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Sooma tDCS for MDD (US FDA Trial)

Major Depressive Disorder (MDD)

Pivotal TrialActive

Key Facts

Indication

Major Depressive Disorder (MDD)

Phase

Pivotal Trial

Status

Active

Company

Sooma

About Sooma

Sooma Medical is a commercial-stage medical device company pioneering accessible transcranial direct current stimulation (tDCS) therapy for depression and chronic pain. Its core innovation combines a portable stimulation device with a remote protocol management platform, enabling scalable treatment delivery in clinics or at home. With over 30,000 patients treated across 35+ countries and the first EU MDR approval for a tDCS system, Sooma has established early market leadership. The company is now advancing a U.S. FDA clinical trial to expand into the critical American market.

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Therapeutic Areas

Major Depressive Disorder Chronic Pain Fibromyalgia Neuropathic Pain

Other Major Depressive Disorder (MDD) Drugs

Drug	Company	Phase	Status
AL001	Alzamend Neuro	Preclinical	Research
Deep TMS (H1 Coil)	BrainsWay	FDA Cleared	Commercial
EXXUA™ (gepirone ER)	Aytu BioPharma	Commercial	Launched
INV-202 (Oral & LAI)	Indivior	Preclinical	Discovery
Gepirone ER	Fabre-Kramer Pharmaceuticals	NDA Submitted	Active
Exablate Neuro	Insightec	Clinical Trial	Active
BrightKaire Platform for Depression	NeuroKaire	Pre-clinical	Active
Tyemvers (CKDB-501)	Healis Therapeutics	Pre-clinical	Active
VENTURA-7	New Hope Clinical Research	Phase 2/3	Active
DT-101	Draig Therapeutics	Phase 2	Active
Major Depressive Disorder Program	Actipulse Neuroscience	Phase 3	Active
Flow tDCS Headset & App	Flow Neuroscience	Approved	Active