MIAMI
BEACH, Fla., July 16,
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.
Study participants have shown significant
improvements in pain levels, migraine-days, and quality of life
indicators
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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SOURCE ShiraTronics, Inc.