BioControl Medical’s FitNeS Approved for Use in Europe

BioControl Medical’s FitNeS Approved for Use in Europe

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BioControl Medical’s FitNeS
BioControl Medical’s FitNeS

BioControl Medical has announced that it received CE marking in Europe for use of its FitNeSvagus nerve stimulation system (together with its spin-off CerebralRx) as an adjunct therapy for treatment resistant depression (TRD). TRD, which is depression that has not responded to four or more antidepressant treatments, is a serious condition affecting 4-10 percent of the worldwide population.1 This is the second indication for FitNeS; the first was for the treatment of drug-resistant epilepsy.

BioControl Medical’s FitNeS
BioControl Medical’s FitNeS

“Along with the team at BioControl Medical who developed the FitNeS technology, I have long believed that this technology would be transformational in treating neurological disorders including treatment resistant depression”

CerebralRx’s FitNeS consists of an implanted stimulator and stimulation lead, which work together to deliver electrical signals to the left vagus nerve. The FitNeS system addresses TRD by applying low amplitude stimulation signals to the vagus nerve in a preferentially directional way toward the brain. The system effectively activates nerve fibers toward the brain while minimizing the activation of non-related nerve fibers and surrounding tissues. This selective approach has the potential to increase stimulation effectiveness while minimizing risk of side effects.

“Depression can be a debilitating disease, particularly when it does not appear to be treatable with traditional medications,” said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical told Tech Spade. “The fact that this technology is now available to these very vulnerable patients – those who may have lost hope of successfully treating their depression – is a great win for everyone.”

Patients who suffer from TRD have typically been treated with several different classes of antidepressants, sometimes at the same time, and have seen little to no relief. When they are finally diagnosed with TRD, they are often quite discouraged at their lack of progress, which can further contribute to their depression. Medically, they tend to be at greater risk of hospitalization, are more likely to abuse drugs and alcohol, are at increased risk of attempting suicide, and are more likely to be diagnosed with or have a family history of mental illnesses. Additionally, they are more likely be experiencing significant life events. These factors suggest that genetics and/or stress might play a role in this disease.2

“Along with the team at BioControl Medical who developed the FitNeS technology, I have long believed that this technology would be transformational in treating neurological disorders including treatment resistant depression,” said Per M. Johansson, M.D., Ph.D., a neuropsychiatrist at the Sahlgrenska Academy, University of Gothenburg, Sweden, and a scientific advisor for CerebralRx. “This latest approval in Europe continues to validate our approach, as well as demonstrate the global opportunity for this technology and what it can offer patients.”

The company is working with its distributors to market the FitNeS system for TRD in Europe in the near future. The FitNeS system is not available in the United States.

Separately, BioControl Medical is continuing enrollment in the third and final phase of the INOVATE-HF clinical study of its CardioFit System. Based on the same underlying technology as FitNes, the CardioFit® system is an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure (HF).

“The INOVATE-HF study enrollment rate continues to exceed expectations, and we are pleased to report that more than 425 patients have been enrolled and 230 implanted with the CardioFit vagal nerve stimulation device thus far,” said Doug Mann, M.D., co-chair of the INOVATE HF steering committee at Washington University in St. Louis.