– RESET is the largest prospective, multicenter randomized controlled trial of SPRINT PNS conducted to date –
Cleveland, Ohio – December 12, 2023 – SPR Therapeutics, Inc. today announced the final patient was enrolled in the RESET Clinical Trial of SPRINT® PNS for the treatment of chronic low back pain (LBP). This large multicenter randomized controlled trial (RCT) compares percutaneous peripheral nerve stimulation (PNS) with standard interventional treatments of chronic LBP.
The “RESET Clinical Trial: A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain” is a large RCT being conducted at more than 20 clinical centers across the United States. Eligible patients are randomized to receive either SPRINT PNS or standard pain management interventions for their chronic LBP. The primary endpoint of the study is a comparison of the proportion of patients in each group experiencing clinical improvements in back pain three months after treatment. The study will collect pain and other patient-reported quality of life outcomes through 24 months post-treatment.
“We are thrilled to announce the completion of enrollment in this important study, which is the largest randomized controlled trial to date studying the SPRINT PNS System. This trial is designed to provide additional robust safety and efficacy data on the use of minimally-invasive, percutaneous PNS targeting the lumbar medial branch nerves for chronic back pain, building upon the large body of evidence that already exists supporting the use of SPRINT PNS for a variety of chronic and acute pain conditions,” said Josh Boggs, PhD, Chief Scientific Officer of SPR Therapeutics. “Our team would like to express our sincere gratitude to the study investigators, their dedicated research staff, and the patients who are participating in this study. We look forward to sharing the results with the interventional pain management community,” added Boggs.
Maria Bennett, President, CEO and Founder of SPR Therapeutics noted, “Chronic low back pain remains a tremendous challenge for millions of Americans and is one of the most frequent causes of work-related disability, time out of work, and avoidance of everyday activities. The RESET trial is a significant step forward in advancing a treatment option designed to address the needs of patients that face ongoing pain, limitations to their personal lives, and indirect challenges and costs that come with chronic pain.”
About the SPRINT PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, 60-day treatment is a First-Line PNS™ option uniquely proposed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, shoulder pain, post-amputation pain, and chronic and acute post-operative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. Market research indicates that this breakthrough neuromodulation treatment is a patient-preferred alternative to more invasive options.
The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only.
For additional information regarding safety and efficacy, visit: SPR Safety Information.
About SPR Therapeutics, Inc.
SPR Therapeutics is a privately held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose – to improve the quality of patients’ lives by providing them with a minimally-invasive, drug-free, surgery-free solution to manage their acute and chronic pain.
More information can be found at www.SPRTherapeutics.com.
SPR Contacts:
Michelle McDonald
Vice President – Marketing
844.378.9108
Dave Folkens
Public Relations
612.978.6547
Minimally Invasive PNS may be an Important Part of Step-Up Approach to Groin Pain Treatment
Marissa Avila came to NM orthopedics about a month ago and I would like to know if I would be eligible for a clinical trial. I have severe low back pain.
Hello, thank you for your interest in SPRINT. Our Low Back Pain study has completed enrollment and is no longer adding new patients. However, you can still receive SPRINT outside of the study. If you don’t already have a physician, we’d be glad to help find a physician near you who can discuss if SPRINT is a good option for you. Please reach out to our Patient Support team by calling 1-844-378-9108 and selecting option 1 from the menu between 8:00 a.m. and 5:00 p.m. EST. If more convenient, you may email them at patientsupport@sprtherapeutics.com.
Interested in finding a doctor in or near Thornton Colorado. I have tried the test spinal cord stimulator and looking at get the permanent implant.
However if the PINS would give me the same if not better results without a permanent implant. Is this covered by insurance?
Hi Adam, thank you for your interest in SPRINT PNS. We’d be glad to help answer your questions about the SPRINT PNS System and help you find a physician in your area. Please reach out to our Patient Support team by calling 1-844-378-9108 and selecting option 1 from the menu between 8:00 a.m. and 5:00 p.m. EST. If more convenient, you may email them at patientsupport@sprtherapeutics.com.
I see enrollment was completed in Dec of 2023. Since the primary endpoint is at 3 months, are you planning to release the results? I am considering this treatment with my doctor and would feel more comfortable if the results of the randomized controlled trial were available before I commit to this.
Thank you for your interest in the RESET trial and about the availability of results. While the study is closed to enrollment at this time, data collection is ongoing. We invite you to review other currently available public data regarding the SPRINT PNS System on our website here: https://www.sprtherapeutics.com/physicians/clinical-outcomes-references/. Announcements of any new data are included on our website as they become available. Again, thank you for your interest in SPRINT PNS.