2017-03-22 08:30:56 CET

2017-03-22 08:30:56 CET


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Revenio Group Oyj - Other information disclosed according to the rules of the Exchange

Revenio Group Corporation: FDA marketing approval granted to Icare HOME tonometer in the United States


Revenio Group Corporation, Stock Exchange Release March 22, 2017, at 09.30


FDA MARKETING APPROVAL GRANTED TO ICARE HOME TONOMETER IN THE UNITED STATES

Revenio Group's subsidiary, Icare Finland Oy has received a marketing approval
for the Icare HOME tonometer in the United States. In late November 2016, the
company filed a supplemented Premarket Approval application to the United States
Food and Drug Administration FDA. The company has now been informed that its PMA
application has been accepted. Icare will immediately start preparations for
launching the product in the United States.

"One of our key goals is to create new treatment practices in which a doctor
treating a glaucoma patient, or someone suspected of having glaucoma, can lend
an Icare HOME tonometer to the patient for around-the-clock home measurement.
The resulting information on the patient's 24-hour intraocular pressure (IOP)
fluctuation would help the doctor to make the proper treatment decisions. For
patients diagnosed with glaucoma, continuous IOP monitoring forms a key part of
the treatment in order to contribute to preventing progression of the disease
and to determine the proper medication. Being granted a marketing approval in
the United States represents a major opportunity to bring the product to market
and, in the future, establish it as a vital part of the glaucoma treatment
process", says Timo Hildén, CEO of Revenio Group.

In addition to the United States, the Icare HOME tonometer has been granted
sales permits in all European countries and in Australia, Japan, South Korea,
Taiwan, Brazil, Canada, and China.

The received marketing approval does not have an affect on the 2017 financial
guidance.

Revenio Group Corporation

For further information, please contact:
President&CEO Timo Hildén
Telephone: +358 40 580 4774
timo.hilden@revenio.fi

DISTRIBUTION:
Nasdaq Helsinki
Financial Supervisory Authority
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 intraocular pressure measurement technology that
has a strong patent. Revenio Group consists of, in addition to the parent
company, Icare Finland Oy which focuses on intraocular pressure measurement
technology and its fully owned subsidiary Icare USA Inc., research and
development company Revenio Research Oy and Oscare Medical Oy, in which Revenio
holds a 53.5% 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 to develop 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 2016, Revenio Group's net sales totaled MEUR 23.4, with its operating margin
for continuing operations standing at 30.1% from continuous operations. Revenio
Group Corporation is listed on Nasdaq Helsinki.


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