MindRhythm launches multicenter clinical trial to research stroke triage

MindRhythm, a new stroke-triage company launching today, has announced the beginning of its multicenter clinical trial to test the effectiveness of its stroke-detecting technology.

The study is being conducted by Wayne State University in partnership with Detroit Receiving Hospital, Henry Ford Hospital, Sinai-Grace Hospital and Ascension St. John Hospital. It will research MindRhythm’s flagship product, Harmony, in helping emergency responders detect Large Vessel Occlusion (LVO) strokes in order to triage patients to a hospital that can treat them.

“We are incredibly excited to now be enrolling patients in the MindRhythm trial,” Dr. James Paxton, a research director at Wayne State University, said in a statement.

“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.”

The Harmony device is a sensor-equipped headband designed to be used by emergency medical technicians. It can detect changes in brain vibrations, an indicator of LVO strokes, according to MindRhythm. Once EMTs get the diagnostic results, they can transport patients to the appropriate care location, all while sending GPS location updates and patient data to the hospital with Harmony.

WHY IT MATTERS

More than 795,000 people in the U.S. have a stroke every year and roughly 150,000 of those result in death, making it the fifth leading cause of death, according to the Centers for Disease Control and Prevention.

Most are ischemic strokes, where blood flow to the brain is blocked. LVO strokes are a particularly dangerous form of ischemic stroke due to a lack of prehospital diagnostic tools, and because only certain hospitals have the necessary equipment to treat them, according to Stroke.

These treatment deficits can result in delayed care. LVO strokes are therefore even more threatening, because timely medical care is vital for minimizing the long-term effects of stroke. Timely care could even prevent death, according to the American Stroke Association.

“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,” John Keane, president and CEO of MindRhythm, said in a statement. “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 LARGER TREND

Several other companies have clinical decision support tools for strokes. Viz.ai, a care-coordination company that uses AI to detect strokes, recently scored $71 million in a Series C round. Last summer, RapidAI received FDA clearance for its Rapid ASPECTS neuroimaging analysis device that searches for early signs of brain infarction.

The Israeli stroke recovery treatment company BrainIQ recently received FDA Breakthrough Device Designation for its system. The company uses AI to deliver electromagnetic field therapy to stroke patients through a wearable device.