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.
