The Commercialization of High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain

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Abstract DESCRIPTION. Our FastTrack SBIR proposal has developed HD64—a high-resolution, spinal cord stimulation therapy to provide more pain relief with greater specificity for those suffering from chronic neuropathic pain and opioid dependence. Over 25 million in the U.S. suffer from debilitating pain in the trunk and extremities and 55% depend on opioids to ease their suffering. Opioid abuse has claimed the lives of over 200,000 over the past decade and has resulted in devastating reductions in quality of life, in ability to work, and in mental health for the living. Spinal cord stimulation (SCS) has provided pain relief for 60% of those with chronic extremity pain and eliminated opioid use entirely in more than 50%. Despite these advantages, SCS has had a limited success treating isolated pain of the knee, foot, groin, or low- back. The lateral positioned fibers of the spinal cord (ex. the dorsal root entry zone and dorsal horn) represent a more selective neural targeting opportunity yet current, implantable plate-type surgical leads are too rigid and bulky to access these fibers without a significant risk of paralysis or nerve root compression. HD64 provides an ultra-thin and conformal blanket of 60 stimulation contacts across the entire width of the spinal cord. Active-lead HD64 technology embeds a tiny electronic chip within the surgical lead and doubles the number of therapy contacts compared with current technology without increasing the number of lead-wires. Collectively, these features improve therapy and simplify surgical workflow. PHASE 2: In Phase 2, we have developed the HD64 active lead technology. We have obtained FDA approval to perform an Early Feasibility Study human feasibility study using the active HD64 active electrodes, AL-EPG wearable stimulator, and IPAD programmer tablet (n=10 subjects, n=23 therapy groups, n=2 waveforms). We have also developed implantable pulse generator prototypes and are beginning to perform mechanical and electrical design verification testing and chronic safety studies in large animals to demonstrate functional performance to inform the final device. PHASE 2 COMMERCIALIZATION READINESS: This Commercialization Readiness proposal seeks to perform activities to extend the business development of our Phase 2 SBIR. This CRP proposal will accelerate the commercialization of the HD64 therapy system by hiring a focused VP of Business Development who is dedicated to commercialization activities. The importance and timing of this commercialization is significant as we have obtained FDA IDE approval and launched intraoperative studies. Specifically, we will source and hire a candidate who has a mix of business, neuromodulation, and marketing/sales skills who can lead fundraising, strategic partnerships, and component licensing initiatives.