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.