Addition of renowned Detroit-based healthcare organization increases trial enrollment and improves data accuracy

LOS ALTOS, CA – July 29, 2021 – MindRhythm, a medical technology company focused on preventing neurological injury in stroke, today announced the expansion of its multicenter trial to Detroit-based Henry Ford Hospital, the flagship hospital of Henry Ford Health System. The trial – based out of Wayne State University and in partnership with Detroit Receiving Hospital, Sinai-Grace Hospital, and Ascension St. John Hospital – started enrolling in April and now has active enrollees at Henry Ford Hospital. 

The intention of the trial is to demonstrate the effectiveness of MindRhythm’s proprietary technology, the Harmony device, 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. The Harmony will also be equipped to identify small vessel stroke types and stroke mimics to ensure that appropriate triage and administration of appropriate treatment will occur efficiently. As MindRhythm prepares the Harmony device for FDA submission, the additional site at Henry Ford Hospital helps strengthen trial results through increased enrollment, improved data accuracy, and clearer results.

“Henry Ford Hospital is thrilled to announce our first patient to be enrolled in the MindRhythm study,” said Dr. Howard Klausner, Medical Director of EMS and Disaster Medicine, Henry Ford Health System Department of Emergency Medicine. “Henry Ford and our prehospital partners are committed to the improvement of stroke care for all, and by participating in research such as MindRhythm’s study we are striving to improve the health of the citizens of Detroit and all of the communities we serve.”

Stroke is the fifth 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 LVO stroke in an emergency medical services (EMS) setting, often leading to delays in treatment. 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 diagnostic capabilities to determine the type of stroke in their patients with a level of accuracy and specificity that will ensure patients receive optimal care at a facility with the appropriate resources in the fastest way possible. 

“We are thrilled that Henry Ford Hospital has decided to deepen its relationship with MindRhythm and is now an official site of our ongoing trial,” said John Keane, co-founder, president and CEO, MindRhythm. “As we prepare MindRhythm’s Harmony device for FDA submission, the expansion of our trial to Henry Ford Hospital will enhance our knowledge with additional, critical insights.” 

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.

MindRhythm, a medical technology company optimizing stroke triage in the prehospital and hospital settings, was founded by Keane, Smith, and Lovoi in 2019. MindRhythm’s Harmony device in development is a novel, non-invasive, diagnostic medical device that can rapidly identify patients with LVO and small vessel 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 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.

To learn more about MindRhythm, visit: https://mindrhythm.com. 

ABOUT MINDRHYTHM

MindRhythm is a medical technology company focused on preventing neurological injury primarily caused by strokes. Founded by world-renowned experts with significant commercialization experience, MindRhythm’s monitoring devices provide novel and real-time visibility to life-threatening situations prehospital and in the operating room allowing clinicians to intervene and prevent brain damage. Collaborating with the healthcare community, MindRhythm looks to apply the same systematic approach to reducing time to treatment in strokes that has been successfully implemented for heart attacks with the STEMI protocol. Together, let’s save lives and improve quality of life: https://mindrhythm.com.

Photo credit: "Henry Ford Hospital, Detroit, Michigan" (CC BY-SA 2.0) by Ken Lund
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