STOCKHOLM, Oct. 4, 2018 /PRNewswire/ -- IRRAS AB (Nasdaq
First North Premier: IRRAS) announced today that it has received
further information from its Notified Body, LNE/G-MED, regarding
the CE Mark of the IRRAflow catheter. The Notified Body
completed its initial review of the IRRAS recertification
application and has provided a list of questions and requests for
some clarifications. These requests by LNE/G-MED should all be
addressable in existing IRRAS documentation, and the company plans
to submit its response within a couple of days. However, due to the
large backlog of applications, LNE/G-MED now estimates completion
of the process around year's end.
"The feedback from the Notified Body is addressable, and we will
respond shortly as we have all the documents requested," said
Kleanthis G. Xanthopoulos, Ph.D.,
President and CEO of IRRAS. "However, the delay is frustrating to
us, our clinicians, and, importantly, the patients. While the delay
has affected our European sales for this year, our long-term sales
projections have not been changed. If anything, the future outlook
of IRRAS has improved with the recent FDA approval of
IRRAflow in the US," he continued.
For more information, please contact:
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.
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 above, on October 4,
2018 at 8.00 a.m. (CET).
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/irras/r/irras-provides-update-on-the-recertification-process-of-the-ce-mark-for-the-irraflow--catheter,c2634893
The following files are available for download:
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SOURCE IRRAS