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

ended

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 200 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 system. The ClearRing solution is the only minimally invasive system for BPH which is implantable inside the prostate with 0% chance of migration or encrustation. It puts ProArc in a unique position as a first company providing significantly improved health conditions and quality of life. 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. The minimally invasive procedure reduces 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 preservers sexual function. 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. Whereas, the key objective of the project is to validate the ClearRing safety and efficacy for BPH treatment through a randomized clinical trial at 3 medical centres. This large scale clinical validation will enable ProArc to obtain the CE mark, and gradually apply for the reimbursement authorisation.