English

Revenio Group Corporation: Further questions related to FDA permit application

Report this content

Revenio Group Corporation, Stock Exchange Release, November 9, 2015 at 9.00 am

FURTHER QUESTIONS RELATED TO FDA PERMIT APPLICATION

Icare Finland Oy, a subsidiary of Revenio Group, submitted in September a sales permit application - for its HOME tonometer for monitoring eye pressure at home - to the United States Food and Drug Administration (FDA). Dialogue between the parties is an essential part of the process and Icare has received a list of further questions from the FDA. According to the sales permit process, the company has 180 days to submit answers to the presented questions. The questions are routine questions related to clarifications and further analyses. The company targets to answer the questions as soon as possible, with precision.

Revenio cannot estimate accurately when the FDA decision will be obtained. The Corporation is still prepared that the permit would be granted during the year 2016.

The Icare HOME tonometer has been granted a sales permit in all European countries as well as Australia, Japan, Canada and China.

Further information about the FDA permit application process is available on its website.
http://www.fda.gov/MedicalDevices/DeviceRegulationand
Guidance/HowtoMarketYourDevice/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.