MindRhythm Completes Enrollment in its Multicenter Prehospital Trial for Identifying Large Vessel Occlusion Stroke

December 04, 2023 11:09 AM EST | By EIN Presswire
Follow us on Google News:
CUPERTINO, CALIFORNIA, UNITED STATES, December 4, 2023 /EINPresswire.com/ -- MindRhythm Incorporated, a neurodiagnostic technology company based out of Cupertino, California, today announced that it reached the number of patients required to complete enrollment in its pivotal stroke trial-EPISODE. This trial was designed to validate that MindRhythm’s Harmony can accurately identify LVO stroke prehospital, with the goal of improving triage decisions. Better quality information will help EMS teams ensure a critical patient is transported to a hospital equipped with the necessary treatment resources. Proper triage can be the the difference between life, death, and debilitation.

EPISODE-hEadpulse for Ischemic StrOke DEtection Prehospital, is a large, EMS based study that included 6 states, 17 hospitals, and 14 EMS facilities participating in research resulting in EPISODE being the largest study of a prehospital stroke identification device. Primary Investigator James Paxton, MD from Wayne State Medical in Detroit, Michigan leads the research with the support of 18 subinvestigators throughout the country. The broad participation in the research provides a demographic representation of the diverse population that will benefit from the Harmony stroke identification technology.

Current practice for identifying stroke, in the absence of brain imaging, is based on presentation of symptoms seen during the event. These symptoms are common in many other clinical scenarios as well, confounding stroke assessment, making the subjective process difficult to perform. Adding a technology that can objectively determine the presence of large vessel occlusion strokes has the potential to significantly improve immediate detection and direct transport to the appropriate facility. This benefit, is the purpose of the EPISODE study.

EPISODE was composed of two parts. The first, was designed to test the hypothesis that the device can identify LVO stroke with a sensitivity and specificity noninferior to a commonly used stroke scale: LAMS (Los Angeles Motor Scale). Part 1 also focused on collecting user feedback from the field to iterate the physical design of the device to match user needs for integration into standard workflows reducing barriers to adoption. The released results of phase 1 significantly proved the initial hypothesis. A blinded part 2 was designed to replicate the results of part 1 while powered for superiority to stroke scales in preparation for FDA clearance. The data for part 2 is currently being unblinded and analyzed, but there is confidence that its goals will be met. While any stroke can be debilitating, LVO is the most debilitating and often fatal type of stroke. MindRhythm’s technology is designed to improve outcomes for patients by ensuring that at the start of care, the best treatment decision for the patient is made.

MindRhythm was granted a Breakthrough Device Designation by the FDA as a result of the part 1 data from EPISODE and will use the combined data sets from part 1 and 2 to submit for clearance with commercialization to follow.

About the Harmony Headset
Harmony is a novel, noninvasive medical device designed to aid in the rapid identification of Large Vessel Occlusion (LVO) strokes, the most debilitating of all stroke types. Harmony monitors a newly discovered physiology MindRhythm calls the “HeadPulse”. The HeadPulse is measured by applying a highly sophisticated sensor to the patient’s head, measuring minute pulsations produced by each heartbeat. The HeadPulse changes dramatically during LVO strokes, which is read by Harmony. Coupling the Harmony results with a simple clinical examination of stroke, the device can discriminate LVO strokes among stroke patients in a matter of seconds.

About MindRhythm
MindRhythm is a medical technology company focused on preventing neurological injury. Founded by world-renowned scientific experts with significant commercialization success, MindRhythm’s monitoring technologies provide real-time visibility to life-threatening situations at home, prehospital, in the operating room, and on the field. MindRhythm’s technologies allow clinicians to intervene, optimize and manage care to prevent brain damage. Collaborating with the healthcare community, MindRhythm looks to apply a systematic approach to reducing time to treatment in strokes and monitor neurological health during recovery from injury. Together, let’s save lives and improve the quality of life: https://mindrhythm.com

Beth Johnson
MindRhythm Incorporated
+1 860-836-8630
[email protected]
Visit us on social media:


The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (Kalkine Media, we or us), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.

Top ASX Listed Companies

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK