Manchester, UK June 28, 2021 – NEPeSMO Ltd, a pioneer in self-monitoring solutions for the prediction of exacerbation in patients with chronic lung diseases is pleased to announce that the Federal Food and Drug Administration (FDA) have accepted for review the de novo regulatory application for COPDPredict™ that was submitted by the Company on June 9th, 2021.
The review clock has now started, with the initial FDA feedback anticipated within 60 days of acceptance for review.
Trevor Phillips, Executive Chairman, commented “This is an important milestone for NEPeSMO. As we embark on the process of commercial roll out of COPDPredict™ in the UK, the filing with FDA opens the possibility of a subsequent approval and commercial launch in the US, which represents a significant market opportunity for NEPeSMO”
About COPDPredict™:COPDPredict™ automatically creates unique personalised bio-clinical profiles from a combination of simple, routinely collected patient-reported symptoms, physiological and biomarker tests. From this data, proprietary exacerbation prediction algorithms identify changes in COPD health status, alerting patients and their clinicians of an impending exacerbation.Unlike other digital health trackers and adherence monitors, COPDPredict™ gives patients and clinicians the opportunity to adjust treatment promptly and prevent hospitalisations. Patients experience an improved quality of life and payors benefit from reduced COPD management costs.
Contacts:For further information please contact Trevor Phillips, Executive Chairman (trevor.phillips@139.59.182.125).