The H200™ and L300™

Hand rehabilitation system and Foot Drop System

Bioness ® is an Alfred Mann Company

Pacesetter Systems,

Inc.

Pacesetter Systems,

Inc.

Alfred Mann,Chairman of the

Board

A medical solutions provider for Physical Medicine & Rehabilitation using innovative technology

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Bioness ® Technologieste

chno

logy

current

BBPM™H200™

EXOSKELETAL IMPLANTABLE

future

L300™

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Clinic modality and home based system

• Leadless: user friendly replacement

• Conductive Grid: uniform distribution of current

• Optimal Contact Area: improve patient comfort

• Proprietary Electrode / Orthosis interface: provides accurate electrode placement

The L300™Conventional Systems: The Problem

Maximize patient comfort

In a survey* performed in 2002 among 98 users of non-invasive,

drop foot stimulators, the following was found:

13% - Reported that they have no problems72% - Problem with finding the correct electrode positions 58% - Difficulties with wires and foot-switches 25–30% of the users ultimately reject the device

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* Lyons GM, Sinkjær T, Burridge JH, and Wilcox DJ. IEEE December 2002;10(4).

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The L300™Product overview

The L300 is designed to overcome existing barriers in the application

of lower-limb FES technology

Design Goal

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The L300™

• Reproducible electrode placement

• Reliable gait sensing

• Single handed application

• Intuitive clinician interface

The L300™Ergonomic Orthosis

Aesthetic Design with Breathable and Flexible Materials

Designed for Single-handed Donning / Doffing

Accurate and Reproducible Positioning via Patella Locator (Patent Pending)

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Accurate and Reproducible Positioning via Patella Locator (Patent Pending)

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Aesthetic Design with Breathable and Flexible Materials

Designed for Single-handed Donning / Doffing

Personal Panel

Quick set-up

Reproducible electrode placement

Hygienic barrier

Use on multiple patients

• Leadless: user friendly replacement

• Conductive Grid: uniform distribution of current

• Optimal Contact Area: improve patient comfort

• Proprietary Electrode / Orthosis interface: provides accurate electrode placement

The L300™Unique electrode design

Maximize patient comfort

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L300 Cloth Electrode: An Alternative Choice

• The cloth electrodes are designed to be skin friendly provide an alternative for persons who do not prefer or have sensitivities to the standard L300 electrodes and/or other known sensitivities (e.g. allergy or skin sensitivity to tape/adhesive).

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Adaptive algorithmsAdapts to speed and fatigue

The Intell i-Sense™ Gait SensorIntuitive event detection

Wireless

Analyzing user’s gait

Energy efficient

Increases patient safety

Promotes weight bearing

New era in event detection

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L300 Home User Patient SelectionL300 Home User Patient Selection

Walking without L300 First walk with L300

The Clinician’s Programmer

Wireless programming

Secure database

“Real-time” adjustments

Document Outcomes

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Range of motion, higher level balance, functional and pre-gait activities

Beyond gait training into therapeutic interventions

Streamline design allows for use throughout the therapy session

Clinical Implementati onTherapeutic Intervention

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Clinical Implementati onIncomplete Spinal Cord Injury

Without L300 With bilateral L300s

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The L300: Impact on Gait Rhythmicity

Hausdorff JM, Ring H: Effects of a new radio frequency– controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil. 2008;87:4–13.

• Stride Time is the duration of the gait cycle.

• Data on graph is raw stride time data for one individual.

• Stride Time Variability (STV) is a measure of the stride to stride variability.

STV = SD of Stride Time X 100

Mean Stride Time

• STV has been associated with risk for falls.

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