Revenio Group Corporation, Stock Exchange Release, 8 September 2015 at 11.00
FDA PERMIT APPLICATION FOR THE ICARE HOME TONOMETER FILED IN THE US
Icare Finland Oy, a subsidiary of Revenio Group, has submitted a sales permit application - for its HOME tonometer for monitoring eye pressure at home - to the United States Food and Drug Administration (FDA). The clinical tests essential to the permit application process have been completed and the results have been analyzed as part of the application.
Revenio cannot estimate accurately when the FDA decision will be obtained. The Corporation is prepared that the permit would be granted during the year 2016.
The Icare HOME tonometer has been granted a sales permit in over 30 European countries as well as Australia, Japan and Canada.
Icare aims 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.
Further information about the FDA permit application process is available on its website.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYour
Device/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 health tech group whose core business is tonometers. The Revenio Health Tech segment comprises the business operations of Icare Finland Oy and Oscare Medical Oy, which specializes in osteoporosis screening and monitoring. In addition, Revenio has identified new growth opportunities relating to health tech in which common denominators are screening, follow-up and the global need to make cost savings in health care via preventive measures. Revenio seeks vigorous growth in health technology, both organically and through acquisitions and mergers.
In 2014, the Revenio Group's net sales totaled MEUR 16.0, with its operating margin for continuing operations standing at 27.5%. Revenio Group Corporation has been listed in Nasdaq Helsinki.