CLEVELAND, Dec. 10, 2019 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc., a leader in neurostimulation technology for pain management, today announced publication of 12-month follow up results of its SPRINT® Peripheral Nerve Stimulation (PNS) System used for the treatment of post-amputation pain. The SPRINT System is the only FDA-cleared short-term PNS treatment that has demonstrated an ability to provide long-term pain relief, with corresponding improvements in function and depression.
The double-blinded, randomized controlled study was awarded “Best of Meeting” at the 18th Annual Meeting of the American Society of Regional Anesthesia and Pain Medicine in New Orleans and has now been published in the society’s official journal, Regional Anesthesia and Pain Medicine.
Study participants had experienced post-amputation pain for up to 30 years. All participants underwent ultrasound-guided placement of SPR’s MicroLeads™ which are constructed using a tiny 100-micron wire, about the size of a human hair. Participants were then randomized to receive treatment using SPRINT PNS for 8 weeks, or placebo for four weeks and SPRINT PNS for 4 weeks.
Study Highlights:
While 67% of the participants in the treatment group reported ≥ 50% reductions in pain 12 months after the start of the 8-week stimulation treatment, none of the participants in placebo group demonstrated these results at the end of the placebo period. Treatment group participants also reported significantly less interference of pain in walking, sleeping, enjoyment of life, and general activity.
Dr. Christopher Gilmore of the Center for Clinical Research in Winston-Salem, NC and principal author, stated: “The results are quite provocative and lead one to question whether a permanently implanted neurostimulation device is necessary for many patients who respond to a temporarily implanted lead. It is also encouraging to see that results are similar to those we’ve seen in patients with low back pain and shoulder pain.”
“This latest study builds on the growing body of evidence demonstrating that our SPRINT PNS System is able to deliver sustained and significant pain relief after the completion of its 60-day treatment,” said Maria Bennett, CEO of SPR Therapeutics, Inc. “We are also encouraged by SPRINT’s early commercial success and look forward to working with our many physician partners to expand the availability of this treatment to patients who could benefit from a non-opioid and non-surgical solution for their pain.”
About SPRINT® PNS System
The SPRINT Peripheral Nerve Stimulation (PNS) System is the only percutaneous PNS device that is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The SPRINT PNS System leads are placed by a physician during an outpatient procedure without surgery, incisions, tissue destruction or anesthesia, and are connected to a wearable stimulator that delivers stimulation for up to 60 days of therapy, after which the leads are withdrawn. In multiple studies, the SPRINT system has demonstrated significant and sustained pain relief following the 60-day treatment. Physicians have used the SPRINT system to treat post-amputation pain, inoperable joint pain, lower back pain, complex regional pain syndrome (CRPS), and post-operative pain following joint replacement and surgical reconstruction (partial listing). For additional information regarding safety and efficacy visit www.sprtherapeutics.com.
About SPR Therapeutics, Inc.
SPR Therapeutics, Inc. is a privately-held medical device company headquartered in Cleveland, Ohio, focused on developing, manufacturing and commercializing non-opioid, minimally invasive, treatment options that improve quality of life. The company’s SPRINT technology is the only percutaneous Peripheral Nerve Stimulation (PNS) System FDA-cleared to treat both chronic and acute pain. More information can be found at: www.sprtherapeutics.com.
About this study
This multi-center, randomized, double-blinded, placebo-controlled, partial-crossover study enrolled 28 lower extremity amputees with post-amputation pain at six U.S. clinical sites. The study was funded by a grant from the United States Department of Defense, Congressionally Directed Medical Research Programs, Peer Reviewed Orthopedic Research Program, under award: W81XWH-12-2-0132. The views expressed in this news release/article are those of the author and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
SPR Contact:
Mark Stultz
Senior Vice President
mstultz@sprtherapeutics.com
612-770-0390
Media Contact:
Helen Shik
Shik Communications LLC
ShikPR@sprtherapeutics.com
617-510-4373
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bbb58e8a-3aff-4593-b57c-d9913f7e740e