FDA Clears neurocare’s Apollo TMS Therapy for Adolescent Depression Treatment

neurocare group AG’s Apollo TMS Therapy devices have been cleared by the U.S. Food and Drug Administration (FDA) to treat Major Depressive Disorder (MDD) in adolescents.

Major depression affects an estimated 5 million U.S. adolescents annually, yet treatment options remain limited. Currently, only two oral antidepressants are FDA-approved for use in this age group, and both carry a “black box” warning—the strongest warning the agency issues for medications—due to an increased risk of suicidal thoughts and actions. These medications have a 35% effectiveness rate in achieving remission, and many patients discontinue the remedy due to side effects or lack of clinical benefit. 

Transcranial Magnetic Stimulation (TMS) offers a safe, non-invasive, and drug-free alternative, with no black box warning and no medication-related side effects, according to neurocare. Clinical studies show that approximately 60% of patients achieve remission with TMS, making it a promising new treatment option for adolescents who have not found success with other treatments. 

During TMS Therapy, clinicians position 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 where the magnetic field is more efficient at providing the prescribed stimulation. This advancement improves the impact of treatment, giving patients the best possible chance to benefit from their psychiatrist’s prescribed therapy. 

“Our mission has always been to expand access to safe and effective treatments for those who need them most,” said Stanford Miller, managing director of neurocare group’s North American operations. “This clearance allows providers to offer adolescents a proven therapy without the risks and limitations of medication, giving hope to families searching for better treatment options.” 
 
Since 2021, neurocare has installed more than 300 Apollo systems in U.S. clinics and major institutions, helping treat complex MDD cases in adults, as well as Obsessive Compulsive Disorder (OCD). The Apollo TMS Therapy product line is FDA-cleared to treat MDD in adults who have not adequately responded to oral antidepressants. It is also FDA-cleared as an adjunctive treatment for OCD in adult patients who have not responded to traditional therapies. Most private and public insurers cover TMS Therapy for adults with MDD, and an increasing number are extending coverage to adolescents.

neurocare group AG has developed a best practice mental health platform, empowering clinicians to offer their patients, through personalized therapy, the best care for various psychological or neurological conditions with more sustainable clinical outcomes. These therapy plans integrate innovative methods and tools, such as psychotherapy, neuromodulation and sleep hygiene, as well as medication. Following a detailed assessment of the patient’s condition, neurocare supports clinicians in developing personalized therapy plans that improve self-regulation, resilience and social skills, while being cost-effective for the healthcare system. 

The key technology elements of neurocare’s platform are developed in-house, including TMS and EEG devices, a cloud-based software platform, as well as an online academy to give professionals the tools and neuroscientific understanding to properly apply these approaches in clinical practice. neurocare’s platform is currently applied throughout the company’s own clinics in the United States, the United Kingdom, the Netherlands ,and Australia, as well as in a growing number of third-party clinics.