We pride ourselves on a strong intellectual property portfolio, which includes granted patents in both the U.S. and Israel as well as applications in China and Europe. These patents cover the unique electrode technology that is central to our innovative approach, ensuring a competitive edge in the market and protecting the company's pioneering research and development efforts.
Huge Unmet Need
Over 6 million children in the US and over 120 million children and adolescents globally have been given ADHD diagnoses. Most American children are on stimulants and studies show these treatments can come with challenging side effects like appetite challenges, increased aggression, headaches, and gastrointestinal issues. Parents want new solutions, with saying they would prefer brain stimulation treatments like Novostim over stimulants.
Pathway to FDA Clearance
With promising results from studies already conducted, Innosphere is embarking on a pivotal multi-site clinical trial at top medical institutions including Mayo Clinic, Baylor College of Medicine, UT Health, and Boston Children’s Hospital. This trial will set the stage for FDA clearance and transform the landscape of ADHD treatment.
Hedged Revenue Strategy
Following FDA clearance, Innosphere has identified a substantial market opportunity for direct out-of-pocket sales as they negotiate reimbursement with payors and are fostering partnership opportunities with educational and clinical institutions for broad revenue potential.
Diverse Indication Potential From Clinical Program
Following FDA clearance, Innosphere has opportunities to conduct further studies in adult populations and explore areas in their clinical program like concomitant therapy with medication and maintenance therapy.