The entrepreneurs and researchers behind Israeli company BioControl Medical Ltd. have already struck gold once. Now they hope they will strike it again with a new device designed to treat congestive heart failure.

Founded originally in 1999 to focus on development of a device for the treatment of urinary incontinence, a condition from which nearly 60 million people suffer globally, BioControl spent seven years toiling on the science, the R&D and the testing of their miniaturo system. Then, according to CEO Dr. Ehud Cohen, something unexpected happened.

“We developed the miniaturo electrical stimulator, conducted clinical trials, and in April 2006 when we were in the middle of discussions with the FDA, we sold the whole line to American Medical Systems,” he told ISRAEL21c.

Minnesota-based medical suppliers AMS paid BioControl $50 million for an exclusive license for the use of the technology in urology, gynecology and other pelvic health applications.

Instead of resting on its laurels, however, BioControl is now using the proceeds of that sale to continue doing what it does best – developing new products based on electrical stimulation.

The first in the pipeline is CardioFit, for the treatment of congestive heart failure, which the company began working on a couple of years ago.

According to the Heart Failure Society of America (HFSA), nearly five million Americans of all ages are affected by heart failure and more than 400,000 new cases of heart failure are diagnosed yearly.

Heart failure is a common condition that usually develops slowly as the heart muscle weakens and needs to work harder to keep blood flowing through the body. Patients who suffer from this condition often complain of exhaustion and it is the cause of more hospitalizations than all forms of cancer combined.

The most commonly prescribed drugs for heart failure today 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.

CardioFit is the first known device that treats heart conditions via nerve stimulation. The electrical stimulator system is designed to improve heart function through the controlled stimulation of the vagus nerve which is found in the neck. Pre-clinical and preliminary clinical data demonstrate that vagus nerve stimulation has a therapeutic role in treating heart failure as it may reduce the heart rate and ventricular volumes, in addition to restoring regular rhythm.

“It’s been found that this stimulation reduces stress on the heart and lets it heal,” said Cohen. “The sympathetic nerve system increases activity to the heart and the parasympathetic system reduces stress on the heart. Whenever there’s a shortage of oxygen or blood supply to the heart, the sympathetic system kicks in to supply more. With more blood, there’s more oxygen, but that’s the cause of heart attacks – the heart can’t cope with that extra stress. By increasing the parasympathetic system – which we do with electrical stimulation, we overcome that imbalance.”

The size of a standard pacemaker, the CardioFit is implanted permanently with an electrode positioned around the vagus nerve in the neck and the device placed in a subcutaneous pocket in the chest.

According to Cohen, it stimulates upon demand; it continuously measures the operation of the heart, and whenever it senses there’s too much stress, it begins to stimulate the vagus nerve.

To test the safety and preliminary efficacy of the CardioFit, BioControl has begun clinical trials in Europe, Australia and Israel. Study investigators will collectively enroll 20 to 30 patients, between the ages of 18 and 75, who meet the inclusion/exclusion criteria. Patients enrolled in the study will be followed by the study investigators for a period of one year.

“I have recruited several patients to the study thus far. It is my opinion that the CardioFit system has great potential as a useful treatment for heart failure,” said Professor Peter Schwartz, the study’s principal investigator at Policlinico S.Matteo University Hospital in Pavia, Italy.

According to Cohen, following completion of the study, the aim is to conduct a much larger one in the US early next year.

“I have closely followed the development of the CardioFit system and am hopeful that sites in the US will soon join the clinical program and begin enrolling for this very important study,” said Dr. Paul Hauptman, director of heart failure, Saint Louis University Hospital, St. Louis, Missouri.

“Physicians who have been exposed to the device or are involved in the trials are very excited – it’s the first device treatment aimed at stopping the deterioration of the disease, not just increasing acute function of the heart,” added Cohen.

According to Cohen, the CardioFit serves a completely different purpose to a conventional pacemaker.

“Pacemakers are only relevant to patients who have ventricular disynchronicity, which means both ventricles aren’t functioning at the same rate. We’re a different subset of the population,” he said.

BioControl, which was founded by Yossi Gross, a serial entrepreneur, was privately funded with investment from the Pitango venture capital fund as well as Swiss investors. Cohen joined the company at its inception.

“My previous background was in military R&D and I have a PhD in astrophysics, so this was something completely different for me,” he said with a laugh.

That diversity is likely to come in handy, however. Based on its track record with the miniaturo urinary incontinence device, BioControl will likely need Cohen to come up with a new device to begin researching once the CardioFit is proven to be the answer to heart failure treatment.