# Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints

> **NIH NIH SB1** · HEALTHY DESIGN, LTD. CO. · 2021 · $1,490,227

## Abstract

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.

## Key facts

- **NIH application ID:** 10260567
- **Project number:** 1SB1AG073026-01
- **Recipient organization:** HEALTHY DESIGN, LTD. CO.
- **Principal Investigator:** Marie Pavini
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,490,227
- **Award type:** 1
- **Project period:** 2021-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10260567

## Citation

> US National Institutes of Health, RePORTER application 10260567, Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints (1SB1AG073026-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10260567. Licensed CC0.

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