First Implants of Innovative Device Completed in the United States and Australia

MINNEAPOLIS,Dec. 3,2024 --ShiraTronics,a clinical-stage innovator in neuromodulation technology,today announced the initiation of its U.S. Food and Drug Administration (FDA)-approved Investigation Device Exemption (IDE) pivotal trial,the RELIEV-CM2 Clinical Study. The first implants of ShiraTronics neuromodulation therapy for Chronic Migraine have been completed in the United States and Australia,marking a new chapter in the company's efforts to develop innovative solutions for individuals impacted by this disabling condition.

ShiraTronics device

TheRELIEV-CM2 Clinical Study will implant up to 148 patients across the United States and Australia to assess the long-term safety and potential efficacy of ShiraTronics implantable neuromodulation therapy. Unlike other approaches that primarily manage migraine symptoms,the ShiraTronics System is designed to provide preventive,sustained relief for those who experience 15 or more headache days per month and have not achieved success with other treatments. For many of the millions who live with the challenging effects of Chronic Migraine,this novel approach could represent a potential new therapy option.

Dr. Sandeep Vaid was the first physician to implant the ShiraTronics System in the United States. "Bringing this new therapy to patients represents an exciting step forward in migraine management. Chronic Migraine has a profound impact on people's lives,limiting daily activities and affecting overall well-being. This device offers a fresh approach that,based on early results,holds promise for improving how patients function day-to-day. It's a privilege to be part of this pivotal study and witness what this technology might mean for patients who have exhausted other options," said Dr. Vaid. Dr. Vaid is Board Certified in Pain Management,Neurology,and Brain Injury Medicine and serves as Medical Director of Clinical Research at Vista Clinical Research in Newnan,Georgia.

Rising Demand for Long-Term Solutions for Chronic Migraine

Migraine affects nearly 2% of the global population and is often marked by severe,pulsating headaches,sensory sensitivity,nausea,and fatigue. Patients with Chronic Migraine,a more severe form of migraine,experience headaches 15 or more days per month,with at least eight days accompanied by intense and disabling migraine symptoms.

Despite available treatments—such as prescription pills,CGRP inhibitors,and Botox injections—millions of patients in the United States are unable to control the disease with current preventive treatment options and therefore continue to struggle with symptoms that significantly impact their quality of life,physical and emotional well-being,and productivity. This has highlighted an urgent need for alternative therapies that could provide more consistent and lasting relief.

The ShiraTronics System was designed with this need in mind. By delivering targeted electrical impulses to key nerve pathways,the device is placed just beneath the skin and aims to relieve,interrupt and prevent migraine frequency and severity,potentially providing a new,non-pharmacologic option for those seeking a solution to Chronic Migraine's disabling effects.

Limitations of Current Chronic Migraine Treatments

Current migraine treatments primarily focus on managing symptoms,and some can lead to dependency,rebound headaches,or difficult side effects. Preventive options often require regular healthcare visits for injections,or repeatedly self-administering injections,which can disrupt patients' lives. Often patients find that these treatments fail to deliver adequate relief or result in side effects that hinder quality of life,making them challenging to continue.

The ShiraTronics System aims to address these limitations by targeting the nerve pathways involved in Chronic Migraine with precise,24/7 electrical neuromodulation. The goal is to provide an approach that can potentially reduce the frequency and intensity of migraine attacks,allowing patients to maintain their daily activities with fewer disruptions and less dependence on continuous medication or invasive treatments.

Early Pilot Study Success

The RELIEV-CM Pilot Study,an earlier study by ShiraTronics,provided encouraging initial insights. Among a cohort of 10 Chronic Migraine patients who had not responded to conventional treatments,80% reported a 50% reduction in migraine frequency after three months,with some experiencing reduced severity as well. Additionally,60% of participants reported decreased reliance on acute medications,with several discontinuing them within the first six months of therapy.

"The minimally invasive nature of this procedure allows us to implant the device efficiently,making the procedure easily adopted by implanting physicians. The initial results we've seen have been very promising,and the procedure itself has been both straightforward and well-received by patients. I'm honored to contribute to the development of a therapy that could offer sustainable benefits for those living with persistent,treatment-resistant migraines," said Associate Professor Marc Russo,an internationally recognized leader in neuromodulation and Immediate Past-President of the International Neuromodulation Society (INS). Associate Professor Russo also serves as Director at Large of the Neuromodulation Society of Australia and New Zealand (NSANZ).

Looking Ahead: Moving Migraine Research Forward

As the RELIEV-CM2 Clinical Study progresses,ShiraTronics is collaborating closely with healthcare professionals and patients to evaluate the long-term safety and potential of its neuromodulation therapy. The company is focused on advancing this technology aiming to improve patient outcomes,with the intention of making this innovative approach widely available to Chronic Migraine patients in the future. While still in the early stages,the study underscores the potential impact of the ShiraTronics System for those who have exhausted traditional treatment options. "Our mission is to provide a new therapy option for chronic migraine patients that will reduce the impact of migraine,restore functionality and improve quality of life," said Fred Ecklund,VP Global Clinical Affairs.

About ShiraTronics

ShiraTronics,a Minneapolis-based,privately-held medical device innovator,is at the forefront of neuromodulation solutions to transform the lives of those suffering from Chronic Migraine. The ShiraTronics Migraine Therapy System is a groundbreaking technology designed to deliver continuous,targeted neurostimulation,aiming to relieve,interrupt,and prevent migraine attacks. With this state-of-the-art system,ShiraTronics is committed to advancing migraine treatment and improving the quality of life for those affected by this challenging condition.

For more information about ShiraTronics and the RELIEV-CM2 Clinical Study,please visit shiratronics.com.

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