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.”