MindRhythm, a US medical technology company focused on preventing neurological injury in stroke, has announced the enrolment of the first patient in a multicentre trial. Through this trial, MindRhythm intends to demonstrate the effectiveness of its proprietary Harmony technology in rapidly identifying patients with large vessel occlusion (LVO) strokes, at the prehospital stage, for direct dispatch to a Comprehensive Stroke Center (CSC) hospital.
The trial will take place out of Wayne State University (Los Altos, USA), and is also being conducted in partnership with Detroit Receiving Hospital, Henry Ford Hospital, Sinai-Grace Hospital, and Ascension St John Hospital.
The enrolment of the first patient in the trial follows a successful, 64-person study completed at University of California San Francisco (UCSF), and the publication of two peer-reviewed papers authored by MindRhythm co-founders Wade Smith and Paul Lovoi, alongside vascular neurologist Kevin Keenan, to further demonstrate the efficacy of the HeadPulse measurement within the company’s Harmony headset.
“We are incredibly excited to now be enrolling patients in the MindRhythm trial,” said James Paxton, an assistant professor in Wayne State University’s School of Medicine. “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 multicentre clinical trial, to help reduce the severity of neurological injury caused by LVO strokes.”
According to a press release from MindRhythm, stroke is the fifth leading cause of death in the USA, with LVO stroke being its most lethal form, but there is currently no technology available to objectively diagnose LVO stroke in an emergency medical service (EMS) setting—often leading to delays in treatment. The company also claims relatively few hospitals in the USA 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.
“With this multicentre 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 MindRhythm co-founder, CEO and president John Keane. “We are proud to be working with some of the brightest minds in medicine to help solve one of medicine’s most critical problems.”
Having been founded in 2019 by Keane, Smith, and Lovoi, MindRhythm is now officially launching as a medical technology company optimising stroke triage in the prehospital and hospital settings as well. Its Harmony headset 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 itself.
MindRhythm has also stated that patients who use the Harmony device can benefit from rapid transport to a CSC that has the physicians, technologists and equipment needed to remove their stroke-causing blood clot. The company’s proprietary technology is designed to effectively triage patients, communicate patient data, and provide remote location status to hospital teams prior to arrival, optimising patient treatment and outcomes in the process.