NewsIRRAS Receives FDA Clearance for IRRAflow® in the US

IRRAflow is a transformative medical device that combines controlled irrigation with ongoing fluid drainage for the treatment of patients with intracranial bleeding

Plans to launch IRRAflow in the US underway 

Stockholm, Sweden, July 16, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on developing and commercializing transformative treatments to manage intracranial fluids, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for IRRAflow, its integrated, closed medical device system that enables controlled cerebrospinal fluid (CSF) management as well as accurate, continuous monitoring of intracranial pressure (ICP). IRRAS expects to launch IRRAflow in the U.S. later this year.

When the brain is injured or becomes infected, the normal flow of fluids within the brain can be disrupted, leading to fluid build-up and swelling. This excess fluid must be drained, or pressure can rise to life-threatening levels. This rise in ICP and complications from attempted treatment result in high rates of disability and death. IRRAflow is designed to provide patients with a safer, more effective treatment than traditional drainage devices by integrating aspiration, targeted infusion, and ICP monitoring in a single system that is automated by a proprietary software that tailors treatment to each patient’s changing condition.

“The United States is the world’s largest market for intracranial procedures and the FDA clearance of IRRAflow is a significant milestone for IRRAS,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “We are committed to advancing new and transformative treatments for neurosurgical patients that result in fewer complications, disabilities, and deaths.”

“We are thrilled to introduce IRRAflow to neurosurgeons in the United States. Following successful case outcomes and significant customer interest in Europe across a variety of neurosurgeries, we are confident that IRRAflowwill significantly improve the outcomes of US patients with its unique mechanism of action,” said Will Martin, IRRAS’ Chief Commercial Officer.

For more information, please contact:
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com