NeuroPace, Inc., a medical device company, which focuses on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures.
The company's novel and differentiated RNS System is the first and only commercially available, brain-responsive neuromodulation system that delivers personalized, real-time treatment at the seizure source. By continuously monitoring and analyzing the brain’s electrical activity, recognizing patient-specific abnorma...
NeuroPace, Inc., a medical device company, which focuses on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures.
The company's novel and differentiated RNS System is the first and only commercially available, brain-responsive neuromodulation system that delivers personalized, real-time treatment at the seizure source. By continuously monitoring and analyzing the brain’s electrical activity, recognizing patient-specific abnormal electrical patterns, and responding in real time with imperceptible electrical pulses to prevent seizures, its RNS System is programmed by clinicians to deliver the precise amount of therapy when and where it is needed and provides exceptional clinical outcomes with approximately three minutes of stimulation on average per day. The company’s RNS System is also the only commercially available device that records continuous brain activity data and allows clinicians to monitor patients not only in person, but also remotely, providing them the data they need to make more informed treatment decisions, thus optimizing patient care.
The company's paradigm-shifting RNS System is indicated in the United States for use in adult epilepsy patients, meaning patients who are 18 years of age or older, with drug-resistant focal epilepsy, which it believes represents an approximately $27 billion total addressable market. While the company is presently focused on this significant market opportunity, it has investigational device exemption, or IDE, approval for clinical trials to evaluate the use of the RNS System to treat drug-resistant idiopathic generalized epilepsy, or IGE, and patients between ages 12 and 17. The company may later seek regulatory approval in markets outside the United States.
The company’s RNS System has an estimated average battery life of nearly 11 years, an increase from the previous model of the device. The sale of replacement neuromodulation devices provides a recurring revenue stream that is additive to the market opportunity for initial implants.
The company developed its RNS System to address the individualized nature of drug-resistant epilepsy and deliver a safe and effective therapy for focal onset seizures anywhere in the brain. Unlike other neuromodulation devices, its RNS System continuously monitors and analyzes the brain’s electrical activity, recognizes patient-specific abnormal patterns, and delivers treatment at the seizure source when needed, providing significant, sustained, and improving reductions in seizure frequency, including, in some cases, eliminating seizures, without stimulation-related side effects at therapeutic settings. In addition, the non-destructive, reversible nature of the implant procedure makes it an attractive option for drug-resistant focal epilepsy patients, the majority of whom are not candidates for, or are unwilling to undergo, resective or ablative surgery.
The company received Pre-Market Approval, or PMA, from the FDA for its RNS System in late 2013 and began the commercial rollout of the RNS System in early 2014. It has historically marketed the RNS System in the United States through a direct sales organization primarily to the epileptologists and neurosurgeons who respectively prescribe and implant neuromodulation devices in the approximately 200 Level 4 Comprehensive Epilepsy Centers (CECs) in the United States. The company has established a significant account base at these CECs. Additionally, as a result of the approval of a PMA-S in 2023, the company is able to expand its commercial efforts to the additional epileptologists, as well as the remaining functional neurosurgeons practicing outside of Level 4 CECs. It initiated a pilot program to begin outreach to these clinicians in 2024 and has commenced program expansion that will continue through 2025. The company plans to address this opportunity in a targeted manner with incremental expansion of its sales force.
The company's near-term research, development, and clinical efforts are focused on continuing to improve therapy effectiveness, enhance the patient and provider experience, and expand the population of patients that can be treated with its RNS System. The company's near-term product development pipeline includes enhanced offerings that leverage its extensive brain activity database and its data analysis, machine learning, and artificial intelligence, or AI, capabilities. It is also pursuing studies to support label expansion for the company’s RNS System in additional epilepsy populations.
Growth Strategies
The company expects that the near-term growth of its business will be primarily driven by new patients being treated with its RNS System.
The company's business strategy is to drive adoption and utilization of its RNS system within level 4 CECS; expand RNS system access outside of level 4 CECS, in the community; broaden indications for its RNS system to include patients with generalized epilepsy and patients under age 18; continue building and using its unique data asset and its monitoring and analysis capabilities; expand into international markets; and pursue additional indications outside of epilepsy.
RNS System
The company's RNS System, which is a compilation of several of its products, represents a paradigm-shifting approach to treating epilepsy that combines the power of continuous iEEG monitoring with responsive neuromodulation. With the RNS System, the company offers a personalized treatment option that delivers a safe and effective therapy for focal onset seizures originating anywhere in the brain.
The company's RNS System includes its RNS neurostimulator, its cortical strip leads, depth leads, and its Patient Remote Monitor, as well as other implantable and non-implantable accessories. As part of the initial implant procedure, the number and configuration of leads implanted, as well as the implantable and non-implantable accessories used in the procedure, are determined by the clinician depending on individual patient needs and clinician preferences, and a Patient Remote Monitor typically included. During a typical replacement implant procedure, performed when the battery in the company’s RNS neurostimulator reaches end of service, the RNS neurostimulator is replaced, while the previously implanted RNS leads remain in place, and a new Patient Remote Monitor is typically included. The company's product offerings also include its Physician Tablet, its Patient Data Management System, or PDMS, and its nSight Platform, which facilitate ongoing patient monitoring and streamline patient support.
The company developed its RNS System to address the individualized nature of drug-resistant epilepsy with a differentiated technology that provides personalized, data-driven treatment. The RNS System is the first and only closed-loop, brain-responsive neuromodulation device approved by the FDA for the treatment of drug-resistant focal epilepsy.
The implantable components of the company’s RNS System include a neurostimulator, which is placed within the patient’s skull, and its RNS System leads with both cortical strip electrodes (on the surface of the brain) and depth electrodes (within the brain) that can be positioned according to clinician preference, as well as implantable accessories such as its burr hole cover.
In addition to the implantable components of the RNS System, the company's RNS System also includes external components, such as the Patient Remote Monitor, as well as optional accessories.
The company's Patient Remote Monitor is provided to each patient in order to collect and transmit data from the neurostimulator to its PDMS, a secure online database. It consists of a handheld wand and a specially programmed tablet or laptop computer. The patient holds the wand adjacent to the implanted device to wirelessly upload the data from the neurostimulator to the tablet or laptop, and then sends that encrypted data to the PDMS using an internet connection.
Additionally, the company provides its Physician Tablet and access to its PDMS and nSight Platform for use with the RNS System.
The company's Physician Tablet is used by prescribing or managing clinicians for programming implanted devices and managing patient care. Using the tablet’s simple, intuitive interface, the clinician retrieves and reviews iEEG data, detections, and stimulations that were recorded by the company’s RNS System and can program new detection and stimulation settings that are personalized to each patient’s brain activity. While the patient is in the clinic, the clinician can look at real-time iEEG data or test stimulation settings.
The company's PDMS is a secure online database that collects data recorded by the company’s RNS System. These data, which include all programmed parameters, detections, stimulations, and stored iEEG activity for RNS System patients, can be accessed through its Physician Tablet or from any internet browser. The clinician may choose to view recent data or to look at longer-term trends in order to assess the effects of RNS System treatment, antiepileptic drugs, or even changes to the patient’s routine. This information, combined with the patient’s own reports, is used by clinicians to make treatment decisions.
In addition to the extensive data set available on its PDMS, the company’s nSight Platform is designed to provide clinicians with personalized patient reports as well as programming suggestions. The company’s nSight Platform, which is designed to streamline patient care, includes objective iEEG data recorded by the company’s RNS System, patient-reported seizure diary data, prior programmed settings, and programming suggestions which are available in a simple and comprehensive report that provides the clinician actionable information about their patient’s seizure trends and treatment outcomes. This quick snapshot gives clinicians a more complete picture of their patient’s health and enables them to remotely manage certain portions of the patient’s care in a telehealth environment.
Current Label Expansion Studies
RESPONSE Study
The company is conducting studies to support label expansion for its RNS System in additional epilepsy populations. It has IDE approval for an open-label study of its RNS System in adolescent patients between ages 12 and 17 who have drug-resistant focal epilepsy from one or two foci. The objective of this study, referred to as the RESPONSE study, is to demonstrate safety and effectiveness in this pediatric population, and to obtain data on quality of life, neuropsychological function, and social function. The company began enrollment in RESPONSE in late 2021. It recently announced its collaboration with the National Evaluation System for health Technology (NEST) and the FDA to pursue the use of real-world data from the Pediatric Epilepsy Research Consortium (PERC) to supplement the RESPONSE study. The company is planning to file the expanded label submission to the FDA in the second half of 2025.
NAUTILUS Study
In February 2021, the company's RNS System received Breakthrough Device Designation from the FDA for the treatment of IGE. In the second half of 2021, it received IDE approval to initiate a study in IGE, called the NAUTILUS study, and in March 2024, it completed implanting patients in NAUTILUS, for a total of 87 patients implanted across 23 centers. In March 2025, the last patient is expected to complete one year of follow-up post-implant, with the data lock and subsequent commencement of data analyses expected to begin in the second quarter of 2025. The company plans to use this data to support its expected expanded label submission to the FDA in the second half of 2025, and it anticipates the final patient two-year completion in the first half of 2026.
Commercial Strategy
The company's commercial strategy historically targeted epileptologists and neurosurgeons at Level 4 CECs in the United States. Within Level 4 CECs, epileptologists are the primary specialists who prescribe and manage therapy for drug-resistant focal epilepsy patients, and neurosurgeons are the specialists who implant its RNS System.
The company markets and sells its RNS System in the United States through a direct sales organization that consists of sales representatives, known as Therapy Consultants, and clinical and programming support specialists, known as Field Clinical Engineers. Substantially all of its sales of the RNS System are in the United States. The company’s Therapy Consultants are highly skilled and technically trained with substantial experience launching new disruptive therapies, particularly in neuromodulation, and establishing them as a standard of care by increasing clinician adoption and utilization. The Field Clinical Engineers have substantial experience training clinicians on the use of sophisticated technology and providing ongoing support for medical centers as they increase adoption of new therapies.
The company supports its sales organization with marketing and training initiatives designed to educate clinicians about its RNS System and support clinician adoption. It has developed a robust professional education program that includes educational symposia, fellows training, programming workshops, and peer-to-peer forums. Through webinars, clinical briefs, and scientific conferences, the company keeps its clinician customers informed about the rapidly growing body of peer-reviewed publications and scientific research involving its RNS System. The company also engages in direct-to-patient marketing activities, including targeted online advertising and social media, to increase awareness about the benefits of its RNS System among potential patients and their caregivers.
Collaborations and Partnerships
DIXI Medical Distribution Agreement
In August 2022, the company entered into an exclusive distribution agreement, or the Distribution Agreement, with DIXI Medical, pursuant to which it became the exclusive U.S. distributor of DIXI Medical’s stereo electroencephalography, or Stereo EEG, product line beginning in October 2022. These products are used in the epilepsy monitoring units, or EMUs, of Level 4 CECs to determine where epileptic seizures originate. The Distribution Agreement has an initial term of three years, which expires September 30, 2025. The Distribution Agreement automatically renews for additional one-year terms, unless either party provides written notice to the other party of its intention to not renew at least 180 days prior to the expiration of the then-current term. The current Distribution Agreement will automatically renew unless either party provides notice of intent not to renew by April 3, 2025.
Rapport Agreement
In November 2023, the company entered into a collaboration agreement with Rapport Therapeutics, Inc., or Rapport, a clinical-stage biotechnology company, to leverage its data as well as its RNS System’s unique biomarker monitoring and data analysis capabilities.
Research and Development
The company’s research and development expenses were $23.7 million during the year ended December 31, 2024.
Competition
The company’s competitors are LivaNova plc, which manufactures the VNS System and Medtronic plc, which manufactures the DBS System.
Intellectual Property
Patents
As of December 31, 2024, the company owned 95 issued U.S. patents and 16 non-provisional patent applications pending in the U.S. Patent and Trademark Office, or the USPTO. The company’s patents have claims that cover its current RNS System or related products, such as the system itself and methods of using it, including detection and stimulation methods, as well as the brain leads, lead connector, neurostimulator tray or ferrule, and elements used in the manufacture of the same.
Trademarks
As of December 31, 2024, the company owned 26 trademark registrations, four of which are U.S. trademark registrations and the rest in various other countries or regions. The company owns trademark registrations for NeuroPace, the NeuroPace logo, and RNS in the United States and various other countries, and WINDOW TO THE BRAIN in the U.S.
Government Regulation
The company’s RNS System and its operations are subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act of 1938 and its implementing regulations, collectively referred to as the FDCA, as well as other federal and state regulatory bodies in the United States.
The company’s RNS System is a Class III device, which required PMA approval before it could be marketed. Additionally, there are certain pre-amendment Class III devices for which the FDA has not yet required a PMA, which are cleared through the 510(k) process.
One of the components of the company’s RNS System, its Burr Hole Cover, which may be used to cover the incision site for depth leads, is subject to premarket notification and clearance under section 510(k) of the FDCA.
The company is subject to the Foreign Corrupt Practices Act of 1977, as amended, or FCPA, which prohibits companies and their intermediaries from making payments in violation of law to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage.
The company is also subject to numerous other federal, state, local, and foreign laws, rules, regulations and standards related to data privacy, security and protection, including consumer protection laws and regulations that govern the collection, dissemination, use, access to, confidentiality and security of patient health and other personal information, such as the Federal Trade Commission Act and the California Consumer Privacy Act of 2018, as amended.
History
NeuroPace, Inc. was incorporated in 1997.
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