in the U.S. in the second half of 2018. We are working closely with the FDA to bring this innovative medical device to the U.S. market, offering patients, neurosurgeons, and hospitals an effective, intelligent solution to treat intracranial bleedings.”


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