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BIA-Brukerstyrt innovasjonsarena

IVS-SUI: Incontinence Valve System (IVS) for treating patients with Stress Urinary Incontinence (SUI)

Alternative title: IVS-SUI: Inkontinensventilsystem (IVS) for behandling av pasienter med stressurininkontinens (SUI)

Awarded: NOK 16.0 mill.

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Project Period:

2024 - 2026

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In the ever-evolving landscape of healthcare, Nowwell is about to emerge as a beacon of innovation, making significant strides in the field of stress urinary incontinence (SUI) management. With a steadfast commitment to improving the quality of life (QoL) of individuals facing SUI after prostate removing surgery due to cancer of the prostate, Nowwell is about to introduce a groundbreaking incontinence valve system (IVS) that aims to redefine the standards of comfort and confidence for users. IVS will occupy a unique position in the urinary incontinence market by conferring dryness to patients without surgery. Current solutions for SUI are often ineffective, have side effects and/or do not confer normality in urine voiding. Moreover, male UI is still a “hidden” problem and associated with a sense of shame and loss of dignity. This significantly decreases patients’ QoL impacting physical and mental health and overall society participation. By offering continence while mimicking normal urine voiding, IVS will increase SUI patients QoL to levels before experiencing UI. The device will be inserted through the urethra into the bladder under local anesthesia. Nowwell will offer a non-surgical solution for SUI, that will give the patient an on-demand, patient-controlled urinary continence. Our device will likely also reduce the risk of urinary tract infections (compared to diapers and urinary catheters). This in addition to have a low carbon footprint with an estimated environmental impact of 650x lower than diapers. This at a competitive cost compared to solutions available on the market today. Nowwell’s latest achievement in building an advanced IVS exemplifies its commitment to making a positive impact on the lives of those dealing with urinary incontinence.

Nowwell AS is developing a novel medical device – the Incontinence Valve System (IVS) – offering cost-effectiveness, full patient continence with a strong reimbursement potential. IVS (PCT-patent pending) is a non-surgical, single-use implantable device with a replacement frequency of +6 months. Our first patient indication is males treated for prostate cancer with a Radical Prostatectomy (surgical removal of the prostate gland) suffering from Moderate to Severe Stress Urinary Incontinence (SUI) as a consequence of Treatment. The patient control's his voiding with a personal remote control. After completing Concept de-risking & Verify Innovation (key components and performance), System Architecture Design and development of non-of the shelf components (with prototype series production of these components with Manufactures), we are entering into finalizing Detail Design, Design for Manufacture, Software Design, System integration, First in Man Study (FIM) at Aker Hospital (p=15) and finally Verification/validation of a Clinical Device ready for Pilot Study (p=50 over 6 months). The device will be implanted in the urethra/urine bladder under local anesthesia using a custom-insertion/extraction tool (Fig. 1), in a minimally invasive and quick (<15 min) procedure. Once implanted, the IVS will retain urine in the bladder until the patient triggers the valve to open with a hand-held remote control based on radiofrequency communication (RFC) (Fig. 1). The 1st IVS generation will be replaced every 6 months, and not daily/monthly as diapers or catheters with subsequent generations reducing replacement frequency. The IVS will be the 1st solution to mimic normal physiological voiding, with a urine flow rate of >20ml/sec (normal urine flow), restoring patients’ Quality of Life (QoL). The three innovative functional technologies that needs futher research and clinical evidence are (1) housing and retention, (2) valve actuator and (3) communications, power, and electronics.

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BIA-Brukerstyrt innovasjonsarena