Drug-resistant focal epilepsy: opportunities
NeuroPace estimates that there are approximately 575,000 adult patients with drug-resistant focal epilepsy in the United States.
This reflects a total addressable market opportunity of approximately $26 billion for its RNS System.
The company’s paradigm-shifting RNS System is currently indicated for use in adults with drug-resistant focal epilepsy and NeuroPace believes it is an attractive therapeutic option for these patients.
Its commercial efforts are focused on CECs in the United States that provide comprehensive epilepsy care.
As such, the company considers its primary annual market to be the 50,000 patients with drug-resistant epilepsy who attend Level 4 CECs each year, 48% of whom are adult patients with drug-resistant focal epilepsy.
NeuroPace estimates that this group of 24,000 patients represents an annual market opportunity of approximately $1.1 billion for initial RNS System implants, and expects it to continue to grow as the number of ECCs increases, the number of epileptologists increases, and referral pathways expand so that more patients can be referred to Level 4 ECCs.
Its RNS System has an average battery life of nearly 11 years, an increase over the previous model of the device, which, through the sale of replacement neuromodulation devices, provides a recurring revenue stream that adds to its current $1.1 billion annual market opportunity.
The average age of patients who received the initial implant in its clinical studies was approximately 34 years, and the company expects many of its patients to return multiple times for replacement procedures over their lifetime.
Supported by evidence published in peer-reviewed journals, NeuroPace believes that its current RNS System can also effectively treat patients under the age of 18 with drug-resistant focal epilepsy, as well as patients with drug-resistant generalized epilepsy, and the company is conducting clinical studies to support label expansion for these indications.
The company has FDA approval for an IDE study to treat drug-resistant focal epilepsy in patients under the age of 18 and began enrollment for that study in late 2021.
In February 2021, our RNS System received FDA innovator device designation for the treatment of idiopathic generalized epilepsy, or IGE.