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Breakthrough in Chronic Migraine Treatment by ShiraTronics

ShiraTronics, Inc., a clinical-stage medical device firm based in Minneapolis, has unveiled encouraging results from the 12-month follow-up of its RELIEV-CM Pilot Study. This groundbreaking research focuses on a potentially transformative implantable neuromodulation therapy designed to alleviate chronic migraine symptoms. The latest findings emphasize a notable and sustained decrease in both the frequency and severity of headaches in participants, showcasing the long-term advantages of this investigational device.

Promising 12-Month Results

The recently announced data demonstrates an average reduction of 9.6 monthly headache days, alongside a comparable decrease in migraine days from baseline measurements. Participants also reported lasting improvements in migraine-specific quality of life, suggesting a significant enhancement in overall well-being. Importantly, the study noted no unexpected adverse events, reinforcing the safety of the therapy.

Rob Binney, CEO of ShiraTronics, expressed optimism about the significance of these results, stating, "For patients grappling with chronic migraine, often struggling with limited success from various medications, the consistent benefits observed over an entire year are profoundly impactful. This investigational therapy has the potential to meet one of neurology's biggest unmet needs."

Building on Initial Success

The current results build on promising data reported from the initial 12-week assessment, where participants experienced an average reduction of 11.3 headache days each month. Remarkably, 80% of patients achieved a reduction of at least 50% in their headache days, coupled with enhancements in quality of life metrics. The stabilization of these beneficial outcomes over twelve months is a promising sign for the therapy's long-term viability.

Unique Design of the Migraine Therapy System

The Migraine Therapy System is a pioneering device designed specifically for patients with chronic migraine. Unlike previous spinal cord stimulator adaptations, this system is uniquely structured for head-related therapy. It features subcutaneous leads that target crucial nerve pathways involved in migraine processing—the occipital (ON) and supraorbital (SON) nerves.

Delivering low-level, patient-controlled electrical stimulation, this therapy aims to adjust pain signaling in the trigeminocervical complex (TCC), a major region in migraine management. This patient-oriented approach offers flexibility in treatment without the unwanted systemic side effects associated with traditional medications.

Addressing Urgent Needs

Chronic migraine impacts more than 5.5 million individuals annually in the United States, classified as one of the most debilitating neurological conditions. It is characterized by debilitating headaches, with patients often experiencing significant disruptions to daily life due to an overflow of headache days monthly.

While current treatments, such as CGRP monoclonal antibodies, provide relief for certain patients, many do not achieve the desired long-term success, leading to a high discontinuation rate among patients. The ShiraTronics Migraine Therapy System presents an innovative, drug-free solution that seeks to remedy these challenges through targeted nerve stimulation, addressing the underlying neurobiology of chronic migraines effectively.

Future Directions and Trials

With the ShiraTronics Migraine Therapy System having received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), the company is advancing into the next phase of clinical investigation. They are currently enrolling participants in the RELIEV-CM2 pivotal trial, a randomized, double-blind study aimed at assessing safety and efficacy across a broader patient demographic.

For those seeking more information about ShiraTronics and their clinical trials, detailed updates can be found at shiratronics.com.

Conclusion

The ongoing advancements in the field of migraine therapy are noteworthy, particularly for individuals who have exhausted conventional treatment methods. As ShiraTronics continues to refine its innovative solutions, the hope for enhanced quality of life for chronic migraine sufferers remains alive and promising.