TORONTO, Sept. 20 /CNW/ - Fralex Therapeutics Inc. (TSX:FXI) ("Fralex" or
the "Company"), a medical technology company, today announced CE marking of
its PRIMA system. The Model 801 PRIMA device is a portable, non-invasive,
non-drug option for the treatment of chronic musculoskeletal pain in adults.
It is a Class IIa medical device in the European Union.
Completion of the European conformity assessment process for medical
devices - commonly referred to as "CE marking" - confirms the Company's
fulfillment of applicable European Union requirements and allows Fralex to
market the PRIMA device for the treatment of chronic musculoskeletal pain
within the EU.
The PRIMA device represents a fundamentally new category of medical
product, supported by the fact that it is the first of its kind within two
newly-created medical device classification codes (UMDNS: Stimulators,
Electromagnetic, Low-Intensity, Brain/Spinal Cord, No. 22-840; GMDN:
Neuromodulator, Central Nervous System, No. 45875).
"This is a significant milestone for Fralex that was delivered on
schedule," said Avi Grewal, President and CEO of Fralex. "We will continue to
execute our commercialization strategy, with formal launch expected in the EU
following successful completion of our RELIEF trial." Fralex's pivotal RELIEF
trial currently is taking place at 10 sites in the United States and three in
Canada, to support North American regulatory approval.
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 US and Canada. For more information
on FRALEX, please visit www.fralex.com; further details on the RELIEF trial
are posted on 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 rights and protect its
proprietary technologies; the ability to obtain and develop partnership
opportunities; the timing of commercial product launches; the ability to
achieve key technical milestones in key products and other risk factors
identified from time to time in the Company's filings.
For further information:
For further information: Avi Grewal, President and Chief Executive
Officer, Fralex Therapeutics Inc., (416) 213-8118 ext. 210,
firstname.lastname@example.org; Christina Bessant, Investor Relations, The Equicom Group
Inc., (416) 815-0700 ext. 269, email@example.com