Investigational Study of the Ekso Bionics Powered Exoskeleton for High-Dosage Use by Individuals With SCI in a Non-Clinical Environment

This is a 36 month exploratory Investigational Study compliant with the NSF Human Subjects
regulations (45 CFR 690) trialing a new device for the SCI populations to aid in ambulatory
function in a home setting. Ekso Bionics will enable up to twelve (12) subjects with SCI to
use an Ekso device in their home for a 12-month period. Qualified subjects will help Ekso
Bionics determine the practical use of the device in the home environment and will enable
Ekso Bionics to gather data to develop a device for use in a home environment. The study will
require a trained spotter to be present at all times that the device is being used. The study
will also evaluate the effectiveness of a non-medically licensed spotter to assist the
subject.

Inclusion Criteria:

- be an experienced user of the Ekso device with a minimum of 20 hours and no more than
50 hours of device use and require no greater than minimal assist (support of up to
25% body weight) for safe and consistent walking.

- no more than 2 episodes of balance loss per 1 hour training session that require no
more than moderate assistance (support of 26% to 50% of body weight)

- participants with more than 50 hours of device experience must agree to a 1 month
period of non-use prior to acquisition of baseline measures

- be between 18-65 years of age.

- be able to physically fit into the exoskeleton device.

- be able to tolerate upright standing for up to 60 minutes.

- have sufficient joint range of motion to fit safely within Ekso: Hip flexion
contracture ≤ 15o; knee flexion contracture ≤ 10o; ankle dorsiflexion to neutral with
no more than 10o of knee flexion.

- have sufficient upper body strength to balance themselves with two arms

- be fluent in English

Exclusion Criteria:

- Height below 60 inches or above 76 inches or with physical characteristics
incompatible with device and testing procedure.

- Weight above 220 lbs.

- Lower extremity joint contractures that exceed device capacity for safe use.

- Any medical issue that precludes full weight bearing and ambulation (e.g. osteoporosis
that prevents safe standing, orthopedic injuries, pain, severe spasticity)

- Skin integrity issues that would prevent wearing the device.

- Cognitive and/or communicative disability inappropriate for testing as determined by
Ekso Bionics clinician. Subjects must be able to follow directions well and
demonstrate learning capability.

- Pregnancy (Self-reported)

- Colostomy

- Medical or environmental conditions arising after the start of the study that are
deemed unsafe per Ekso Bionics discretion.