Neuropace Inc

Invention:	Anti-seizure neural implant
Trademark:	RNS® System
Patents:	122
NASDAQ:	NPCE

The invention

The RNS System is an innovative neuromodulation device designed to address drug-resistant epilepsy. It continuously monitors the brain's electrical activity, recognizes abnormal patterns specific to the patient, and delivers targeted treatment at the seizure source when needed. This system is unique because it offers significant, sustained, and improving reductions in seizure frequency, including, in some cases, eliminating seizures without stimulation-related side effects at therapeutic settings. It is considered superior in tolerability and efficacy compared to other neuromodulation approaches. The RNS System is also distinguished as the only commercially available device that records continuous brain activity data, allowing clinicians to monitor patients in person and remotely. This feature provides invaluable data for making informed treatment decisions and optimizing patient care​​.


Clinical stage

The RNS System's efficacy and safety are supported by four multi-center FDA-approved prospective clinical studies involving approximately 600 patients, with up to nine years of follow-up. These studies demonstrated a 44% median reduction in seizure frequency at one year, improving to a 75% median reduction at nine years. The system has also shown enduring improvements in quality of life and cognition. Real-world outcomes from a post-approval retrospective study published in 2020 align with these results, showing a median seizure frequency reduction of 67% at one year and 82% at three or more years. These outcomes demonstrate the RNS System's utility in effectively managing therapy across different patient cohorts over time​​.


Performance advantages

Here is how RNS compares to the incumbent devices:

Key Opinion Leaders

Key Opinion Leaders (KOLs), including epileptologists and neurosurgeons at Level 3 and Level 4 epilepsy centers, have expressed a strong preference for the RNS System over VNS or DBS systems. In a survey, 88% of these experts agreed that the 24/7 monitoring capability of the RNS System, with its chronic high-resolution intracranial EEG data, is a significant advantage and an important consideration in choosing it over other options. This preference is attributed to the RNS System being the only neuromodulation device that records intracranial electroencephalograms (iEEGs), providing valuable data for clinicians to actively manage patient care and support improved outcomes over time. Additionally, the RNS System's capability to provide this data allows for established clinician and facility reimbursement for both initial and replacement implant procedures, as well as for in-person or remote iEEG data review and device programming​​.

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Intellectual property

As of December 31, 2022, the company owned 122 issued U.S. patents and had 20 non-provisional patent applications pending. These patents and applications cover various aspects of the RNS System, including the system itself, methods of use, and elements used in its manufacture. Additionally, patents are pending for technologies related to detecting and modulating brain activity, which are critical for treating disorders and diseases of the nervous system​​.

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Addressable market

The total addressable market for the RNS System, as per the annual report, is approximately $26 billion, with a core annual market opportunity of around $1.1 billion for initial RNS System implants. This market opportunity is based on addressing 24,000 patients annually within the 50,000 drug-resistant epilepsy patients who present at Level 4 Comprehensive Epilepsy Centers (CECs) in the United States​​.


Upside

As of 25 January 2024, Neuropace has a market cap (USD$386) that is modest relative to the company's addressable market.


Sources

Neuropace Annual Report 2023
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