MindRhythm, a medical device technology company focused on preventing neurological injury, announces today the expansion of part 1 of its first multicenter clinical trial in stroke to 2 additional sites in California. The trial is based out of Wayne State University in Detroit, in partnership with Henry Ford, Detroit Receiving, Sinai-Grace, and Ascension St. John Hospitals, all of which began enrolling subjects in April of 2021. Over 350 patients have been enrolled in the trial in Michigan since inception and enrollment is expected to grow exponentially with these 2 new sites. Following the addition of 2 prominent Michigan destinations for specialty care during summer of 2022: Ascension Borgess and Bronson Methodist, the trial has expanded to University of California San Francisco Medical Center (UCSF) and California Pacific Medical Center (CPMC), which share strong academic ties. Both institutions are consistently ranked among the top research organizations in the nation. These two San Francisco based locations will enhance the quality and variety of data points collected to more widely reflect the population at risk of stroke. UCSF and CPMC will begin enrolling patients imminently.
The intention of the trial is to demonstrate the effectiveness of MindRhythm’s proprietary Harmony device in rapidly identifying patients with Large Vessel Occlusion stroke (LVO) prehospital, for direct dispatch to a Comprehensive Stroke Center (CSC) to receive optimal care. Augmenting the data pool with subjects from Part 1 has allowed MindRhythm to optimize the device for the EMS environment.
Dr. Debbie Madhok, Director of the Emergency Stroke Program at UCSF shared, “There have been groundbreaking strides in stroke treatment over the past 10 years. MindRhythm’s Harmony device has the potential to be the missing link-a way to connect patients with the best possible treatment.”
MindRhythm CEO John Keane adds, “The patient data and EMS feedback provided during part 1 of the Episode trial have allowed the company to make significant enhancements to the Harmony technology, with both performance and ergonomic improvements implemented. This will augment part 2 of the trial thus enabling the company to achieve robust device performance.
Stroke is the 5th leading cause of death in the U.S. and its most lethal form is the LVO stroke. There is no technology available to objectively diagnose stroke type in emergency medical services (EMS) which often delays treatment and contributes to the morbidity and mortality associated with the neurological injury. Approximately only 300 hospitals in the US are CSCs which are equipped with the necessary technology and trained staff to effectively treat LVO stroke patients; their presence is even more rare in rural or lower populated areas. The Harmony headset is expected to empower emergency workers with a level of diagnostic specificity and sensitivity capabilities to confidently triage patients to the appropriate facility to receive optimal treatment as fast as possible.
MindRhythm, was founded by John Keane, Dr. Wade Smith MD, PhD, and Dr. Paul Lovoi, PhD in 2019 to optimize stroke triage in the prehospital and hospital settings. MindRhythm’s Harmony device in development is a novel, non-invasive, diagnostic medical device that can rapidly identify patients with LVO via monitoring of a specific waveform found in the brain discovered by UCSF and MindRhythm. Patients who use MindRhythm’s device can benefit from rapid transport to a CSC that has the appropriate physicians, technologists, and equipment needed to remove the clot that has caused the stroke. MindRhythm’s finely-tuned, proprietary technology effectively triages patients, communicates patient data, and provides remote location status to hospital teams prior to the arrival thus optimizing patient treatment and outcomes.