Executive Clinical Evidence Summary

• More than two decades of peer-reviewed research support electromagnetic pelvic floor stimulation for urinary incontinence and pelvic floor dysfunction.

• Randomized and sham-controlled trials demonstrate statistically significant improvements versus placebo.

• Objective urodynamic outcomes include increased urethral closure pressure and inhibition of detrusor overactivity.

• Comparative studies show magnetic stimulation achieves neuromuscular activation comparable or superior to electrical stimulation, with improved patient comfort.

Pelvic Floor & Urinary Incontinence Human Clinical Studies

Executive Overview

Extracorporeal Magnetic Innervation (ExMI) Technology

Extracorporeal Magnetic Innervation (ExMI) is a non-invasive neuromuscular stimulation

technology that utilizes rapidly changing magnetic fields to induce electrical currents within

targeted neural tissue. Unlike surface electrical stimulation, magnetic stimulation penetrates

tissue without requiring conductive pads or direct skin contact, allowing for activation of deeper

motor neurons with improved patient comfort.

When applied over the sacral nerve roots and pelvic floor musculature, ExMI induces

depolarization of motor neurons supplying the levator ani and associated pelvic floor muscles.

Repeated supramaximal contractions promote neuromuscular strengthening, improved urethral

closure pressure, and modulation of detrusor overactivity.

The GazelleTM system utilizes ExMI technology consistent with protocols evaluated across more

than two decades of peer-reviewed research.

Clinical Evidence Base

The published evidence base included in this bibliography consists of:

● 46 Pelvic Floor / Incontinence Human Studies

Collectively, these studies demonstrate:

● Inhibition of detrusor overactivity

● Increased urethral closure pressure

● Reduction in stress urinary incontinence episodes

● Neuromuscular activation comparable or superior to electrical stimulation

● Biologic and cellular responses supporting neuromodulatory mechanisms

The following sections provide structured summaries of each study, including study type,

population, intervention details, outcomes measured, and clinical relevance to the ExMI

mechanism utilized in Gazelle.

Mechanism of Action

ExMI technology generates time-varying magnetic fields that induce electrical currents within

excitable neural tissue. These induced currents depolarize motor neurons without the discomfort

associated with surface electrode stimulation.

When delivered in a seated configuration targeting the sacral plexus and pelvic floor, ExMI

produces:

● Involuntary supramaximal pelvic floor contractions

● Enhanced motor unit recruitment

● Neuromodulatory suppression of involuntary bladder contractions

● Improved functional muscle conditioning over repeated sessions

This non-invasive neuromuscular activation mechanism underlies the therapeutic approach

employed in the Gazelle system.

Rehabilitation & Neuromuscular Human Studies

Mechanistic, Cellular & Animal Studies

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Important Notice & Disclaimer

This document is provided for educational, informational, and professional review purposes only. It summarizes published research related to electromagnetic pelvic floor stimulation and associated neuromuscular applications. This material does not constitute medical advice and does not replace independent clinical judgment. Healthcare providers must comply with all applicable regulatory and professional requirements. This appendix is intended for scientific reference, provider education, and professional evaluation.

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