NeuroPace Announces Final Results from the Largest Prospective Clinical Study in the Field of Neuromodulation with 9-Year Follow-Up at the 2018 American Epilepsy Society Annual Meeting

NEW ORLEANS–(BUSINESS WIRE)–American Epilepsy Society Annual Meeting, Booth 519—NeuroPace,
Inc., a Silicon Valley-based medical technology company that recently
launched the Next-Gen RNS® System for refractory epilepsy,
today announced complete results from its groundbreaking Long-Term
Treatment Study that prospectively evaluated 256 patients across 33
epilepsy centers with nearly 1,900 patient implant years of follow-up.
Treatment with the RNS System, the world’s only brain-responsive
neuromodulation system, resulted in significant seizure reduction and
improved quality of life for patients, including improved memory and
cognition1. Drug-resistant epilepsy patients in the study
(who had a median of 10 seizures per month) experienced the following
long-term clinical outcomes:

  • Approximately 3 out of 4 patients responded to therapy, achieving at
    least 50% seizure reduction; 1 in 3 patients achieved at least 90%
    seizure reduction.
  • 28% of patients experienced seizure-free periods of six months or
    longer and 18% experienced seizure-free periods of one year or longer.
  • Median seizure reduction across all patients was 75% at 9 years.
  • Quality of life improvements (including cognition) were sustained
    through 9 years, with no chronic stimulation-related side effects.

“This 9-year landmark study is the largest and longest prospective
neuromodulation trial in the field of epilepsy,” noted Dr. Dileep Nair,
a paid consultant to NeuroPace, principal investigator of the study and
section head of adult epilepsy at Cleveland Clinic’s Neurological
Institute. “Brain-responsive neurostimulation not only demonstrates
compelling long-term seizure reduction for patients, but also provides
physicians with ongoing neural recordings that have improved our
understanding and treatment of seizures.”

As the first and only FDA-approved medical device that utilizes
brain-computer interface technology for epilepsy, the RNS System offers
the most advanced treatment option for patients with focal seizures who
have not responded well to medication. Unlike anti-epileptic drugs or
resective surgery, brain-responsive neuromodulation outcomes typically
improve with time and do not cause the cognitive side effects that are
associated with those alternatives. The RNS System is now available at
nearly all comprehensive epilepsy centers in the United States and is
widely covered by private and government insurance.

“We are excited about the strong results demonstrated in our Long-Term
Treatment Study, but we recognize that this is just the beginning,”
noted NeuroPace Chief Medical Officer Martha Morrell. “The neural
recording capability of the RNS System provides us with an unprecedented
window to the brain. Our research focus now is to apply artificial
intelligence to this rich data set to optimize therapy settings and
improve clinical outcomes faster. The neural data has revealed
remarkable discoveries about how the brain functions over months and
years—these insights have the potential to lead to the treatment of
other brain disorders that affect millions of people worldwide.”

About Epilepsy
1 in 26 Americans will develop epilepsy in
their lifetime, with approximately 150,000 new cases of epilepsy
diagnosed annually. An estimated 3 million Americans currently live with
epilepsy. Epilepsy is a chronic disorder, the hallmark of which is
recurrent, unprovoked seizures. More people live with epilepsy than
autism spectrum disorder, Parkinson’s disease, multiple sclerosis and
cerebral palsy – combined. 2

About the RNS® System
The RNS
System is the world’s first and only closed loop brain-responsive
neurostimulation system designed to prevent epileptic seizures at their
source. As a type of brain-computer interface, the RNS System treats
seizures by continuously monitoring brain waves, recognizing each
patient’s unique “seizure onset fingerprint,” and automatically
responding with imperceptible electrical pulses before seizures occur.
The RNS System is composed of a neurostimulator, leads that are placed
at the seizure foci, a remote monitor used by patients to upload their
data, and a RNS Tablet and Patient Data Management System (PDMS) used by
physicians. Physicians can remotely view their patient’s electrographic
data on a secure website, and program the device settings to personalize
therapy for each individual’s unique brain patterns.

The RNS® System is an adjunctive therapy for adults with
refractory, focal onset seizures with no more than 2 epileptogenic foci.
See important safety information at https://www.neuropace.com/safety/

About NeuroPace
NeuroPace is the global leader in the
emerging field of brain-computer interface technologies, which is
projected to become a $1.2 billion market by 2024. We are dedicated to
developing groundbreaking technology and advancing brain science to
improve the quality of life for millions of individuals who suffer from
neurological disorders. The company’s first product, the RNS System, is
the only FDA-approved brain-responsive neurostimulator for the treatment
of focal onset refractory epilepsy. In addition to treating epilepsy,
brain-responsive neuromodulation holds the promise of treating other
brain disorders that impact quality of life for millions of patients
throughout the world.

1 Loring DW et al., Epilepsia, 2015

2 Epilepsy Foundation. “Facts about Seizures and Epilepsy.” http://www.epilepsy.com/learn/epilepsy-101/facts-about-seizures-and-epilepsy

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