Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 14
Deep Brain Stimulators (DBS) – Pipeline Products by Territory 15
Deep Brain Stimulators (DBS) – Pipeline Products by Regulatory Path 16
Deep Brain Stimulators (DBS) – Pipeline Products by Estimated Approval Date 17
Deep Brain Stimulators (DBS) – Ongoing Clinical Trials 18
Deep Brain Stimulators (DBS) Companies – Pipeline Products by Stage of Development 19
Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 22
Actipulse Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Fast Gamma Magnetic Stimulation Device – Product Status 25
Fast Gamma Magnetic Stimulation Device – Product Description 25
Adaptive Neuromodulation GmbH Pipeline Products & Ongoing Clinical Trials Overview 26
CR-Capable Implant – Product Status 26
CR-Capable Implant – Product Description 26
Adept Neuro SA Pipeline Products & Ongoing Clinical Trials Overview 27
Stereo-Electro-Encephalo-Graphie Electrode – Product Status 27
Stereo-Electro-Encephalo-Graphie Electrode – Product Description 27
Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 28
directSTIM – Product Status 28
directSTIM – Product Description 28
Aleva Neurotherapeutics SA – Ongoing Clinical Trials Overview 29
directSTIM – A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System 30
directSTIM – A Prospective, Multi-center, Single Arm, Observational, Post-market Clinical Follow-up Study on the Use of the directSTIM DBS System to Treat Essential Tremor 30
Allegheny Health Network Pipeline Products & Ongoing Clinical Trials Overview 31
Deep Brain Stimulation System – Alzheimer’s Disease – Product Status 31
Deep Brain Stimulation System – Alzheimer’s Disease – Product Description 31
Deep Brain Stimulation System – Obesity – Product Status 32
Deep Brain Stimulation System – Obesity – Product Description 32
Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 33
Adaptive Deep Brain Stimulation (aDBS) Device – Product Status 33
Adaptive Deep Brain Stimulation (aDBS) Device – Product Description 33
Bioinduction Limited Pipeline Products & Ongoing Clinical Trials Overview 34
Picostim – Product Status 34
Picostim – Product Description 34
Picostim-DyNeuMo – Product Status 35
Picostim-DyNeuMo – Product Description 35
Bioinduction Limited – Ongoing Clinical Trials Overview 36
Picostim – Simpler and Safer Deep Brain Stimulation for Parkinson’s Disease 37
Picostim-DyNeuMo – Exploratory Safety and Electrophysiological Study of Closed-loop Pudendal Neuromodulation Using an Implantable (Picostim-DyNeuMo) Device in Women With Urinary Incontinence 38
Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 39
Deep Brain Stimulation Device – Depression – Product Status 39
Deep Brain Stimulation Device – Depression – Product Description 40
Deep Brain Stimulation Device – Stroke – Product Status 40
Deep Brain Stimulation Device – Stroke – Product Description 40
Enspire DBS Therapy System – Traumatic Brain Injury – Product Status 40
Enspire DBS Therapy System – Traumatic Brain Injury – Product Description 41
Next Generation DBS System – Product Status 41
Next Generation DBS System – Product Description 41
Vercise Deep Brain Stimulation System – Alzheimer’s Disease – Product Status 41
Vercise Deep Brain Stimulation System – Alzheimer’s Disease – Product Description 42
Brainsway Ltd Pipeline Products & Ongoing Clinical Trials Overview 43
Deep TMS System – Alcohol Use Disorder – Product Status 43
Deep TMS System – Alcohol Use Disorder – Product Description 44
Deep TMS System – Alzheimer’s Disease – Product Status 44
Deep TMS System – Alzheimer’s Disease – Product Description 44
Deep TMS System – Bipolar Disorder – Product Status 45
Deep TMS System – Bipolar Disorder – Product Description 45
Deep TMS System – Chronic Pain – Product Status 45
Deep TMS System – Chronic Pain – Product Description 46
Deep TMS System – Multiple Sclerosis – Product Status 46
Deep TMS System – Multiple Sclerosis – Product Description 46
Deep TMS System – Obesity – Product Status 47
Deep TMS System – Obesity – Product Description 47
Deep TMS System – Opioid Use Disorder – Product Status 47
Deep TMS System – Opioid Use Disorder – Product Description 48
Deep TMS System – Post-Stroke – Product Status 48
Deep TMS System – Post-Stroke – Product Description 48
Deep TMS System – PTSD – Product Status 49
Deep TMS System – PTSD – Product Description 49
Next-Generation Multi-Channel TMS Stimulator – Product Status 49
Next-Generation Multi-Channel TMS Stimulator – Product Description 50
Brainsway Ltd – Ongoing Clinical Trials Overview 51
Deep TMS System – Bipolar Disorder – A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction with Mood Stabilizers in Subjects with Bipolar Depression 52
ClearPoint Medical Pipeline Products & Ongoing Clinical Trials Overview 53
Neuro Navigation Device – OCD – Product Status 53
Neuro Navigation Device – OCD – Product Description 53
ClearPoint Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Neuro Navigation Device – Insomnia – Product Status 54
Neuro Navigation Device – Insomnia – Product Description 54
Neuro Navigation Device – Parkinson’s Disease – Product Status 55
Neuro Navigation Device – Parkinson’s Disease – Product Description 55
Neuro Navigation Device – Stroke Rehabilitation – Product Status 55
Neuro Navigation Device – Stroke Rehabilitation – Product Description 56
Cleveland Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 57
ParkinTune – Product Status 57
ParkinTune – Product Description 57
Clinatec Pipeline Products & Ongoing Clinical Trials Overview 58
Intracranial Deep Brain Stimulation Device – Product Status 58
Intracranial Deep Brain Stimulation Device – Product Description 58
Deep Brain Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 59
TOPS Device – Alzheimer’s disease – Product Status 59
TOPS Device – Alzheimer’s disease – Product Description 59
TOPS Device – Depression – Product Status 60
TOPS Device – Depression – Product Description 60
TOPS Device – Epilepsy – Product Status 60
TOPS Device – Epilepsy – Product Description 61
TOPS Device – Obesity – Product Status 61
TOPS Device – Obesity – Product Description 61
TOPS Device – Obsessive-Compulsive Disorder – Product Status 62
TOPS Device – Obsessive-Compulsive Disorder – Product Description 62
TOPS Device – Parkinson’s disease – Product Status 62
TOPS Device – Parkinson’s disease – Product Description 63
Deep Brain Stimulation Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 64
Adaptive Deep Brain Stimulation Device – Product Status 64
Adaptive Deep Brain Stimulation Device – Product Description 64
Endonovo Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 65
DSF-rTMS – Product Status 65
DSF-rTMS – Product Description 65
Enspire DBS Therapy Inc Pipeline Products & Ongoing Clinical Trials Overview 66
Enspire DBS Therapy System – Product Status 66
Enspire DBS Therapy System – Product Description 66
Enspire DBS Therapy Inc – Ongoing Clinical Trials Overview 67
Enspire DBS Therapy System – Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study 68
Functional Neuromodulation Inc. Pipeline Products & Ongoing Clinical Trials Overview 69
Deep Brain Stimulation Device – Mild Alzheimer’s Disease – Product Status 69
Deep Brain Stimulation Device – Mild Alzheimer’s Disease – Product Description 69
Deep Brain Stimulation Device – OCD – Product Status 70
Deep Brain Stimulation Device – OCD – Product Description 70
Functional Neuromodulation Inc. – Ongoing Clinical Trials Overview 71
Deep Brain Stimulation Device – Mild Alzheimer’s Disease – A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients with Mild Probable Alzheimer’s Disease: ADvance II 72
Hangzhou General Stim Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 73
Dual-Channel Implantable Deep Brain Stimulation System – Product Status 73
Dual-Channel Implantable Deep Brain Stimulation System – Product Description 73
Hangzhou General Stim Biotechnology Co Ltd – Ongoing Clinical Trials Overview 74
Dual-Channel Implantable Deep Brain Stimulation System – A Prospective, Multi-center, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Dual-channel Implantable Deep Brain Stimulation System for Improving Clinical Symptoms of Parkinson’s Disease 75
Louisiana State University Pipeline Products & Ongoing Clinical Trials Overview 76
Wireless Implantable Neural Stimulator – Product Status 76
Wireless Implantable Neural Stimulator – Product Description 76
Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 77
Deep Brain Stimulation Device – Product Status 77
Deep Brain Stimulation Device – Product Description 77
Deep Brain Stimulation System – Product Status 78
Deep Brain Stimulation System – Product Description 78
Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 79
Implantable Micro – Cannula Device – Product Status 79
Implantable Micro – Cannula Device – Product Description 79
Medtronic Neuromodulation Pipeline Products & Ongoing Clinical Trials Overview 80
Percept PC BrainSense – Product Status 80
Percept PC BrainSense – Product Description 80
Medtronic Neuromodulation – Ongoing Clinical Trials Overview 81
Percept PC BrainSense – Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease 82
Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 83
Cranial Mounted DBS – Product Status 83
Cranial Mounted DBS – Product Description 83
Reclaim Deep Brain Stimulation System – Depression – Product Status 84
Reclaim Deep Brain Stimulation System – Depression – Product Description 84
Sapiens DBS Field Steering System – Product Status 84
Sapiens DBS Field Steering System – Product Description 85
National Cheng-Kung University Hospital Pipeline Products & Ongoing Clinical Trials Overview 86
Responsive Epilepsy Control System-On-Chip – Product Status 86
Responsive Epilepsy Control System-On-Chip – Product Description 86
Neurode Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 87
Neurode Wave – Product Status 87
Neurode Wave – Product Description 87
NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 88
Deep Brain Stimulation System – Product Status 88
Deep Brain Stimulation System – Product Description 88
Therapeutic Electrode – Chronic Stimulation – Product Status 89
Therapeutic Electrode – Chronic Stimulation – Product Description 89
Neuroparticle Corp Pipeline Products & Ongoing Clinical Trials Overview 90
Non-Invasive Deep Brain Stimulation Device – Product Status 90
Non-Invasive Deep Brain Stimulation Device – Product Description 90
NeuroPro Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 91
Deep Brain Stimulation – Product Status 91
Deep Brain Stimulation – Product Description 91
Neurosigma Inc Pipeline Products & Ongoing Clinical Trials Overview 92
Deep Brain Stimulation System – Cachexia – Product Status 92
Deep Brain Stimulation System – Cachexia – Product Description 92
Deep Brain Stimulation System – Obesity – Product Status 93
Deep Brain Stimulation System – Obesity – Product Description 93
Newronika s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 94
AlphaDBS – Product Status 94
AlphaDBS – Product Description 94
Newronika s.r.l. – Ongoing Clinical Trials Overview 95
AlphaDBS – A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered through AlphaDBS System in Patients with Parkinson’s Disease 96
AlphaDBS – A Prospective, Multi-center, Open-label, Pivotal Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Advanced Levodopa-Responsive Parkinson’s Disease Treated With Bilateral Deep Brain Stimulation 96
Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 97
Synapse – Product Status 97
Synapse – Product Description 97
Viant Deep Brain Stimulation System – Product Status 98
Viant Deep Brain Stimulation System – Product Description 98
Nia Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 99
Smart Neurostimulation System – Product Status 99
Smart Neurostimulation System – Product Description 99
Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 100
ARC-DBS-Mobility – Product Status 100
ARC-DBS-Mobility – Product Description 100
Oxford University Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 101
Closed-Loop DBS Device – Product Status 101
Closed-Loop DBS Device – Product Description 101
Salvia Bioelectronics BV Pipeline Products & Ongoing Clinical Trials Overview 102
Neuromodulation Device – Chronic Migraine – Product Status 102
Neuromodulation Device – Chronic Migraine – Product Description 102
Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 103
HD-tDCS System – Product Status 103
HD-tDCS System – Product Description 103
Soterix Medical Inc – Ongoing Clinical Trials Overview 104
HD-tDCS System – Modulating Prospective Memory in Older Adults with Noninvasive Brain Stimulation 105
HD-tDCS System – Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients 105
HD-tDCS System – Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment 105
HD-tDCS System – Transcranial Direct Current Stimulation for Gait Recovery Following Stroke 106
Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 107
Deep Brain Stimulator – Parkinson’s Disease – Product Status 107
Deep Brain Stimulator – Parkinson’s Disease – Product Description 107
Indigenous Deep Brain Stimulation Device – Product Status 108
Indigenous Deep Brain Stimulation Device – Product Description 108
St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 109
Libra Deep Brain Stimulation System – Depression – Product Status 109
Libra Deep Brain Stimulation System – Depression – Product Description 109
Next Generation Implantable DBS System – Primary Cell – Product Status 110
Next Generation Implantable DBS System – Primary Cell – Product Description 110
St. Jude Medical LLC – Ongoing Clinical Trials Overview 111
Libra Deep Brain Stimulation System – Depression – Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression 112
Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 113
Deep Brain Stimulation Device – PTSD – Product Status 113
Deep Brain Stimulation Device – PTSD – Product Description 113
Sunnybrook Health Sciences Centre – Ongoing Clinical Trials Overview 114
Deep Brain Stimulation Device – PTSD – Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-traumatic Stress Disorder (PTSD): Pilot Trial 115
SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 116
Low-Frequency Sine Wave Neurostimulation Therapy Device – Product Status 116
Low-Frequency Sine Wave Neurostimulation Therapy Device – Product Description 116
The Magstim Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 117
Magstim Super Rapid2 Plus1 – Product Status 117
Magstim Super Rapid2 Plus1 – Product Description 117
The Magstim Co Ltd – Ongoing Clinical Trials Overview 118
Magstim Super Rapid2 Plus1 – Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study 119
Magstim Super Rapid2 Plus1 – Neuromodulation in the Elderly Depressed: A Brain Im-aging Pilot Study 119
University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 120
Deep Brain Stimulation Device – Product Status 120
Deep Brain Stimulation Device – Product Description 121
Implantable Ultrasound Neuromodulation Device – Product Status 121
Implantable Ultrasound Neuromodulation Device – Product Description 121
Wireless Deep Brain Stimulating System – Product Status 122
Wireless Deep Brain Stimulating System – Product Description 122
University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 123
Deep Brain Stimulation Device – Severe Depression – Product Status 123
Deep Brain Stimulation Device – Severe Depression – Product Description 123
University of California San Francisco – Ongoing Clinical Trials Overview 124
Deep Brain Stimulation Device – Severe Depression – Study Evaluating the Efficacy of Closed-loop Neuromodulation in Patients with Treatment-resistant Depression 125
University of Central Florida Pipeline Products & Ongoing Clinical Trials Overview 126
Deep Brain Stimulation System – Product Status 126
Deep Brain Stimulation System – Product Description 126
University of Florida Pipeline Products & Ongoing Clinical Trials Overview 127
Closed-Loop Deep Brain Stimulation System – Product Status 127
Closed-Loop Deep Brain Stimulation System – Product Description 127
Closed-Loop Seizure Control System – Product Status 128
Closed-Loop Seizure Control System – Product Description 128
Deep Brain Stimulation System – Product Status 128
Deep Brain Stimulation System – Product Description 129
University of Houston Pipeline Products & Ongoing Clinical Trials Overview 130
Closed-Loop Brain Stimulator – PTSD – Product Status 130
Closed-Loop Brain Stimulator – PTSD – Product Description 130
University of Illinois Pipeline Products & Ongoing Clinical Trials Overview 131
Wireless Deep Brain Stimulation System – Essential Tremor – Product Status 131
Wireless Deep Brain Stimulation System – Essential Tremor – Product Description 131
University of Milan Pipeline Products & Ongoing Clinical Trials Overview 132
Smart Brain Device – Product Status 132
Smart Brain Device – Product Description 132
University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 133
Closed-Loop Deep Brain Stimulation Device – Product Status 133
Closed-Loop Deep Brain Stimulation Device – Product Description 133
University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 134
Adaptive Deep Brain Stimulation System – Product Status 134
Adaptive Deep Brain Stimulation System – Product Description 134
University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 135
Automated Brain Stimulation System – Product Status 135
Automated Brain Stimulation System – Product Description 135
University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 136
Deep Brain Magnetic Stimulator – Product Status 136
Deep Brain Magnetic Stimulator – Product Description 136
University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 137
Deep Brain Stimulator – Product Status 137
Deep Brain Stimulator – Product Description 137
Wedge Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 138
SONS System – Product Status 138
SONS System – Product Description 138
Glossary 162