Flow Neuroscience recently announced FDA approval of their breakthrough Flow at-home brain-stimulation device for the treatment of major depressive disorder (MDD). The FDA approval marks the first time in history American clinicians are able to prescribe a novel at-home non-drug therapy as both a stand-alone and an adjunctive treatment for adults with moderate to severe depression.

Currently, depression affects more than 20 million U.S. adults, a 60% increase over the last decade. Around a third of these patients are not responsive to antidepressants, and many stop treatment because of side effects such as sexual dysfunction, weight gain, a sense of feeling emotionally blunted, and many others.

“We’re on a mission to make effective, affordable non-drug treatment available to the millions of Americans suffering from depression. Flow’s FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects.”

said Erin Lee, CEO of Flow Neuroscience.

Transcranial direct current stimulation, or tDCS, the technology behind Flow, is backed by more than 9000 publications and over 25 years of clinical research in depression treatment, stroke recovery, pain management, and other use-cases. Flow’s neurostimulation device applies a gentle electrical current to the prefrontal cortex, the part of the brain involved in mood regulation and stress response, which is often underactive in people with depression.

To prove device effectiveness, Flow published their landmark randomized controlled clinical study in Nature Medicine, showing that patients using Flow’s FL-100 tDCS device experienced symptom reductions as early as within 3 weeks. These results revealed a clinically meaningful response to treatment and side effects were, in general, mild and transient.

“Among our real world users, 77% see improvements in as little as three weeks. Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care,”

added Flow’s Chief Medical Officer, Dr. Kultar Garcha.

Flow’s clinical trial was the largest of its kind and demonstrated that for the first time at scale, a fully remote, home-based neuromodulation treatment is effective in treating major depression. Active tDCS treatment with FL-100 not only outperformed sham stimulation but achieved two to three times higher remission and response rates, with 58% of patients in remission by the end of the 10 week study. Results were also observed among patients already on medication or psychotherapy who used FL-100 adjunctively, making it far closer to real-world conditions than most previous trials.

“For more than 6 years since the device’s launch in Europe, we’ve been building an evidence base globally with clinical trials, peer-reviewed research, and real-world case reports. The approval of FL-100 in the US will now offer millions of patients an accessible and effective non-drug treatment option.”

said Daniel Månsson, co-founder and Chief Scientific Officer of Flow Neuroscience

Flow has been used by more than 55,000 people in the EU, UK, Switzerland, and Hong Kong. In the UK, it is used by multiple NHS trusts and is prescribed by doctors in their public health system. Flow expects the device to be available in the U.S. as early as Q2 2026.

“We are committed to ensuring that Flow becomes a part of a standard treatment pathway for depression care. We are singularly focused on helping as many patients as possible achieve remission from depression,”

says Erin Lee.

The Flow System received Breakthrough Device Designation from the FDA in 2022, a program designed for technologies that offer potentially more effective treatment or diagnosis for debilitating diseases. The company is also planning to evaluate its platform as a treatment for additional neuropsychiatric indications, including traumatic brain injury, addiction and sleep disorders.

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The app has launched in Sweden and the UK last month, and the startup has recently received an investment of €1.3 million from Khosla Ventrures. The investment is planned to be used for expansion within the EU (perhaps the USA too), introduction of Flow to healthcare clinics and funding clinical studies.

“The technology combines portable hardware and software, and we believe this offers an exciting and scalable solution for potentially hundreds of millions of people living with depression globally, empowering patients directly with new options for treatment”,  said Alexander Morgan, MD PhD, Principal at Khosla Ventures.

Flow Neuroscience’s headset uses transcranial direct current stimulation (tDCS) to neutralise and stimulation a specific part of the brain (left frontal lobe), which has lower neural activity, if a person has depression. The headset offers neurostimulation therapy similar to anti-depressants, but it has fewer and less sever side effects.

The app, on the other hand, educates users with videos about depression and advice on how to reduce symptoms, similar to the ones on https://fizzymag.com/articles/a-complete-guide-to-mental-health-counseling-for-first-timers, using the latest expert knowledge from the fields of sleep, nutrition, fitness, and meditation.

“We’re increasing treatment choice and empowering people to self-manage their symptoms at home with an effective, personalized and non-pharmacological alternative,” said Daniel Mansson, a clinical psychologist and co-founder of Flow. “This has the potential to improve the standard of care, and reduce global healthcare costs. The Khosla Ventures investment will support the next stage of our journey as we cement our position as European leaders of brain stimulation treatment for depression.”

Source: EU-startups.com

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