27 Jan 2014

Israel Ministry of Health Approves Clinical Trials for BioControl Medical’s CardioFit® System in Heart Failure

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YEHUD, Israel and NEW HOPE, Minn. – January 27, 2014 – BioControl Medical, a medical device company headquartered in Yehud, Israel, has received approval from the Israel Ministry of Health to conduct clinical trial of its CardioFit® system in patients with chronic heart failure (HF) as part of INOVATE-HF. With the approval, Israel will join European countries and the United States to participate in the company’s third phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a U.S. Food and Drug Administration-approved investigational device exemption (IDE) study of CardioFit being conducted in 80 centers worldwide.

Initiated in April 2011, INOVATE-HF is a prospective, randomized, controlled clinical study to determine the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function and the first medical device to treat chronic heart failure using neurostimulation.  The study will evaluate the system’s potential to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.1

“This will be the first time we recruit patients in our own country for a clinical trial with the CardioFit®” said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. “We have anticipated the day when we could bring our technology to patients in Israel, and it is only fitting that we are able to include our neighbors, family and friends in our ground-breaking INOVATE-HF trial.”   

Three medical centers will participate in the study: Barzilai in Ashqelon; Bnai-Zion (Rothschild) in Haifa; and Kaplan in Rehovot. Patients diagnosed with Class III heart failure caused by left ventricular dysfunction who routinely take prescription drug therapy may qualify to participate in the trial.  Patient recruitment is already underway.

“INOVATE-HF is an incredibly important trial that could offer new hope to patients with heart failure and provide medical professionals with new insights into how to treat and prevent the progression of the disease,” said Prof. Uri Rosenschein, director of the department of cardiology, Bnai-Zion Medical Center and a lead investigator in the trial.  “We are honored to be part of a potentially groundbreaking clinical trial for a product that was designed and developed in Israel.”

INOVATE-HF is designed to explore CardioFit’s potential to help treat one of the hallmarks of HF: an imbalance in the autonomic nervous system, which regulates involuntary bodily functions including heart muscle activity. In healthy individuals, the two branches of the autonomic nervous system, called the sympathetic and the parasympathetic, work in concert to regulate the heart. At the most basic level, the sympathetic increases cardiovascular activity, while the parasympathetic decreases it. In people with HF, the balance between these two branches is disrupted, leading to added stress on the heart and progressive deterioration of cardiovascular function.

While prescription medications have been successful at treating the sympathetic branch to reduce select symptoms, there have been no treatments designed to specifically and safely target the parasympathetic branch. CardioFit was developed to activate the parasympathetic nervous system directly to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.

HF is a serious condition in which the heart cannot supply adequate blood flow and oxygen to the body. An estimated 100,000 people in Israel and 23 million people worldwide suffer from the disease, which is the leading cause of hospitalization in people over the age of 65.

About the CardioFit

The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator’s electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit System can be programmed on and off via external communication with the device.

The safety and performance of the CardioFit have been validated in a 32-patient, multi-center, pilot clinical study conducted in Germany, Italy, The Netherlands and Serbia.2 Study data showed that patients experienced sustained significant improvement across key clinical measures including left ventricular function and structure, heart rate variability, and resting heart rate.2 Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests.3 The results of this pilot study supported BioControl Medical’s filing for CE mark certification to market and sell CardioFit in the European Union, which it was granted in December 2008.