First patient receives brain-responsive neuromodulation for LGS, a severe and disabling childhood-onset epilepsy

NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the first patient with Lennox-Gastaut Syndrome (LGS) was treated in its feasibility investigational device exemption (IDE) study. LGS is a devastating form of childhood onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury. The study uses the RNS^® System, which has demonstrated safety and effectiveness of brain-responsive stimulation for treating medically intractable focal onset seizures in people 18 and older, to test whether brain-responsive neurostimulation can also be used to treat LGS.

The first procedure took place at Emory Healthcare in Atlanta and was performed by Robert E. Gross, MD, PhD, the MBNA Bowman Chair in Neurosurgery and Professor and Vice Chair, Emory University Department of Neurosurgery. “An exciting aspect of this study is that the implant location for each patient is based on customized models of their brain connectivity.”

NeuroPace received a $9.3 million National Institutes of Health (NIH) grant through the Brain Research through Advancing Innovative Neurotechnologies^® (BRAIN Initiative) to evaluate its responsive neuromodulation technology in those who suffer from LGS. Six study sites will enroll a total of 20 patients 12 years of age and older with LGS and drug-resistant generalized onset seizures.

“The NIH looks for ideas that could be transformative, with the potential to change how LGS is treated today,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “In addition to finding the best detection and stimulation settings for responsive neurostimulation in LGS, we are looking to identify changes in the recorded brain data that indicate whether the therapy is effective. These so-called biomarkers may help clinicians treat LGS and also facilitate future research, including the possibility of a larger clinical study into the mechanisms of the disease and treatment approaches.”

Presently, antiseizure medications are the standard of care for treatment of LGS. However, even with multiple medications, seizures are rarely controlled, and it is typical for people with LGS to experience increasing disability over their lifetime.

"Overall, treatment is rarely effective in LGS, and the outcome remains very poor," said Tracy Dixon-Salazar, PhD, Executive Director of the LGS Foundation and mother of an adult living with LGS. "Those living with LGS need new treatment options for the many seizures, LGS-associated disorders, and treatment side-effects our loved ones suffer. The impact of LGS extends to the whole family, as we shoulder this unpredictable disease and try to manage the many physical, emotional, and financial burdens. We need better treatments now."

Disclaimer: Research reported in this press release was supported by the National Institutes of Health’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative under award number UH3NS109557. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Epilepsy

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.^[i]

About the RNS^® System

The RNS^® System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA. The closed-loop technology delivers personalized, data-driven treatment targeted to the seizure source by continuously monitoring brain activity, recognizing a patient’s unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures. By recording ongoing EEG data, the RNS System provides physicians with a unique “window to the brain,” enabling them to remotely monitor their patients, gain insights based on brain activity, and use that information to optimize patient care. Long-term clinical studies demonstrate that the RNS System provides significant reduction in seizure frequency and enduring improvements in quality of life and cognition with no stimulation-related side effects. The RNS System is available at most comprehensive epilepsy centers in the United States and is widely covered by insurance. It is currently approved in the United States as an adjunctive therapy for patients 18 years of age and older with drug-resistant focal epilepsy. See important safety information at www.neuropace.com/safety/.

About NeuroPace, Inc.

Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients suffering from drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders.

Forward Looking Statements

In addition to background and historical information, this press release contains “forward-looking statements” based on NeuroPace’s current expectations, forecasts and beliefs, including NeuroPace’s expectations and beliefs about future growth and indication expansion, commercialization efforts, expected returns, growth plans and revenue expectations, as well as our assumptions underlying these expectations. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the possibility of delays or failures associated with implementation, regulatory actions, failure to maintain or renew key customer and other business relationships, failure to maintain competitive offerings, the possibility of unfavorable results, and other risks associated with our commercialization efforts or business. You should not put undue reliance on these statements or the information presented. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its public filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 10, 2022 and its quarterly report on Form 10-Q filed with the SEC on November 8, 2022, as well as any reports that it may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace.

^[i]Epilepsy Foundation. “Facts about Seizures and Epilepsy.”

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