Supports Value of Insights Provided by Brain Recordings from the NeuroPace RNS® System for Drug-Resistant Epilepsy
MOUNTAIN VIEW, Calif. — February 12, 2019 – NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced that the American Medical Association (AMA) has issued a new Category I Current Procedural Terminology (CPT®) code for electrocorticography from an implanted brain neurostimulator. The new code is applicable to services that physicians perform with the company’s RNS® System, a first-of-its-kind technology for the treatment of patients with refractory epilepsy.
Beginning January 1, 2019, providers are able to report the new CPT code for the review and interpretation of electrocorticograms (measurements of brain activity) captured and stored by the RNS System. CPT codes are widely recognized by public and private health insurance payers in the United States to describe healthcare services and procedures to facilitate reimbursement. The CPT code application was submitted by the American Academy of Neurology, American Clinical Neurophysiology Society, and the National Association of Epilepsy Centers.
“The support of the medical societies for this newly issued CPT code is a testament to the strength of the long-term clinical evidence supporting this technology as well as the valuable insights from neural recordings that only the RNS System provides,” said NeuroPace CEO Frank Fischer. “The new code should give even greater access to this information and facilitate patient access to RNS therapy.”
Neural data from the RNS System provides information that helps clinicians better understand the location, frequency, and triggers of an individual patient’s seizures, allowing them to personalize care and empowering patients to better manage their condition. Using artificial intelligence and machine learning, NeuroPace scientists are analyzing millions of electrocorticographic recordings to develop algorithms designed to optimize and individualize patient care.
The RNS System treats focal seizures by continuously monitoring brainwaves, recognizing each patient’s unique “seizure fingerprint,” and automatically responding with imperceptible electrical pulses to stop seizures before they occur. Results from a landmark nine-year study of the technology demonstrated that the system resulted in significant seizure reduction, with one in three patients achieving at least 90% seizure reduction, and improved quality of life for patients, including cognitive and epilepsy-related measures.1
Of the roughly 3.4 million adults in the U.S. with epilepsy, as many as one-third have seizures that are not controlled by existing therapies. As the only FDA-approved medical device that utilizes brain-computer interface technology for epilepsy, the RNS System offers an advanced treatment option for patients with refractory focal seizures.
One in 26 Americans will develop epilepsy in their lifetime, with approximately 150,000 new cases of epilepsy diagnosed annually. An estimated 3.4 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. 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 view their patient’s electrographic data on a secure website and program the device to personalize therapy for each individual. Unlike anti-epileptic drugs or resective surgery, brain-responsive neuromodulation outcomes typically improve with time and do not cause the cognitive side effects that can be 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.
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/
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 Nair et al., presented at AES 2018.
2Epilepsy Foundation. “Facts about Seizures and Epilepsy.”