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MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- ShiraTronics, Inc., a trailblazing clinical-stage medical device company, today announced a landmark achievement with the successful implantation of its Chronic Migraine System in the world's first six patients. This remarkable milestone represents a significant leap forward in neuromodulation, as the company unveils the first-ever fully implantable system for head location utilizing a minimally invasive approach.
Migraine, globally recognized as the second leading cause of disability and the primary cause among pre-menopausal women, remains a considerable health issue. For approximately 2% of the world's population, migraine frequency escalates to chronic attacks, subjecting individuals to debilitating symptoms such as intense headaches, nausea, and sensitivity to light for a minimum of 15 days each month, detrimentally impacting their overall quality of life. Existing treatments often offer limited relief, underscoring the significant need for innovative solutions. In response, ShiraTronics has developed a system engineered specifically to address the debilitating symptoms faced by these patients.
Lynn Elliott, Co-Founder of ShiraTronics, reflects on the remarkable journey, "It is gratifying and humbling to witness the evolution of this innovative approach to treating chronic migraine. Originating as a visionary concept by a creative group of physicians, it has now materialized into a tangible reality that has the potential to restore quality of life to many enduring this debilitating condition."
ShiraTronics Chief Executive Officer, Rob Binney, notes, "The achievement of this crucial milestone has validated all aspects of our procedure, system, and therapy settings. Notably, it is encouraging that all six patients who completed the trial procedure opted for the permanent implantation of the ShiraTronics system. We are thankful for the invaluable guidance and contributions by our investigators to date and look forward to additional patient implants currently scheduled in the new year."
About the RELIEV-CM Study
The RELIEV-CM clinical study, conducted in partnership with leading Australian researchers, brings together a team of distinguished neurologists and pain management physicians who will oversee the study's execution and data collection. The study evaluates the performance of ShiraTronics Chronic Migraine System and establishes the foundation for future clinical studies.
The ShiraTronics system delivers precise electrical pulses tailored to disrupt migraine pain signals. The fully implantable, programmable device aims to offer patients and physicians a new and potentially more effective treatment option.
Dr. Matthew Green, Director of Cercare, an Australian clinical research organization focusing on improving the delivery of evidence-based treatment for chronic pain conditions, is the world's first physician to implant the ShiraTronics Chronic Migraine System. He comments, "I am thrilled to be at the forefront of medical innovation as the first to implant this groundbreaking neuromodulation product. The simplicity and swiftness of the minimally invasive procedure marks a substantial breakthrough procedurally, eliminating the complexities of previous therapies. The entire Cercare team and I are excited to continue ongoing enrollments into the RELIEV-CM Study for chronic migraine. With two successful implants completed at our center, we are highly encouraged by the results. This technology introduces a new therapy option previously unavailable to patients and offers great hope where previously there was none for those grappling with chronic migraine."
About ShiraTronics
ShiraTronics, Inc. is a privately held, venture-backed medical device company committed to enhancing the lives of individuals with chronic migraine disease. By harnessing the potential of neuromodulation and pioneering innovative technology, ShiraTronics is at the forefront of the migraine industry, committed to enhancing the well-being of chronic migraine sufferers. ShiraTronics achieved FDA Breakthrough Device designation in 2021 and is headquartered in Minneapolis, MN.
For more information about ShiraTronics, please visit www.shiratronics.com.
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