HF10? SCS Therapy
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Leadership Through Innovation™ 10 kHz High-Frequency Spinal Cord Stimulation Therapy (HF10™ SCS) Spinal cord stimulation (SCS) is an established pain treatment that delivers electrical pulses to the spinal cord to alter the transmission of abnormal pain signals to the brain. The electrical pulses are delivered by small electrodes that are placed near the spinal cord and connected to a compact battery-powered generator implanted under the skin. Traditional (low-frequency) SCS typically attempts to mask the sensation of pain with a tingling or buzzing sensation, known as paresthesia. Pioneered by Nevro, HF10 SCS aims to reduce chronic pain without inducing paresthesia, so that patients feel pain relief without feeling the therapy. Nevro’s Senza® system is the only system capable of the HF10 SCS therapy. The novel HF10 SCS therapy features a stimulation frequency that is orders of magnitude higher than traditional SCS. Traditional SCS Therapy • oal is to “mask” pain with a tingling G • oal is to reduce pain without G sensation called paresthesia triggering paresthesia Clinical Results The Senza system has been evaluated in numerous clinical studies involving hundreds of patients in the United States, Europe, and Australia. Following early feasibility studies, Nevro sponsored a prospective, multicenter European clinical study to evaluate the safety and effectiveness of 10 kHz high-frequency spinal cord stimulation (HF10 SCS) for the treatment of patients with chronic back and leg pain. Nevro EU Prospective Multicenter Study Highlights1 Design • 2 patients studied 8 • ey inclusion criteria: back pain visual analog K • Key exclusion criteria: standard score (VAS) ≥ 5 out of 10 Key Results • ery high (88%) trial phase success rate (patients V typically evaluate stimulation via a trial stimulator prior to deciding whether to get an implant) • ignificant reduction in median back pain VAS (67%) S and in median leg pain VAS (67%) at 24 months Oswestry Disability Index (a measure of quality of life) at 24 months • ean dosage of oral morphine equivalents M per patient decreased from 84 mg/day at baseline to 27 mg/day at 24 months

Significant and Sustained Pain Relief Continuing Clinical Evaluation In June 2012, Nevro initiated the landmark SENZA-RCT study, a prospective, randomized, controlled U.S. pivotal trial. In March 2013, Nevro announced the completion of enrollment of 241 patients at 11 leading pain centers across the U.S. The study is the first to include active spinal cord stimulation systems in both arms of the trial. Patients were randomized to receive either the Nevro® Senza system or a traditional low-frequency SCS system. Patient Experiences Nevro conducted a pilot clinical study involving 24 patients...

Procedure Overview The Senza system is a surgically placed device about the size of a stopwatch. It delivers mild electrical signals to the epidural space near the patient’s spine through one or more leads (special medical wires). Before receiving a permanent implant, a trial of HF10 SCS with a temporary system is first conducted. If the trial is successful, a stimulator (also called the implantable pulse generator, or IPG) is typically implanted under the skin of the lower back/buttocks and permanent leads are positioned in the epidural space. The surgery to implant the SCS system takes...

The Senza System The only SCS system capable of delivering HF10 SCS therapy References 1 . Van Buyten JP and Smet I. International Neuromodulation Society Meeting, 2013. 2. Tiede et al. Novel Spinal Cord Stimulation Parameters in Patients with Predominant Back Pain. Neuromodulation 2013 Feb 21. doi: 10.1111/ner.12032. Nevro Corp. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 USA www.nevro.com The Senza® Spinal Cord Stimulation System from Nevro Corp. is limited by U.S. law to investigational use in the U.S. and is not available for commercial sale in the U.S. © 2013 Nevro Corp. All...