MIAMI BEACH, Fla., July 17, 2024 /PRNewswire/ — ShiraTronics, a trailblazing clinical-stage neurostimulation company, proudly presented findings from its Australian Pilot Study, RELIEV-CM, at the American Society of Pain and Neuroscience (ASPN) Pain Conference. This pioneering study showcases the world’s first fully implantable neurostimulation system specifically engineered for chronic migraine.
The ShiraTronics System reduced migraine frequency and significantly enhanced the quality of life for participants in the Pilot Study.
Promising Potential Migraine Treatment
The ASPN (American Society of Pain & Neuroscience) Conference, a premier gathering of the world’s leading experts in pain management and neuromodulation, was the perfect venue for ShiraTronics to present their Pilot Study results. The presentation highlighted ShiraTronics’ leadership in medical innovation and reinforced its commitment to addressing unmet patient needs in the realm of chronic migraine.
Dr. Steven Falowski, a renowned neurosurgeon from The Argires Marotti Neurological Associates Clinic in Lancaster, PA, and a leading expert in neurostimulation therapies, presented the compelling 12-week results. He emphasized the potential transformative impact of ShiraTronics’ system, which may offer a promising treatment for chronic migraine sufferers. ShiraTronics’ system is a minimally invasive, head-located device designed to provide continuous stimulation without interruption.
About the RELIEV-CM Pilot Study
The RELIEV-CM Pilot Study is evaluating the preliminary safety and performance of the ShiraTronics Migraine Therapy System. The system is designed to provide a discreet, continuous solution for chronic migraine sufferers. Chronic migraine, affecting millions worldwide, is characterized by severe headaches occurring at least 15 days per month, frequently accompanied by debilitating symptoms such as nausea and light sensitivity. Current treatment options often fail to deliver consistent and lasting relief.
ShiraTronics’ innovative system administers precise electrical pulses intended to disrupt migraine pain signals. Its unique, head-located design marks a significant departure from traditional neurostimulation systems typically intended for spinal placement. This novel approach is intended to address the mechanical and functional challenges unique to providing implantable stimulation to both the occipital and supraorbital nerves while delivering uninterrupted therapy 24 hours a day.
Key Highlights from the 12-Week Data:
Significant Reduction in Migraine Frequency: Participants experienced a substantial decrease in the number of headache and migraine days per month, alongside notable reductions in the severity of migraines. Improved Quality of Life: Participants reported marked enhancements in daily activities and overall well-being. High Safety Profile: The system demonstrated an excellent safety profile.
Dr. Falowski stated, "The RELIEV-CM study’s results are very promising. For the first time, we have a fully implantable neurostimulation system designed specifically for chronic migraine patients, placed in the head and above the flex points of the neck and spine. This customized approach reduced migraine frequency and significantly enhanced the quality of life for participants in the Pilot Study. This has the potential to be a transformative solution for millions suffering from chronic migraine disease."
Physician Insights and Next Steps
Dr. Matthew Green, a Pain Medicine physician at Pain Med SA and the Director of CerCare Clinical Research in Adelaide, Australia, was among the first to implant the system. Reflecting on the Pilot Study, he said, "Our experience in this Australian Pilot Study has highlighted the positive health impacts of the innovative ShiraTronics Migraine Therapy System for chronic migraine suffers who have tried and failed standard treatment options. Excitingly, our participants have shown significant improvements in pain levels, migraine-days, and quality of life indicators. We look forward to continuing our involvement in the upcoming randomized controlled trial to further explore the benefits of this technology for patients worldwide."
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 with chronic migraine. "We are delighted to present these groundbreaking results to the global medical community," said Rob Binney, President and CEO of ShiraTronics. "Our unwavering focus has always been on addressing the unmet needs of chronic migraine sufferers. The results of our Pilot Study validate the potential impact our therapy represents for the patients we serve, and who contend with the debilitating symptoms associated with chronic migraine. This data provides early indicators that our innovative platform has the potential to transform patient outcomes, restore functionality and improve quality of life. We are enthusiastic about accelerating our next phase of clinical research and continuing the relentless pursuit of our mission. Thank you to our Pilot Study investigators, advisors and, most importantly, our patients who participated in the RELIEV-CM Pilot Study."
For more information about ShiraTronics and the RELIEV-CM study, please visit shiratronics.com.
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