Emerging Neurostimulation Devices with Recent Headlines                 www.strategyinc.net
Technique Indication Company/Device Milestones
Deep Brain Stimulation Epilepsy NeuroPace
NeuroPace RNS System
neuropace.com
California, US
  • 03/21: Filed IPO target of $75M upsized to proceeds of $102M
  • >3,000 patients had received its closed loop RNS system (12/20)
Neurodegenerative Disease Functional Neuromodulation
Vercis DBS Systems
fxneuromod.com
Toronto, Canada
  • 01/21: Breakthrough Device designation
  • ADvance II pivotal study currently enrolling
  • Received funding from Genesys Capital, Foundation Medical Partners and Boston Scientific
Newronika
AlphaDBS
newronika.com
Minnesota, US
Milan, Lombardia, Italy
  • First closed-loop deep brain neuromodulation system for Parkinson’s
  • Spin-off company of Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico Hospital and the University of Milan
  • 02/21: AlphaDBS receives CE mark; first patient implanted with AlphaDBS
  • $11.1M raised over 3 rounds, including a Series A with lead investor Omnes Capital
Nia Therapeutics
Smart Neurostimulation
System
niatherapeutics.com
Pennsylvania, US
  • 05/21: Received $1M subcontract from US Army to complete development
  • Improves memory function
Migraine + Cluster Headache Unity HA
Pulsante SPG Microstimulator
unity-ha.com
Missouri, US
  • Stimulation of the sphenopalatine ganglion, battery-free device
  • 1/21 Results of double-blind RCT published in Lancet
  • 04/21: FDA has granted Breakthrough Device designation
  • Acquired Autonomic Technologies assets
  • Treated over 700 patients in US and EU
Traumatic Brain Injury (TBI) Michael Kahana and Team
USAMRDC project
University of Pennsylvania
  • 06/21: $3.4 Million Grant
  • Sponsored by the U.S. Army Medical Research and Development Command (USAMRDC)
  • Closed-loop brain stimulation
  • Builds on a recently completed $24.5 million DARPA-funded study
Sacral Nerve Stimulation Overactive Bladder (OAB) Axonics Modulation Technologies
Axonics r-SNM
axonics.com
California, US
  • r-SNM implantable neurostimulator and wireless patient remote control
  • 05/21: CE mark for Gen2 device
  • 05/21: FDA approval expanding MRI labeling
  • 05/21: $201.3M IPO
  • 2014 – 2021: Raised a total of $604.4M in funding over 9 rounds
  • 02/21: Acquires Contura, developer of Bulkamid, an FDA-approved treatment for stress urinary incontinence
BlueWind Medical
Renova iStim Leak
Fempulse Vaginal Ring
Neuspera SNS System
bluewindmedical.com
Israel and Utah, US
  • 3 Clinical trials for 3 devices, study being completed by UW Medicine; estimated completion date: December 2022
  • 06/20: $40M, Later Stage VC
Spinal Cord Stimulation Chronic Pain Boston Scientific
WaveWriter Alpha
bostonscientific.com
Massachusetts, US
  • 05/21: Best Overall Medical Device Solution MedTech Breakthrough Awards
  • 12/20: FDA approved
  • 10/20: Launched in Europe
Medtronic
Vanta SCS Neurostimulator
medtronic.com
Minnesota, US
  • Recharge-free, battery life of up to 11 years
  • 05/21: FDA cleared
  • 2021: Medtronic stock has risen 3.9% against the industry’s 1.9% drop
Nalu Medical
Nalu Neurostimulation System
Nalumed.com
California, USA
  • Also FDA cleared for PNS applications
  • 03/21 micro-implantable pulse generator received FDA clearance for an expanded service life of 18 years
  • 04/20 FDA clearance for MRI-conditional labeling for full-body 1.5T scans
  • 04/20 New CEO Earl Fender; Keegan Harper remains Chairman of the Board
  • Total funding $11.9M (2015) Advent Life Sciences and Stanford-Start-X Fund
Saluda Medical
Evoke Closed-Loop System
saludamedical.com
New South Wales, Australia
  • Investigational device in the US
  • 2015 – 2019: $124.5M in funding over 4 rounds
  • Redmile Group and Boston Scientific are the most recent investors
Chronic Low Back Pain Mainstay Medical
ReActiv8
mainstay-medical.com
Swords, Ireland
  • Stimulates nerves in low back for stabilization and for treatment of pain
  • FDA Approved
  • US commercialization to begin 1H 2021
  • 02/21: Closing of an equity financing: $108M
  • 03/21: Commercial launch in Australia
Spinal Injury ONWARD
onwd.com
Eindhoven, Noord-Brabant, The Netherlands
  • 01/21 Trial for non-invasive SCS IPG
  • Developing and commercializing innovative therapies to enable functional recovery for people with spinal cord injuries
  • Formerly GTX Medical
  • 04/21 raised $37M from Gimv and 5 other investors
  • Total investment $73.1M
Vagal Nerve Stimulation Autoimmune disease SetPoint Medical
VNS MicroRegulator
setpointmedical.com
Valencia, CA
  • Total investment $216.4M in 10+ rounds including $64M 1/21 lead by NEA. Other recent investors include SVE Capital, Topspin, Morgenthaler, Shangbay Capital
  • 01/21 RESET-RA Clinical trial for chronic inflammation-mediated autoimmune disease – initially for RA 250 patients at 40 sites
  • FDA Breakthrough Device Designation
Peripheral Nerve Stimulation
Technique Indication Company/Device Milestones
Carotid Artery Baroreceptor
Stimulation
Heart Failure CVRx
Barostim Neo
Implantable baroreflex activation therapy
cvrx.com
Minnesota, US
  • 6/21 filed for $75M IPO
  • Booked $7 M in sales for the 12 months ending March 31, 2021
  • 2020: Secured reimbursement with CMS
  • FDA Breakthrough device designation
High Frequency Nerve
Block
Post-amputation Pain Neuros Medical
Altius System High Frequency Nerve Block
neurosmedical.com
Ohio, US
  • 01/21: $38.5M in Series BB Funding for Completion of Pivotal Clinical Study
  • Raised $34M (2018) + $20M (2017)
Hypoglossal Nerve
Stimulation
Obstructive Sleep Apnea (OSA) Inspire Medical Systems
Two-Incision Implant
inspiresleep.com
Minnesota, US
  • 03/21: FDA approval
  • Raised $186M in funding over 6 rounds
  • 12/18: $75M, Post-IPO Equity
  • Revenue: $115.4 million (2020)
Nyxoah Genio
Bilateral hypoglossal nerve stimulation
genio.nyxoah.com
Mont-Saint-Guilbert, Belgium
  • Genio system better sleep trial in Australia reached primary endpoints
  • CE mark and FDA approval for MRI compatibility
  • 01/21: DREAM pivotal IDE study underway
  • 02/21: Exclusive licensing agreement with Vanderbilt University
  • 09/20 Oversubscribed IPO of $85M on Euronext Brussels
  • Revenue was $224,000 for the three months ended March 31, 2021
Phrenic Nerve Stimulation ZOLL Medical
remedē System
Transvenous phrenic nerve stimulation
zoll.com
Massachusetts, US
  • Implantable device approved by FDA
  • 04/21: Acquired 13 organizations including Respicardia and its neurostimulation technology for treating sleep apnea
  • 2021: Over $500M in revenue
PNS Chronic Nerve Pain BioVentus
StimRouter PNS System
bioventus.com
The Netherlands and
North Carolina, US
  • 3/21: Acquired Bioness, Inc. for $45M in up-front consideration, with up to $65M of contingent consideration
  • 2021: Net Income of $24.5M, up $14.0M, or 133.9%, year-over-year
Retinal Nerve Stimulation Dry AMD Pixium Vision
pixium-vision.com
Paris, France
  • Bionic vision for lost sight, enabling regain visual perception
  • Prima retinal implant system for dry AMD nearing end of Phase 2
  • 7 patients implanted US/EU with positive endpoint results
  • Final pivotal study underway in EU
Non-implanted Neurostimulators
Technique Indication Company/Device Milestones
Cardionomic Pulmonary
Neuromodulation System
Chronic Heart Failure Cardionomic
Cardionomic Pulmonary Neuromodulation System
cardionomicinc.com
Minnesota, US
  • 04/21: Pilot Study, initial enrollment
  • 02/21: Later Stage VC (Series A2): $15.8M
Cranial Nerve Innovation Gait deficit in MS Helius Medical Technologies
Portable Neuromodulation Stimulator (PoNS) Device
heliusmedical.com
Pennsylvania, US
  • Raised a total of $68.9M over 10 rounds
  • 01/21: $11M, Post-IPO Equity
  • 03/21: Authorized marketing for use as a short-term treatment of gait deficit due to MS
Deep Transcranial Magnetic
Stimulation (TMS)
Depression, OCD Brainsway
Theta Burst
brainsway.com
New Jersey, US
and Jerusalem, Israel
  • 04/21: Granted 510(k) clearance
  • 100,000 patients have been treated with its Deep TMS therapies to date
  • > 620 TMS systems are in place in 22 countries
Kinetic Oscillation
Stimulation
Chronic Migraine, Chronic rhinitis Chordate Medical
chordate.com
Kista, Sweden
  • Received CE marking even before migraine study was completed
  • Planning to launch in Italy, Nordic countries, and Israel
Magnetic Stimulation Pain Management NeuraLace Medical
Axon Therapy
neuralacemedical.com
California, US
  • Post-traumatic peripheral neuropathic pain
  • Investigational use only, not for sale in the US – clinical study phase
  • 06/19: $3M additional funding
Multichannel brain
Neuromodulation
(occipital and trigeminal nerves)
Chronic Migraine Neurolief
Relivion
Multi-channel brain neuromodulation system
neurolief.com
Netanya, Israel; Florida, US
  • 02/21: FDA clearance
  • Fall 2021: planned entrance into the US market through a limited market release
  • 2022: Planned full market release
Percutaneous Tibial
Neuromodulation (PTNM)
Overactive Bladder (OAB) Medtronic
NURO System
medtronic.com
Dublin, Ireland
  • 05/21: TITAN 1- A prospective, multicenter, feasibility study
Transcutaneous Electrical
Nerve Stimulation
Epilepsy, Depression Neuroelectrics
Starstim – neurostimulating electrical headcap
neuroelectrics.com
Barcelona, Spain
  • 05/21: Raised $17.5M in Series A
  • Developing platform into clinical trials
  • Recently ran a pilot study; Based on Phase III trial results will submit to FDA
Opioid Withdrawal Syndrome Spark Biomedical
The Sparrow
Therapy System
sparkbiomedical.com
Texas, US
  • S. Patent for use of neurostimulation in treating substance use disorder
  • 05/19: Grant round raised a total of $50k, (1) Funding Round
Vagal Nerve Stimulation Chronic Migraine electroCore
gammaCore
electrocore.com
New Jersey, US
  • Successful study involving gammaCore device, published in NPJ Parkinson’s Disease
  • FDA cleared and CE-marked
  • 05/21: Q1 revenue of $1.2M, 64% increase over 2020 and 30% sequentially
  • 06/21: To join Russell Microcap Index
Vibro-tactile Wrist
Stimulation
Hand tremor (Parkinson’s, Essential Tremor) Encora Therapeutics
AI-powered wearable
encoratherapeutics.com
Massachusetts, US
  • 03/21: Breakthrough Device designation, patent-pending AI-powered tremor reduction wearable
  • 09/20: $1.5 million in pre-seed funding
  • Senses wrist essential tremor severity and introduces personalized vibro-tactile stimulus