STOCKHOLM, June 25, 2019 /PRNewswire/ -- 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:
U.S.
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).
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/irras/r/irras-wins-regulatory-approval-of-irraflow--in-israel-and-costa-rica,c2848646
The following files are available for download:
https://mb.cision.com/Main/16550/2848646/1067900.pdf
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