SPR® Therapeutics Unveils Long-term Data on SPRINT® PNS and Initial MONARCH™ Trial Update

Five total abstracts presented at ASPN 2024

/EIN News/ -- CLEVELAND, July 15, 2024 (GLOBE NEWSWIRE) -- Five abstracts featuring SPR Therapeutics’ SPRINT PNS System generated interest from leading pain physicians at the American Society of Pain & Neuroscience (ASPN) Annual Conference in Miami.

“Four-Year Follow Up from a Prospective, Multicenter Study of 60-day Medial Branch Nerve Stimulation for the Treatment of Chronic Axial Back Pain” was selected as an ASPN Top Abstract and featured as an oral presentation by Dr. Christopher Gilmore, MD, of the Carolinas Pain Institute and lead author, who presented long-term follow-up data from study participants who received SPRINT PNS for their low back pain. More than two-thirds (n=15/22) of participants reported clinically significant pain relief (greater than or equal to 30 percent) an average of 4.7 years after receiving 60-day PNS treatment.

“The long-lasting results we are seeing from SPRINT PNS participants over four years out from the end of treatment is truly impressive and makes a strong case for 60-day PNS as it is a short-term treatment that can deliver significant, sustained relief according to these data,” said Dr. Gilmore.

The abstract titled “Primary Endpoint Results From a Prospective Single-Arm Study of 60-Day Peripheral Nerve Stimulation Treatment Targeting the Occipital Nerves for Head Pain” by Dr. Jerry Gutierrez, Medical Director of The Pain Relief Surgicenter and lead author, highlights the first primary endpoint data from the MONARCH Case Series Study. The MONARCH study is the first prospective evaluation of 60-day PNS designed to learn more about relieving headache pain. Eighty-five percent of participants (n=17/20) reported greater than or equal to 50 percent reductions in pain and/or pain interference at the end of treatment (EOT).

Additional abstracts featuring SPRINT PNS included-

• “Percutaneous PNS Used for Treatment of Chronic Shoulder Pain: A Multi-Center Retrospective Chart Review” (Aman et al.) Overall, 60-day PNS was shown to be an effective treatment for chronic shoulder pain where 75 percent of patients in this review with EOT outcomes available (n=132/176) reported greater than or equal to 50 percent pain relief. These 132 patients had a variety of shoulder pain causes and treatment histories, with patients receiving Bimodal PNS^® treatment (concurrent motor and sensory stimulation targeting two nerves) reporting the highest rates of success.
  
• “Retrospective Review of 60-day Peripheral Nerve Stimulation in the Treatment of Complex Regional Pain Syndrome” (Patel et al.) This review of over 400 CRPS patients treated with PNS showed that 72 percent were responders (n=306/424), defined as reporting at least 50 percent pain relief and/or an improvement in Patient Global Impression of Change (PGIC) quality of life scores.
  
• “Percutaneous Peripheral Nerve Stimulation Relieves Chronic Postoperative Pain and Improves Function After Total Knee Arthroplasty: Holistic Responders in a Double-blind, Placebo-controlled Randomized Controlled Trial” (Goree et al.) In this analysis of holistic improvements in pain relief, function, walking ability, and/or quality of life for participants experiencing postoperative pain after knee replacement surgery, a significantly larger proportion of participants who were treated with 60-day PNS were holistic responders (with at least 30 percent improvement from baseline in pain relief and substantial improvements in at least one additional outcome) compared to those receiving placebo (sham) stimulation (n=15/20 versus n=7/20; p<0.05). Outcomes from this multicenter, randomized, double-blind, placebo-controlled trial were recently published in the journal Neuromodulation.
  

The most common adverse events for the SPRINT PNS System in both clinical studies and real-world data include skin irritation and erythema. All three clinical studies (Goree et al., Gutierrez et al., and Aman et al.) reported no study-related serious or unanticipated adverse events. Safety was not analyzed in the long-term follow-up survey (Gilmore et al.) and the retrospective chart review (Patel et al.).

See all five abstracts shared at ASPN by clicking here.

Drs. Gilmore, Gutierrez, Aman, and Patel are consultants for SPR Therapeutics.

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, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative 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 postoperative 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
mmcdonald@sprtherapeutics.com
844.378.9108

Dave Folkens
Public Relations
dfolkens@sprtherapeutics.com
612.978.6547