MINNEAPOLIS, Nov. 30, 2023 /PRNewswire/ -- ShiraTronics, Inc., a pioneering medical device company, today announced the initiation of its groundbreaking RELIEV-CM pilot study in Australia, marking the world's first seven patients' successful completion of trial phase procedures for their Chronic Migraine Therapy System. This development underscores the company's commitment to advancing innovative solutions that provide relief and improved quality of life for the millions of individuals who endure the burdens of chronic migraine disease.
Chronic Migraine affects approximately 2% of the global population, inflicting severe headaches, nausea, sensitivity to light, and a severely diminished quality of life, with sufferers experiencing symptoms on at least 15 days each month. For far too many, existing treatments offer little relief. In response to this unmet clinical need, ShiraTronics has engineered a fully implantable system designed to address the symptoms faced by these patients.
Rob Binney, CEO of ShiraTronics, commented, "The initiation of our Pilot Study is a momentous step forward in our mission to alleviate the suffering of those afflicted with chronic migraine. It is our belief that we have developed the world's first head-located, active implantable designed to address the unmet needs of the millions of patients who are still searching for a solution that can help improve their symptoms and quality of life. We look forward to working with our investigators to demonstrate the safety and efficacy of our novel system, as we prepare for the initiation of our IDE study in 2024."
ShiraTronics Co-Founder and Chairman of the Board, Mudit K. Jain, PhD, remarked, "The first-in-human trial phase study is a critical step in the development of this highly differential novel therapy. I am extremely proud of the efforts of the ShiraTronics team in achieving this major milestone. These efforts will ultimately help us in beating chronic migraine, a devastating disease that impacts millions globally and many people I know personally."
About the RELIEV-CM Study
The RELIEV-CM 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's primary objective is to furnish preliminary evidence regarding the performance of the ShiraTronics Chronic Migraine Therapy System, which will inform future clinical research.
The ShiraTronics system delivers precise electrical pulses tailored to disrupt migraine pain signals and aims to offer patients and physicians a new and potentially more effective treatment option.
Dr. Marc Russo, a key contributor to the study, noted, "We have known for very many years the efficacy of nerve stimulation for treating refractory headache syndromes, but the issue has been a lack of custom designed hardware specifically for the cranial region. Here we have access to that for the first time and I think this could open up a vista of treatment options that previously we have shied away from. I'm looking forward to seeing the outcomes from this very important research project."
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 chronic migraine industry, dedicated to enhancing the well-being of chronic migraine sufferers. ShiraTronics achieved FDA breakthrough device designation in 2020 and is headquartered in Minneapolis, MN.
For more information about ShiraTronics and their Chronic Migraine Therapy System, please visit www.shiratronics.com.
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