Transcript NeuroPace, Inc.

The NeuroPace® RNS System:
Clinical Development of Responsive
Cortical Stimulation as a Treatment
for Medically Refractory Epilepsy
Martha J. Morrell MD
NeuroPace, Inc.
NeuroPace Overview
• Founded in 1999 to design, develop,
manufacture and market implantable
responsive neurostimulation devices for
treating epilepsy by direct brain stimulation
The RNS™ System Approach
• Detect abnormal brain electrical activity with
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electrodes implanted near the area of seizure
onset
Stimulate at the time of detection and before
a seizure develops
Program detection and stimulation for
individual patient
Transmit device and electrocorticogram data
to interactive web-based repository
View data on-line at any time to assess
clinical response
The RNS™ System
• Cranially implanted
battery powered
responsive
neurostimulator
• Connected to 2
leads (depth and/or
subdural) with 4
electrode contacts
each
The RNS™ System
Neurostimulator detects
and stimulates
abnormal brain
electrical activity with
implanted electrodes
Programmer sets
detection and
stimulation parameters
Programmer and Patient
Data Transmitter send
ECoG data to webbased repository for
review
Patient Data Management System
Caution: Investigational Device. Limited by US Law to
Investigational Use Only.Caution: investigational device. Limited by
Overview: RNS System Clinical
Trials in Epilepsy
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Feasibility Trial: completed
Pivotal Trial: on-going
Long-term Treatment Trial: 5 year
follow-up all subjects
RNS™ System Feasibility Investigation
• Designed to assess safety of the RNS™
System and to show preliminary evidence for
efficacy as an adjunctive therapy in reducing the
frequency of seizures in individuals 18 years of
age or older with partial onset seizures that are
refractory to two or more antiepileptic
medications
• Multi-center investigation
RNS™ System Feasibility Investigation:
Inclusion Criteria
• 18 to 65 years of age with disabling simple,
complex partial and/or generalized tonic clonic
seizures
• Failed treatment with 2 or more antiepileptic
drugs
• 4 or more simple, complex or secondarily
generalized TC seizures/month
• One or two localized epileptogenic zones
RNS™ System Feasibility Investigation:
Trial Design
Implant
RNS System
-n
1
2
3
4
24 months
Therapy ON
Therapy OFF
Baseline: > 3
months
PostImplant:
28 days
Evaluation: 3-28 day
periods
Follow-up: 24 months postimplant
After 2 year Feasibility trial, subjects transition to
Long-term Treatment Trial for additional 5 year follow-up
Responder Rate During Efficacy
Evaluation Period
(2-4 Months Post-Implant, N= 50*)
• Responder Rate: patients with > 50% reduction in seizure
frequency over most recent 84 days vs. baseline
All disabling
seizures*
Complex partial
seizures
Generalized TC
seizures
24% (12/50)
27% (12/44)
65% (11/17)
Disabling seizures= SPM, CPS and GTC
*5 subjects excluded due to inconsistencies in the data, 1 had no disabling seizures
at baseline, 14 subjects randomized to sham stimulation
Responder Rate Over Most Recent
84 Days of Data (N = 59*):
All Disabling Seizures
• Analysis by seizure onset location
Total
47%
Hippocampal
74%
Neocortical
34%
*5
subjects excluded due to inconsistencies in the data, 1 had no disabling seizures
at baseline
Data are current as of 11/2008; not completely verified.
Feasibility: Response over Time
60%
Responder Rate
Median % Reduction in Seizures
50%
40%
30%
20%
10%
0%
3 mo
(N=64)
6 mo
(N=63)
12 mo
(N=63)
Data are current as of 02/19/2009; not completely verified.
18 mo
(N=61)
24 mo
(N=56)
30 mo
(N=46)
36 mo
(N=42)
RNS™ System Feasibility Investigation:
Summary Experience
• Safety milestone reached
No unanticipated device related or surgery
related serious adverse events
• Preliminary evidence for efficacy
 Reduction in SP motor, CPS, GTC seizures
 Subjects with hippocampal onset had
especially good response
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RNS™ System Pivotal Trial
• Randomized, double-blinded, multicenter, sham stimulation controlled
• 240 patients enrolled at 29 sites
• Objective
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Demonstrate that the RNS System is safe and
effective in reducing the frequency of disabling
seizures in adults with medically intractable partial
onset seizures
RNS™ System Clinical Experience
• All epilepsy trials combined
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310 subjects enrolled
246 subjects implanted
> 426 patient years of post-implant
experience
> 367 patient years of stimulation
experience
Data current as of March 3, 2009; not completely verified.
RNS™ System Clinical Trials in Epilepsy
• Technology successful
• Safety profile appears favorable
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No unanticipated device related serious adverse events
• Feasibility trial shows evidence for durable efficacy
• Future plans
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Pivotal trial complete in August 2009
Analysis of clinical response as a function of
– Detection and stimulation programming
– Epileptogenic region
– Epilepsy etiology