An innovative, minimally invasive medical device used for treatment of Benign Prostatic Hyperplasia symptoms

Project Information

ClearRing

Grant agreement ID: 872707

DOI

10.3030/872707

Project closed

EC signature date 16 September 2019

Start date 1 August 2019

End date 31 January 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 776 750,00

EU contribution

€ 1 943 725,00

Coordinated by

PROARC MEDICAL LTD
Israel

Periodic Reporting for period 2 - ClearRing (An innovative, minimally invasive medical device used for treatment of Benign Prostatic Hyperplasia symptoms)

Reporting period: 2020-11-01 to 2022-01-31

Summary of the context and overall objectives of the project

The overall objective of ProArc is to introduce a benign prostatic hyperplasia (BPH) treatment which is effective, affordable and with no side-effects, therefore men seek for the treatment instead of watchful waiting for the worsening.
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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Within the first reporting period, ProArc optimised the ClearRing implant and delivery system. The implant was reshaped for improved safety and efficacy; and an electronic delivery system was implemented. Clinical preparation is underway with Ethics documents submitted in several locations. The clinical protocol has been fully defined and first surgeries are expected in early 2021.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Benign Prostatic Hyperplasia (BPH), or prostate enlargement, is one of the most common urological diseases among men. As the prostate enlarges with the age, it presses on and blocks the urethra, causing bothersome urinary symptoms. Over 70% of men in their 60s have symptoms of BPH 1, and 80-90% of men over 80-year-old. BPH affects around 550 million men worldwide. The current methods present a significant unmet need for minimally invasive or less invasive BPH therapy as a less costly, more tolerable, and comparatively safe alternative to drugs and invasive surgery, which carry greater risk of undesirable side effects and complications. ClearRing is a revolutionary treatment of BPH symptoms, based on a pre-shaped implant and a dedicated delivery device. Its rapid procedure enables hospitals to get patients in and out more quickly, creating a better patient experience as well as a more efficient management of medical resources. Moreover, the ClearRing solution allows physicians to provide an outpatient clinical service, minimizing pressure on hospitals and enabling them to focus on the severe cases. The minimally invasive procedure will reduce the range and severity of side effects allowing patients to resume their normal lifestyles potentially twice as fast as the current standard operation procedure. Furthermore, it preserves sexual function of patients with a significant impact on the quality of life.

ClearRing implant