Problem

Actipulse Neuroscience addresses the access, cost, and usability barriers that keep non-invasive brain stimulation for depression largely inside hospitals. Although this treatment is widely used and FDA-cleared for depression, conventional systems are expensive and difficult to administer, requiring repeated supervised visits. Actipulse’s stated economics compare an anticipated $1,200–$1,600 three-month home treatment with roughly $15,000 for hospital-based neuromodulation, making affordability and convenience central to the proposition.

The primary use case is Major Depressive Disorder: enabling patients who need repeated stimulation sessions to receive therapy at home rather than travel to a hospital or psychiatric practice. The company also frames a broader ambition around psychiatric, neurological, and neurodegenerative disorders, but its most advanced disclosed indication is MDD, listed in its clinical pipeline as a Phase 3 pivotal study.

Product / Service

Actipulse develops non-invasive brain-stimulation and transcranial neuromodulation devices. Its approach is based on high-frequency magnetic pulses, described as a patent-pending innovation on traditional TMS that uses high-frequency, low-intensity stimulation. The company says this enabled a smaller hospital device that is simpler to use and can be applied by general medical personnel rather than only highly specialized clinicians.

The delivery model combines a hospital-setting device already described as being on the market with a planned direct-to-patient home device. The proposed home protocol involves 60 sessions, twice daily, without a medical professional applying each treatment, delivered through a monthly subscription. Actipulse positions the home version as offering comparable efficacy at lower cost, although the home product’s FDA pathway remains clinical-stage in the evidence gathered.

Market

Actipulse competes in medical devices and neurotechnology, specifically the non-invasive brain-stimulation, TMS-derived neuromodulation market for depression and other CNS disorders. Tracxn identifies Newronika, NeuraWorx, and NovaVision among its competitors, while Flow Neuroscience’s FL-100 became a relevant home-treatment benchmark after being reported as the first U.S.-approved at-home brain-stimulation device for depression in 2025. Actipulse’s latest explicit regulatory update in the corpus, from September 2024, placed its home MDD device in Phase 3 and said FDA trials were scheduled to start in Q2 2025; the evidence does not document subsequent FDA clearance.

The company is not best characterized as pre-revenue. Its 2021 fundraising materials reported more than $2 million in lifetime revenue, over 10,000 patients treated, more than 210 hospital-setting devices in use, and profitability since 2019; the hospital device was described as generating about $30,000 per end-user annually. A current Y Combinator listing still labels the company active with 38 employees. Exact present-day revenue is uncertain because third-party estimates conflict, with one source reporting less than $1 million as of December 2022 and another estimating $5 million in 2024, but the disclosed hospital deployment and historical revenue indicate meaningful commercial traction while the home product remains in development.