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Pivotal Therapeutics
Pivotal Therapeutics is a publicly traded (CNSX: PVO) specialty pharmaceutical company with a focus on the treatment of cardiovascular diseases. Pivotal’s innovative and proprietary lead product, VASCAZENTM, is a prescription grade, ultra-pure Omega 3 fatty acid for the dietary management of cardiovascular disease in patients manifesting an Omega 3 fatty acid deficiency.
VASCAZENTM
VASCAZENTM is a prescription medical food regulated by the FDA under the Orphan Drug Act and is intended for use under physician supervision with consideration for the distinct Omega 3 fatty acid nutritional requirements of patients with cardiovascular disease through elevating Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) to levels associated with reduced risk of cardiac death – New England Journal of Medicine.
Clinical studies have shown EPA and DHA to be effective in safely managing the unique nutritional needs of patients with cardiovascular disease, with few side effects, comparable to placebo.
VASCAZENTM contains a proprietary, >90% pure formulation of EPA and DHA from oily fish species, providing levels of these Omega 3’s needed to meet the distinctive nutritional requirements of patients with cardiovascular disease by attaining levels which cannot be obtained through simple changes in diet.
VASCAZENTM is manufactured according to FDA (Food and Drug Administration) current Good Manufacturing Practices (cGMP) and each capsule of VASCAZENTM provides 680 mg of EPA and 110 mg of DHA. FDA regulations require that VASCAZENTM be used only under a physician's supervision and therefore, is available by prescription only.
VASCAZENTM is protected by a series of both issued and pending US and foreign patents.
*Albert CM, Campos H, Stampfer MJ,et al.: Blood levels of long- chain n-3 fatty acids and the risk of sudden death. N Engl J Med 2002, 346:1113–1118.
