SPRINT® PNS Meets Primary Endpoint of Reduction in Head Pain in First Publication of Multicenter Prospective MONARCH™ Study

CLEVELAND, May 21, 2025 (GLOBE NEWSWIRE) — Today, SPR announced the publication of the MONARCH (Multicenter Occipital Neuralgia and Cervicogenic Headache) Study, which evaluates the use of 60-day SPRINT PNS treatment in relieving pain by delivering stimulation to the occipital nerves. In the prospective study, 90 percent (18/20) of participants met the primary endpoint with clinically significant (≥30 percent) reductions in average occipital pain and/or pain interference at the end of treatment (EOT) compared to baseline.

Headache conditions are prevalent and commonly disabling, with debilitating impacts noted across physical function, social function, sleep, and quality of life, all commonly related to both pain severity and pain interference on daily life. The MONARCH study investigated the safety and effectiveness of 60-day SPRINT PNS treatment in patients with cervicogenic headache or occipital neuralgia, two significantly disabling headache conditions.

Published in the journal Headache and titled “A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache”, the publication featured several key clinical findings including:

• The proportion of subjects with substantial (≥50 percent) reductions in average pain and/or pain interference was also evaluated with 85 percent (17/20) of participants achieving this threshold at EOT.
• At EOT, 100 percent (20/20) of participants reported at least minimal improvement (≥1) as measured by the Patient Global Impression of Change.
• Prospective outcomes to date suggest sustained reductions in pain and pain interference in a majority of subjects with follow-up ongoing.

No study-related adverse events (AE) were serious or unanticipated. Of 23 AEs in 11 participants, all were mild (21/23) or moderate (2/23) in severity. Dermatological AEs (e.g., skin irritation due to bandaging) were the most common events (12/23).

“This study and the clinical outcomes seen by participants are important measures in better addressing head pain for patients,” said Maria Bennett, President, CEO, and Founder of SPR. “Successfully targeting nerves in a highly mobile part of the body is a challenge and we are excited to see the strong performance of SPRINT PNS in both pain relief and overall device performance.”

About the SPRINT PNS System
The SPR^® SPRINT^® PNS System 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
SPR 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. SPR – Solutions for pain. Inspired by life.™

More information can be found at www.SPRPainRelief.com.

SPR Contacts:
Dave Folkens
Public Relations
[email protected]
612.978.6547

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