Challenge

Heart failure is globally on the rise.
According to the World Health Organization, 17.9 million people die due to cardiovascular diseases worldwide, each year. This represents 31% of global deaths. Additionally, 85% of these deaths are due to heart attacks and/or stroke. ​An aging and growing population, with poor diet and lifestyle choices, are drivers to this tendency.

According to the New York Heart Association (NYHA), Heart Failure is classified into four classes (Class I to IV).

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Class  III     

Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnoea.

There are 4.5 million patients in the world (1 million in the U.S.) per year in this category.

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Class IV             

Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

There are 1 million patients in the world (0.3 million in the U.S.) per year in this category.​

The medical eco-system does not have today any durable solution to offer to >96% of class IV patients.  Why?

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There are two major explanations​:
Either related to Medical facts or related to the cost of treatment.

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Medical facts:

Currently, there are only two possible solutions, and unfortunately, both of them require heart or chest surgery.

1.  Heart transplant: The preferred solution. In the USA alone there are only ≈ 2,200 donations per year, a highly insufficient amount to meet the demand (300.000). 

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2.  Ventricular Assistance Device (VAD): Only 5,500 VAD implantation surgeries are performed annually in the US, a highly insufficient amount to meet the demand (300.000).

Patients who suffer from advanced Heart Failure often have other diseases, and are weak, or frail; For these reasons, overcoming an open chest or heart surgery (with or without general anesthesia or cardiopulmonary bypass) becomes a very high risk and extreme challenge when considering the markedly increased risk for perioperative complications such as infection, bleeding, thrombosis and increased hospitalization time.

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Cost of treatment:

Medical health insurance company's effectiveness index: American health insurance companies have an Index that measures treatment cost-effectiveness.

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If the treatment cost of an advanced stage illness is below 20K dollars per year, it is considered very profitable. If the treatment cost is above 100K per year, it is considered unprofitable.