MindRhythm, a medical technology company focused on preventing neurological injury in stroke, today announced the enrollment of its first patient in a multicenter trial out of Wayne State University in partnership with Detroit Receiving Hospital, Henry Ford Hospital, Sinai-Grace Hospital, and Ascension St. John Hospital.
The intention is to demonstrate the effectiveness of MindRhythm’s proprietary technology in rapidly identifying patients with Large Vessel Occlusion (LVO) strokes prehospital for direct dispatch to a Comprehensive Stroke Center (CSC) hospital able to treat LVO stroke.
“We are incredibly excited to now be enrolling patients in the MindRhythm trial,” said Dr. James Paxton, Wayne State University. “MindRhythm’s technology has the potential to save lives and change the course of stroke triage. We plan to hit the ground running in order to validate the effectiveness of MindRhythm through the multicenter clinical trial to help reduce the severity of neurological injury caused by LVO strokes.”
Stroke is the fifth leading cause of death in the United States, and its most lethal form is termed Large Vessel Occlusion (LVO) stroke. However, there is no technology available to objectively diagnose LVO stroke in an EMS setting, often leading to delays in treatment. Further, relatively few hospitals in the U.S. possess the necessary equipment to effectively treat LVO strokes and need fully-trained critical care staffing to support the use and treatment of patients with this type of equipment. To date, EMS and paramedics don’t have the means to determine the type of stroke in their patients and therefore have trouble deciding if they should transport the patient to a CSC hospital able to treat LVO stroke.
“With this multicenter trial, MindRhythm is providing a new opportunity for hospitals and EMS to more easily identify and treat one of the most debilitating types of strokes,” said John Keane, President and CEO, MindRhythm. “We are proud to be working with some of the brightest minds in medicine to help solve one of medicine’s most critical problems.”
The enrollment of the first patient in the multicenter trial follows a successful, 64-person study completed at UC San Francisco and the publication of two peer-reviewed papers authored by MindRhythm co-founders Wade Smith, MD, PhD, Chair, Scientific Advisory Board and Paul Lovoi, PhD and CTO, alongside Kevin Keenan, MD, Vascular Neurologist to further demonstrate the efficacy of the HeadPulse measurement within the Harmony headset developed by MindRhythm.
A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model, published in October 2019, explores the cranial accelerometry technique in a cohort of code stroke patients to see whether a signature could be identified to aid in the diagnosis of LVO stroke. The second publication, The Neurological Examination Improves Cranial Accelerometry Large Vessel Occlusion Prediction Accuracy, published in November 2020, combined cranial accelerometry, a device-based approach to LVO prediction, with neurological examination findings to determine if this improves diagnostic accuracy compared to either alone.
MindRhythm, founded in 2019 by Keane, Smith, and Lovoi, also officially launched today as a medical technology company optimizing stroke triage in the prehospital and hospital settings. MindRhythm’s Harmony device is a novel, non-invasive, diagnostic medical device that can rapidly identify patients with LVO strokes via monitoring of a specific physiology discovered by UCSF and MindRhythm. Patients who use MindRhythm’s device can benefit from rapid transport to a Comprehensive Stroke Center (CSC) that has the physicians, technologists and equipment needed to remove the clot. MindRhythm’s finely-tuned, proprietary technology effectively triages patients, communicates patient data, and provides remote location status to hospital teams prior to arrival thus optimizing patient treatment and outcomes.