PMD Solutions Supports RSRT's Biosensor VIBRANT Study for Rett Syndrome with Donation of FDA-cleared RespiraSense Devices and Analytics
Trumbull, CT - PMD Solutions, a leading provider of innovative healthcare technologies, is proud to announce its partnership with the Rett Syndrome Research Trust (RSRT) in their upcoming biosensor validation study called VIBRANT. PMD Solutions will generously donate their state-of-the-art RespiraSense devices and advanced analytics to support RSRT's efforts in assessing autonomic dysfunction in individuals with Rett syndrome, utilizing cutting-edge digital technologies.
Rett syndrome is a rare neurodevelopmental disorder that primarily affects girls, causing severe impairments. Autonomic dysfunction is a significant challenge faced by individuals with Rett syndrome, impacting their breathing patterns, heart rate variability, sleep, and overall health. RSRT's VIBRANT study aims to validate novel solutions to monitor autonomic dysfunction using innovative digital technologies. The ultimate goal of RSRT’s biosensor development program is to develop direct and objective measures of symptoms that support and expedite the clinical development of curative therapeutics.
PMD Solutions' RespiraSense devices are highly advanced wearable sensors designed to objectively monitor and analyze respiratory patterns. These FDA-cleared non-intrusive and user-friendly devices provide real-time data on respiratory rate, tidal volume, and other important parameters. The integration of RespiraSense devices with PMD Solutions' cutting-edge analytics offers a comprehensive solution for tracking and analyzing breathing parameters in Rett syndrome patients.
By donating RespiraSense devices and analytics for RSRT's biosensor validation study, PMD Solutions will contribute significantly to the advancement of RSRT's mission to cure Rett syndrome. "We are thrilled to partner with the Rett Syndrome Research Trust in their innovative VIBRANT study," said Myles Murray, Founder and CEO at PMD Solutions. "At PMD Solutions, we are committed to leveraging our technological expertise to improve healthcare outcomes. By providing our RespiraSense devices and analytics, we aim to advance RSRT's research efforts, enhance their understanding of autonomic dysfunction in Rett syndrome, and support faster development of a cure for Rett syndrome."
RSRT's Chief Scientific Officer, Jana von Hehn, PhD, who will oversee the study is coordinating the use of several innovative devices to maximize the impact of the study. "We are thrilled that PMD Solutions will contribute in such a meaningful and selfless way, said Dr. von Hehn. "PMD Solutions is dedicated to serving patients and we are excited to align on this mission for Rett."
In addition to PMD Solutions, Emerald Innovations is supporting the study with their “invisibles” sensor technology. The Emerald sensor gathers data without body contact, relying on radio signals in the home for continuous monitoring, and utilizes artificial intelligence (AI) to assess and characterize sleep, breathing, and movement for individuals with Rett. VivoSense, Inc who has assisted RSRT to define breathing abnormalities and deduce breathing from ECG signals is also involved. The lab of Gari Clifford, DPhil, at Emory University and the Georgia Institute of Technology, who are experts in biomedical informatics, have assessed breathing and heart rate variability in prior studies and have linked Rett disease severity to unusual deceleration capacity, will continue to collaborate on this study. The PMD Solutions team is testing the FDA-cleared RespiraSense breathing patch for the first time in Rett and will expand their use case. The Vivalink team who is providing the FDA-cleared Multi-Vital ECG patch and Viatom Kids O2 pulse oximeter ring to target heart rate parameters and oxygen saturation as autonomic symptoms in addition to breathing, will round out the collaboration.
Data generated from the study’s attended in-lab overnight polysomnogram, serving as the gold standard comparator for all devices, will assist PMD Solutions' expansion of RespiraSense to pediatric populations and at-home use. This significant collaboration showcases the dedication of PMD Solutions and RSRT to advance cutting-edge research. The collective expertise of PMD Solutions, RSRT, Emerald Innovations, The Clifford lab, VivoSense, and Vivalink, promises to unlock new insights into autonomic dysfunction, paving the way for improved measurement of Rett symptoms in therapeutic development, and expediting a cure for Rett.
About PMD Solutions
PMD Device Solutions AB develops and sells medical products for respiratory monitoring in both the hospital and homecare setting. Its primary product is RespiraSense, a solution used for monitoring respiratory rate to detect deterioration of a patient’s general condition early and to avoid preventable respiratory failure and adverse patient outcomes. RespiraSense is, to the Company’s knowledge, the world’s only continuous, motion-tolerant respiratory rate monitor delivering class-leading reliability in measuring respiratory rate. RespiraSense is a novel technology that is commercialized in Europe, the UK, and FDA cleared in the US. For additional information please visit www.pmd-solutions.com
About Emerald Innovations, Inc.
Emerald Innovations is a health analytics company that specializes in digital health solutions for
passive, contactless in-home monitoring. Emerald seamlessly captures continuous health data
from patients as they go about their normal lives. The Emerald DHT sensors fall under a cutting-
edge category known as Invisibles. Installed in the homes of study participants, these sensors continuously analyze surrounding radio signals. Using artificial intelligence, they extract patient physiological data while prioritizing their privacy. Emerald simplifies clinical trials for its clients by obtaining statistically significant biomarkers, making them readily available to clinicians and data analysts, and consistently providing updates on the progress of clinical trials. Emerald’s clientele encompasses big pharma, Fortune 500 pharmaceutical firms, innovative biotech companies, and leading disease research foundations. For further details, please visit www.emeraldinno.com
About Rett Syndrome Research Trust
RSRT is the patient advocacy organization working to cure Rett syndrome. As the largest funder of Rett syndrome research worldwide, RSRT has played a vital role in initiating and evolving the trajectory of progress toward a cure. All genetic therapies in development by biopharmaceutical companies have leveraged discoveries and resources made possible by RSRT. Learn more at reverserett.org.
About Rett Syndrome
Rett syndrome is a genetic childhood neurological disorder caused by random mutations of the MECP2 gene on the X chromosome. The disorder affects predominantly girls but can rarely also affect boys. Symptoms typically become apparent between the ages of 12 to 18 months. Rett syndrome is devastating as it deprives toddlers of speech, hand use, and normal movement often including the ability to walk. As childhood progresses the disorder brings anxiety, seizures, tremors, breathing difficulties, and severe gastrointestinal issues. While their bodies suffer, it is believed that their cognitive abilities remain largely intact. Although most children survive to adulthood, they require total round- the-clock care.
