Revenio Group Corporation: FDA did not grant sales permit for Icare HOME in the US
Revenio Group Corporation, Stock Exchange Release, March 17, 2016 at 09:35
FDA DID NOT GRANT SALES PERMIT FOR ICARE HOME IN THE US
Icare Finland Oy, a subsidiary of Revenio Group, submitted in September 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 has now received information from the FDA that the sales permit was not granted in the United States for Icare HOME.
Revenio will publish further inform about the impact of the negative decision as soon as possible.
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
Financial Supervisory Authority (FIN-FSA)
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.