YEHUD, Israel--(BioControl Medical, has announced market entry with the launch of its FitNeS vagus nerve stimulation system. Designed to treat epilepsy patients with partial onset seizures who do not achieve full seizure control with available prescription drugs (or those with “refractory epilepsy”), the FitNeS system has been successfully implanted in the first two patients at the Institute for Clinical Neurosciences at the Shalgrenska Academy in Götenberg, Sweden. CerebralRx has also reported its first order for the FitNeS system from the AMS Group, a leading distributor of neuromodulation medical devices in Italy.)--CerebralRx, a newly formed spin-off of implantable neuromodulation systems developer
“The formation of CerebralRx and launch of FitNeS are significant milestones that will increase our technology’s penetration in the global neuromodulation market”
The FitNeS system employs platform technology developed by BioControl Medical, maker of the CardioFit® system for treating congestive heart failure (HF). CerebralRx spun out of BioControl Medical to expand the use of this technology outside of cardiology for the treatment of a range of neurological disorders, including epilepsy.
“The formation of CerebralRx and launch of FitNeS are significant milestones that will increase our technology’s penetration in the global neuromodulation market,” said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. “CerebralRx is built on years of development of the CardioFit by BioControl Medical, giving it the scientific and business foundation essential for success as it targets the field of neurology. The first implants and first commercial order of FitNeS are great testaments to the early interest in this new treatment option for patients with refractory epilepsy.”
CerebralRx’s FitNeS consists of an implanted stimulator and stimulation lead, which work together to deliver electrical signals to the left vagus nerve. Designed to deliver targeted, unidirectional nerve stimulation, the system effectively activates nerve fibers toward the brain while minimizing the activation of non-related nerve fibers. This selective approach has the potential to increase stimulation effectiveness while minimizing risk of side effects.
“The opportunity presented by FitNeS system is exceptional, thanks to the characteristics and the innovation brought by this device. In my opinion, the FitNeS system will capture a segment of the vagus nerve stimulation market with no competitors among the producers of active implantable systems and will conquer part of the market that to date has been stronghold of the pharmaceutical companies,” said Mauro Vendrami, president and chief executive officer of the AMS Group. “For more than 20 years, we have collaborated with companies that produce active implantable systems, but we have seldom experienced the level of synergy, collaboration and enthusiasm that we have found in the CerebralRx team.”
CerebralRx is launching FitNeS into a therapeutic area with a very large patient population. Epilepsy is a common condition estimated to affect 50 million people worldwide.1 More than one percent of the population is at risk for developing chronic epilepsy, and onset may occur at any age.2 The prevalence of active epilepsy in the United States is estimated at nearly three million, with 200,000 new cases diagnosed every year; in Europe, these prevalence and annual diagnosis statistics are estimated at 3.5 million and 300,000, respectively.3,4 Fifty percent of patients with epilepsy suffer from partial onset seizures, which are typically treated with anti-epileptic prescription drugs.3 However, 30 percent of these patients are “refractory,” or unable to achieve seizure control with available drug therapy.3
The FitNeS system was developed to offer a new treatment option for refractory epilepsy patients while delivering improvements over existing vagus nerve stimulation devices. In addition to its potential to increase stimulation efficacy and minimize side effects, the FitNeS system was designed to employ lower currents, minimize nerve damage through a unique nerve electrode interface, reduce current leakage through improved cuff isolation, and allow for safe and easy explant of the electrode if required.
The FitNeS system has CE marking and is available in Europe. The device is not available in the United States.
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 www.biocontrol-medical.com.
Based in Yehud, Israel, CerebralRx was founded in 2010 as a spin-off of BioControl Medical to develop breakthrough implantable neuromodulation systems for the treatment of autonomic nervous system-related neurological disorders. The company’s flagship product is the FitNeS system, an implantable vagus nerve stimulation device for treating patients with refractory epilepsy. CerebralRx plans to expand the application of its technology for treating additional disorders, including Alzheimer’s and depression.
1 “Epilepsy: aetiogy, epidemiology and prognosis,” World Health Organization, February 2001.
2 “What is Epilepsy?” The National Society for Epilepsy, 2009.
3 Epilepsy Foundation of America
4 Forsgren, L. et al., “The epidemiology of epilepsy in Europe - a systematic review,” Journal of Neurology, 2005 Apr;12(4):245-53.