HemoSense's INRAtio System Receives Marketing Approval in Canada
January 30 2007 - 7:00AM
Business Wire
HemoSense, Inc. (AMEX:HEM) today announced that it has received
medical device licenses from Health Canada to market its INRatio�
PT/INR monitoring system for point-of-care and patient self testing
in Canada. HemoSense expects to formalize distribution
relationships during the current fiscal quarter, and begin selling
INRatio within Canada in the coming months. �We believe that entry
into the Canadian market represents a significant growth
opportunity with an estimated 600,000 patients on chronic warfarin
therapy,� said Timothy Still, executive VP and chief commercial
officer of HemoSense. �We are committed to providing convenient and
easy-to-use PT/INR monitoring solutions to assist patients in
managing their warfarin levels. To further strengthen our ability
to expand into international markets, we received ISO 13485
certification in July of last year. ISO certification is an
internationally recognized quality standard for medical devices,
which is mandatory for obtaining commercial approval in a number of
countries, including Canada.� Canada's health care system is a
group of socialized health insurance plans that provide
preventative care and medical treatment coverage to all Canadian
citizens. About HemoSense HemoSense is a point-of-care diagnostic
healthcare company that develops, manufactures and markets
easy-to-use, handheld blood coagulation systems for monitoring
patients taking warfarin. The HemoSense INRatio� system, used by
healthcare professionals and patients themselves, consists of a
small monitor and disposable test strips. It provides accurate and
convenient measurement of blood clotting time, or PT/INR values.
Routine measurements of PT/INR are necessary for the safe and
effective management of the patient�s warfarin dosing. INRatio is
sold in the United States and internationally. For more
information, visit www.hemosense.com. This press release contains
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Statements in this press
release regarding the Company's business that are not historical
facts may be "forward-looking statements" that involve risks and
uncertainties. Specifically, the statements regarding the Company�s
ability to formalize distribution relationships during the current
fiscal quarter, and begin selling INRatio within Canada in the
coming months are forward-looking statements within the meaning of
the Safe Harbor. Forward-looking statements are based on
management's current, preliminary, expectations and are subject to
risks and uncertainties which may cause the actual results to
differ materially from the statements contained herein. Further
information on the Company's business and risk factors are detailed
in its filings with the Securities and Exchange Commission,
including its 2006 Form 10-K filed on December 27, 2006. Undue
reliance should not be placed on these forward-looking statements,
which speak only as of the date they are made. The Company
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events or circumstances
after the date they were made, or to reflect the occurrence of
unanticipated events. HemoSense� and INRatio� are registered
trademarks of HemoSense, Inc.
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