Fralex Therapeutics Inc. receives ISO 13485 certification



    TORONTO, March 8 /CNW/ - Fralex Therapeutics Inc. (TSX: FXI) ("FRALEX" or
the "Company") today announced that it has achieved ISO 13485 certification, a
critical step in the development and commercialization of its therapy for the
treatment of chronic pain.
    ISO 13485:2003 is an internationally recognized quality management
standard developed for medical devices by the International Organization for
Standardization (ISO). ISO 13485 specifies requirements for a quality
management system which demonstrates the organization's ability to provide
medical devices and related services that consistently meet customer and
applicable regulatory requirements. This entails staff training, customer and
regulatory communication, product design and development, sourcing and
purchasing of materials and services, and delivery of products and services.
    "Achieving ISO certification is a critical milestone for the Company and
demonstrates our commitment to operating within a well integrated quality
management system," said Avi Grewal, President and CEO of Fralex. "It greatly
improves our ability to execute on the initiatives necessary to reach our goal
of successfully commercializing CNP therapy. Obtaining ISO certification
allows for the implementation of a product development process that will bear
regulatory scrutiny and the creation of a corporate culture focused on
quality."

    About FRALEX:

    FRALEX is a medical technology company focused on developing and
commercializing Complex Neural Pulse or CNP, a novel neuromodulation therapy
for chronic pain, which utilizes specifically designed, low-frequency
electromagnetic pulses. FRALEX has received approval from the FDA to proceed
with its pivotal clinical trial (the "RELIEF trial") to evaluate the safety
and effectiveness of CNP in the treatment of chronic pain associated with
fibromyalgia. The trial is to be conducted in 2007 at leading medical centres
within the US and Canada. For more information on FRALEX, please visit
www.fralex.com.

    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,
agrewal@fralex.com; Christina Bessant, Investor Relations, The Equicom Group
Inc., (416) 815-0700 ext. 269, cbessant@equicomgroup.com

Organization Profile

FRALEX THERAPEUTICS INC.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890