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VistaGen Therapeutics, Inc. (VSTA) Utilizing Stem Cell Technology to Improve Predictability in Clinical Trials

Unexpected cardiotoxicity, which damages the heart muscles, is among the most prevalent reasons for failure of both drugs and drug candidates. VistaGen Therapeutics, Inc. (OTCQB: VSTA), through its customized cellular assay system, CardioSafe 3D™, is working to enhance current testing practices and dramatically improve clinical predictability for new drugs.

The company’s CardioSafe 3D™ technology utilizes VistaGen’s human pluripotent stem cell-derived cardiomyocytes (hPSC-CM) and customized assays to screen for heart complications of new drug candidates, including cardiomyocyte cytotoxicity and the development of irregular beating patterns. By incorporating its groundbreaking system early in preclinical development, VistaGen expects to decrease development costs by avoiding instances of late-stage clinical termination and product recall from the market.

With its proprietary human stem cell differentiation technology, the company is able to generate hPSC-CMs at higher levels of purity without the need for genetic modification or cell selection, which can distort results and clinical predictively. VistaGen expects CardioSafe 3D™ to be effective as both a method of identifying novel drug candidates with potential cardiotoxicity side effects and a new generation tool to study important potential mechanisms of cardiotoxicity for drug discovery and regenerative medicine applications.

According to a report from The National Center for Biotechnology Information (NCBI), cardiovascular toxicity remains a major cause of concern for a variety of drug candidates, including those used to treat various types of cancer, antidepressants, antipsychotics and antibiotics. Current testing methods, such as live animal models and the hERG assay, simply can’t provide the far more comprehensive levels of human biological accuracy needed to prevent potentially costly oversights in drug development.

NCBI reports that the costs associated with bringing a new drug to market exceed $1.5 billion, and experts agree that the cost of research and development, particularly in terms of clinical trials, is still on the rise. For that reason, it’s imperative for pharmaceutical companies to use the most accurate tools available in order to avoid potentially massive financial missteps. VistaGen, through the continued development and implementation of its CardioSafe 3D™ technology, is creating a preclinical tool that major pharmaceutical developers and the FDA won’t be able to ignore.

For more information on the company, visit

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