Revenio Group Oyj - Company Announcement

Revenio Group Corporation: Renewed FDA permit application for the Icare HOME tonometer filed in the US

Revenio Group Corporation

Stock Exchange Release November 30, 2016 at 9:00 am
EET

RENEWED FDA PERMIT APPLICATION FOR THE ICARE HOME TONOMETER FILED IN THE US
Icare Finland Oy, a subsidiary of Revenio Group, has submitted a renewed sales
permit application - for its HOME tonometer for monitoring eye pressure at home
- to the United States Food and Drug Administration (FDA). After the negative
FDA decision in March 2016, the company decided to submit a new sales permit
application to the FDA. Now the new human factors tests related to the process
are completed and Icare has filed a renewed sales permit application for the
FDA. The company cannot estimate when the FDA decision will be obtained.

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

Further information about the FDA permit application process is available on its
website:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDev
ice/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, globally operating health technology corporation whose
worldwide success is based on a strongly patented intraocular pressure
measurement technology. The Revenio Group consists of Icare Finland Oy, Revenio
Research Oy and Oscare Medical Oy, in which Revenio holds a 53% interest. The
common denominators of Revenio's business operations include screening, follow-
up and the global need to make cost savings through preventive health care.
Revenio seeks vigorous growth in health technology. Revenio aims at developing
even more efficient and easily adopted methods for the early-stage detection of
diseases with significance for public health. The focus of Revenio's screening
technology is on the early detection of glaucoma, osteoporosis, skin cancer and
asthma, and the monitoring of these during the treatment process.

In 2015, the Revenio Group's net sales totaled MEUR 20.3, with its operating
margin for continuing operations standing at 28.4%. Revenio Group Corporation is
listed on Nasdaq Helsinki.

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