Medical devices & diagnostics · Neuromodulation
Actipulse Neuroscience
A Mexico-rooted company selling a clinician-operated magnetic stimulation console across Latin America. The at-home depression device promised since 2021 has no marketing authorization on record from the FDA.
A headline and a conclusion
On September 30, 2021 the company issued a release headlined “Actipulse Neuroscience Announces Successful Clinical Trial Using Fast Gamma Magnetic Stimulation for the Treatment of Alzheimer’s Disease.”
The paper behind it had appeared three weeks earlier in Frontiers in Neurology. Its conclusion, written by five authors, two of them working in the company’s science department, was narrower. The device was tolerated over six months. And then: “However, no statistically significant changes in cognitive, functionality, or depression scores compared to sham stimulation were observed.”
Both are true at once. The trial’s primary endpoint was the proportion of patients with any adverse effect, and it met that endpoint. Cognition was a secondary measure, and it did not move. The word in the headline does work the data does not, and that distance is worth holding onto here.
The bet on very weak fields
Magnetic stimulation for depression is established medicine. The FDA authorized the first system, Neuronetics’ NeuroStar, through a De Novo request, DEN070003, decided October 7, 2008. BrainsWay followed with DEN170078 in August 2018. Both are clinic equipment: expensive, operator dependent, and they require repeated visits over weeks.
Actipulse approached the physics from the opposite end. Conventional systems fire pulses near one tesla at 1 to 50 Hz. The Actipulse device, per its own published case series, delivered pulses of roughly 0.5 milliteslas in bursts at 550 to 600 Hz. That is on the order of a thousandth of the field strength at more than ten times the frequency. Fields that weak need no high voltage and no cooling, which is what makes a desktop console, and in principle a home headset, possible at all. It is also the part of the story with the least independent evidence behind it.
A French founder and a Mexican neuroscientist
Adrien Châtillon had launched and closed two startups in France before this one. He tells the origin as a firing: he lost two jobs, he says, for the same stated reason, that his entrepreneurial spirit did not fit the company culture.
His co-founder, Gabriel Villafuerte, is a Mexican physician with a PhD in neuroscience and an author on nearly every paper the company cites. He is now chief scientific officer, and the 2025 Frontiers paper discloses that he “has submitted patents related to TMS devices.”
The corporate shape follows the split. A Mexican operating company, Actipulse International SA de CV, was incorporated on April 17, 2017; a Delaware parent, Actipulse Neuroscience, Inc., on June 27, 2019 in Cambridge, Massachusetts. Mexico was a cost decision, and the CEO has said so directly. The earliest filed numbers describe a small real business: revenue of $583,433 for 2019 and $248,406 for 2020, profitable in both years, before any venture capital.
Four dates for one clearance
In July 2021, opening a public fundraising on Republic, the company said it was “preparing to launch an at-home device for depression treatment in the U.S. market, aiming for FDA clearance by Q3 of 2023.” In February 2022, out of Y Combinator’s Winter 2022 batch, Châtillon told Forbes Mexico it was one study away from the United States market. In September 2024 the chief of staff told a Paris agency the home version was in Phase 3, with FDA trials starting in the second quarter of 2025 and approval expected by the end of 2026.
As of September 22, 2026 the FDA device databases return nothing under Actipulse: no 510(k), no De Novo, no premarket approval, no registration or device listing. ClinicalTrials.gov holds no United States pivotal trial either. Both registered studies sit in Mexico City, sponsored by the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, with Actipulse a collaborator on one.
Someone else arrived first. In December 2025 the FDA authorized Flow Neuroscience’s FL-100 for at-home treatment of major depressive disorder, reported as the first such device in the United States. It uses transcranial direct current stimulation, an electrical rather than magnetic technique. Not the same product. The same market.
Actipulse moved too. It incorporated in France in 2023 and joined iPEPS, the incubator of the Paris Brain Institute. That work is preclinical and points elsewhere: using the same stimulation to transiently open the blood brain barrier so drugs can reach the brain, with glioblastoma and metachromatic leukodystrophy as first targets.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA status | No 510(k), De Novo, PMA, registration or device listing under Actipulse as of Sep 22, 2026. Company materials call the technology based on previously developed FDA-approved technology, which describes the modality, not this device. | Public record |
| NCT03983655 | Sponsored by a Mexican national institute, Actipulse collaborator. Randomized, triple masked, device feasibility. Started May 17, 2019, enrollment 37, completed Aug 1, 2020. Registry status: terminated, reason given as the COVID-19 pandemic. | Public record |
| The same trial, as announced | The Sep 30, 2021 release calls it a successful clinical trial and reports 34 participants. The registry records 37 enrolled and a terminated status. Neither the release nor the coverage of it mentions the termination. | Differs from registry |
| 2021 pilot, as published | Frontiers in Neurology, Sep 2021. Adverse effects in 4 of 17 active and 1 of 17 sham participants over six months. No significant change in cognition, function or depression against sham. Actipulse financed the study and supplied the devices; two authors were employees. | Public record |
| 2025 crossover pilot | Frontiers in Neurology, May 2025, registered as NCT05784298. Single session, 14 analyzed. Significant EEG gamma changes, no significant improvement in cognition against baseline. Four authors employed by Actipulse. | Public record |
| Depression evidence | The strongest depression publication is a report of three cases, Mar 2021, no control group. A smoking cessation paper, Sep 2021, is retrospective data from ten patients. Both list Actipulse employees as authors. | Public record |
| Commercial footprint | 210 clinics and about 10,000 patients in 2021 and 2022, restated in Oct 2024 as more than 400 clinics in Latin America. Sold in Mexico, Chile, Ecuador and El Salvador at a stated $15,000 to $18,000. No independent count found. | Company-stated |
| Mexican regulatory record | No COFEPRIS sanitary registration number was located in public sources. The Mexican site describes PRO2S as a device for professional use whose indication requires clinical assessment. | Not found |
| Revenue | Claims range from $2 million in lifetime revenue in 2021 to over $7.5 million in 2024. SEC filings by the Delaware issuer report $583,433, $248,406, $2,609 and $173,963 for 2019 to 2022, totalling $1,008,411. Reporting stopped in April 2023. | Differs from filings |
| Recognition | YC Winter 2022, iPEPS from 2023, and a Prix Galien USA 2024 Best Startup nomination, of which the company’s own site notes: “Se trata de una nominación, no de un premio obtenido.” | Company-stated |
Read plainly: Actipulse has a shipping product, clinics that pay for it, and a founder who built a small profitable business before taking outside money. What it lacks, nine years in, is a marketing authorization for the home device that is the entire premise, or a controlled trial showing the therapy changes an outcome.
What to watch
- Any Actipulse submission appearing in the FDA 510(k), De Novo or registration databases.
- A pivotal trial registered with Actipulse as sponsor. The Phase 3 described in September 2024 has no registry entry.
- A COFEPRIS registration number for PRO2S, which would settle what is authorized in Mexico, and for which indication.
- Any peer-reviewed efficacy result with a control group. Every study published so far is a pilot, a case series or a chart review.
In their words
“The funding injection will allow us to finance our clinical pipeline and ultimately bring neuromodulation treatment from the hospital to the home, as there are not enough hospital places to treat the 17 M+ Americans suffering from MDD”
Adrien Châtillon, CEO, July 2021 · Company release
“We are extremely happy with the results from this safety trial and are eager to start the efficacy study with the hope of finding a new method to slow disease progression”
Adrien Châtillon, in Alzheimer’s News Today, 2021 · Independent
“However, no statistically significant changes in cognitive, functionality, or depression scores compared to sham stimulation were observed.”
Mimenza-Alvarado and colleagues, Frontiers in Neurology, 2021 · Public record
“We are one FDA clearance away from becoming the brain-tech company of tomorrow.”
Adrien Châtillon, Kingscrowd, 2021 · Interview
“It’s extremely capital intensive to launch a medical company in the Boston area. What Mexico City brings us is flexibility, and most importantly, cost-effective trials.”
Adrien Châtillon, StartUp Beat, 2022 · Independent
“Yes, our at-home version for treating Major Depressive Disorder is currently in Phase 3, with FDA trials starting in Q2 2025.”
Eliane Benaroya, chief of staff, Choose Paris Region, 2024 · Interview
“The device used to apply the magnetic stimulation was designed and manufactured exclusively for this study by Actipulse Neuroscience (Boston, USA).”
Castillo-Aguilar and colleagues, Case Reports in Psychiatry, 2021 · Public record
Related companies
Sources
- Public recordClinicalTrials.gov NCT03983655
- Public recordClinicalTrials.gov NCT05784298
- Public recordUse of Fast Gamma Magnetic Stimulation for MCI and Mild Alzheimer’s Disease
- Public recordLow intensity gamma-frequency TMS safely modulates gamma oscillations
- Public recordPatterned TMS as Treatment for MDD
- Public recordFDA De Novo DEN070003 and DEN170078; no Actipulse record
- Public recordForm C, C-U, C-AR and C-TR filings, CIK 0001860502
- IndependentPortable Neurostimulator Safe With Home Use
- IndependentEsta startup quiere llevar su tecnología de neuroestimulación a la casa
- InterviewAdrien Chatillon on the Future of Mental Health Therapy
- InterviewOpening the Pathway to the Brain
- IndependentFDA Approves First At-Home Brain Stimulation Device for Depression
- CompanyAnnounces Successful Clinical Trial Using Fast Gamma Magnetic Stimulation
- CompanyBegins a Public Fundraising to Finance FDA Pivotal Trial
- CompanyRepublic offering page and Actipulse Mexico site
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
