Revenio Group Oyj - Company Announcement

Revenio Group Corporation: Revenio repeats its financial guidance for 2016 and prepares to submit a new sales permit application for the US

Revenio Group Corporation, Stock Exchange Release, March 18, 2016 at 12:20

REVENIO REPEATS ITS FINANCIAL GUIDANCE FOR 2016 AND PREPARES TO SUBMIT A NEW
SALES PERMIT APPLICATION FOR THE US

Icare Finland Oy, a subsidiary of Revenio Group, submitted in September 2015 a
sales permit application - for its Icare HOME tonometer for monitoring eye
pressure at home - to the United States Food and Drug Administration (FDA). The
company received on March 17, 2016 a negative decision on its application. After
analyzing the FDA decision, the company has made a decision to take measures to
start a new human factors tests, after which, the company will submit a new
sales permit application to the FDA. The new application is estimated to be
ready to be submitted during 2016.

The company estimates that the decision made by the FDA will not affect the
financial guidance given for 2016. The company repeats its previous guidance:
Net sales growth is expected to remain strong. Profitability is expected to
remain at a healthy level despite growth investments.

"Naturally we are extremely disappointed with the decision made by the FDA. We
prepared the application and the related human factors tests in accordance with
the FDA requirements with extreme care. The FDA, however, changed the
requirements related to the human factors tests during the application process.
We will start a new human factors tests that were the grounds for the FDA's
negative decision and will submit a new sales permit application", states Olli-
Pekka Salovaara, CEO to the Revenio Group Corporation.

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.

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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