Investigational research. Safety and effectiveness have not been established. The system is not FDA-cleared or approved and is not available for commercial sale.
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These files contain the same public company-reported information and limitations shown here. They contain aggregate figures only, no participant records, and are not the underlying participant-level study data or a peer-reviewed publication.
Company-reported study
- Design
- Randomized, double-blind, sham-controlled
- Participants
- 280 total · 190 active / 90 control
- Study visits
- 1–3 sessions · 30 minutes per session
- Setting
- Single center · Puerto Vallarta, Mexico
- Measure
- Self-reported pain, 0–10 numerical rating scale
Company-reported aggregate observations · active n=190, control n=90
| Outcome | Active | Control |
|---|---|---|
| Baseline pain score (0–10) | 6.28 | 6.00 |
| First-session mean reduction | 68.3% | 33.5% |
| Cumulative mean reduction | 84.0% | 51.7% |
| Final mean pain score (0–10) | 0.99 | 3.00 |
| Participants with ≥50% cumulative reduction | 93.2% | 57.8% |
| Participants reporting a final pain score of zero | 51.1% | 17.8% |
| Reported device-related adverse events | 0 | 0 |
The company summary reports 697 total study sessions and no device-related adverse events during the observation period. This does not establish safety or rule out uncommon, delayed, or unobserved risks. A final pain score of zero does not establish a cure or lasting resolution.
The reported differences warrant careful review and further investigation. They do not establish effectiveness, durability, or generalizability. The control group also reported substantial changes in pain scores.
This was a single-center study with up to three sessions per participant. Interpretation requires the full protocol, analysis plan, missing-data handling, masking assessment, confidence intervals, adverse-event definitions, and follow-up information. The public summary does not include those underlying materials. Prospective collaborators and investors should review them with the study team.
The study did not compare Biocurrent with medicines, implanted devices, or other marketed treatments. “Phase II” is the company’s study designation and does not indicate FDA authorization or endorsement.
Source: Biocurrent’s company-provided summary titled Efficacy and Safety of a Closed-Loop, AI-Modulated, EEG-Guided Non-Invasive Bioelectronic Neuromodulation Device for Pain: A Double-Blind, Randomized, Sham-Controlled Phase II Trial (n=280, Puerto Vallarta, Mexico), as reproduced on the prior company website.
The title describes the study’s subject, not an established safety or effectiveness conclusion. This page is a summary, not a publication of the full study. Contact the study team for publication status, registration information, and ethics documentation. This summary does not imply regulatory acceptance.
Request the research materialsQuestions about Biocurrent
What is Biocurrent?
Biocurrent is developing an investigational closed-loop bioelectronic system for chronic pain research. AI analyzes EEG feedback to optimize the alternating current (AC) delivered through skin-surface electrodes.
Is Biocurrent FDA-cleared or approved?
No. The system is investigational, has not been FDA-cleared or approved, and is not available for commercial sale. Safety and effectiveness have not been established.
What research does the company report?
Biocurrent reports a randomized, double-blind, sham-controlled study at one center in Puerto Vallarta, Mexico, with 280 participants (190 active and 90 control) and 697 sessions. Participants had up to three 30-minute sessions. Phase II is the company’s study designation.
Is there a public trial registration or peer-reviewed paper?
No public registry identifier or peer-reviewed publication is linked in this summary. The source is the company-provided summary reproduced on the prior company website. Contact the study team for the protocol, analysis plan, registration information, ethics documentation, and publication status.
Is the V6 pictured the device used in the study?
The supplied photographs show the current Biocurrent V6 in development. The website does not identify the pictured V6 as the specific hardware used in the reported study.
Can I buy the device or enroll in a study here?
The investigational system is not available for commercial sale. This website does not enroll participants and does not confirm current recruitment. The contact form is for company and research inquiries.
How can investors, advisors, and collaborators contact Biocurrent?
Email ablount@biocurrent.com or use the inquiry form on the homepage. You can request research materials or discuss scientific, clinical, engineering, advisory, or investment interests. No securities are offered on this website.
What makes Biocurrent a closed-loop system?
The EEG signal provides feedback on the user’s brain activity. AI analyzes that signal and adjusts the delivered electrical current in response. Continuing EEG feedback informs further current adjustments, closing the loop.
How is stimulation delivered?
The investigational system delivers alternating current (AC) through electrodes on the skin near the spine or the area of chronic pain. This is electrical stimulation, not an audio or listening therapy.
How to cite this summary
Biocurrent, Inc. Biocurrent clinical research: company-reported study summary. Website content updated September 6, 2026. Include this page’s URL and your access date. This is a company website source, not a journal publication.
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Not medical advice. This website does not enroll study participants.