SB1AG073026

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.PROJECT NARRATIVE To prevent self-removal of endotracheal and nasogastric tubes, and intravenous lines, older critically ill patients in the intensive care unit are often restrained with traditional wrist restraints causing agitation, increased use of sedatives, prolonged immobility, and delirium, all of which can lead to long-term cognitive impairment similar to Alzheimer’s Disease and Related Dementias. Healthy Design has developed a novel restraint alternative intended to allow freedom of movement while deterring entanglement of vital tubes and lines thereby reducing the need for these harmful interventions. Successful completion of this project will result in a sustainable source of the Exersides™ Refraint™ System novel restraint alternative through early consultation and contracting to strengthen the Company’s infrastructure and position it for strategic partnership or organic growth through revenue.