|NeuroPace has won FDA approval of its RNS Stimulator.--Courtesy of NeuroPace|
California's NeuroPace gained the FDA's long-awaited signoff for its antiepilepsy neurostimulation implant, capping years of development and testing.
"We believe the RNS System has the potential to provide substantial improvement in quality of life to hundreds of thousands of people diagnosed with epilepsy in the U.S. who are unable to achieve seizure control with medications," Frank Fischer, NeuroPace CEO, told FierceMedicalDevices via email. "We anticipate that physicians will be able to make this breakthrough therapy available to eligible patients in the very near future."
Plans call for marketing the RNS system initially to the original 32 pivotal trial sites and then to other comprehensive epilepsy centers. NeuroPace also has reimbursement coding in place and expects that to be "positive" postapproval.
The agency itself announced its approval of the RNS Stimulator, based, in part, on a three-month randomized controlled trial of 191 patients who had drug-resistant epilepsy. After three months, the device helped reduce the average number of seizures per month by nearly 38%. An FDA panel of experts in February 2013 unanimously backed approving the RNS implant.
In short, the RNS Stimulator is designed to stop epileptic seizures before they start, by way of a small implant placed under the scalp on the skull that's connected to a few electrodes placed on areas of the brain from which doctors believe the seizures originate. It detects abnormal brain electrical activity and then delivers a small electrical impulse, normalizing brain activity before a seizure takes place.
NeuroPace's accomplishment is significant, considering that as many as 3 million people in the U.S. alone suffer from epilepsy, according to statistics cited by the FDA. What's more, as many as 40% with the condition suffer from major problems and still experience seizures with treatment, so the device has significant market potential. But there are limitations along with the device. The FDA noted that patients with the implant can't undergo MRI procedures, electroconvulsive therapy or transcranial magnetic stimulation. Each procedure could cause permanent brain damage for RNS implant patients, regulators said.
NeuroPace will not be alone in the neurostimulation market. Cyberonics ($CYBX) is one of the larger makers of implantable neuromodulation devices to treat epilepsy and treatment-resistant depression. NeuroSigma began a pivotal study earlier this year of its Monarch system for the treatment of drug-resistant epilepsy. Medtronic ($MDT) is testing a new "smart" brain implant designed to manage epilepsy, and it, Boston Scientific ($BSX) and St. Jude Medical ($STJ) have neurostimulation technology under various stages of development to treat a number of different conditions.
In July, NeuroPace reeled in $18 million of a planned $50 million funding round. While it didn't disclose the new investors, its past VC roster is impressive: New Enterprise Associates, InterWest Partners and Johnson & Johnson ($JNJ). Since its launch in 1997, the company has raised about $180 million, according to a previous report in the Silicon Valley Business Journal.
- read the FDA release
Editor's note: This story was updated to include comments from the NeuroPace CEO and information about market rollout.