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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ClearRing (An innovative, minimally invasive medical device used for treatment of Benign Prostatic Hyperplasia symptoms.)

Teaser

Summary

Overall objective of ProArc is to introduce a 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 randomized a clinical trial at 4-5 Medical Centres in up 4 target countries, 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

Throughout the duration of the project, ProArc reviewed in more detail the current stage of the ClearRing technology and defined a sound development plan based on the remaining activities for ClearRing commercialisation. The scope of the clinical validation was defined, including the size, locations, objectives and participants. ProArc defined the commercialisation strategy and decided to commercialise initially without reimbursement by selling to private medical centres and early adopters physicians. A large available market was identified for ClearRing. The Phase 1 feasibility assessment has clearly shown that the ClearRing development plan is technically and commercially viable, and that the implementation of the commercialisation plan should be pursued. SME Instrument Phase 2 funding could provide the necessary amount of funding to complete the activities required to advance toward the market launch of the ClearRing solution around Europe.

Final results

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.