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Pivotal Therapeutics Inc (PVTTF) RSS Feed

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A specialty pharmaceutical company with a focus on the treatment of cardiovascular disease and overall health.
VASCAZENTM is a specially formulated, >90%pure prescription medical food product for the clinical dietary management of Omega 3 deficiency in patients with cardiovascular disease.

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, for oral administration.  The recommended 4 capsules/day dose delivers 3g of EPA and DHA, attaining levels that cannot be reasonably achieved through normal diet alone. A review of the scientific and medical literature identifies that there are medically determined nutrient requirements supporting the recommendation of consuming up to 3g of EPA and DHA per day in patients with cardiovascular issues*.  It would be difficult to achieve this high level of EPA and DHA through mere modification of the “normal” diet.  Exclusive consumption of fatty fish for breakfast, lunch and dinner, every day may sufficiently approach the level of 3g of EPA and DHA per day.  However, the typical American diet consists of approximately 1/15th of these levels and increasing fish consumption 15-fold to reach the clinically beneficial EPA and DHA levels through diet modifications, would not be considered “normal”*, as required by the medical food definition. Our proprietary EPA/DHA formulation delivers the required EPA and DHA levels (3g/day), levels not achievable through diet modifications alone and act to elevate and sustain Omega-3 fatty acids in patients to levels associated with reduced risk for sudden cardiac death*.  Long-term physician monitoring of blood Omega 3 levels to remain in the cardioprotective range outlined in clinical studies* is critical, ensuring effective dietary maintenance of the distinct, medically determined nutritional requirements of patients with cardiovascular disease and Omega-3 deficiency.

VASCAZENTM’s unique properties derive from a combination of innovative processing techniques coupled with a novel ratio of EPA and DHA Omega 3s.  Both the processing methodology and EPA:DHA blend are the subject of a patent estate including U.S. and foreign patents, as well as pending applications.

*Kris-Etherton PM, Harris WS, Appel LJ, et. al.:  Fish Consumption, Fish Oil, Omega-3 Fatty Acids, and Cardiovascular Disease.  Circulation 2002 106; 2747-57

*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.

*Kris-Etherton PM, Shaffer Taylor D, Yu-Poth S, et. al.:  Polyunsaturated fatty acids in the food chain in the United States.  Am. J. Clin. Nutr. 2000; 71 (suppl) 179S-88S
What is a Medical Food?

The term ‘medical food’ means a food which is formulated to be consumed or administered orally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” – FDA; section 5(b) of the Orphan Drug Act.

Medical foods are not foods in their natural state. Rather, specific formulations are processed in FDA-monitored, good manufacturing practices (GMP)-compliant facilities and are intended for the dietary management of a disease or condition. Medical foods are administered by prescription only, to patients with medically determined nutrient requirements that cannot be met through modification of the normal diet alone.  Medical food prescriptions must be followed with active and ongoing medical supervision
Product Safety and GRAS

The ingredients that comprise VASCAZENTM, including the main Omega 3 ingredients EPA and DHA have attained GRAS status (Generally Recognized As Safe) by strict FDA standards. The ingredients in medical foods are “generally recognized as safe” (GRAS) by the FDA, as demonstrated through rigorous toxicity, and safety studies, sustained public use and classification by the FDA Code of Federal Regulations (CFR) Title 21, Part 182 and 184.

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