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NANO2021-Nanoteknologi og nye materiale

InSense: A life-changing tool to solve global problems for urinary incontinence

Alternative title: InSense: A life-changing tool to solve global problems for urinary incontinence

Awarded: NOK 17.1 mill.

Project Manager:

Project Number:

309275

Project Period:

2020 - 2024

Partner countries:

Urinary dysfunction affects around 900 million people globally with an estimated cost of 1.4 trillion euros. This problem grows with the aging population and increasing incidents of diabetes and obesity. 80% of patients can be cured or treated with correct diagnosis. Deciding upon the right treatment (medication, assistive devices, rehabilitation, and/or surgery) can be challenging. Life-threatening situations and problems associated with shame, social isolation, and depression can also arise from urinary dysfunction. Urologists have reported that there is an urgent need for better solutions in this field. Bladder pressure measurement is the current standard for evaluating bladder function. This standard is a mere "snapshot" based on the artificial filling of the bladder and results only provide limited understanding of the patient's true bladder function. The new technological solution physicians are claiming for, is the ability to continuously measure bladder pressure under normal physiological conditions and during normal daily routines. InVivo is advancing the field of micro and nanotechnology solutions for direct monitoring of bladder and abdominal pressures. The InSense project aims to find a wireless solution for long-term monitoring of bladder pressure in outpatients. This innovation will improve patients' bladder management and general wellbeing. The stretch goal for this project is to be able to trigger alarms on the patient's smartphone or smartwatch that serves as a warning to empty their bladders. To succeed, InVivo must overcome several challenges: - long-term operation of microsensors in the human body - safety concerns - bespoke software development - clinical feasibility - biocompatibility - wireless powering, and - signal transmission Finally, to produce personalised alarms, the system must be able to understand and autonomously adapt to each patient bladder. InVivo has ongoing relationships with leading institutions in Europe and is partnering with University of Rostock and SINTEF for the InSense project. During 2021, we have had around 20 online meetings with clinical experts in Europe and the USA. The purpose of the meetings was to present the project and to get input on the innovation. Furthermore, we have made progress in the development of the technology towards a robust solution for long-term use. We have also started work on developing new software solutions to produce clinical data in an appropriate way for the end users. Furthermore, we have worked on preparing clinical studies on animals and humans together with our clinical partner. During 20201 InVivo Bionics have been nominated to two prestigious awards prices for startups: InVivo Bionics was nominated as one of the 10ths best Norwegian deep tech startups at the Technoport Conference and was also nominated as one of the 8th most promising MedTech/HealthTech startups in the Nordics (Life Science Battle of the Nordics).

Voiding problems are a global burden that affects an estimated 45% of the global population. Urinary incontinence (UI) alone affects more than 400 million people. The problem is growing with aging population and increasing incidence of diabetes and obesity. UI is associated with shame, social isolation, and depression. There is an urgent need to mitigate or overcome problems related to UI and to reduce the associated health costs expenditure. Bladder pressure is the best indication of bladder function. With the InSense project we aim to develop a wireless device for long-term monitoring of urinary bladder pressure. The core component is a pressure sensor element made by advanced micro- and nanotechnology. The tiny size (< 1 mm wide) allows for placement directly in the bladder and tissue. The device must operate under hostile conditions inside the human body. For bodily contact exceeding 30 days critical factors are: i) long-term operation in the body, ii) wireless powering and iii) wireless signal transmission. To achieve a functional and robust system we must focus on mitigating immunologic reactions and developing a sensor element with long-term stability. Furthermore, current consumption must be minimized through a smart system design. The means for powering and for wireless communication must ensure safe and proper energy and signal transmission. Finally, to get a personalized solution the alarm system must be adapted to each individual urinary bladder. Analysis of collected data will be applied to add precision to the system. An implantable solution for continuous and long-term monitoring of urinary bladder pressure is not available in the market today. The project will create new market opportunities for InVivo Bionics globally, allowing the company to put an early footprint in the market for long-term implants and with a highly scalable business model.

Funding scheme:

NANO2021-Nanoteknologi og nye materiale