Beruflich Dokumente
Kultur Dokumente
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
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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.
2 2
Next Gen DBS System: Device under development. Not for sale or use worldwide.
Positioned for Leadership
in Two Fast-Growth Markets
15+ ongoing clinical research studies & RCTs3 to help prove personalized therapy is the future of pain relief:
• 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
Strong
4 cadence of technology with 2 new platforms expected to launch over next 24 months
Challenges and Opportunities in SCS
4 7.7
Maximize Responders:
2
• First system approved to simultaneously 2.0 1.7
provide paresthesia and sub-perception 0
therapies Baseline End of Trial Last F/u Visit
(N=79) (N=69) (n=79)
Simplify Personalization:
∆ 6.0 reduction in NRS
• Real-time patient rating and data on
~30 Day Follow Up
waveform usage
+
Designed for deeper, lasting relief by layering Designed to easily find and keep the optimal
waveforms simultaneously or sequentially target with a personalized stimulation field
Paresthesia Sub-perception
T10T10
T9 T9
T8 T8
T7 T7
T10T10
T9 T9
T10T10
T8 T8
T9 T9
T7 T7
T8 T8
Responders Responders
Infinion Infinion Infinion
Infinion Infinion Infinion
Infinion Infinion Infinion
Infinion Infinion Infinion
WaveWriter vs Competition
Multiple Therapies Infinon CX (16 contacts) 8-contact leads +
~15% responder + Contour Conventional Bi-Pole
increase13
Multiple Vertebral Level Limited Coverage
Coverage
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WHISPER & PROCO: Foundational Studies
for Spectra WaveWriter™
Spectra WaveWriter™
Responder Rate
Mean 30%
duration of 4 +/- 1.9 yrs. 0 yrs. 4
25%
implant 3 2.5 20%
Duration of
18.3 yrs. 13 yrs. 2
chronic pain 15%
Disability per
1 10%
Oswestry 69.4 54
Disability (Crippling) (Severe) 0 5%
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Path to Leadership in Brain Modulation:
Differentiated Technology, Strong Clinical Evidence
Next Generation
System
Vercise™ - U.S. launch with Vercise™ PC – First Directional System with Therapy
first and only MICC powered, integrated Clinical Effects Map Expansion
rechargeable system, 8 level
Vercise™ Gevia™ – First MRI conditional MRI and
leads, and 5 years of proven personalized
Rechargeable Directional System
therapy in Europe visualization
U.S. expected
launch timeline 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
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Revolutionizing Brain Modulation Therapy
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Boston Scientific NANS 2018
• 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
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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
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