Incontinence Valve System (IVS) for treating patients with stress urinary incontinence

Urinary incontinence (UI) is a disfunction that implies involuntary leakage of urine, which unfortunately is a common problem, affecting >450M people worldwide. Patients also experience a severely reduced quality of life, which often leads to depression. Stress Urinary Incontinence (SUI) is when urine leaks out with sudden pressure, and is the most prevalent subtype of UI. Besides age, other risk factors for SUI are surgical procedures: e.g., 40% of prostate cancer patients undergo radical prostatectomy which causes persistent SUI in 10% of the cases. Today the efficacy of UI treatment correlates to the risk and invasiveness of the urinary incontinence solution. The invasive extra urethral products (like the commonly used artificial sphincter AMS 800) have high risk of complications (associated with a demanding surgical intervention) and bear the risk of sequelae for the rest of patient’s life, while pharmacological treatments, or the conservative low risk solutions such as the use of diapers are ineffective. Bio Medical Device (BMD) – a Norwegian MedTech SME – is now developing a patient-friendly and effective solution - the Incontinence Valve System (IVS) - to address the widespread SUI problem. Our custom-designed valve technology gives these patients a surgery-free and remotely controlled device, allowing them to control employing and closing the urine bladder with an inserted valve in urethra. The main barriers for BMD going forward are related to prevailing technical and market-related challenges. The EIC Accelerator project will enable performing the final maturation of the solution, ensuring user functionality and safety targets, securing regulatory requirements, performing initial clinical studies, and creating marketing awareness around the IVS technology. The EIC Acc. provides a unique opportunity for us to showcase the potential of our innovation and gain market intelligence.