Periodic Reporting for period 1 - ClearRing (An innovative, minimally invasive medical device used for treatment of Benign Prostatic Hyperplasia symptoms)
Reporting period: 2019-08-01 to 2020-10-31
The key objective of development is to validate the ClearRing safety and efficacy for BPH treatment through a multi-centre clinical trial, leading to the CE Mark certification and reimbursement authorisation. This large scale clinical validation will enable to obtain the scientific and clinical support from KOLs and Urology Leading Associations to recommend ClearRing as a standard-of-care treatment for benign prostatic hyperplasia-related lower urinary tract symptoms. The clinical and economic evidences from the clinical trial will enable ProArc to gradually apply for the reimbursement authorisation in target countries.