With success in achieving the primary safety and efficacy endpoints, the data from the RELIEF study will form part of a Premarket Approval ("PMA") submission to the FDA. Fralex is seeking to be the first company to market a medical device in the U.S. and Canada which is indicated for the treatment of chronic pain associated with fibromyalgia.
FRALEX is a medical technology company focused on developing and commercializing Complex Neural Pulse or CNP(TM), a novel neuromodulation therapeutic technology for chronic pain, which utilizes specifically designed, low frequency electromagnetic pulses. FRALEX is proceeding with its FDA- and Health Canada-approved pivotal clinical trial (the "RELIEF" trial) to evaluate the safety and effectiveness of this technology in the treatment of chronic pain associated with fibromyalgia. The trial is to be conducted in 2007 and 2008 at leading medical centres within the U.S. and Canada. For more information on FRALEX, please visit http://www.fralex.com; further details on the RELIEF trial are posted on http://www.clinicaltrials.gov.
Certain statements contained in this release containing words like
"believe", "intend", "may", "expect", and other similar expressions, are
forward-looking statements that involve a number of risks and
uncertainties. Factors that could cause actual results to differ materially
from those projected in the Company's forward-looking statements include
the following: market acceptance of Company's technologies and products;
the ability to obtain financing; Company's financial and technical
resources relative to those of its competitors; Company's ability to keep
up with rapid technological change; government regulation of therapeutic
technologies; the Company's ability to enforce its intellectual property
|SOURCE Fralex Therapeutics Inc.|
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