|NeuroPace's RNS System--Courtesy of NeuroPace|
The $40 million Department of Defense research program into restoring memory will use NeuroPace's implantable neurostimulator, a move that the company said could help it expand the product's indications beyond epilepsy.
"The RNS System is the only commercially available product that continuously monitors the brain's electrical signals, delivers stimulation only when needed and then monitors the response," said NeuroPace CEO Frank Fischer in a July 22 statement. "This capability is critical to the research phase of projects like the DARPA RAM program. Restoring active memory could improve the lives of so many. We are thrilled to be a part of this program and hope to be part of similar brain research and product development projects in the future."
Epilepsy patients at 7 Comprehensive Epilepsy Centers (those rated level 4 by National Association of Epilepsy Centers) will receive the RNS implant as part of the Restoring Active Memory initiative. Others RNS System patients will be studied at the University of California, Los Angeles under the direction of Dr. Itzak Fried.
"Using the RNS System, we will be able to immediately explore ways in which brain stimulation can restore memory function in patients with epilepsy. Insights derived from these early studies will help to guide future research in patients with other neurological disorders that result in memory loss," professor Michael Kahana, one of the project's investigators and the director of the University of Pennsylvania's Computational Memory Lab, said in a statement.
NeuroPace says that the RNS System is the only neurostimulation device that delivers stimulation on an as-needed basis due to its unique ability to monitor and assess the brain's response to its treatment.
In what FierceMedicalDevices deemed one of the most significant approvals of the year, the RNS System received a PMA from the FDA in November 2013 after randomized controlled trials found that the implant reduced the number of seizures per month by almost 38%. As many as 3 million people in the U.S. alone suffer from epilepsy, according to statistics cited by the FDA.
By March 2014, 110 epilepsy centers in the U.S. with sophisticated diagnostic testing had filed paperwork to be able to offer the implant, NeuroPace told the The New York Times, which wrote an article profiling patients who have been helped by the device.
- read the release
- read the NYT article (sub. req.)
Special Report: 2013's top FDA approvals in med tech - NeuroPace's antiepilepsy neurostimulation implant