StimRouter Neuromodulation Therapy For Chronic Peripheral Nerve Pain

LIVE YOUR LIFE!CONTROL YOUR PAIN,

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TARGET PAIN AT ITS ORIGIN

The StimRouter™ Neuromodulation System is the only implantable neuromodulation device indicated

for pain management in adults with severe intractable chronic pain of peripheral nerve origin,

excluding the craniofacial region.

CLINICAL STUDY RESULTS: SAFETY & EFFICACY

Ninety four (n=94) subjects with chronic peripheral pain in the

upper extremity, lower extremity or trunk, were implanted with

the StimRouter Neuromodulation System for a 12-month study.

• 19 different peripheral nerves were stimulated

HOW DOES IT WORK?

Applications may include chronic pain conditions located at or relating to:

• Upper or lower limbs

• Entrapment syndromes

• Intercostal neuralgias

• Other peripheral injuries

or diseases

QUICK AND EASY PROGRAMMING

StimRouter stimulation amplitude can be set up to 30mA with up to eight (8) custom stimulation programs set via the Clinician’s Programmer.

Programming Parameters:

• Frequency: up to 200 Hz

• Pulse width: up to 500 ms

• Amplitude: up to 30 mA

ADVANCED DESIGN DELIVERS SIMPLICITY

EPT and Electrode Patch:The External Pulse Transmitter (EPT) delivers Neuromuscular Electrical Field Stimulation (NMEFS) through the electrode patch to the implanted lead.

• Attaches (snaps) onto the disposable gel electrode patch

• Externally worn, low-profile design

• Rechargeable; can last up to two days on one charge

The Lead:The implantable lead delivers low-level electrical impulses directly to the site of pain. It is the only component of theStimRouter system that is implanted.

• Three stimulating electrodes and a receiver

• Flexible, thin, 15cm length for deep or shallow implants

• Integrated anchor designed to minimize lead migration

Patient Programmer:The patient programmer is a small, handheld device that wirelessly controls the EPT.

• Stores up to 8 custom stimulation programs

• Tracks compliance and usage

• Allows patients to monitor and manage their

stimulation programs and level of stimulation intensity

WHAT’S THE ADVANTAGE?

• A one-time, 20-30 minute, minimally invasive lead implant procedure.

• Targets pain at its precise origin, controlled by the patient.

• No implanted pulse generator. StimRouter pulse transmitter resides outside the body.

• Conditional MRI Safety to minimize restrictions on future diagnostic tests.

• Primary Efficacy Endpoint defined as a 30% decrease in pain

using the StimRouter without an increase in pain medicine.

• At 3-months, the group receiving StimRouter treatment

demonstrated a statistically significant improvement in pain

as compared to the control group (p<0.0001).

• StimRouter users showed significantly favorable outcomes

related to quality of life, pain reduction and satisfaction as

compared to those in the control group.

• No serious or unanticipated device related adverse events

occurred during active stimulation treatment, which yields

a 95% confidence interval of [0, 4.0%) for the SAE rate.

• Over 50% of the treatment group rated their satisfaction

at 8 or higher on a 10-point scale, with 0 indicating not satisfied

at all and 10 indicating completely satisfied.

Treatment vs. Control Group Responder Rates at 3-months (p<0.0001)

60%

40%

20%

0%

Control Group Treatment Group

14% 14%

38%40%

0%

33%

Lower Extremity Trunk Upper Extremity

Percent Pain Reduction in Secondary Efficacy Measures (p<0.0001)

50%

30%

10%

0%

Control Group Treatment Group

Worst Pain Score Normal WorkWalking Ability Enjoyment of Life

5% 8%

30%48% 36% 36%

6%

% P

ain

Red

uctio

n

3%

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StimRouter™, Bioness and the Bioness Logo® are trademarks of Bioness Inc. | www.bioness.comRx Only

© 2016 Bioness Inc.

Before using the StimRouter system, be certain to read the entire StimRouter Procedure Manual and Clinician Manual. Be certain to understand the following safety information:

Indications for Use: The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Contraindications: The Bioness StimRouter Neuromodulation System is contraindicated for:Patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or any metallic implant in the immediate area intended for implant. Maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter Electrode with External Pulse Transmitter and all other active implanted devices and metallic implants. Patients exposed to diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on patients who have a StimRouter Neuromodulation System.

Warnings: Warnings: Magnetic resonance imaging (MRI), body-worn devices, security screening devices, electrosurgery devices, high-frequency surgical equipment, pregnancy, long-term effectiveness of neurostimulation, programming, device components, flammable fuel or chemicals, driving and operating machinery.

Precautions: Clinician training, medical devices/therapies, post-operative care, implant location, for single patient use only, postural changes, keep out of reach of children, skin abnormalities, skin irritation, known or suspected heart problems, user patch placement and stimulation, expiration date, x-ray examinations, implant failure, storage and handling. Adverse Effects: Risks related to the implant procedure, risks related to stimulation, additional risks related to the system.

1. Poduri KR. Shoulder pain in stroke patients and its effect on rehabilitation. J Stroke Cerebrovascular Dis. 1993. 3:261-62. Van Ouwenaller, C, Laplace, P. M., & Chantraine A. (1986) Painful shoulder in hemiplegia. Archives of Physical Medicine and Rehabilitation, 67, 23–26.3. See Bioness_StimRouter_Dcoument11_McRoberts Poster

Bioness Inc.25103 Rye Canyon Loop | Valencia, CA 91355 800.211.9136 | 661.362.4850 info@bioness.com | www.bioness.com | www.stimrouter.com

Bioness Europe B.V.Stationsweg 41 | 3331 LR Zwijndrecht, NederlandTelefoon: +31.78.625.6088 | E-mail: international@nl.bioness.com

Bioness Neuromodulation Ltd.8 Hanager St., POB 7304 | Hod Hasharon, Israel+972.9.790.7100 | www.bioness.co.il

THE STIMROUTER ADVANTAGE

• Highly versatile implant to target multiple peripheral nerves

• Minimizes surgical and post-surgical complications

• Minimize recovery time and scarring

• Minimizes costs compared to more invasive treatments

• Targets precise area of pain, focal instead of global

• Custom pain management solution controlled by clinician and patient

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