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TRANSCRIPT
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North American Neuromodulation Society Investor Update
January 12, 2018
Maulik Nanavaty
Senior Vice President and President, Neuromodulation
Jim Cassidy
Vice President and Franchise Lead, Pain Management
Milad Girgis
Vice President and Franchise Lead, Deep Brain Stimulation
2 2
Safe Harbor for Forward-Looking Statements and Regulatory Disclaimers
This presentation contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,”
“estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the time and are not intended to be
guarantees of future events or performance. If our underlying assumptions turn out to be incorrect, or
if certain risks or uncertainties materialize, actual results could differ materially from the expectations
and projections expressed or implied by our forward-looking statements.
Factors that may cause such differences can be found in our most recent Form 10-K and Forms 10-Q
filed or to be filed with the Securities and Exchange Commission under the headings “Risk Factors”
and “Safe Harbor for Forward-Looking Statements.” Accordingly, you are cautioned not to place
undue reliance on any of our forward-looking statements. We disclaim any intention or obligation to
publicly update or revise any forward-looking statements to reflect any change in our expectations
or in events, conditions, or circumstances on which they may be based, or that may affect the
likelihood that actual results will differ from those contained in the forward-looking statements.
Market Estimates:
Unless noted otherwise, all references to market sizes, market share positions, and market growth
rates are BSX internal estimates.
Regulatory Disclaimers:
Vercise™ PC Deep Brain Stimulation System/Vercise™ Directional System - CE Marked. US:
“Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not
available for sale.”
Vercise Gevia™ Deep Brain Stimulation System - CE Marked. Not available for use or sale in the U.S.
Next Gen DBS System: Device under development. Not for sale or use worldwide.
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Positioned for Leadership in Two Fast-Growth Markets
Overview BSX Growth Drivers
• Spectra Wavewriter ™ SCS System
First & only system FDA approved to simultaneously
provide paresthesia and sub-perception therapy
• Comprehensive SCS Platform with Illumina 3D™
Personalized therapy with neural targeting algorithm
across broad IPG* and lead portfolio
• Cosman RF Ablation
Early stage treatment options for pain patients
• Vercise™ Deep Brain Stimulation Platform
First & only MICC*-based directional system
• International expansion
Under-penetrated market opportunity in both pain and
brain
Market
Size (2017E)
~$2.5B
Market
Growth (2017E)
+14%
2017-2020 est. Market
CAGR
+10%-15%
Preliminary
BSX 20171
Revenue Growth
+14%
*IPG: Implantable Pulse Generator; MICC: Multiple Independent Current Control
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15+ ongoing clinical research studies & RCTs3 to help prove personalized therapy is the future of pain relief:
Pain: Expanding a Winning Pain Portfolio and Leading with Rigorous Clinical Research
Illumina 3D™ Spectra™ SCS
Systems Infinion CX™ Multiwave™ Cosman
Precision with Neural
Targeting Algorithm
Options for Patients (32 contacts, MRI
compatibility2, Non-Rechargeable)
Personalized Therapy
Through Multiple
Waveform Options
Broadest Coverage of
the Spine for Multi
Therapy Targeting
RF Ablation:
Denervation
Strong cadence of technology with 2 new platforms expected to launch over next 24 months
• PROCO4 (Q2:17): Double-blind crossover RCT to evaluate the role of frequency on SCS patient outcomes
• WHISPER5 (Q1:18): Crossover RCT to evaluate the safety and effectiveness at sub-perception amplitudes
• ACCELERATE6 (H2:18): Crossover RCT to evaluate the safety and effectiveness at high-rate SCS
• VERITAS7 (2019): Prospective, multicenter study to evaluate the effectiveness of multiple modalities with
Spectra WaveWriter
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Challenges and Opportunities in SCS
Multiple recent studies (PROCO4,
SUNBURST9) show patients respond
variably to different therapies –
• Non-responders to one modality
may be responders to another
modality
Expect multiple mechanisms of
action involved11
Variation in Response
Opportunity to improve therapy
longevity • 3 - 6% annual explant rate due to
inadequate pain relief8
Recently launched modalities
haven’t resolved loss of therapy
issue • 10 kHz: 5% annual explant rate due
to inadequate pain relief8
• Burst: 5% of patients with diminished or loss of symptom relief after 24
weeks9
• DRG*: 9% of patients experience loss of stimulation after one year10
Longevity of Therapy
*DRG: Dorsal Root Ganglion
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Spectra WaveWriter™ SCS System: Multiple Therapies. One Device.
Maximize Responders: • First system approved to simultaneously
provide paresthesia and sub-perception therapies
Simplify Personalization: • Real-time patient rating and data on
waveform usage
Spectra WaveWriter System Q1:18 US Launch
The Power of Combination Therapy with
the Simplicity of Waveform Automation
Early Clinical Data – NANS 2018 Multi-site observational outcomes collection12
∆ 6.0 reduction in NRS ~30 Day Follow Up
Significant Pain Reduction
in Early Follow-Up
0
2
4
6
8
10
Baseline
(N=79)
End of Trial
(N=69)
Last F/u Visit
(n=79)N
RS S
co
re (
0-1
0)
Change in Overall Pain Scores
(NRS*) at Last Follow-up
D = 6.0 (p < 0.0001)
*Numeric Rating Scale
7.7
2.0 1.7
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Spectra WaveWriter™ SCS System: Multiple Therapies. One Device.
Combination Therapy New Sub-perception Algorithms
+ Waveform Automation
Paresthesia Responders
Sub-perception Responders
Multiple Therapies
~15% responder
increase13
Designed for deeper, lasting relief by layering waveforms simultaneously or sequentially
Competition 8-contact leads +
Conventional Bi-Pole
Limited Coverage
WaveWriter Infinon CX (16 contacts)
+ Contour
Multiple Vertebral Level
Coverage
vs
T8
T9
T1
0
T7
Infinion
Infinion
T8
T9
T1
0
T7
Infinion
Infinion
T8
T9
T1
0
T7
Infinion
Infinion
T8
T9
T1
0
T7
Infinion
Infinion
T8
T9
T1
0
T7
Infinion
Infinion
T8
T9
T1
0
T7
Infinion
Infinion
Designed to easily find and keep the optimal target with a personalized stimulation field
+
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WHISPER & PROCO: Foundational Studies for Spectra WaveWriter™
PROCO RCT4
(de novo patients)
WHISPER RCT5
(previously implanted patients,
average ~4 years on therapy)
Key Takeaways • Similar pain relief across 1, 4, 7 & 10 kHz
• 1/3 charge burden with 1kHz
• Neural dosing algorithms are critical
Key Takeaways • <1.2 kHz delivered significant, long term,
sub-perception pain relief in a real world
population
• Multiple therapies provide superior
outcomes when patients are able to
choose most effective therapy
Spectra WaveWriter™
Next gen sub-perception technologies • Contour™Algorithm
• Therapy Rater and Waveform Automation
Impactful clinical outcomes • Exciting new data at NANS: WaveWriter
Observational Outcomes
• VERITAS Study (2019E)
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WHISPER RCT5: Multiple Therapies Provide Superior Outcomes
Challenging Patient
Population
• WHISPER results showed clinical value
of SCS in challenging, long-term, implanted patients
Positive Outcomes in
Paresthesia Responders Superior Outcomes with
Waveform Options
• Subgroup : ≥50% improvement with supra-perception during crossover phase
• Outcomes consistent with de novo PROCO RCT patients
• Met primary endpoint • Superiority demonstrated
• 62% increase in responder rate
when patients are able to
choose between multiple
waveform options
Study
AspectsWHISPER SENZA
Patients
Previously
implanted
Precision
patients
De-novo
patients
Mean
duration of
implant
4 +/- 1.9 yrs. 0 yrs.
Duration of
chronic pain18.3 yrs. 13 yrs.
Disability per
Oswestry
Disability
Index
69.4
(Crippling)
54
(Severe)
CRPS
Yes
(19%)
No
(0%)
0
1
2
3
4
5
6
7
8
Baseline Best Option
(sub or supra)
NR
S S
co
re (
0-1
0)
7.2
2.5
n=20
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Supra-perception
only
Sub-perception
only
Best option
(supra or sub)
Re
spo
nd
er
Ra
te 29%
39%
47% n=70
62% increase
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Our History in Neuromodulation: A Different Path to Deep Brain Stimulation
Advanced Bionics
technology, acquired by
Boston Scientific in 2004
A heritage in cochlear vs pacemaker
•Utilization of multi-channel stimulation
•Precise control
Applying cochlear technology to
neurological disorders
•Focus on stimulation modality
• Multiple Independent Current Control
•Focus on patient centric technology
• Wireless
• Rechargeable
• Ease-of-use
• Size
• Precision
DBS Vercise
RC System (EU)
1st DBS system with 16
independent sources of
current
SCS Spectra Platform (WW)
1st 32 Channel
Rechargeable Platform 2012
2004
SCS Precision Plus (WW)
1st and only MICC ,
1st Rechargeable Platform
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Path to Leadership in Brain Modulation: Differentiated Technology, Strong Clinical Evidence
MRI and
personalized
visualization
Next Generation System
Vercise™ PC – First Directional System with
integrated Clinical Effects Map
Vercise™ Gevia™ – First MRI conditional
Rechargeable Directional System
Therapy Expansion
Vercise™ - U.S. launch with
first and only MICC powered,
rechargeable system, 8 level
leads, and 5 years of proven
therapy in Europe
2018 2019 2020+
Anticipate 18+3 ongoing clinical research studies will drive Brain Modulation to be a meaningful contributor:
• INTREPID14 (Q4:17) : First & only prospective, double-blind, sham-controlled, multi-center RCT;
evaluating Vercise™ DBS system for U.S. entry
• DBS Directional15 (2019): Evaluating therapeutic advantages of Cartesia™ Directional Lead with
Vercise™ PC DBS System
• DBS Registry16 (on-going): Comprehensive registry of real world outcomes to establish improvement
in quality of life
• Investments in indication expansion studies: Stroke rehabilitation, Alzheimer’s disease, depression,
others
U.S. expected
launch timeline
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Revolutionizing Brain Modulation Therapy
BSX best-in-class system solution to meet market needs:
• High-growth, underpenetrated market
• ~$600M worldwide opportunity shifting away from a single player market
• BSX entering U.S. with compelling new technology
• System capabilities with potential to treat other neurological disorders
Vercise™ DBS Systems
Precision Control of
Directionality with MICC
Brainlab
Advanced Surgical
Planning
Visualization
Personalizes Programming
for Patients
Smart Programming
Captures Outcomes
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Boston Scientific NANS 2018
WHISPER: A Multicenter, Prospective Randomized Controlled Trial
Evaluating Sub-perception SCS at ≤ 1.2 kHz
Friday, January 12
7:35AM - 7:45AM
Forum Ballroom 14, 15, and 16
James North, MD
Effects of Rate on Analgesia in Kilohertz Spinal Cord Stimulation:
Final Results of the PROCO RCT
Saturday, January 13
3:45PM - 3:55PM
Octavius Ballroom 7, 8, and 9
Simon Thomson, MBBS FRCA FIPP FFPMRCA
No Effects of High-Rate (Multi-kHz) Electric Fields on Brain Slice on Excitability Friday, January 12 7:15AM - 7:25AM Octavius Ballroom 5 and 6 Marom Bikson, PhD
Artifactual Hyperpolarization During Extracellular Electrical Stimulation: Proposed Mechanism of High-Rate Neuromodulation Disproved Friday, January 12
7:25AM - 7:35AM Octavius Ballroom 5 and 6 Steven A. Prescott, MD PhD
Dependence of c-Fos Expression on Amplitude of High-Frequency Spinal Cord Stimulation in an Animal Model Friday, January 12 4:45PM - 4:55PM Octavius Ballroom 7, 8, and 9
Robert Foreman, PhD A Computational Study of Dorsal Column Versus Dorsal Horn Modulation Using Higher Rate (≥250 Hz) Spinal Cord Stimulation Saturday, January 13
7:25AM - 7:35AM Forum Ballroom 14, 15, and 16 Tianhe Zhang, PhD
RCTs Basic Science and Mechanism Of Action
DBS
DBS Registry: Outcomes and Safety E-Poster Deuschl, Vesper
DBS Registry: Outcomes and Safety using the Directional Lead E-Poster Deuschl, Vesper
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Neuromodulation: Strong Growth Driven by Leading Innovation
• Exciting, large, underpenetrated and high-growth markets: SCS and DBS
• Strong start to 2018 with significant new FDA product approvals
– Spectra WaveWriter™ SCS System
– WHISPER RCT sub-perception labeling
– Vercise™ DBS System
• Pain: Defining the future of SCS through personalized therapy
– Broadest portfolio: neural targeting algorithms &waveforms, MRI, primary cell, 32 contacts, RF
– Commitment to rigorous clinical and pre-clinical research: LUMINA17, PROCO4 , WHISPER5, ACCELERATE6
– Significant international expansion momentum and opportunity
• Brain: Poised for share gains with the most innovative platforms and U.S. market entry
– INTREPID14, VANTAGE18, CUSTOM19 data
– Differentiated directional system supported by extensive clinical data
– Integrated offering: Directional System, visualization, MRI, Brainlab partnership
• Convergence of technology and clinical insights unlocking new treatments for neurological disorders (stroke rehabilitation, Alzheimer’s disease, depression and others)
15 15
References
1) Neuromodulation reported revenue growth based on preliminary, unaudited sales results issued January 9,
2018. Results are preliminary and subject to completion of year end financial reporting processes, reviews and
audit.
2) 1.5 Tesla MRI conditional when all conditions of use are met
3) Includes company and investigator-sponsored research studies
4) Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized
Controlled Trial. Simon J. Thomson, MBBS, et al. Neuromodulation, November 2017
5) North, J., et. al. WHISPER: A Multicenter, Prospective Randomized Controlled Trial Evaluating Sub-perception
SCS at ≤ 1.2 kHz. NANS 2018, Las Vegas
6) Safety and Effectiveness Study of the Precision SCS System Adapted for High-Rate Spinal Cord Stimulation
(ACCELERATE) NCT02093793
7) Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System (VERITAS)
NCT03251937
8) Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review
Study. Dr. Jean-Pierre Van Buyten, MD; et al Neuromodulation, October 2017
9) Proclaim™ Implantable Pulse Generator CLINICIANS MANUAL, 2016-04 ARTEN100125494B
10) PREDICT: A prospective post-market trial to evaluate DRG stimulation for the management of chronic
intractable pain. S. Eldabe,, MD; et al. INS 2017
11) Rauck, R. PET Study. NANS 2015, Las Vegas
12)Metzger, C., et. al. Outcomes Using an SCS Device Capable of Delivering Combination Therapy (Simultaneous
or Sequential) and advanced waveforms/field shapes. NANS 2018, Las Vegas
13)Thomson et al., PROCO RCT, INS 2017
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References
14) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID) NCT01839396
15) Directional Data:
• Steigerwald et al. “Directional deep brain stimulation of the subthalamic nucleus: a pilot study using a
novel neurostimulation device.” Movement Disorders. 2016;
• Reker et al, “Directional deep brain stimulation: A case of avoiding dysarthria with bipolar directional
current steering: Parkinsonism and Related Disorders 2016 Aug
• “Scientists Test Next Generation Deep Brain Stimulation Leads to Improve Targeting the Subthalamic
Nucleus with Fewer Adverse Effects” NEUROLOGY TODAY | Jul 2016
16) Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry NCT02071134
17) Veizi et al, “SCS with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain
Relief Compared to Traditional SCS.” Pain Medicine Jan 2017.
18) Vantage:
• 1 Year: Timmermann et al., Multiple-source current steering in subthalamic nucleus deep brain
stimulation for Parkinson’s disease (the VANTAGE study): a non-randomised, prospective, multicentre,
open-label study Lancet Neurology 2015; 14: 693–701
• 3 Years: Timmerman et al, “Three-Year Outcomes of a Prospective, Multi-center Trial Evaluating Deep
Brain Stimulation With a New Multiple-Source, Constant-Current Rechargeable System in Parkinson
Disease.” Neurosurgery. Aug 2016.
19) CUSTOM-DBS: Volkmann et al., Presented at 2014 Annual Meeting of the International Parkinson and
Movement Disorders Society, June 2014