Activas Diagnostics
The epidemic of Alzheimer’s disease incidence is projected to affect 50M people by 2050. There exists a $236-billion-dollar health care cost for Alzheimer’s Disease assessment and intervention. Early diagnostic tools are in development, as more than 60% of patients are undiagnosed in early stages prior to dementia. Sleep disturbance is an early symptom, but in-hospital sleep studies are challenging and uncomfortable for aging patients. Activas Diagnostics, LLC has developed an overnight test in the home bed with SleepMove wireless mattress system to be used as a provider diagnostic adjunctive for early diagnosis. As a home diagnostic, SleepMove is easy and convenient for the patient and family, is a medical grade device that produces an inexpensive diagnostic test, is reusable and is proposed as a service model, but later sales to hospital systems and sleep clinics are planned. The competitive advantage rests on the sensor system design and AI software for identification of Alzheimer’s risk. Early market adopters aim to aid medical providers in diagnosis, as well as offer a broader application platform for neurological diseases and injury, including a larger market related to accidents, falls, TBI, and sports injury. Current business strategy is focused on FDA pre-submission regulatory needs to continue clinical studies (assigned de novo status); engage CMS (Centers for Medicare and Medicaid) reimbursement, and medical marketing penetration. FDA pre-A was successful (assigned de novo status). Activas Diagnostics, LLC was incorporated in 2010. Co-founders, MJ Hayes, Ph.D. and A. Abedi , Ph.D. lead the organization and science work. Other employees: chief engineer, PhD-level software architect, operations manager, clinical study coordinator and research assistants. Advisory Board is shown on our website: www.activas diagnostics.com . IP protection is through the patent award (US10244977B2; owned by University of Maine System), license granted to Activas Diagnostics, 2020. Current assets: NIH SBIR Phase I and II awards ($1.1M) and NIH CRP continuation award under consideration ($3.2M). Tech-start grants through NASA and Maine Technology Institute support commercialization efforts.