[August 29, 2014]

BioControl Medical Crosses Important Enrollment Milestone in INOVATE-HF Study Evaluating CardioFit® System in Heart Failure

BioControl Medical announced today that it has reached an important clinical trial milestone, reaching 480 randomized subjects - or 70 percent - of the planned 650 subjects with congestive heart failure (HF) in the INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) trial of its CardioFit® system, the first medical device designed to treat HF using neurostimulation. With more than 65 participating centers in the United States and Europe, INOVATE-HF is the largest prospective, randomized global study ever to evaluate the treatment of HF with vagus nerve stimulation.

CardioFit is a unique, implantable vagus nerve stimulation system, which includes a pacemaker-like stimulator placed in the upper chest and a proprietary nerve stimulation cuff placed on the right vagus nerve in the neck. It is designed to help patients achieve optimal therapy parameters by providing stimulation only when a patient's heart rate is between pre-set limits. The primary endpoint of the study is to compare the number of HF hospitalizations and all-cause mortality in patients with CardioFit vs. those on standard evidence-based management.

"Reaching the 70 percent milestone in the INOVATE-HF trial has been incredibly important to the entire company, as well as our investigators," said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. "Since its inception, the entire team has been working tirelessly to move the study forward because we believe in the promise this pioneering technology holds for patients with heart failure."

The milestone follows a recent grant of an additional U.S. patent on BioControl Medical's technology, one of 45 that have been awarded over the past few years. The patent (No. 8,718,791) is for a nerve stimulation electrode that enables fiber selection within a nerve and is part of the company's efforts to develop nerve simulation electrodes designed for specific clinical uses.

"No other nerve stimulation electrode on the market is specifically designed for cardiac application," said Shai Ayal, Ph.D., chief technology officer, BioControl Medical. "This is an industry-leading technology and allows the CardioFit system to achieve stimulation currents of 3.5 millamperes and above, and activate the cervical vagus nerve in a way that no other system is capable. We believe this technology has made a tremendous difference in our INOVATE-HF trial."

Initiated in April 2011, INOVATE-HF is an investigational device exemption (IDE) clinical study to determine the safety and efficacy of CardioFit in reducing hospitalization and death among patients with HF by comparing treatment with CardioFit to standard evidence-based management.¹ The study is randomized at a 3:2 ratio, so that for every five subjects enrolled, three are implanted with CardioFit and two are randomized to the control group. The company expects at least 80 percent of the patients in the trial will also have an implantable cardioverter defibrillator and 30 percent of patients will have a cardiac resynchronization therapy device.⁵

More than 275 CardioFit implants have been completed to date as part of the INOVATE-HF study. Results of the study will be used to supporta Premarket Approval Application to the U.S. Food and Drug Administration.

About the CardioFit

The CardioFit system, designed for cardiac use, 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 wireless communication with the device.

The initial safety and performance of the CardioFit were 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 Recognized as seminal original research in the European Journal of Heart Failure, the pilot study supported BioControl Medical's filing for CE mark certification in Europe, which it was granted in 2008.⁴

About BioControl Medical

Headquartered in Yehud, Israel with offices in New Hope, Minn., BioControl Medical develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results. For more information on BioControl Medical, visit http://www.biocontrol-medical.com.

Caution: In the United States, the CardioFit is an investigational device. Limited by Federal (or United States) law to investigational use.

References

¹ Luscher, TF, et al. "The European Heart Journal and the European Journal of Heart Failure: partners in scientific publishing." European Journal of Heart Failure (2012) 14, 1075-1082

² De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J,Raspopovic S, Klein H, Swedberg K, Schwartz PJ. "Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure." Eur Heart J (2011) 32 (7): 847-855.

³ Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling (News - Alert), RC, Mann DL. "Rationale and study design of the INcrease Of Vagal TonE in Heart Failure study: INOVATE-HF." American Heart Journal (June 2012) 163 (6): 955-962.

⁴ Luscher, TF, et al. "The European Heart Journal and the European Journal of Heart Failure: partners in scientific publishing." European Journal of Heart Failure (2012) 14, 1075-1082

⁵ Gold, MR. "Vagal Stimulation for the Treatment of CHF and Arrhythmias." Presented at International Dead Sea Symposium (IDSS) 2014.

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