2015-11-09 08:00:00 CET

2015-11-09 08:00:52 CET


REGULATED INFORMATION

English Finnish
Revenio Group Oyj - Company Announcement

Revenio Group Corporation: Further questions related to FDA permit application


Revenio Group Corporation, Stock Exchange Release, November 9, 2015 at 9.00 am

FURTHER QUESTIONS RELATED TO FDA PERMIT APPLICATION

Icare Finland Oy, a subsidiary of Revenio Group, submitted in September a sales
permit application - for its HOME tonometer for monitoring eye pressure at home
- to the United States Food and Drug Administration (FDA). Dialogue between the
parties is an essential part of the process and Icare has received a list of
further questions from the FDA. According to the sales permit process, the
company has 180 days to submit answers to the presented questions. The questions
are routine questions related to clarifications and further analyses. The
company targets to answer the questions as soon as possible, with precision.

Revenio cannot estimate accurately when the FDA decision will be obtained. The
Corporation is still prepared that the permit would be granted during the year
2016.

The Icare HOME tonometer has been granted a sales permit in all European
countries as well as Australia, Japan, Canada and China.

Further information about the FDA permit application process is available on its
website.
http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/HowtoMarketYourDevice/PremarketSubmissions/
PremarketNotification510k/ucm070201.htm

For further information, please contact:
President & CEO Olli-Pekka Salovaara, tel. +358 40 567 5520
olli-pekka.salovaara@revenio.fi
www.revenio.fi

DISTRIBUTION:
Nasdaq Helsinki
Financial Supervisory Authority (FIN-FSA)
Principal media
www.revenio.fi

The Revenio Group in brief

Revenio is a Finnish health tech group whose core business is tonometers. The
Revenio Health Tech segment comprises the business operations of Icare Finland
Oy and Oscare Medical Oy, which specializes in osteoporosis screening and
monitoring. In addition, Revenio has identified new growth opportunities
relating to health tech in which common denominators are screening, follow-up
and the global need to make cost savings in health care via preventive measures.
Revenio seeks vigorous growth in health technology, both organically and through
acquisitions and mergers.

In 2014, the Revenio Group's net sales totaled MEUR 16.0, with its operating
margin for continuing operations standing at 27.5%. Revenio Group Corporation
has been listed in Nasdaq Helsinki.

[HUG#1965275]