Revenio Group Oyj

Regulatory Filings • Nov 30, 2016

Disclosure 347241

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. []