SYS-CON MEDIA Authors: Pat Romanski, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

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Regulatory Approval in Canada Expands Access to the New Single-size Female Contraceptive Diaphragm

Product Launch May 8, 2014 Will Introduce Caya Contoured Diaphragm to Canada

CONCORD, ON--(Marketwired - May 05, 2014) - Health Canada, has approved a new single-size diaphragm for over-the-counter sale, giving women a non-hormonal option for contraception that is reusable and inexpensive Caya® will be launched in Canada on May 8 by the diaphragm's Canadian supplier, Trimedic Supply Network Ltd., of Toronto, at the Primary Health Care trade show in Toronto. The launch represents another step toward expanding contraceptive options for women, especially non-hormonal options like diaphragms that have been limited both in Canada and the United States.

Canada's approval follows European regulatory approval of the SILCS diaphragm last year, which opened the way for its commercial debut.

Expanding contraceptive options to address unmet needs of women in Canada and worldwide

Distribution of Caya in Canada will initially be through Pharmacy wholesale distributers i.e. McKesson, and Trimedic's sub distribution partners who will also sell direct to Doctors and Naturopaths. Paula Gelbfarb at Trimedic said "within the next 12 months we expect the Caya to be the first ever Female contraceptive available on the retail shelf at all Pharmacies across Canada." According to Gelbfarb Trimedic is presently in negotiation with several large retail outlets, but is considering an exclusive deal with a single national retail banner.

The introduction of this new barrier contraceptive in Canada, will help raise awareness and inform future introduction in low-resource settings where diaphragms have not been available in recent decades.

A recent analysis of the unmet need for family planning in many countries suggests that women want access to a method that has few side effects, can be used when the woman needs it, and is safe and effective. The Caya diaphragm addresses these needs for many women.

The manufacturer company Kessel is planning for additional market registrations, including a regulatory submission to the US Food and Drug Administration for clearance to market the diaphragm in the United States.

About the diaphragm

Caya® is inserted before sex and should cover the cervix completely. The single-size Caya, reusable diaphragm has an anatomically shaped, contoured rim that allows coverage of the cervix. Diaphragm guidelines recommend applying contraceptive gel for added protection and spreading gel on the rim to aid insertion. The Caya can be used over again for up to 2 years. After use of the Caya simply wash with soap and warm water and then place back into its container for future use.

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