Revenio Group Corporation :FDA TRADING LICENSE PROCESS FOR ICARE ONE PRODUCT SUSPENDED
Revenio Group Corporation
Stock Exchange Release 3 October 2012, 18:25 hrs
FDA TRADING LICENSE PROCESS FOR ICARE ONE PRODUCT SUSPENDED
Icare Finland Oy, a subsidiary of the Health Care segment of Revenio Group
Corporation, has decided to suspend the FDA trading license process for the
Icare One self-tonometry product, while further action is taken. The application
is not deemed to have progressed in a way and at a speed that would justify the
continuation of the current application process. The main reason for the slow
progress is assumed to be the regulation related to obtaining a trading license
for products in the FDA's so-called home use category. Part of this regulation
is still in its draft stage and expected to be specified by the FDA at a later
date.
Icare One has previously been granted trading licenses for other principal
market areas where it continues to be sold as normal. The product features of
the device are still being developed on the basis of medical research work
related to self-tonometry. Icare Finland will relaunch the FDA license process
at a later date, utilizing the new product features and increased medical
research evidence.
In the United States, Icare Finland currently sells its main product, the TA-01
tonometer, and sensors for professional use. The sale of these products
continues as normal. The suspension of the licensing process will have no impact
on the market situation of Icare Finland's products or the Revenio Group
Corporation's financial guidance for 2012.
Revenio Group Corporation
Olli-Pekka Salovaara
President and CEO
For further information, please contact:
Olli-Pekka Salovaara, President & CEO, +358 (0)40 567 5520 (mobile)
olli-pekka.salovaara@revenio.fihttp://www.revenio.fi/
DISTRIBUTION:
NASDAQ OMX Helsinki
Financial Supervisory Authority (FIN-FSA)
Key media
www.revenio.fi