SBIR-STTR Award

Direct to Phase II

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. Public Health Relevance Statement 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.

Project Terms:
Adoption ; Elderly ; advanced age ; elders ; geriatric ; late life ; later life ; older adult ; older person ; senior citizen ; Alzheimer's Disease ; AD dementia ; Alzheimer ; Alzheimer Type Dementia ; Alzheimer disease ; Alzheimer sclerosis ; Alzheimer syndrome ; Alzheimer's ; Alzheimer's disease dementia ; Alzheimers Dementia ; Alzheimers disease ; Primary Senile Degenerative Dementia ; dementia of the Alzheimer type ; primary degenerative dementia ; senile dementia of the Alzheimer type ; American Medical Association ; Amputation ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Breathing ; Respiratory Aspiration ; Respiratory Inspiration ; inspiration ; Blood Vessels ; vascular ; Clinical Trials ; Communication ; Consultations ; Counseling ; Critical Illness ; Critically Ill ; Cessation of life ; Death ; decubitus ulcer ; Bed Sores ; Bedsore ; Pressure Sore ; Pressure Ulcer ; pressure injury ; Delirium ; delirious ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Early Mobilizations ; Education ; Educational aspects ; Engineering ; Environment ; Equipment ; Exhibits ; Feedback ; Freedom ; Liberty ; Goals ; Growth ; Generalized Growth ; Tissue Growth ; ontogeny ; Hospitals ; Human ; Modern Man ; Immobilization ; orthopedic freezing ; Incidence ; Industrialization ; Intensive Care Units ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Market Research ; Medical Device ; Methods ; mortality ; Movement ; body movement ; Legal patent ; Patents ; Patients ; Pilot Projects ; pilot study ; Production ; Research ; Resources ; Research Resources ; Physical Restraint ; Physical Immobilization ; Risk ; Risk Factors ; sedative ; Syndrome ; Testing ; Wrist ; Caregivers ; Care Givers ; Intensive Care ; Agitation ; Psychomotor Agitation ; Psychomotor Excitement ; Psychomotor Hyperactivity ; Psychomotor Restlessness ; Restlessness ; Device Designs ; Enteral Feeding ; enteric feeding ; feeding tube ; gastric feeding ; tube feeding ; Family member ; Specialist ; Caring ; Muscle Weakness ; Muscular Weakness ; Tube ; improved ; Mechanical ventilation ; mechanical respiratory assist ; mechanically ventilated ; Clinical ; Phase ; Medical ; Chemicals ; Licensing ; satisfaction ; Collaborations ; Contracting Opportunities ; Contracts ; tool ; restraint ; Cognitive Disturbance ; Cognitive Impairment ; Cognitive decline ; Cognitive function abnormal ; Disturbance in cognition ; cognitive dysfunction ; cognitive loss ; Impaired cognition ; sedation ; Sedation procedure ; Intravenous ; Source ; System ; Amentia ; Dementia ; Physical Function ; Consult ; experience ; Family-Centered Nursing ; Family Nursing ; endotracheal ; Remote Education ; Distance Education ; novel ; novel technologies ; new technology ; Prevention ; Devices ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; Position ; Positioning Attribute ; Coding System ; Code ; Modeling ; response ; Intervention Strategies ; interventional strategy ; Intervention ; preventing ; prevent ; Legal ; Preparedness ; Readiness ; Address ; International ; Cognitive ; Small Business Technology Transfer Research ; STTR ; Process ; Development ; developmental ; pandemic disease ; pandemic ; design ; designing ; Outcome ; cost effective ; innovation ; innovate ; innovative ; modifiable risk ; malleable risk ; usability ; economic outcome ; commercialization ; multi-site trial ; multisite trial ; clinical practice ; arm ; phase I trial ; phase 1 trial ; phase 1 testing ; phase 1 evaluation ; phase I evaluation ; phase I testing ; Infrastructure ; Alzheimer's disease related dementia ; AD related dementia ; ADRD ; Alzheimer related dementia ; safe patient ;