–Data from 5,518 Patients were Critical to Achieving the Broader Indication–
Cleveland, Ohio- October 19, 2021- SPR Therapeutics® has obtained clearance from the U.S. Food and Drug Administration (FDA) of a broader indication for use for its SPRINT Peripheral Nerve Stimulation (PNS) System. Prior clearance limited use of the SPRINT PNS System to the back and extremities, but the new indication allows the device to be used in areas of the head, neck, and the front of the torso. The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.
Even without this expanded indication the pace of SPRINT System growth has more than doubled in the past year, having been used to treat nearly 7,000 patients to date, many of whom are seeking a pain management solution that does not require tissue destruction or a permanent implant. The expanded indication allows access to the many millions of patients with certain types of head, neck and torso pain.
“I have had great success in utilizing the SPRINT PNS System for many of my patients and I’m pleased that the expanded indication allows me to now treat these areas of high interest in an on-label manner while also allowing many more patients to receive prior authorization support from the SPRcare® market access team,” said Dr. Matthew Pingree of Rochester, MN.
“This is a tremendous milestone for SPR and the SPRINT System,” said Maria Bennett, CEO, President and Founder of SPR Therapeutics. “We look forward to the opportunity to bring effective pain relief to even more patients seeking alternatives to other more invasive treatment options.”
About the SPRINT® PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, restorative, 60-day treatment is a First-Line™ PNS option uniquely designed 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, and is cleared for use up to 60 days. Recognized by leading pain management centers, the breakthrough neuromodulation treatment offers 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 treat pain in the region innervated by the cranial and facial nerves.
For additional information regarding safety and efficacy, visit www.SprintPNS.com.
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, 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.
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SPR Contacts:
Mark Stultz
Senior Vice President
mstultz@sprtherapeutics.com
612.770.0390
Dave Folkens
Public Relations Contact
dfolkens@sprtherapeutics.com
612.978.6547
SPR Therapeutics Closes $37 Million Growth Equity Financing for Commercial Expansion of its SPRINT® PNS System
What empiracle research has been done that led to approval for neck pain? Can you forward me the research papers (copies) please?
Thank you
Deborah Klecker
Hello Deborah Klecker – Thank you so much for your message! We’d be glad to offer technical, clinical or other information about the SPRINT PNS System. Please reach out to us at 1-844-348-9108 between 8:00 a.m. and 4:00 p.m. EST or email us at support@SPRTherapeutics.com.
Hello, can you let me know if the using this Sprint unit for knees has been FDA approved yet? Thanks, Jean Hathaway
Dear Jean, thank you for your interest in SPRINT PNS! The SPRINT PNS System isn’t approved for specific indications, such as knee pain, but rather has been cleared for use as a general treatment option for various pain types though results may vary. SPRINT PNS has been studied extensively for low back pain, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative pain. Here is a link to some of our patient success stories using SPRINT for knee pain: https://www.sprtherapeutics.com/patients/stories/#knee
We’d be glad to help answer your questions about the SPRINT PNS System or help you find a physician in your area if you don’t already have one. Please reach out to us at 1-844-378-9108 between 8:00 a.m. and 4:00 p.m. or email us at support@SPRTherapeutics.com.