ShiraTronics Announces Positive 12-Month Follow-Up Results from RELIEV-CM Pilot Study, Demonstrating Sustained Clinical Benefit with Investigational Implantable Neuromodulation Therapy for Chronic Migraine

MINNEAPOLIS, Sept. 16, 2025 /PRNewswire/ -- ShiraTronics, Inc., a clinical-stage medical device company focused on developing novel neuromodulation therapies for chronic migraine, today announced compelling 12-month follow-up data from its RELIEV-CM Pilot Study. The findings demonstrate sustained reductions in headache frequency and severity, continued improvement in migraine-specific quality of life, and a consistently favorable safety profile, underscoring the long-term potential of the company's investigational, fully implantable Migraine Therapy System.

This new dataset validates the promising outcomes first reported at 12 weeks and highlights the durability of benefit over time in a patient population where chronic migraine remains difficult to treat with existing therapies.

"These 12-month outcomes reinforce the strength and sustainability of our early findings," said Rob Binney, CEO of ShiraTronics. "For patients living with chronic migraine - who often cycle through medications with limited or temporary success - the consistency of benefit seen over an entire year is a meaningful signal. We believe this investigational therapy is positioned to address one of the largest unmet needs in neurology and eagerly await further validation when we reveal the results of our Pivotal Study in 2026."

Key 12-Month Results from the RELIEV-CM Pilot Study Include:

• 9.6 average reduction in monthly headache days (MHD) from baseline
• 9.6 average reduction in monthly migraine days (MMD) from baseline
• Sustained improvements in migraine-specific quality of life (MSQ) across multiple domains
• Reduction in rescue medication use and headache severity
• No unanticipated adverse events reported

Building on Earlier Success
The 12-month results are built on the previously reported 12-week data, where patients experienced a mean 11.3-day reduction in monthly headache days, with 80% achieving a ≥50% reduction, alongside meaningful improvements in migraine-specific quality of life scores. Importantly, these improvements were not only sustained over a full year but continued to trend positively across multiple endpoints, including headache severity, rescue medication use, and patient and clinician global impression of change scores.

A Precision-Engineered Approach to a Complex Neurological Disease
The ShiraTronics Migraine Therapy System is a first-of-its-kind, fully implantable neuromodulation platform designed specifically for patients with chronic migraine. Unlike earlier off-label adaptations of spinal cord stimulators, the ShiraTronics system is purpose-built for head-based therapy, with subcutaneous leads targeting the occipital (ON) and supraorbital (SON) nerves—two key nerve pathways implicated in migraine pathophysiology.

The therapy delivers low-level, patient-controlled electrical stimulation that is intended to modulate pain signaling within the trigeminocervical complex (TCC), a central hub in migraine processing. Patients can use the system continuously or adjust therapy parameters based on individual needs, providing a personalized approach to prevention without systemic drug side effects.

"The long-term results from this pilot study are particularly encouraging and reinforce the potential of this therapy to deliver meaningful, sustained relief for people living with chronic migraine," said Dr. Samer Narouze and Dr. Brian Grosberg. "As National Co-Principal Investigators of the RELIEV-CM2 study, we're optimistic about what this investigational neuromodulation system could represent for patients who have exhausted conventional treatment options. These findings offer real hope for a population that has long needed better solutions." 

Study Design & Patient Experience
The RELIEV-CM Pilot Study was a prospective, multi-center clinical investigation conducted across four international sites. Participants were first screened using a 28-day electronic headache diary to confirm eligibility under ICHD-3 criteria for chronic migraine. Those who qualified underwent a temporary external trial phase to evaluate tolerability.

Patients who tolerated stimulation during the trial phase proceeded to receive bilateral, subcutaneous implantation of pulse generators and leads targeting the ON and SON nerve pathways. Participants were then followed closely over 12 months, with outcome measures including monthly headache days, migraine days, MSQ scores, MIDAS scores, and rescue medication use.

"Many of my patients with chronic migraine have tried multiple drug therapies, including CGRPs and Botox, and still suffer significantly," said Dr. Matthew Green, a principal investigator in the RELIEV-CM study. "The sustained improvements we're seeing over a full year with this investigational therapy are both clinically meaningful and personally hopeful, for both patients and physicians."

Targeting an Urgent & Unmet Need
Chronic migraine affects more than 5.5 million individuals in the U.S. each year and is classified by the World Health Organization as one of the most disabling neurological disorders. It is characterized by 15 or more headache days per month, with 8 or more featuring migraine characteristics, often leading to significant personal, professional, and emotional disruption.

Current pharmacologic treatments, including CGRP monoclonal antibodies and Botox, can be effective in some patients but often fall short in real-world durability, tolerability, and patient adherence. Roughly 30–40% of patients discontinue preventive therapies within the first year, and many remain refractory to existing options.

The ShiraTronics system offers a drug-free, continuous, and patient-controlled therapy modality, designed to overcome these barriers through targeted nerve stimulation that addresses the underlying neurobiology of chronic migraine.

Regulatory Pathway & Next Steps
The ShiraTronics Migraine Therapy System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
The company is actively enrolling participants in its RELIEV-CM2 pivotal trial, a larger, randomized, double-blind study intended to further evaluate the system's safety and efficacy across a broader patient population.
For more information on the ShiraTronics therapy or clinical trial enrollment, visit:
www.shiratronics.com/clinical-trial

About ShiraTronics
ShiraTronics is a pioneering medical device company dedicated to developing state-of-the-art neurostimulation solutions aimed at improving the quality of life for patients living with chronic migraine. The ShiraTronics Migraine Therapy System demonstrated encouraging reductions in headache days and decreased severity of migraine attacks, as well as improvement in quality-of-life scores in its first-in-human pilot study. The company is currently enrolling its pivotal trial for FDA premarket approval, the RELIEV-CM2 Clinical Study. Based in Minneapolis, ShiraTronics is the first spinoff company from medical accelerator NuXcel and is backed by investors including Norwest Venture Partners, U.S. Venture Partners, Amzak Health, Treo Ventures, Aperture Venture Partners, Seroba, OSF Ventures, the Global BioAccess Fund, and others. For more information, visit shiratronics.com.

About Principal Investigators
Samer Narouze, MD, PhD, MMM
Division Chief of Pain Medicine at University Hospitals
Founder of the American Interventional Headache Society

Brian Grosberg, MD
Director of the Hartford HealthCare Headache Center
Ayer Neuroscience Institute
Professor of Neurology at the University of Connecticut School of Medicine

Matthew Green, MD
MBBS, FAFRM (RACP), FFPMANZCA, FIPP, Grad. Dip. MUSCMED
Pain, Rehabilitation and Musculoskeletal Physician. Fellow of Interventional Pain Practice

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

SOURCE ShiraTronics, Inc.