NANS 2021 Investor Briefing - January 15, 2021
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NANS 2021 Investor
Briefing
January 15, 2021
1
Agenda
• Welcome and Introductions
Julie Dewey
• Company Overview and Recent Business Updates
D. Keith Grossman
• Clinical Research Results
David Caraway, MD, PhD
• Question and Answer Session
D. Keith Grossman, Dr. David Caraway, Rod MacLeod
2
Forward-looking Statements
In addition to historical information, this presentation contains forward-looking statements with respect to our business,
capital resources, strategic initiatives and growth reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including regarding continuing
adoption of, and interest in, our therapy and products in the U.S. and international markets; our beliefs regarding market size
of the traditional back and leg pain, PDN and NSRBP markets and future growth of these markets and share for our therapy
and products; our beliefs regarding the advantages of our products and HF10 therapy, including additional opportunities
around our clinical efforts and potential indication expansion; our belief that we are uniquely positioned, with multiple
growth drivers; our expectations around approval of our PDN indication and ability to begin commercializing in the second
half of 2021; our belief that there is significant pent-up SCS demand from the COVID-19 pandemic as we head into 2021; our
belief that we are under-indexed from a market share perspective; and our expectations regarding our commercialization
efforts. These forward-looking statements are based upon information that is currently available to us or our current
expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to
continue to successfully commercialize our products; our ability to manufacture our products to meet demand; the level
and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated
growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business
without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry;
additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims.
These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed on February 25,
2020 and our Quarterly Report on Form 10-Q filed on November 5, 2020, as well as any reports that we may file with the
Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ
materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any
obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
3
Company Overview and
Recent Business Updates
D. Keith Grossman
Chairman, CEO & President
4
Large, Underpenetrated Lower Back/Leg Market
2019 Global SCS Market Total Addressable U.S. Lower Back/Leg Market²
$2.5B Annually¹ $12.9B Annually, ~10% Penetrated
$0.5B
U.S
$7.5B 300K Patients/Yr
~4% Penetrated
Int'l 58%
(FBSS)
$2.0B
($ in billions)
$5.4B (NSRBP)
. 215K Patients/Yr
~19% Penetrated 42%
FBSS: Failed Back Surgery Syndrome
NSRBP: Non-Surgical Refractory Back Pain
1Includes DeNovo and Replacement 2Includes DeNovo patients only
Sources: Guidepoint Qsight U.S. Pain Modulation Market, as of Sources: US Census Bureau; CLBP Market Research; CMS OP Hospital SAF Data 2012 – 2018;
November 2020; Company data https://www.neuromodulation.com/failed-back-surgery-syndrome-definition; Company data.
5
NSRBP: Clinical Data
$7.5B
Total
Expected to Drive Addressable
Market
Market Penetration
$300M
NSRBP is already on-label Current
for Omnia Market
Development of clinical
data supports continued
market penetration: Only 4%
penetrated
Expanded payer coverage
Increased patient
referrals for therapy
First data release at
NANS 2021
6
PDN:
Large Patient Population with Significant Unmet Need
PREVALENCE INCIDENCE
Diagnosed PWD 20% with PDN 45% Refractory to CMM Annual TAM
~$3.5-5.0 Billion
26.8 MM PATIENTS 5.3 MM PATIENTS 2.3 MM PATIENTS 140-200K PATIENTS
Current Treatment Options Demonstrate Mild Efficacy and Low Adherence
PWD = Patients with Diabetes PDN = Painful Diabetic Neuropathy CMM = Conventional Medical Management TAM = Total Addressable Market
Sources: CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354;
Trinity Partners Market Research 2017
7
The Power of a PDN Indication
PDN Market Opportunity
Increase volume of PDN referrals $47 Billion
2M Patients 1% =
Enable on-label treatment with
HF10® therapy ~$500M
Strengthen HF10 therapy
with Level 1 scientific data
Facilitate payer approvals
If approved, Nevro would be the ONLY company with on-label access
8
Clinical Research Results
David Caraway, MD, PhD
Chief Medical Officer
9
NANS 2021: Significant Clinical Presence
20 Abstracts Accepted for Presentation
Two late-breaking presentations in Plenary Session 1:
PDN RCT NSRBP RCT
Friday, Jan 15 Friday, Jan 15
4:53-5:05 pm CST 4:17-4:29 pm CST
Presenter: Dr. Erika Petersen Presenter: Dr. Leo Kapural
18 audio-guided, e-Poster presentations
Highlights
Comprehensive 6-month data and subset of 12-month data for
SENZA-PDN RCT
First look at NSRBP RCT Study data (3-month results)
ULN Studies demonstrate pain and opioid reduction
RESCUE STUDY results highlight real-world capability for HF10 to help
patients failing traditional SCS
FREQUENCY PAIRING REAL WORLD STUDY - HF10 paired with other
waveforms improves pain relief and function for subset of patients
10Erika Petersen, MD, FAANS, FACS
Professor of Neurosurgery
Director of Functional & Restorative Neurosurgery and Neuromodulation
University of Arkansas for Medical Sciences
Little Rock, AR
11Prevalence and Cost of Painful Diabetic Neuropathy (PDN)
Diabetes is a PDN is common
National Epidemic • Present in 20% to 26% of those with diabetes
34.2 million people with diabetes =
10.5% of the population
Another 88 million people
with prediabetes (more than
1 in 3 adults)
Annual cost: $327 billion
34+ 7 Million
Million Patients with PDN
Direct medical costs = $237 billion Patients with Diabetes
Indirect costs = $90 billion
CDC National Diabetes Statistics Report 2020
Davies et al. Diabetes Care 2006
Schmader Clin J Pain 2002
12Pharmacotherapy for PDN
Number-needed- Number-needed-
to-treat to-harm
First-Line Agents:
Pregabalin 7.7 13.9
Gabapentin 6.3 25.6
Duloxetine 4.2 NR
Second-Line Agents:
Other anticonvulsants
(carbamazepine, etc) NR NR
Other SNRIs (venlafaxine) 4.5 NR
TCAs 3.6 13.4
Other Agents:
Oral opioids 4.3 11.7
IV analgesics (lidocaine,
ketamine) NR NR
Staudt et al. J Diab Sci & Tech 2020
Finnerup et al. Lancet Neurol 2015
13Low-frequency SCS for PDN
• Two prior RCTs demonstrated 50%-69% pain responders to LF-SCS at 6 months
7.3 • Prospective, multicenter RCT comparing LF-SCS+CMM to CMM alone
3.1 • 60 subjects randomized 2:1, 6-month follow-up
- 36 LF-SCS subjects at 6 months
- 69% pain responders (25/36)
- No report of neurological improvements
de Vos et al. Pain 2014
NRS scores for Pain
7.3 Daytime • Prospective, two-center RCT comparing LF-SCS+CMM to CMM alone
• 36 subjects randomized 3:2, 24-month follow-up
4.1 - 16 LF-SCS subjects at 6 months
3.3
- 56% pain responders daytime (9/16)
- 50% pain responders nighttime (8/16)
- No report of neurological improvements Slangen et al. Diabetes Care 2014
van Beek et al. Diabetes Care 2015
14Low-frequency SCS for PDN
• Long-term data show attrition for LF-SCS with 36%-42% pain responders at 12 months
• Long-term data from two prospective cohorts with LF-SCS+CMM
• 40 subjects implanted, median 60-month follow-up • Complications:
• At 12 months: - Deep infections: 2 (5%)
- 42% pain responders daytime (15/36) - Uncomfortable stimulation: 9 (23%)
- 36% pain responders nighttime (13/36) - Battery replacements: 18 in 13 subjects (33%)
van Beek et al. Diabetes Care 2018
15Methods: SENZA-PDN
• Subjects with PDN of the lower limbs, refractory to conservative treatments
T8
• ≥5 of 10 cm on pain VAS, HbA1c < 10%, BMI < 45
• Independent Medical Monitors reviewed all subjects
• 18 US centers, 216 subjects randomized 1:1
Conventional medical management (CMM) alone
vs.
CMM + 10 kHz SCS (Nevro Corp.)
• 6-month follow-up assessing
- Pain
- Quality of life
- Neurological function: including diabetic foot exam w/ Semmes-Weinstein 10g
monofilament and 40g pinprick tests
• Option to crossover to alternate treatment arm at 6 months
• Responder defined as ≥50% pain relief
• Analyses performed in PP population, reported as means ± 95% CI
• Study designed and conducted in accordance with CONSORT/SPIRIT guidelines
• Registered on ClinicalTrials.gov - NCT03228420
Mekhail et al. Trials 2020
16Assessed for eligibility
Subject Disposition n=430
Did not meet I/E (n=146)
Declined to participate (n=65)
End of enrollment, not randomized (n=3)
Conventional Medical Intention-to-treat 103 113
Randomized n=216 Withdrew consent (n=5) 10 kHz SCS
Management (ITT) population
Secondary to AE (n=3) + CMM
(CMM) Lost to follow-up (n=1)
Trial
n=104 Trial failures (n=6)
IPG declined (n=4)
Lost to follow-up (n=1)
Lost to follow-up (n=3)
Secondary to AE (n=1)
Secondary to AE (n=1)
Implant
n=90
1 Month 1 Month
n=90 n=90
(11 missed visits)
Lost to follow-up (n=2) Secondary to AE (n=1)
Secondary to AE (n=1)
3 Month 3 Month Per-protocol (PP) population
n=96 n=88
(2 missed visits) (1 missed visit)
Withdrew consent (n=2)
Secondary to AE (n=1)
Lost to follow-up (n=1)
6 Month 6 Month Hierarchical analysis of
n=93 n=87 secondary endpoints
(n=2 included in safety pop) (n=1 included in safety pop) Subjects missing primary endpoint visit excluded
from PP analyses but included in safety population 17Baseline Characteristics
CMM 10 kHz SCS + CMM Standardized
n = 103 n = 113 Difference
Age in years, mean (SD) 60.8 (9.9) 60.7 (11.4) 0.01
Male, n (%) 66 (64%) 70 (62%) 0.04
Race
White, n (%) 85 (82.5%) 87 (77.0%) 0.14
Black or African American, n (%) 13 (12.6%) 18 (15.9%)
Native Hawaiian or other Pacific Islander, n (%) 1 (1.0%) 3 (2.7%)
American Indian or Alaska Native, n (%) 0 (0.0%) 2 (1.8%)
Asian, n (%) 1 (1.0%) 1 (0.9%)
Other, n (%) 3 (2.9%) 2 (1.8%)
Diabetes
Type 1, n (%) 3 (3%) 8 (7%) 0.19
Type 2, n (%) 100 (97%) 105 (93%)
Duration in years
Diabetes, mean (SD) 12.2 (8.5) 12.9 (8.5) 0.09
Peripheral neuropathy, mean (SD) 7.1 (5.1) 7.4 (5.7) 0.06
Lower limb pain VAS in cm, mean (SD) 7.1 (1.6) 7.5 (1.6) 0.22
< 7.5 cm, n (%) 57 (55%) 54 (48%) 0.15
≥ 7.5 cm, n (%) 46 (45%) 59 (52%)
HbA1c, mean (SD) 7.4% (1.2%) 7.3% (1.1%) 0.11 Effect size index (Cohen’s d):
< 7.0%, n (%) 40 (39%) 46 (41%) 0.04 ≥ 0.20 = small
≥ 7.0%, n (%) 63 (61%) 67 (59%) ≥ 0.50 = medium
BMI, mean (SD) 33.9 (5.2) 33.6 (5.4) 0.06 ≥ 0.80 = large
18Primary Endpoint Analysis at 3 Months
• Composite endpoint: subjects with ≥ 50% p < 0.001
pain relief and no worsening of baseline
neurological deficits
• Assessed in PP population
• Analysis of ITT population also
demonstrated significant difference
between groups (p < 0.001)
• 10 kHz SCS safe and effective for PDN
CMM 10 kHz SCS + CMM
(n = 94) (n = 87)
19Pain Relief over 6 Months
CMM (n = 93)
10 kHz SCS + CMM
(n = 87)
Baseline 3 Months 6 Months
20Individual Pain Relief at 6 Months
5% responders 85% responders
(n = 5/93) (n = 74/87, p < 0.001)
1% remitters 60% remitters (p < 0.001)
-2%
Individual Subjects
average
pain relief
76%
average
pain relief
% % % % % % % % %
Change from baseline pain VAS Change from baseline pain VAS
CMM 10 kHz SCS + CMM
Remission defined as pain VAS ≤ 3.0 cm for 6 consecutive months
21Investigator Assessed Neurological Improvement
Did the investigator note improvement at 6 months
compared to baseline in motor, sensory, or reflex function,
Neurological examination: without deterioration in any category?
• Lower limb motor strength
• Light touch sensation L1-S1 p < 0.001
• Reflexes: patellar, Achilles, Babinski
• 10-point foot assessment
• pinprick
• 10-g monofilament
CMM 10 kHz SCS + CMM
(n = 92) (n = 84)
22Patient Reported Reduction in Dysesthesias with 10 kHz SCS
Baseline 6 Months Baseline 6 Months
Front Back Front Back Front Back Front Back
Proportion of subjects
Proportion of subjects
80% 80%
60% 60%
Numbness Tingling
40% 40%
(n = 31) (n = 20)
20% 20%
0% 0%
80%
Proportion of subjects
Proportion of subjects
80%
60%
60%
Burning Cold
40% 40%
(n = 15) (n = 16)
20% 20%
0% 0%
23Study-Related Adverse Events
CMM 10 kHz SCS + CMM
n = 103 n = 113
Total study-related AEs, n (# of subjects, %) None reported 18 (14, 12.4%)
Rated as Serious AEs - 2 (2, 1.8%)
Study-related AEs by type Reported SCS infection rates:
Infection - 3 (3, 2.7%) • 2.45% (Hoelzer et al. 2017)
Wound dehiscence - 2 (2, 1.8%) • 2.5% (PDN RCT, de Vos et al. 2014)
Incision or IPG discomfort - 2 (2, 1.8%) • 3.4% (Kumar et al. 2006)
Irritation from surgical dressings - 2 (2, 1.8%) • 4.5% (Mekhail et al. 2011)
Impaired healing - 1 (1, 0.9%) • 4.5% (PDN RCT, Slangen et al. 2014)
Device extrusion - 1 (1, 0.9%) • 8.9% (Diabetes cohort, Mekhail et al. 2011)
Lead migration - 1 (1, 0.9%)
Radiculopathy - 1 (1, 0.9%)
Uncomfortable stimulation - 1 (1, 0.9%)
Gastroesophageal reflux - 1 (1, 0.9%)
Myalgia - 1 (1, 0.9%)
Arthralgia - 1 (1, 0.9%)
Hyporeflexia - 1 (1, 0.9%)
• Of 90 permanent implants, 2 devices explanted d/t infection (2.2%)
24Quality of Life Improvements at 6 Months
Always
Sleep VAS (cm)
Never
Baseline 3 Months 6 Months
CMM 10 kHz SCS + CMM
(n = 93) (n = 87)
25Preliminary Health Economic Trends
Health-related QoL improvement
Average EQ-5D-5L Index
CMM (n = 92)
10 kHz SCS + CMM
(n = 87)
p < 0.001
Baseline 3 Months 6 Months
Opioid reduction
• Decreased or eliminated: 23% of 10 kHz SCS subjects vs 8% of CMM subjects
• Increased: 2% of 10 kHz SCS subjects vs 11% of CMM subjects
Reduced hospital & ED visits
• Over 6 months, there were 7 fewer visits per 100 patients in the 10 kHz SCS group
• 1.35 visits/CMM subject vs 1.27 visits/10 kHz SCS subject, difference = 0.07 visits/subject
26Pain Relief Beyond 6 Months
Criteria for crossover at 6 months: 10 kHz SCS +
CMM
• < 50% pain relief CMM
• dissatisfied with treatment
Met criteria to 88% 0%
• Investigator agrees that it is crossover (82/93) (0/87)
medically appropriate
Met criteria and 82% 0%
p < 0.001
elected to crossover (76/93) (0/87)
Study status:
• All crossover implants were completed late 2020
• All subjects originally randomized to 10 kHz SCS have completed 12-month follow-up
27Pain Relief Beyond 6 Months
Average Pain
Average
Scores
Pain
& Scores
Responder Rates
Proportion of responders
Lower limb pain VAS (cm)
CMM (n = 93)
10 kHz SCS
+ CMM
(n = 87)
Baseline 1 Month 3 Months 6 Months 9 Months 12 Months
(n = 87) (n = 87) (n = 87) (n = 87) (n = 82) (n = 84)
28Conclusions
SENZA-PDN Investigators
• Study primary endpoint met - A large proportion of
subjects benefited from 10 kHz SCS
Kas Amirdelfan Matthew Bennett Rick Bundschu Paul Chang Heejung Choi Michael Creamer
• Met 7 of 8 prespecified secondary endpoints showing
clear differences from the best available medical
treatments
David DiBenedetto Vincent Galan Gennady Gekht Johnathan Goree Maged Guirguis Nathan Harrison
• 10 kHz SCS is a safe and effective treatment for PDN
patients with symptoms refractory to CMM
Ali Nairizi Denis Patterson Christopher Paul Dawood Sayed
• Sensory improvements observed in many patients with Nandan Lad Neel Mehta
10 kHz SCS
• Durability of 10 kHz SCS shown over 12 months Jim Scowcroft Khalid Sethi Shawn Sills Thomas Stauss Kostandinos Tsoulfas Judith White
• Study follow-up will continue for 24 months total with
further evaluation of health economics
Paul Wu Jijun Xu Cong Yu
29Spinal Cord Stimulation at 10kHz for Non-Surgical
Refractory Back Pain: Multicenter RCT Primary
Endpoint Results
Leonardo Kapural, MD, PhD
Medical Director, Carolinas Pain Institute
30Presenting on behalf of the NSRBP investigators:
• Jessica Jameson, MD, Axis Spine Center, Coeur d’Alene, ID
• Naresh Patel, MD, Mayo Clinic, Phoenix, AZ
• Curtis Johnson, MD, James Scowcroft, MD, Midwest Pain Management Center, Overland Park, KS
• Aaron Calodney, MD, Texas Spine and Joint Hospital, Tyler, TX
• Srinivas Nalamachu, MD, Daniel Kloster, MD, Mid-America Polyclinic, Overland Park, KS
• Peter Kosek, MD, Oregon Neurosurgery Specialists, Springfield, OR
• Julie Pilitsis, MD, PhD, Albany Medical Center, Albany, NY
• Markus Bendel, MD, Mayo-Clinic, Rochester, MN
• Erika Petersen, MD, University of Arkansas for Medical Sciences, Little Rock, AR
• Shivanand P. Lad, MD, PhD, Duke University Medical Center, Durham, NC
• Chengyuan Wu, MD, MSBmE, Thomas Jefferson University Hospitals, Philadelphia, PA
• Taissa Cherry, MD, Kaiser-Permanente, Redwood City, CA
• Cong Yu, MD, Swedish Health Services, Seattle, WA
• Dawood Sayed, MD, University of Kansas Hospital, Kansas City, KS ,, MD7, David Caraway, MD, PhD10
31Introduction
Chronic Back
What is Non-Surgical Refractory Back Pain (NSRBP)? Pain and
Surgery -Naive
Study Objective:
Refractory to
• Few treatment options exist for NSRBP patients Conventional
Medical
• Need to produce level 1 evidence* comparing Management
10 kHz SCS to Conventional Medical
Management (CMM) for treatment of NSRBP in
Not a good
terms of clinical and cost-effectiveness candidate for
* Current evidence is limited: Surgery
1. Al-Kaisy A, et al. Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal
Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months. Pain Med.
2018;19(6):1219-1226.
2. Al-Kaisy A. et al. 10 kHz spinal cord stimulation for the treatment of non-surgical refractory back pain:
subanalysis of pooled data from two prospective studies. Anaesthesia. 2020;75(6):775-784. NSRBP
3. Ahmadi SA et. al. High-Frequency Spinal Cord Stimulation in Surgery-Naive Patients-A Prospective Single-
Center Study. Neuromodulation. 2017;20(4):348-353. Population
32Study Design
• Randomization 1:1 to
• 10kHz SCS + CMM
• CMM Alone
• N = 216
• Main Inclusion
• Not a candidate for back surgery based on spine
surgeon assessment
• No previous back surgery
• Back pain > 5 cm on VAS
• Predominantly neuropathic pain
• Primary Endpoint – 3 Months
• Comparison of Responder Rate (≥ 50% Pain Relief)
• Secondary Endpoints – 6 Months
• disability, pain relief, global impression of change,
quality of life, opioid use
• All Endpoints assessed at 12 and 24 months
Study Design published: Pain Practice August 16, 2020
https://doi.org/10.1111/papr.12945
33Conventional Medical Management (CMM)
Study Guidelines Examples
• The choice of appropriate medical • Oral medications (analgesics, nonsteroidal anti-
management will be made by the inflammatory drugs, anticonvulsants,
Investigator -best standard of care for antidepressants, counter-irritants)
each individual patient. • CPPM (combined physical and psychological
management)
• Appropriate interventional procedures • Physical therapy
should have been tried prior to • Back rehabilitation program
enrollment in the study, and ongoing
beneficial treatments may be • Spinal manipulation and spinal mobilization
continued. • Traction
• Protocol specifies invasive • Acupuncture
interventional procedures (e.g. facet • Cognitive behavioral therapy (CBT)
blocks, nerve blocks, and RFA) should • Biofeedback
not be performed within 4 weeks • Nerve blocks
leading up to a follow-up visit so • Epidural steroid injections
patient in stable state • Transcutaneous electrical nerve stimulation (TENS)
34Results: Subject Disposition Enrolled
N = 211
Screen Fail
N = 52 (24.6%)
Pre-specified interim analysis showed study Randomized
had the power to meet its primary endpoint, N = 159
so enrollment was stopped early
CMM HF10 + CMM
N =76 N =83
Withdrawals Withdrawn
N = 1 (1.3%) N=3 (3.6 %)
Trial Trial Failures
N=80 N=6 (7.5 %)
Withdrawn
Implant N= 6 (7.2 %)
N =68
CMM HF10 + CMM
3 M Primary Endpoint N =75 N =68
35Results: Demographics
CMM 10kHz-SCS+CMM
(n = 76) 95%CI (n = 83) 95%CI
Age, median (range), year 58.5 (26 - 77) (53.5 - 58.9) 53.0 (29 - 87) (51.8 - 57.1)
Female (%) 40 (52.6%) (40.8 - 64.2) 49 (59.0%) (48.9 - 70.8)
BMI, median (range) kg/m2 30.5 (18.7 - 49.8) (29.3 - 32.2) 31.4 (19.2 - 49.8) (30.4 - 33.3)
Years since diagnosis median (range) 8.1 (1.1 - 59.3) (8.7 - 14.1) 8.5 (0.4 - 51.7) (9.25 - 13.6)
Back Pain VAS, median (range) 7.2 (4.5 - 9.9) (7.0 - 7.5) 7.6 (4.0 - 10.0) (7.1 - 7.7)
Leg Pain VAS, median (range) 4.6 (0.0 - 8.5) ((3.2 - 5.1) 4.9 ( 0.0 - 8.7) (3.9 - 5.6)
Pain Etiology n (%) n (%)
degenerative disk disease 52 (68.4%) (56.7 - 78.6) 60 (72.3%) (61.4 - 81.6)
spondylosis 49 (64.4%) (52.7 - 75.1) 47 (56.6%) (45.3 - 67.5)
radiculopathy 35 (46.1%) (34.5 - 57.9) 34 (41.0%) (30.3 - 52.3)
mild / moderate spinal stenosis 24 (31.6%) (21.4 - 43.3) 23 (27.7%) (18.4 - 38.6)
spondylolisthesis (Grade I) 9 (11.8%) (5.6 - 21.3) 7 (8.4%) (3.5 - 16.6)
internal disc disruption / annular tear 6 (7.9%) (3.0 - 16.4) 8 (9.6%) (4.2 - 18.1)
sacroiliac dysfunction 5 (6.6%) (2.2 - 14.7) 3 (3.6%) (0.7 - 10.2)
Other chronic back pain without sciatica 3 (3.9%) (0.8 - 11.1) 2 (2.4%) (0.3 - 8.4)
36Results: Primary Endpoint at 3 Months
• Primary Endpoint met with a superior
100%
responder rate for the 10kHz SCS+CMM 80.9%
Responder Rate (±95%CI)
p < 0.001
arm over CMM in Intent-to-Treat analysis 80%
(p < 0.001)
60%
• Per-Protocol analysis is shown comparing
40%
responders (≥ 50% pain relief) between
groups 20%
1.3%
0%
10 kHz SCS + CMM CMM
(n = 68) (n = 75)
37Results: Pain Relief from Baseline
3 Months
10KHz-SCS + CMM10 CMM
% Pain Relief % Pain Relief
-60% -40% -20% 0% 20% 40% 8
60% 80% 100% -60% -40% -20% 0% 20% 40% 60% 80% 100%
*
p < 0.001
6
VAS (CM)
4 7.5 7.2 7.2
2
1.9
0
10kHz-SCS+CMM
10kHz-SCS+CMM
51.5% at ≥ 80% PR CMM
Baseline 3 Month
80.9% at ≥ 50% PR
Responder Non-Responder Responder Non-Responder
(n=68) (n=74) 38Results: Safety
All study related AE in first 3 months were in 10kHz-SCS+CMM arm
• Events and rates were typical including: 3 pocket pain (4%), 2 slow wound
healing (3%), 2 infection (3%), and 2 lead migration (3%)
2 study related SAE, both procedure related, were resolved
• Severe lethargy due to post-implant medication
• Osteomyelitis of lumbar spine
39Results: Change in Disability (Oswestry Disability Index)
100
MCID* = 10 pts
80
24 pt ↓ 2.1 pt ↑
ODI Total Score
*p< 0.001
60
Severe
Disability >2/3 improved by
40
Moderate one or more
46.8 Disability 47.4 49.5
20 disability categories
Minimum
22.4
Disability
0
10kHz-SCS+CMM
10kHz-SCS+CMM CMM
CMM
Baseline 3 Month
*Minimum Clinically Important Difference
40Results: Patient Global Impression of Change
A great deal better 35.3%
0.0%
88.2% Better
1.3%
33.8%
Moderately better 19.1%
0.0%
Somewhat better 4.4%
2.6%
A little better 1.5%
7.9%
Almost the same 2.9%
27.6%
No Change 2.9%
59.2%
0% 20% 40% 60% 80%
Population Reporting (%)
10kHz-SCS+CMM CMM
(n=68) (n=75) 41Discussion
• Primary endpoint achieved in largest study in this population
• Results achieved with 10kHz SCS in this NSRBP population is
1
equivalent to RCT in predominant failed back surgery syndrome
2
• Safety profile as expected in this post-market population
• Reduction in disability reflected significant change in ability to
perform daily activities which was also reflected in patient’s
impression of change
1. Kapural L, Yu C, Doust MW, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal
Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology.
2015;123(4):851-860.
2. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation:
indications and complications. Pain Pract. 2011;11(2):148-153.
42RESCUE Study¹
Background:
• Retrospective multi-center study of 120 patients who had
failed traditional SCS
• 105 evaluable subjects replaced with Senza IPG or full
system delivering HF10. 96 subjects had 16 contact leads.
• Minimum 12-month follow-up, 2-year median
Results:
• 81% of patients (85/105) patients improved with 50% or
more long term pain relief with HF10
• 90% of patients achieved at least 30% pain relief with
HF10
• Baseline average VAS of 8.4 decreased to 3.36 at most
recent visit (24 months median; range 1-4 years)
• Baseline opioid daily dose of 60.3 mg reduced to 44 mg at n=105
12 months
1. Kapural et al, Journal of Pain Research 2020:13 2861–2867
43RESCUE Study
Key Findings:
• HF10 is an effective therapeutic option to "rescue" failed traditional SCS
patients and can provide these patients long term relief from chronic
pain.
• The large difference in sustained effect size with HF10 treatment after
failed conventional SCS further supports that HF10 operates with a
frequency dependent mechanism of action.
• The RESCUE study further reinforces the importance of access to 10kHz SCS
combined with versatility of multiple waveforms to achieve best possible
outcomes.
44EARLY CLINICAL EXPERIENCE
WAVEFORM PAIRING
n=230 patients
Waveform Pairing may improve
outcomes in select difficult patient Ave duration of IPG 755.1 ± 29.3 days
(mean ± SEM) (approx. 2.1 years)
populations
Follow-Up 239 ± 13.1 days
(mean ± SEM)
• Back = Leg – 46.5%
Indication breakdown • Predominant Back – 27.4%
Frequency Pairing Burst10K • Other – 17.3%
• Predominant Leg – 8.8%
• Across 17 clinics in Australia, patients
(n=230) were provided waveform • Frequency Pairing – 203/230*
Waveform Pairing
• Burst10K – 39/230*
pairing programming (Frequency *Some patients were offered more than one pairing option
Pairing or Burst10k) to optimize their
treatment
Russo, M et al. Improved Versatility and Frequency Pairing Capabilities with 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain. E-Poster presented at the North American
Neuromodulation Society Meeting 2021 Orlando, FL.
45EARLY CLINICAL EXPERIENCE
MCID PAIN RELIEF
Proportion of patients reporting a minimum
clinical important difference3 in pain
relief prior to undergoing these alternate
programming options was reported to be
52.1%.
This notably improved to 74.6% at an
average follow-up of 239 ± 13.1 days.
3. Dworkin et al. J Pain. 2008;9:105–121
46EARLY CLINICAL EXPERIENCE
RESPONDER RATE
Responder rate (≥50% pain relief) improved from 34.8% prior to additional programming to 57.5% at last follow-up.
47EARLY CLINICAL EXPERIENCE
IMPROVED QUALITY OF LIFE
At last follow-up:
• 63% of patient reported
improved function
• For those using analgesics at
baseline, 86% reported stable
or decreased medications
• 34% reduced their
intake
48Conclusion
Promising results using waveform pairing of LF or Burst with 10,000 Hz in difficult to treat
patients
Clinically meaningful improvements at last follow-up (average. 239 ± 13.1 days)
- MCID in pain relief improved from 52.1% to 74.6%
- Responder rates improved from 34.8% to 57.5%
- Improved function in 62.7% of patients
- Reduction in pain medications in 33.5% of patients
Here we demonstrate that increased versatility and paired waveforms may help improve
therapeutic outcomes in difficult populations
49Closing Comments
D. Keith Grossman
50Question and Answer Session
D. Keith Grossman – Chairman, CEO & President
David Caraway, MD, PhD – Chief Medical Officer
Rod MacLeod – Chief Financial Officer
51Thank You
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