Two days ago Medgadget ran a post about European launch of CerebralRx‘s FitNeS vagus nerve stimulation system for patients with partial onset seizures that cannot be effectively controlled by pharmacological treatments. To follow up on that post, we got in touch with Ehud Cohen, CEO of BioMedical Control and a member of the CerebralRx board. (CerebralRx is a spinoff of BioMedical Control.) Here’s our interview about the new company, technology and its future:
1. How effective is the FitNeS system expected to be in preventing seizures? Do you expect it to be more effective than competing systems?
The FitNeS system was designed to offer several improvements over competing systems. The surgical technique is easier, the stimulation is more efficient and the unidirectionality of nerve stimulation is improved. The improved performance of BioControl Medical’s stimulation technology was demonstrated in the various CardioFit studies, and these benefits have the potential to improve treatment effectiveness. CerebralRx will be conducting an extensive post-market study to measure the effectiveness of FitNeS.
2. Can you tell us some more about the “unique” nerve electrode interface and how the system achieves unidirectional nerve stimulation?
The proprietary nerve electrode interface protects the integrity of the nerve by placing a recessed conductor that enables direct contact between the nerve and a soft silicon layer (see attached image). Improved unidirectionality is achieved by increased anodal current density. The electrode performance and build was recently published in the Journal of Neural Engineering (2011 J. Neural Eng. 8 034004). (1)
3. What difficulties did you encounter when transferring the technique from cardiac to nervous application?
We recognized that the clinical development path for FitNeS was going to be very different from CardioFit, since vagus nerve stimulation is already an established therapy for epilepsy. For this same reason, the market launch for FitNeS would be different as well. This was the reason for opening the spin-off company CerebralRx.
4. In the future, do you expect vagus stimulation to be a viable option in more epilepsy patients, or will it stay limited to those with partial onset seizures who do not respond to pharmacological treatment?
We believe there is a significant growth potential for vagal stimulation within partial onset seizures patients, and that is where our focus will be. As mentioned (and cited) in the press release, fifty percent of patients with epilepsy suffer from partial onset seizures, and 30 percent of this group is refractory. With the improved electrode, CerebralRx aims to increase market penetration substantially.
5. What other diseases do you aim at treating with this technology and when do you expect this to happen?
CerebralRx will look at a range of neurological disorders for treatment with FitNeS, including depression and Alzheimer’s. Depression is likely to be next, with Alzheimer’s further out in the pipeline.