Soturi, Newel Health’s Digital Solution for Parkinson’s Disease concluded the patient participation phase of a study to assess Soturi’s potential to collect Real World Data for improving Parkinson’s disease management.
PRESS RELEASE | Italy, Salerno, October 14, 2024 – Newel Health, a leading software medical devices solution provider, is pleased to announce the completion of the Last Patient Last Visit (LPLV). for Soturi, a Digital Therapeutic solution for Parkinson’s disease management.
Following the successful initiation of the NWL-SOT-CS-001 study, announced earlier this year, Newel Health is thrilled to report the completion of the Last Patient Last Visit (LPLV). This pivotal moment concludes patient participation in the study, which aimed to assess the potential of using proprietary digital health technology to collect Real World Data for improving Parkinson’s disease management.
Study Overview
Funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and conducted in collaboration with three clinical centers in Italy [AOU San Giovanni di Dio e Ruggi d’Aragona, Salerno, Italy (PI: Prof. Maria Teresa Pellecchia), IRCCS San Raffaele Pisana, Rome, Italy (PI: Prof. Fabrizio Stocchi), IRCCS Fondazione Santa Lucia, Rome, Italy (PI, Dr. Clelia Pellicano)], this pilot study enrolled over 50 patients, all successfully completing the 6-month study period. Participants were closely monitored through the innovative Soturi Mobile App, which allowed for continuous data collection on various aspects of their treatment and daily experiences.
Thanks to Soturi’s advanced digital health tools, Newel Health was able to gather [28000] hours of sensor data through a wearable sensor, 1600 patient-reported outcomes about symptoms, as well as [18000] unique data points on medication adherence. The platform facilitated real-time tracking of symptoms, treatments, and patient feedback, offering a comprehensive dataset to inform future treatment strategies.
Why This Study Is Important
Parkinson’s disease is a progressive neurodegenerative disorder affecting millions worldwide, with no cure and limited treatment options. By leveraging the power of digital health this study offers a novel approach to improving care by integrating real-world data and pharmacological models to individualize and optimize medication therapy. The results will inform new strategies for personalized Parkinson’s disease management, support tools for the treating clinicians, aiming to enhance quality of life for patients. These findings will now undergo detailed analysis as Newel Health prepares to present the full study results, expected in Q1 2025.
“The completion of the Last Patient Last Visit in this study phase marks an important milestone for our Parkinson’s Program Soturi,” said Ervin Ukaj, CEO of Newel Health. Thanks to the study we have gathered critical data that will guide the next steps in our program. As we await the final readout, we remain focused on our ultimate goal: achieving automatic dose management for levodopa, which has the potential to revolutionize personalized treatment for Parkinson’s patients.”
“This pilot study has demonstrated the feasibility of using digital technologies for self-management and remote monitoring in advanced Parkinson’s disease,” said Giovanni Gentile, Clinical Trial Manager at Newel Health. “By employing a naturalistic study design, we’ve collected valuable data on levodopa response, including ON-OFF fluctuations and dyskinesia. This information is crucial for developing digital biomarkers to understand individual treatment responses. As we proceed with data analysis, expected to conclude in Q1 2025, we anticipate that our findings will contribute to advancements in personalized care for Parkinson’s patients.”
Collaborations and Acknowledgments
Newel Health conducted this study with funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) under the Grant ID MJFF-022711. Their funding and collaboration have been instrumental in advancing this important research.
The NWL-SOT-CS-001 study represents an exciting step toward a future where digital health technology play a central role in Parkinson’s disease care, combining real-world data with innovative treatment approaches, supported by algorithms and advanced pharmacological models to individualize treatments.
For more information about the clinical trial, please visit the official ClinicalTrials.gov record: https://clinicaltrials.gov/study/NCT05904288
About Newel Health
Newel Health is a pioneering digital health company at the forefront of chronic disease management. The company develops innovative Software as a Medical Device (SaMD) solutions that leverage advanced behavioral science and data analytics to transform patient care and empower lives.
The company’s product portfolio includes Amicomed, a CE Class IIa certified solution for hypertension management; Rohkea, a VR-based therapy for chronic pain management; and Soturi, an advanced platform for Parkinson’s disease management currently in development. These solutions target key therapeutic areas including cardio-metabolic, neuroscience, and pain management.
At the heart of Newel Health’s technology is H.Core, a proprietary framework that accelerates the development of compliant, feature-rich digital therapeutics. This platform enables the company to rapidly deploy personalized, patient-centric solutions across various chronic conditions.
Strategic partnerships are central to Newel Health’s approach, with collaborations like its work with Orion Pharma enhancing the company’s ability to innovate and expand its reach. Newel Health’s team of experts combines deep expertise in digital health, behavioral science, and data analytics with extensive experience in the life sciences industry.
Newel Health is committed to advancing the field of digital therapeutics through continuous innovation and clinical validation. As the company expands into key markets across Europe and prepares for future growth in the US and emerging markets, it remains focused on its mission: to provide the right support at the right time for everyone managing a chronic condition.
Contact Information
For more information, please visit newel.health and follow us on LinkedIn and Twitter
