Munich, Germany; Atlanta, Georgia – September 10, 2025 – neurocare group AG (“neurocare” or the “Company”), a prominent innovator in personalized mental health and performance, announced today that its Apollo TMS Therapy devices, an advanced Transcranial Magnetic Stimulation (TMS) system, have received FDA clearance for the treatment of Major Depressive Disorder (MDD) in adolescents.
Major depression impacts an estimated 5 million adolescents in the U.S. annually, yet therapeutic options remain limited. Currently, only two oral antidepressants are FDA-approved for this age group, both carrying a “black box” warning—the most severe warning issued by the FDA for medications—due to an elevated risk of suicidal thoughts and behaviors. These medications achieve remission in only about 35% of cases, and many patients discontinue use due to side effects or a lack of clinical benefit.
TMS offers a safe, non-invasive, and drug-free alternative, without a black box warning or medication-related side effects. Clinical research indicates that approximately 60% of patients achieve remission with TMS, positioning it as a promising new treatment avenue for adolescents who have not responded to other therapies.
During TMS Therapy, clinicians place a magnetic coil on the patient’s head to deliver targeted stimulation to specific brain regions involved in mood regulation. neurocare’s engineering team in Germany has developed advanced technology that makes the magnetic field more efficient at providing the prescribed stimulation. This enhancement improves the treatment’s effectiveness, offering patients the best possible opportunity to benefit from their psychiatrist’s prescribed therapy.
“Our fundamental mission has always been to broaden access to secure and effective treatments for those who require them most,” stated Stanford Miller, Managing Director of neurocare group’s North American operations. “This clearance empowers providers to offer adolescents a proven therapy without the associated risks and limitations of medication, providing hope to families seeking superior treatment alternatives.”
Since 2021, neurocare has installed over 300 Apollo systems in clinics and leading institutions across the U.S., aiding in the treatment of complex Major Depressive Disorder (MDD) in adults, as well as Obsessive Compulsive Disorder (OCD). The Apollo TMS Therapy product line holds FDA clearance for the treatment of MDD in adult patients who have not shown an adequate response to oral antidepressants. It is also FDA-cleared as an adjunctive treatment for OCD in adult patients who have not responded to traditional therapies. This same advanced technology is now FDA-cleared as an adjunctive treatment for adolescents with MDD. Most private and public insurers cover TMS Therapy for adults with MDD, and an increasing number are extending coverage to adolescents.
About neurocare group AG
neurocare group AG has developed a leading mental health platform, enabling clinicians to provide their patients, through personalized therapy, with optimal care for a range of psychological or neurological conditions, resulting in more sustainable clinical outcomes. These therapy plans integrate innovative methods and tools, such as psychotherapy, neuromodulation, sleep hygiene, and medication. Following a thorough assessment of the patient’s condition, neurocare assists clinicians in crafting personalized therapy plans that enhance self-regulation, resilience, and social skills, while also being cost-effective for the healthcare system.
The core technological elements of neurocare’s platform are developed in-house, including advanced TMS and EEG devices, a cloud-based software platform, and an online academy to equip professionals with the tools and neuroscientific understanding to correctly apply these approaches in clinical practice.
neurocare’s platform is currently deployed across the company’s own clinics in the U.S., the U.K., the Netherlands, and Australia, as well as in a growing number of third-party clinics.
Contact
Sally Remington
neurocare group AG
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