Startup meets development service provider

Insight in Brief

Digital therapy solutions for Alzheimer’s patients | When developing new medical devices, it is important for startups to realize the products in compliance with regulations, with a short development time and low costs. The more experience the partner has, the more the startup team benefits. The collaboration between Bottneuro and IMT shows that this starting position has advantages for both partners.

Introduction

Alzheimer’s disease (AD) is a progressive neurodegenerative disease that leads to the death of nerve cells in the brain. AD is the most common form of dementia and leads to a continuous decline in cognitive performance. As a result, personality and behavioral changes usually occur. This leads to the loss of one’s independence and ultimately to death by brain failure. To date, Alzheimer’s is incurable and will be one of the greatest challenges of this century due to demographic change. More than 50 million people worldwide are affected – in Europe and the US alone, eight new patients are diagnosed with AD every minute.

The latest design of Bottneuro’s 3D-printed personalized headset for non-invasive brain stimulation (Image: Bottneuro).

Basel-based startup Bottneuro is working on an early and reliable AD diagnostic option, as well as a non-invasive and cost-effective therapeutic approach. This will make AD treatment available to the general population before the onset of cognitive decline. Currently, the diagnosis of AD is usually made only after cognitive impairment has been established. However, pathological changes in the brain can be detected decades earlier. This is where Bottneuro AG, with its vision, comes into play. For the diagnosis of AD, the company plans to set up brain clinics with a new generation of positron emission tomography (PET) scanners to detect the onset of AD at a very early stage – before cognitive decline sets in.

The therapeutic approach for patients in the early and middle stages of AD uses personalized alternating current therapy. It is designed to restore neuronal activity and stop underlying chronic inflammation. The therapy is implemented using an ultralight 3D-printed headset and is painless and side-effect-free. Due to its design, the therapy, which lasts for months, can be performed at home without the help of medical professionals.

Printed Circuit Board (PCB) shoulder piece with integrated electronic für Alzheimer’s therapy (Image: IMT AG)

Treatment of Alzheimer’s disease with digital solutions
The PET data are used to identify the brain areas affected by the disease. This allows optimal electrode positioning for stimulation of specific brain areas and thus personalized stimulation therapy. Personalized treatment of the affected brain areas promises to be highly effective. The patient device consists of a 3D-printed helmet with embedded electrodes and a tablet for simplified operation, including therapy monitoring by healthcare professionals.

The mechanism of action is based on the induction of neuronal activity at defined frequencies in the affected brain regions. The induced oscillations can modulate the activity of the brain’s own immune cells, the microglia, from a neurotoxic to a neuroprotective state and thus stop the chronic, nerve-damaging inflammation. The goal is to slow or even stop the progression of the disease.

Partner from conception to development

When launching a new project, start-ups often wonder what is required to turn their vision into successful products. From the concept phase to the development of the device, Bottneuro works together with IMT Information Management Technology AG. The Buchs (SG)-based company was contracted to develop the electronics, embedded software, tablet-based user interface, cloud-based therapy compliance application, and technical documentation for medical device registration. “IMT is a competent partner for Bottneuro and provides the required know-how for us. They are innovative, reliable, and fast – so the time to market can be significantly accelerated compared to in-house development,” says Dr. Bekim Osmani, CEO and Co-Founder of Bottneuro.

For such complex projects to be successfully implemented, the development partner must bring the necessary expertise to the table. Especially in the field of medical technology, certified processes and the ability to adapt to the customer’s tools are of high importance. This ensures efficient project management and enables development to be successfully implemented with precise documentation – which in turn saves time and costs. Open and proactive communication on the part of development service providers means, that the customer is fully informed at all times and that important decisions can be made quickly.

For the development of the electronics of Bottneuro’s headframe and shoulder section, IMT relies on its experts and agile processes to ensure that ideas can be implemented quickly and efficiently. The development of the hardware and stimulation software was able to take place in parallel thanks to simulations using Matlab Simulink. To simulate the electrical currents delivered to the patient, a model of the head as well as the electronics was created. The generated code from the simulation was tested with the hardware in the next step. Adjustments to the software could easily be made in the simulation since no physical adjustments, such as reconnecting cables, had to be made.

Various eval kits were used to create a board design with the most important functionalities and components so that problems could be identified early and corrected before prototyping. This process results in fewer iterations during development and allows functions to be fully tested before the final product. Consequently, Bottneuro can implement the project faster and begin clinical trials early. Future functions are already taken into account during development and can be implemented quickly later with enhanced software.

More information

On the medical technology start-up and the diagnosis and non-invasive treatment of Alzheimer’s disease in patients: www.bottneuro.ch

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