First Patient in the United States Successfully Treated with IRRAflow®
-US Launch on Track-
Stockholm, January 10, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company, today announced that the first patient in the United States was successfully treated with IRRAflow, the company’s initial product that offers an innovative, therapeutic approach to the fluid management of patients with intracranial bleeding.
“The US is the largest market for intracranial procedures, and we are making significant progress engaging neurocritical care centers and specialty hospitals across the country,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “We’re thrilled to see the first patient treated in the United States and remain confident that IRRAflow will dramatically improve the outcomes for many future patients.”
This first IRRAflow patient treatment in the US was performed at the University of California – Irvine (UCI) Medical Center, located in Orange, California. The team, led by UCI Health neurosurgeon Dr. Sumeet Vadera, successfully treated a patient suffering from a chronic subdural hematoma that formed after a recent fall.
“We are excited to be the first site in the United States to use the IRRAflow system,” said Dr. Vadera, Associate Professor of Neurological Surgery, UCI School of Medicine. “At UCI, we pride ourselves on providing our patients the latest in cutting-edge treatment options, and we can now provide the first active, therapeutic treatment to manage intracranial fluid with IRRAflow.”
IRRAflow addresses the complications associated with current passive treatment methods by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Since receiving US Food and Drug Administration (FDA) clearance in 2018 to market the system in the United States, IRRAS has taken many needed steps to launch the product, including establishing a customer service and shipping partnership with global logistics specialist, HealthLink Europe & International, hiring Territory Managers, and developing needed marketing and training materials.
This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below on January 10, 2019 at 08.00 a.m. (CET).
For more information, please contact:
US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com
Europe
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com
About IRRAS
IRRAS AB (Nasdaq First North Premier: IRRAS) is a publicly-traded, commercial-stage medical technology company focused on developing and commercializing innovative solutions for brain surgery. The company’s initial product, IRRAflow®, addresses the complications associated with the current methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. IRRAflow received FDA clearance in July 2018.
Regularly during treatment, the IRRAflow catheter is automatically flushed to prevent common catheter occlusions from forming. Because IRRAflow is a completely closed system, it is designed to reduce the documented infection risk of these procedures. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.
With its unique product portfolio, protected by property patents and patent applications, IRRAS is well positioned to establish a leadership position in the medical device market. IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.
IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the company. Wildeco is reached at + 46 706 67 31 06 or at info@wildeco.se.
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