WOODBRIDGE, ON,
April 27, 2015 /PRNewswire/
- Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO),
("Pivotal" or the "Company"), a specialty pharmaceutical company
with a focus on Omega-3 therapies for cardiovascular disease and
overall health, announced today that it received Health Canada
approval to expand the indication of
OMAZEN®'s product line
specifically for cardiovascular health. The Natural and
Non-Prescription Health Products Directorate of Health Canada
(NNHPD) issued Natural Product Number (NPN) NPN 80060196
with the claim that helps to maintain and support
cardiovascular health and NPN 80060197 with the
claim helps to support and maintain normal serum/blood
triglycerides/triacylglycerol levels. These new products
contain the same unique formulation and high purity as
OMAZEN® and will also be positioned
for the professional market such as Wellness Clinics, Cardiac
Rehabilitation Clinics, Sports Medicine Clinics and Private
Executive Healthcare Clinics.
"This is the first greater than 90% pure Omega-3 fatty
acid prescription grade formulation in Canada with a claim to maintain and support
triglyceride levels and cardiovascular health," said Dr.
George Jackowski, Pivotal's
Co-Founder and Chief Scientific Officer. "Physicians to date can
only prescribe fenofibrates which can damage the liver. This is the
first natural alternative in Canada that is supported by clinical data for
cardiovascular patients."
"The approval of Health Canada and the issuance of the
NPN's allows consumers to feel assured that the product is safe,
effective and of high quality," said Mrs. Rachelle MacSweeney, Pivotal's Co-Founder
President and Chief Operating Officer. "As part of the process,
companies must provide information about the product including
scientific research supporting any health claims, medicinal and
non-medicinal ingredients used, product labeling and information
about the manufacturing site. This process is among the many steps
Pivotal takes to ensure that consumers can feel confident they are
truly taking a product that can make a positive difference in their
health."
About OMAZEN
OMAZEN®
is Pivotal's second
commercial product to market and is available for sale and
distribution for the professional over the counter (OTC) market in
Canada.
OMAZEN® contains greater than
90% pure, pharmaceutical grade Omega-3 with a unique ratio of EPA
to DHA for the maintenance of good health.
OMAZEN®, like all
of Pivotal's products, is backed by clinical data and scientific
support providing a superior alternative to what is currently
available on the market.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded
(OTCQX:PVTTF; CSE:PVO),
specialty pharmaceutical company with a focus on
cardiovascular disease and overall health. Pivotal Therapeutics'
lead product VASCAZEN®
is a prescription only medical food formulated to meet the
dietary Omega-3 deficient needs of patients with cardiovascular
disease through elevating Eicosapentaenoic acid (EPA) and
Docosahexaenoic acid (DHA) to levels associated with reduced risk
of cardiovascular complications.
OMAZEN®
is a pharmaceutical grade Omega-3 providing over 90% pure
Omega-3 in each capsule for the maintenance of good health.
OMAZEN® is a patented product available for sale
and distribution in Canada for the
professional market. BeneFishial™
is the first product in Pivotal's new nutraceutical product line,
which has been specifically designed to be sold in the
OTC direct to retail or direct to consumer markets.
Disclosure Notice
The information contained in this document is as
April 27, 2015. This press release
contains forward-looking statements. Such forward-looking
statements are subject to a number of risks, assumptions and
uncertainties that could cause Pivotal's actual results to differ
materially from those projected in such forward-looking statements.
These statements can be identified by the use of words such as
"will", "anticipate", "estimate", "expect", "project", "forecast",
"intend", "plan", "believe", "project", "potential", and similar
expressions with any discussion of future operating or financial
performance or events. In particular, factors that could cause
actual results to differ materially from those in forward looking
statements include the following: Pivotal's inability to obtain
additional financing on acceptable terms; growth in costs and
expenses; inability to compete with others who provide comparable
products; risk that the Company's products will not gain widespread
market acceptance; risks relating to the Company's ability to
maintain its CSE listing. Forward-looking statements speak only as
of the date made and are not guarantees of future
performance. The Company undertakes no
obligation to publicly update or revise any forward-looking
statements contained in this document as a result of new
information or future events or developments. The CSE has not
reviewed and does not accept responsibility for the adequacy or
accuracy of this
information.
SOURCE Pivotal Therapeutics Inc.