|
FDA AMENDMENT SUBMITTED
FOR IMMEDIATE RELEASE
February 18, 2002
Burlington, Ontario
THE JENEX CORPORATION ("Jenex" or the "Corporation")
(CDNX - JEN), reports they have submitted their response
to the questions received from the FDA, in reference to their
Premarket Notification application. (Re: requesting clearance
to market their medical device, for the prevention
of cold sores) Jenex (www.jenexcorp.com) is seeking clearance
from the FDA to make a similar claim in the United States,
to the one received from Health Canada's Therapeutic Products
Programme (TPP). The Corporation was issued a license to market
their device as an OTC (over-the-counter) product in Canada
with the claim: "For prevention and relief
of the symptoms of herpes labialis (cold sores), such as blistering,
lesions, inflammation, and discomfort. Also helps alleviate
the embarrassment that is typically associated with herpes
labialis (cold sore) outbreaks". The Corporation
expects a reply from FDA in the 2nd quarter of 2002.
Jenex is the first company to receive marketing clearance
from an internationally recognized regulatory body to make
the prevention claim for cold sores. The HSV-1 virus
that causes cold sores, is endemic in North America, and is
estimated to affect 80% of the population. As the only product
clinically proven to prevent the outbreak of cold sores,
the Corporation's thermal therapy product has the potential
to dominate a large and underdeveloped market.
"Prevention is the Solution"
Michael A. Jenkins, President
The Jenex Corporation
207 - 940 Sheldon Court
Burlington, Ontario
L7L 5K6
Telephone: (905) 632-3830
Facsimile: (905) 632-3774
Email: Jenex@sprint.ca
Web Site: www.jenexcorp.com
The Canadian Venture Exchange Inc. has not reviewed and
does not a
|