IRRAS wins regulatory approval of IRRAflow® in Israel and Costa Rica

Stockholm, June 25, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received regulatory approval for its flagship product, IRRAflow, from the Ministries of Health in Israel and Costa Rica. As a result of these approvals, IRRAS will expand its global commercialization and can now begin to market and sell IRRAflow in both countries.

“We are pleased to advance our global regulatory strategy with the approval of IRRAflow in important markets like Israel and Costa Rica,” said Vinny Podichetty, Vice President, Clinical, Regulatory Affairs & Quality at IRRAS. “These approvals are signs that our global regulatory strategy is progressing as planned, and we continue the work needed to receive clearance for IRRAflow in additional markets, including the EU.”

“The ability to commercialize IRRAflow outside of the United States represents a significant milestone in our efforts to expand IRRAS’ neurocritical care portfolio across the globe,” said Will Martin, Chief Commercial Officer at IRRAS. “With regulatory approval now in place in Israel and Costa Rica, our first Latin American country, we can build upon the enthusiastic response that we’ve seen for IRRAflow in the US by initiating patient treatments and generating revenue in these markets in the second half of 2019.”

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 neurocritical care.

The company’s flagship product, IRRAflow, is the world’s first irrigating ventricular drain. Its unique mechanism of action 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAS also has several other innovative neurocritical care products that are commercially available in the US, including the Hummingbird intracranial pressure (ICP) monitoring system.

With its unique and comprehensive product portfolio, protected by multiple 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 8 545 271 00 or at info@wildeco.se.

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com
 

Europe
Sabina Berlin
CFO
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on June 25, 2019 at 08.00 a.m. (CET). 

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