Thursday, August 11, 2022
NeuroPace, Inc., a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the company has entered into a commercialization agreement with DIXI Medical® USA (“DIXI”). NeuroPace will become the exclusive U.S. distributor of DIXI’s product line effective October 1, 2022.
Under the terms of the agreement, NeuroPace will have exclusive rights to promote and sell stereoelectroencephalography (SEEG) electrodes in the U.S. DIXI will continue to support U.S. physicians as well as education and outreach activities to inform patients and HCPs of the treatment options available for drug refractory epilepsy. For these support services, DIXI will receive an upfront payment along with two additional payments in 2023 and 2024. SEEG electrodes are used in the epilepsy monitoring units of comprehensive epilepsy centers to determine where epileptic seizures originate. Physicians use this information to target interventional treatments at the seizure source, including with the NeuroPace RNS System®.
“Epilepsy centers in the U.S. are increasingly using SEEG as a minimally invasive approach to determine appropriate treatment options for epilepsy patients, including through the use of the RNS System,” said Mike Favet, CEO of NeuroPace. “This synergistic partnership leverages the existing NeuroPace field organization, which is already calling on the same customers, and supports our objective to engage earlier in the diagnostic and therapy selection process."
“As SEEG becomes more and more popular among U.S. epileptologists and neurosurgeons, we needed to extend our reach. We are pleased to entrust DIXI electrodes in the U.S. to the strong and competent team at NeuroPace. The untapped potential of interventional treatments for epilepsy is so large that it deserves combining the energy and creativity of our companies," said Frederic Koehn, President of DIXI Medical. "As a specialty provider in this market for more than 40 years, DIXI shares a commitment with NeuroPace to deliver innovative solutions for healthcare providers to better manage epilepsy care."
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.1
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 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.
About DIXI Medical
Forty years ago, French and Italian neurosurgeons pioneered intracerebral diagnostic for epilepsy called stereoelectroencephalography (SEEG). They approached DIXI, a French company based in Besançon, to develop the first SEEG electrodes. Since then, DIXI continued to develop this revolutionary diagnostic tool allowing for a precise location of epileptic zones. DIXI sells its product in more than 40 countries around the world and initiated commercialization in the U.S. market in 2019.
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, 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 to be filed with the SEC on August 11, 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.
Media Contacts:
Health+Commerce for NeuroPace
Shay Smith
shay@healthandcommerce.com
Investor Contact:
Gilmartin Group
Matt Bacso, CFA
investors@neuropace.com
