Innovations and Trends Marion Webb Managing Editor Medtech Insight Chrystal Larsen Lead Market Analyst Meddevicetracker David Filmore Editor in Chief Medtech Insight Presenters ID: 809023
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Slide1
Neuromodulation Device
Market
–
Innovations
and Trends
Slide2Marion Webb
Managing Editor - Medtech Insight
Chrystal Larsen
Lead Market Analyst - Meddevicetracker
David Filmore
Editor in Chief - Medtech Insight
Presenters
Slide3Agenda
Introduction
Overview of neuromodulation
Neuromodulation Market Overview
Market size
Market forecast /drivers & limiters
Competitors/market share
Technology trends driving growth
PNS Overview
Trends, key innovations
US Policy Developments
More support for neuromod?
Q&A
Slide4Overview – Neuromodulation
Neuromodulation (also termed “neurostimulation”) uses implantable devices (battery-powered implantable pulse generators or IPGs and electrical leads) to stimulate targeted nerves.
Goal: modulate abnormal nerve activity, alleviate debilitating pain or neurological symptoms (tremor, seizures, etc).
Pioneered by Medtronic (invented DBS, SCS).
In use since the late 1960s; commercial use since the 1970s-80s; majority of growth past 5-7 years.
Indication: severe, intractable cases when traditional medication/surgery fails.
Slide5Neuromodulation Devices - Similar in Design of Pacemakers
Cardiac pacemakers stimulate heart muscle using electrodes to correct abnormal heartbeat. Neuromodulation devices target nerves implicated in neurological disorders
.
Cardiac pacemaker
Source: HHS
Slide6Largest Neuromodulation Segments
Top 4 segments*:
1) spinal cord stimulation (SCS)
2) deep brain stimulation (DBS)
3) vagus nerve stimulation (VNS)
4) sacral nerve stimulation (SNS)
*Note: For the purposes of this webinar, we are focusing on SCS/DBS/VNS. Excluding SNS, currently monopolized by Medtronic (InterStim & NURO systems for OAB) and cochlear implants for hearing loss.
Slide7SCS, DBS, VNS defined
Sources: Abbott; Medtronic; Mayo Clinic
SCS
DBS
VNS
Transmits mild electrical impulses to nerves along the spinal cord to “mask” pain by blocking or changing pain signals before they reach the brain
Targets specific areas in brain; blocks abnormal nerve signals responsible for involuntary movements or tremor
Targets left vagus nerve, a major nerve network
that communicates
sensory information to the brain, to control seizures
Slide8Prevalence
SCS: 1.5 billion people suffer from chronic pain worldwide
100 million chronic pain sufferers in the US; 30 million from chronic back pain (US)
addresses opioid epidemic in US: 100 people die every day from opioid overdose
DBS: Parkinson’s disease: 10 million worldwide; 1.1 million (US)
Essential tremor: 7-10 million (US)
Dystonia: <300,000 (US)
VNS: epilepsy: 50-65 million worldwide; 3.4 million (US)
Drug-refractory epilepsy: 1 million (US)
Source: See Meddevicetracker’s reports cited at end of webinar: Spinal Cord Stimulation Devices Market and Deep Brain Stimulation & Vagus Nerve Stimulation Devices Market
Slide9Global Neuromodulation Market –
nearly $4.3bn in 2017
Neuromodulation Segment
Total Sales ($m; %)
SCS
$2,534 (59%)
SNS
675 (16%)
DBS
620 (15%)
VNS
450 (11%)
Total
$4,279m
Source: Meddevicetracker; company financials
All 4 segments = $4.3bn
SCS/DBS/VNS = $3.6bn, or 85% of total sales
SCS = $2.5bn, or 60% of total sales
Slide10SCS/DBS/VNS Segment Valuations & Growth Expectations
Neuromodulation Segment
Estimated Revenues/
Expected Growth
(%)
SCS
$2,534m (2017)
$4,713m (2022)
CAGR: 13.2%
DBS
$620m (2017)
$1,081m (2022)
CAGR: 11.8%
VNS
$450m (2017)
$688m (2022)
CAGR: 8.9%
Total
$3.6bn (2017)
$6.5bn (2022)
CAGR: 12.5%
Source: Meddevicetracker; company financials
Growth: upper single-digit or double-digits
Highest growth segment = SCS
SCS: 13.2%
DBS: 11.8%
VNS: 8.9%
Nearly doubling in size by 2022
Slide11Market Drivers & Limiters
Slide12Competitive Landscape – Market Leaders
SCS
DBS
VNS
Slide13Source: Meddevicetracker; company financials
Market Share By Segment (2017) – SCS/DBS/VNS
Segment
Competitors
Estimated 2017
revenues ($m)
Estimated 2017
market share (%)
SCS:
Medtronic
850
34
Abbott
746
29
Boston Scientific
585
23
Nevro
327
13
Nuvectra
26
1
Total
2,534
100
DBS:
Medtronic
508
82
Abbott
62
10
Boston Scientific
50
8
Total
620
100
Source: Meddevicetracker; company financials
Slide14*Notes: Totals may not sum due to rounding. The 2017 VNS market also includes RNS therapy from NeuroPace. Medtronic did not enter the refractive epilepsy market with its DBS technology until mid-2018, and therefore revenues are not included in 2017. As NeuroPace does not report financials, revenues are conservatively estimated at under $100m.
Market Share By Segment (2017) – SCS/DBS/VNS
Segment
Competitors
Estimated 2017 revenues ($m)
Market share (%)
VNS:
LivaNova
375
83
NeuroPace*
75
17
Total
450
100
Source: Meddevicetracker; company financials
Slide15FY2018
Quarterly Growth - Top 3 Neuromodulation Rivals
Company
Quarterly growth (%) FY2018
Abbott
Q1: 21%
Q2: 7%
Boston Scientific
Q1: 19%
Q2: 32%
Medtronic
(
Pain Therapies)
Q1 (FY2018): -5%
Q2: -8%
Q3: 10%
Q4: 13%
Q1 (FY2019): 17%
Source: Company quarterly financials
Avg. quarterly growth - neuromodulation/pain therapies:
Abbott: 14% (Q1/Q2)
BSC: 26% (Q1/Q2)
MDT (Pain Therapies): 5.4% (Q1-Q4 FY2018, Q1 FY2019)
*
Returned to growth in Q3 FY2018 due to launch of new Intellis SCS system, experiencing growth in mid-teens
Note: MDT has an odd fiscal year ended April 27, 2018
Slide16Technology Trends/Innovations
Miniaturization (of IPGs)
Improved lead technology
Improved precision/targeting of nerves
Less invasive/avoiding implantation of IPGs or batteries
MRI compatibility (all competitors)
Longer-life batteries, recharge-free systems
Customizing therapy, patient tracking, wireless communication
Expanding new indications/nerve targets
New indications/targets
Improving trial process
Future goal: significantly improving pain relief (80% or higher)
Combining SCS & PNS
Next gen, closed-loop, “responsive” systems; eliminating patient use of remote control
Non-invasive peripheral & brain stimulation technologies
Slide17Abbott’s
BurstDR stimulation (SCS) & new Proclaim DRG system
Proclaim
Elite Recharge-free SCS System
Proprietary BurstDR stimulation waveform technology
Both paresthesia & paresthesia-free (no tingling sensation)
Clinically proven to provide superior pain relief vs. traditional SCS (SUNBURST study; over 50% reduction in pain and high patient satisfaction for BurstDR)
Proclaim DRG Neurostimulation System
FDA approved October 2017
First neuromodulation device approved for treating complex regional pain syndrome types I and II
Slide18Boston Scientific’s New Spectra Wavewriter for SCS
FDA approved January 2018
Offers both paresthesia & sub-perception (no paresthesia)
First SCS system with Waveform Automation
First SCS system with Contour Field-Shaping
Customized to each patient’s spinal anatomy for superior pain relief
Slide19Medtronic’s
New Intellis SCS system
FDA approved September 2017; CE Mark November 2017
World’s smallest implantable neurostimulator (40% smaller)
Powered by proprietary Overdrive battery technology (recharging in 1 hour)
Evolve technology
Advanced patient tracking
Proprietary AdaptiveStim and SureScan MRI technology
Expanding indications to peripheral nerve stimulationVECTORS study (NANS 2019)
Slide20Nevro’s Senza II System for SCS
FDA approved January 2018
Proprietary HF10 Therapy; 10 kHz frequency
Smaller discreet design
First SCS system with clinically proven sustained 24-month superiority in pain reduction for back & leg pain; SENZA-RCT trial (76.5% reduction in back pain & 73% reduction leg pain vs. approx. 50%)
First to offer paresthesia-free therapy
10-year battery life
Company experiencing double-digit growth
Slide21New Directional Lead Technology - DBS (Abbott & Boston Scientific)
Abbott’s Infinity DBS System
First FDA-approved proprietary Directional Lead technology
Allows more precise targeting/fewer side effects
Lead: designed w/segmented electrodes, individually controlled
Smallest non-rechargeable battery
First DBS system with wireless connectivity
Clinicals/PD= doubled “on-time”(4.27 hrs vs 1.77 hrs) & 90% rated good-excellent
BSC’s Vercise DBS System
FDA approved Dec. 2017
Longest rechargeable battery (15 yrs)Unique MICC lead technology sculpts current field; Cartesia Directional Lead
INTREPID study = 50% improvement motor functionsNew Vercise Gevia (CE Mark June 2017); 25 yr rechargeable battery; Stimview software; first fully MRI compatible
Slide22Saluda Medical: The EVOKE System
First proprietary “closed-loop” neurostimulation system for chronic pain and other applications (eg, DBS)
The next-generation of neuromodulation
Investigational
Continuously measures & records the body’s response of neurons to stimulation and automatically adjusts to patient’s preferred stimulation levels (a “closed-loop” system)
Remote-control free; automatic stimulation
Evoke clinical trial
Goal: greater than average 50% pain relief (80% or higher)
-Pipeline includes DBS, peripheral nerve stimulation, the sciatic, tibial, and vagus nerves
-Secured $40m (US) in financing in 2017
-Medtronic major investor
Slide23Brainsway:
Deep TMS
Noninvasive Deep Transcranial Magnetic Stimulation (Deep TMS) stimulation device for major depression and other applications
Patents exclusively licensed from the National Institutes of Health (NIH)
FDA approved in May 2018 for major depressive disorder (MDD); FDA approved
de novo
for OCD (August 2018)
CE Mark approval several indications
Outpatient/no anesthesia/20-minute sessions
Stimulates
deeper & broader neuronal targets in the brain than conventional TMS
Electric field stimulates larger volume of gray matter
US pivotal trial response rate of 38.4% (vs. 21.4% with sham) after 20 sessions
Over 60 clinical studies; 15,000 patients treated; good reimbursement
Slide24PNS development is lagging amid success of SCS
Different from SCS: implant is placed directly over the nerve at targeted area
ACPA: Peripheral neuropathy typically causes pain and numbness in hands and feet, often described as tingling, burning or pricking sensation (paresthesia) or muscle weakness
Causes: Infection, traumatic injury, metabolic disorders, exposure to toxins
More than 100 different types of PN: diabetes common cause
Peripheral Nerve Stimulation (PNS) Overview
Slide25Peripheral Nerve Stimulation (PNS): Growth Drivers/Challenges
Slide26SPR Therapeutics: SPRINT PNS System
First, only US FDA-cleared percutaneous PNS system for treating chronic and acute pain, including post-operative and post-traumatic pain
Next-gen SPRINT endura (single-lead) and extensa (dual-lead) systems FDA approved in August 2018 for 60-day implantation in the back/extremities
Fills a gap in between opioids and more invasive conventional neuromodulation
Features/Benefits:
Threadlike, flexible coiled MicroLead is placed percutaneously by physician during out-patient procedure
Lead is connected to small patch-like SPRINT Wearable Stimulator
Delivers neurostimulation for 60 days, can be removed non-surgically
Clinical Trials:
Preliminary results multicenter study treating chronic post-amputation pain showed ≥50% pain reduction/pain interference in 2/3rds of subjects after 8 weeks; enduring, significant pain relief ≥50% was reported by 4 of 5 patients who completed 12-month study (data, Napa Pain Conference, August 2018)
Funding:
October 2018: $10m grant US DOD; $30m total in research government grants and contracts to advance SP
September 2017: $25m in Series C round led by a “prominent family office” and Frontcourt Ventures
Slide27Bioness: StimRouter
US FDA cleared 2015; Canada approved January 2018; CE mark 2014
Indication: Pain management of severe, intractable chronic pain of peripheral nerve origin as adjunct to other less invasive therapies, such as pain medications
Targets 22 different peripheral nerves around body
Features/Benefits:
All electronics are outside the body in wearable transdermal electrical stimulation device, reduces implantation time and anesthesia from 90 to 15-30 minutes
Battery is implanted underneath skin; SPR battery is external
Lead is implanted through small incision and placed on nerve; backend is external pulse transmitter (EPT), sends electrical signal through skin to lead; programmer patch wirelessly connects to EPT, allows patients to turn stimulation on/off
Clinical Trials:
7 patients implanted with StimRouter to manage post-stroke shoulder pain, average 70% reduction in chronic pain using visual analog scale (Poster, NANS 2017)
Reimbursement:
May 2017, Aetna
February 2018, Highmark Blue Cross Blue Shield
Slide28electroCore: gammaCore
Features/Benefits:
Delivers non-invasive vagus nerve stimulation (VNS) to patient’s neck, block signals that cause headache
Vagus nerve, longest cranial nerve in body, brings information from visceral organs to the brain
Registry/Clinical Trials:
ElectroCore developed US commercial registry with expert headache centers in US to distribute up to 1,200 gammaCore units for free for first 2 months
FDA clearance based on results of 243-patient PRESTO trial, showed gammaCore was superior to sham, well tolerated, higher proportion of patients achieved pain relief within 2 hrs vs. control group
Funding:
November 2017 completed $70m Series B funding round led by Core Ventures II, Merck’s Global Health Innovation Fund
Completely noninvasive, US FDA cleared 2018 for treating acute migraine; April 2017, FDA de novo for treating episodic cluster headaches, CE-marked in Europe 2017
Treats multiple attacks a day, and up to 4 attacks or 8 tx for a total of 24 stimulations/day
Slide29NeuroMetrix: Quell TENS unit
Wearable TENS unit used for treating common types of chronic, intractable pain
First FDA-cleared device for treating chronic pain during sleep
Sold OTC without prescription, can be worn 24 hrs a day
Features/Benefits:
Two components: an electronic device carried in a neoprene band worn on upper calf and electrode that interfaces the device with the skin
Stimulates nerves to trigger release of body’s own natural pain blockers for widespread pain relief
Designed to relief chronic pain: arthritis, diabetic nerve pain, fibromyalgia, lower back and leg pain
Sales Agreement with GlaxoSmithKline :
January 2018, NeuroMetrix (Waltham, Mass.) signed agreement with GlaxoSmithKline to expand intl. sales of Quell – GlaxoSmithKline gains exclusive ownership of device for markets outside US; up to $21m upon in milestones; NeuroMetrix retains US marketing rights
Slide30Emerging Technology
Mainstay Medical: ReActiv8
Small implantable device to treat chronic low back pain
Differs from SCS systems: electronically stimulates nerves responsible for activating or contracting key stabilizing muscles of the lumbar spine to restore muscle control and stabilize spine over time
Patient uses wireless, handheld remote control 30 min./2 x a day
Features/Benefits:
Implantation of two leads bilaterally near the dorsal ramus nerve at the L3 vertebra. Leads are connected to a small battery-powered IPG, which generates electrical pulses to dorsal ramus nerves to activate muscles.
External programmer communicates wirelessly with IPG
Customized stimulation by patient
Clinical Trials:
Two international, multi-center trials:
ReActi8-A supported CE mark in May 2016, showed significant and sustained improvement in chronic low back pain
ReActiv8-B, US IDEA trial, 204 patients, data expected year-end for hopeful US approval and in Australia
Funding:
In February 2018 raised €30.1m to complete US trial and advance European commercialization
Slide31FDA has launched an “
Innovation Challenge
” Winners announced next month
US Congress recently passed
“SUPPORT for Patients and Communities Act” to address the opioid epidemic Further focuses FDA efforts on alternative pain controlMedicare provisions, but nothing specific for neuromodulation
More Broadly: CMS has signaled it is working hard to improve the reimbursement process for innovative medical devices
US Policy: More Support For Neuromod?
Slide32After years of non-coverage, Medicare recently re-opened a National Coverage Analysis for vagus nerve stimulation for Treatment-Resistant Depression.
Based on a request from LivaNova, a proposed decision is anticipated next month
Medicare Progress? VNS For Depression
Slide33For detailed market intelligence, see our Meddevicetracker reports:
Spinal Cord Stimulation Devices Market:https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=372
Deep Brain Stimulation & Vagus Nerve Stimulation Devices Market: https://www.meddevicetracker.com/ReportDetail.cfm?ReportID=383
Slide34Q&A
Slide35Thank you
For further questions or to find out more:
Email:
pharma@informa.com
Visit:
pharmaintelligence.informa.com
Chrystal.Larsen@informa.com
Marion.Webb@informa.com
David.Filmore@informa.com