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Magnetic Tides' kTMP Wins FDA Breakthrough, Eyes Stroke Trials

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Published on November 18, 2025
Magnetic Tides' kTMP Wins FDA Breakthrough, Eyes Stroke TrialsSource: Usman Yousaf on Unsplash

Berkeley startup Magnetic Tides says its new non-invasive brain stimulation method, called kilohertz transcranial magnetic perturbation (kTMP), is showing early promise for helping stroke survivors and has just received a regulatory boost this summer. The company, founded by Ludovica Labruna, Daniel Sheltraw, and UC Berkeley professor Richard Ivry, reports pilot work involving healthy volunteers and a small number of chronic stroke patients, which it says has pushed the technology toward clinical testing. Magnetic Tides is recruiting for trials and says sessions were imperceptible and free of reported side effects, and the startup hopes to move kTMP into clinical settings in the next few years.

Peer‑Reviewed Lab Results Show Short‑Term Brain Change

A team that includes Magnetic Tides researchers published a peer-reviewed paper in eLife, showing that a 10-minute session of kTMP produced consistent increases in cortical excitability in healthy volunteers, as measured by motor-evoked potentials. The experiments replicated increases in MEP amplitudes at certain kilohertz carrier frequencies and found that the only percept associated with stimulation was an audible tone. According to eLife, the authors state that these are promising physiologic effects that require larger, controlled trials to assess their clinical benefit.

Regulatory Boost And Federal Support

Local reporting indicates that the U.S. Food & Drug Administration granted kTMP Breakthrough Device designation this summer, a status that can expedite development and prioritize reviewer attention. As reported by Berkeleyside, Magnetic Tides also received federal SBIR funding that supported its spinout and recent human trials, and public grant records show a new NIMH R44 award in 2025, according to HigherGov. Those federal grants and the Breakthrough tag have helped the team transition from lab studies toward registered clinical testing.

Trials And UC Partnerships

Magnetic Tides has a public trial record for a UCSF‑linked study testing kTMP for anhedonia in major depressive disorder, with timelines and study details listed online. The trial listing on the UCSF/ClinicalTrials platform lists Andrew Krystal as a collaborator and provides an estimated start and completion window. Those entries indicate the company is preparing to test kTMP in symptomatic patients, not just in laboratory physiology.

What Early Participants Experienced

The company and local reporting indicate that pilot work involving approximately 400 participants, including roughly 20 chronic stroke patients, found that kTMP sessions were largely imperceptible, and participants reported no discomfort or side effects. Magnetic Tides' research materials describe the Weill Neurohub pilot and the rationale for targeting upper-limb recovery after stroke, while the peer-reviewed eLife paper notes that the only perceptible effect during lab testing was an audible tone. Clinicians caution that physiologic change does not automatically translate into functional improvement, which larger controlled trials must demonstrate.

Regulatory Note

Breakthrough Device designation can accelerate development and the agency's engagement, but it is not the same as clearance or marketing authorization. The FDA's Breakthrough Devices Program page explains that the designation is intended to speed development and review for devices that could provide more effective treatment for serious conditions, while maintaining the same safety and effectiveness standards. Magnetic Tides will still need confirmatory clinical evidence and formal FDA clearance before kTMP can be offered widely in clinics.

What’s Next

Magnetic Tides is accepting sign-ups for research participants and posts the inclusion criteria and contact information on its participation page for the stroke pilot. Interested survivors and clinicians can review the recruitment materials and contact the company through its website. If larger trials confirm the early signals, kTMP could become another option in the neuromodulation toolkit; however, for now, the technology remains in an early clinical trial phase.