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TECHNOLOGY
CLINICAL OVERVIEW
Pharmaceuticals and to a lesser extent medical devices are the primary therapeutic modalities used today to treat heart failure. Though both serve a salutary function, a significant therapeutic chasm continues to exist.

The most commonly prescribed drugs for heart failure are ACE inhibitors and b-blocking agents. While current pharmacological agents treat symptoms and slow-disease progression, more than half of all chronic heart failure patients die within five years of diagnosis. BVPs (Biventricular pacing devices) as an example are pacemakers that seek to coordinate asynchronous ventricular contractions by programming the activity of the left ventricle to perform in concert with that of the right ventricle. Data show that BVP improves cardiac output, optimizes myocardial energy consumption, and reduces mitral insufficiency. With all of this promise, however, researchers hypothesize that only up to 30% of chronic heart failure patients with moderate to severe symptoms may benefit from this technology.

BioControl’s solution for autonomic disorders offers a more universal therapeutic treatment for myocardial infarction that has the potential to reverse the damage caused by this condition and improve cardiac function.

BioControl’s therapy augments the b-blockers’ sympathetic reduction effect by impacting the heart upon demand via parasympathetic selective neurostimulation.

Three Nitric Oxide Synthases (NOS) enzymes are described in mammalian systems, all of which play a modulatory essential role in the cardiovascular system. Significant changes in NOS expression levels are known to be related to cardiac diseases.

Pre-clinical study data indicates that the long-term application of CardioFit™ therapy enhances NO production and normalizes mRNA and protein expression of all 3 NOS subtypes in the LV myocardium of dogs with HF. Furthermore, in HF-controls, the mRNA and protein expression of endothelial NOS decreased, and the inducible NOS and neuronal NOS significantly increased, in comparison with normal levels. The CardioFit therapy was shown to normalize all. Additionally, overall NO production as determined by nitrate + nitrite pool, decreased in HF-controls compared to normal and significantly increased with the CardioFit therapy.

BioControl’s unidirectional selective neurostimulation technology to stimulate the vagus nerve is based on the company’s 10 issued U.S. patents and the additional 20 patents pending.
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