Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints

ABSTRACT The goal of this NIA STTR Commercialization Readiness Pilot is to traverse the Valley of Death in the early Launch period of Healthy Design’s commercialization to market a novel arm restraint alternative in older critically ill mechanically ventilated or confused patients that increases mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long-term cognitive impairment, reduced physical functioning, and mortality.6-15 Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer’s Disease and Related Dementias.12,15 Healthy Design has developed the novel Exersides™ Refraint™ that allows arm mobility while keeping the patient safe from entanglement in the vital tubes and lines attached to the patient.162-164 Because it permits mobility, Exersides™ may reduce agitation and the need for sedatives. In a Pilot Study and a Phase I testing, Exersides™ has demonstrated very encouraging results. The objectives of this CRP project are to create the infrastructure necessary to meet production requirements and sustain independent growth. Now in Phase II/Year II of its clinical trial, Healthy Design is preparing for imminent Launch. This project has high potential to lead to a paradigm shift in the care of older critically ill or confused patients by demonstrating that a novel restraint device reduces physical and cognitive impairment.