NeoSync, Inc. Information

Founded in 2008, NeoSync, Inc. is a clinical stage company that is pioneering personalized transcranial magnetic stimulation for the treatment of Major Depressive Disorder and other diseases of the Central Nervous System (CNS). The company is well-positioned to unlock the enormous potential of an existing but still nascent market (TMS for treatment-resistant depression), with a disruptive home use design. Over 27MM adults globally (16MM in US) suffer from depression each year. Pharmacological therapy is the current mainstay treatment for major depression, with over 300MM scripts written per year in the US alone, but large studies have shown that only 30% of depressed patients respond to leading antidepressants (STAR*D). Antidepressants also have significant side effects, including dizziness, anxiety, insomnia, sexual dysfunction, fatigue, restlessness, and fibromyalgia. Non-pharmacological options like Electroconvulsive Therapy (ECT) are considered more effective, but reserved for the most severe cases (100k/year) because of the need for sedation and serious side effects (memory loss and confusion). NEST® (NeoSync-EEG Synchronized TMS) delivers low energy, alternating magnetic field stimulation in daily 30 minute sessions to gently adjust a depressed patient’s brain toward a more normal state. Unique among TMS therapies, NEST® is personalized to a patient’s unique alpha frequency, as measured by the electroencephalogram (EEG). In follow up to a successful 45 patient pilot study, NeoSync conducted a 200 patient randomized, multi-center, sham-controlled clinical trial with investigators from 17 leading academic and private psychiatry sites. The results for treatment-resistant depression patients as intended compared favorably to the results seen from prior TMS clinical studies in comparable patient populations. In addition, the NeoSync NEST® shows a superior safety and tolerability profile relative to literature on other existing therapies, with no device-related major adverse events. NeoSync is currently conducting a clinical study to support its planned 510K submission to seek FDA clearance of the NEST® device for home use.