Several clinical studies conducted at top medical centers by key opinion leaders in the field of ADHD, have already yielded significant results showing major improvement in multiple measures of ADHD. These clinical studies results are will be used to support Innosphere's request for FDA clearance for the ADHD treatment.
Two clinical trials ran at Hadassah medical center on 43 children in total, ages 7-12, led by Prof. Itai Berger, Head of Pediatric Neurology Unit at Assuta Hospital, yielded positive results, showing significant improvement in ADHD symptoms. It is worth noting, the improvements were maintained even three weeks after the end of treatment. The clinical trials show a substantial improvement in working memory, and overall symptom alleviation. In This trial, we achieved a significant reduction of 43% of ADHD symptom severity after only 10 treatment sessions, 20 minutes each.
Innosphere is planning to start a multisite pivotal clinical trial for the FDA clearance, in collaboration with top tier key opinion leaders at top medical institutes, including Mayo Clinic, Baylor College of Medicine and UTHealth