– Commercial expansion and real-world evidence results in doubling of total implants in just over a year –
Cleveland, Ohio – August 22, 2023 – SPR® Therapeutics, a private medical device company focused on treating pain and improving the quality of life for patients managing acute or chronic pain, announced the 20,000th patient implant of the SPRINT® PNS System.
The 20,000th treatment was performed to address low back/leg pain for a patient with the new SPRINT extensa XT™ System, which offers bimodal nerve stimulation designed to activate motor and sensory fibers via two leads placed in complimentary locations.
Since its commercialization six years ago in July 2017, many pain specialists have utilized the SPRINT PNS system as a new approach to offer their patients a less-invasive, 60-day treatment that does not require a permanent implant. Based on one of the largest real-world datasets compiled evaluating peripheral nerve stimulation, more than 70 percent of patients were defined as responders following completion of treatment with SPRINT PNS across all nerve targets. This real-world data corroborates previously published clinical studies which have consistently found that a majority of patients reported substantial pain relief and improvements in function. The outcomes of real-world applications are a strong supplement to patient experience in clinical trials as the population is broader and more diverse. Responders in this real-world dataset experienced greater than 50 percent pain relief and/or improvement in quality-of-life measurements at the completion of treatment.
Dr. Denise Lester is a Board-Certified Anesthesiologist and Pain Management physician. She also holds a board certification in Addiction Medicine from the American Board of Preventive Medicine and performed the very first commercial implant of the SPRINT PNS System in 2017 along with implanting the 20,000th patient. “I am consistently working to offer the most appropriate option for my patients living with pain and believe that SPRINT PNS has been an important tool in my treatment algorithm. Many treatment options that exist have significant limitations on the patient population that can benefit from a particular treatment. Given the shorter treatment period with SPRINT and the data on multiple nerve targets, I have been able to help many of my pain patients with this approach that might not fit other treatment options.”
Dr. Christopher Gilmore, MD, of the Carolinas Pain Institute, Investigator on multiple SPRINT clinical trials for lower back pain and SPR Consultant, shared, “One of the key advantages I have experienced with this treatment is the non-destructive nature of the approach where ablation of the nerves does not occur. It is a less intrusive approach and has shown that the non-permanent 60-day treatment period can offer long-term pain relief to patients. It’s particularly exciting to see consistent results across multiple nerve targets in real-world applications.”
Dr. David Dickerson, MD, and section chief for pain medicine, NorthShore University HealthSystem and SPR Consultant noted, “I truly appreciate the importance of safe and effective non-opioid options for treating my patients’ pain. I I have used the SPRINT System extensively with positive outcomes including the reduction of opioid use post-treatment, both in controlled trials as well as clinical practice.”
“While I am tremendously proud of our business outcomes and accelerating growth, it is most rewarding for all of us at SPR to know that each of these implants represents a patient that was offered hope to address the pain that they had been living with that was holding them back from experiencing their best life,” said Maria Bennett, President and CEO at SPR Therapeutics. “Treatment with SPRINT PNS may allow a patient to actively spend time with their children or grandchildren, it could mean getting back a career they love, and for some it means travel and independence. We continue to be inspired by those we serve and look forward to changing thousands more lives with this innovative treatment.”
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
Carly Grimes
Neck Pain
SPR Therapeutics
Hi Carly, ultimately your personal physician will be most knowledgeable about how SPRINT PNS will work for you and your unique circumstances. We have seen SPINT PNS used with some success in the head and neck area though results may vary – for more information visit our Head & Neck page: https://www.sprtherapeutics.com/head-neck/. We’d be glad to help you find a physician in your area. Please reach out to us at 1-844-378-9108 between 8:00 a.m. and 4:00 p.m. or email us at patientsupport@SPRTherapeutics.com.
Janie Hollowell
What is the cost of this treatment and do most insurances cover it ?
SPR Therapeutics
Hi Janie, thank you so much for your interest in SPRINT PNS! We’d be glad to help answer your questions about the SPRINT PNS System and/or how the procedure may be covered by your insurance provider, please email sprcare@sprintpns.com or call 833.877.2884 M-F 8:30 AM to 4 PM CST.
Pat Newcomb
Need information from you on this implant for people who have an ICD . How many procedures have been done to people with ICDs?
SPR Therapeutics
Hi Pat, thank you for your comment, and we appreciate your interest. However, the SPRINT PNS System is contraindicated for patients who have an implanted active cardiac implant, such as a pacemaker or defibrillator. For more information please see our important safety information page: https://www.sprtherapeutics.com/physicians/important-safety-information/ We wish you the best going forward!
Lee M Nalewajk
Hi…my fiancé has been treated with your SPRINT system and it’s the first treatment she’s come upon on 20+ years which has made a difference. She suffers from (I believe it’s called) Post-Traumatic Neuralgia. This has left her disabled and prescribed copious pain medications. She’s tried Stellate Blocks, a spinal cord stimulator implanted, TENS devices, Botox and Eastern Medicine. All of these only helped to reduce her pain in the 0-15% range.
The SPRINT system however provided “as much as 50%” pain reduction. At times, possibly a bit more. Amazing!
The problem is the 60 day time-limit. The residual effects of the treatment do not last long after removal (perhaps 2-3 weeks). I’m not sure if the delays are from insurance approval or scheduling, but it can take many months for her to get another lead inserted. After the device is removed, she’s not used to it and has to steel herself against the returning pain. What I’m wondering is if you have, or are working on a device which can be left in longer or indefinitely?
Thank you!
SPR Therapeutics
Hi Lee, thank you for reaching out and sharing you and your fiancée’s experience with the SPRINT PNS System. Currently, we do not have anything on the market that would be longer duration, as the SPRINT PNS System is only cleared for use for 60-days. However, we will definitely note your feedback here, as it is very helpful for us to understand the needs and experiences of our patients when conducting our R&D efforts. We wish you both the best going forward and hope that your fiancée is able to find relief!
Lee M Nalewajk
For the record her condition is “Postherpetic neuralgia”.