• The NordDEC digital health evaluation criteria help differentiate and create visibility for high-quality evidence-based Digital Therapeutics (DTx), relative to so-called 'health apps', which do not have evidence or live up to high-quality standards.
• Standardized digital health frameworks like NordDEC make it easier for Digital Therapeutics companies like Brain+ to scale across the Nordics and other markets.
• In the Nordic countries, half a million people suffer from dementia disease or mild cognitive impairment, the target disease areas for Brain+.

Kim Baden-Kristensen, CEO & Co-founder:" We welcome the NordDEC initiative, as it will mean that we will be able to scale much more smoothly across not only the Nordics, but also across other geographies because the NordDEC criteria sets a high-quality bar. I hope and foresee that an initiative like the NordDEC is a first step towards national and regional Nordic reimbursement pathways as well. This is a great step for digital therapeutics in the Nordics."

NordDEC will create trust among medical professionals to prescribe Digital Therapeutics

In several ways, the DTx market has been emerging in Europe since its inception in the US in 2017 (with the founding of the Digital Therapeutics Alliance). In the same period 350,000 unregulated health apps have been launched into what has been termed the 'wild west' of health apps, often with unsubstantiated claims, limited credentials, and rarely with any clinical evidence. Hence, there is an urgent need for new standards to carve out serious and proven technologies validated by clinical evidence and living up to the highest safety and quality standards.

The Nordic region aims to be the most integrated health region in the world by 2030, according to the Nordic Council of Ministers. A shift towards digital health, and its focus on the self-management of health by Nordic populations, will be an important step on this journey, but it also brings new risks. Despite the 350,000 digital health technologies on the market, no standardized regulation or risk management system is in place in any of the Nordic countries. This has left medical professionals unable to find and prescribe digital technologies safely. NordDEC will be an extremely robust digital health assurance system, testing products against more than 500 measures across data and technical security, clinical assurance and usability (NordDEC.org).

Watch the CEO, Kim, and CTO, Paula of Brain+ discuss what this means for Brain+: https://vimeo.com/729092696  (2 minutes)

NordDEC program

On NordDEC from key stakeholders

NIP's (Nordic Interoperability Project) CEO, Anders Tunold-Hanssen, said: "The Nordics is home to a vibrant and growing health tech industry. This programme provides suppliers with an attractive platform to reach the whole of the Nordics healthcare system, breaking down current barriers to market access. The next stage will be the creation of a digital library for the Nordics, containing thousands of top-quality apps which healthcare professionals can use safely and confidently." (NordDEC.org)

Founding CEO of ORCHA, Liz Ashall-Payne, said: "This has been a landmark project for ORCHA and all the countries involved and the learning can be rolled out across other geographical regions. It also gives suppliers a good springboard to easily meet the requirements to enter other geographies, such as the UK, Netherlands, Canada and the US."(NordDEC.org)

Read more: https://norddec.org/2022/06/15/the-worlds-first-cross-border-digital-health-accreditation-system-to-be-launched-at-himms-europe/

Dementia in the Nordics

The number of people with dementia in the Nordic region is expected to increase sharply, now that the large number of people born in the 1940s are reaching old age, and it is estimated that the incidence of dementia will have doubled by 2050. (Nordic Dementia Network)

Read more: https://nordicwelfare.org/en/welfare-policy/nordic-dementia-network/

About BRAIN+ [BRAINP]

Brain+ is a pioneer of Digital Therapeutics for dementia and Alzheimer's disease, including disease stages of prodromal/mild cognitive impairment, and pre-clinical/subjective cognitive impairments.

PROBLEM:

Dementia is a terrible condition, crippling a person's independence and putting a heavy burden also on the family. This puts an enormous emotional burden on the patients and their loved ones. As cognitive abilities deteriorate, behaviors change, and independence is lost. The complexity of the underlying pathology of dementia has so far made it hard for traditional pharmaceutical companies to deliver effective treatments, and there is an increasing focus on new non-drug therapies that can pave the way to help relieve the heavy burden of dementia - for people living with the disease, their relatives and healthcare systems. With an aging population, dementia - and in particular Alzheimer's dementia - is a growing problem, threatening to overwhelm the health care systems of the world.

PURPOSE:

Making effective dementia treatment and prevention available to everyone in need, as digital therapeutics (also called as `Software-as-medicine').

CLINICAL TARGETS

To slow cognitive decline, maintain functional abilities, preserve independence, and add more healthy years for people living with dementia; additionally, to prevent progression into dementia for people-at-risk of dementia.

SOLUTION:

Together with world-leading experts and institutions, we are digitizing the best-in-class, non-drug dementia therapies, making them available on regular digital devices - both in people's homes and at the clinics. A therapy here, simply means a person having to actively do something, interacting with a software program or another person, which is stimulating to the brain, or which results in changes in behavior that brings measurable health benefits. Our digital therapeutic solutions also benefit the patient caregivers in their work and can help ease the pressure on the health care systems.

DIGITAL & DRUGS:

Software-as-medical treatments can be used on their own or be combined with traditional drug treatments. We believe the future will combine the best of both the digital and the pharmacological world for mutually enhancing benefits, including synergies in compliance, patient engagement, and mechanisms of action for better health outcomes.

PERSONALIZED, DATA-DRIVEN MEDICINE:

We believe a key benefit of digital medicine is also to proactively collect and use data to create tailored and more effective personalized therapy experiences, and to help improve clinical and scientific practice, while always adhering to strict ethical standards of personal data protection.

OUR DNA:

We are a digital biotech company. Our technologies and products are being built on a deep understanding of the challenges and needs associated with dementia, rigorously tested, scientifically and clinically validated, and regulated as software-as-medical-devices (software-as-treatments). These treatments will be prescribed by health care professionals and paid for by health insurance or state health care.

PRODUCTS & TECH:

• Cognitive Stimulation Therapy is a dementia therapy that treats the main symptoms of dementia. This technology is the basis of the first dementia treatment product, `Cognitive Stimulation Therapy - Therapist Companion, which will be launched in Denmark and Germany in 2023. A second product, called `Cognitive Stimulation Therapy - Home Extension, is planned next.
• Computerized Cognitive Training is essentially like fitness exercises for the brain. A 2[nd] generation of this technology is currently being developed for use in the pre-stages of dementia, like mild cognitive impairment, or in people who are in high-risk groups for developing dementia.
• Starry Night Test is a special memory test, which was originally developed by Professor Masud Husain at Oxford University, and then further co-developed, gamified, and made scalable with Brain+, with the aim of doing early detection of Alzheimer's disease and monitoring of disease progression.

CLINICAL PIPELINE:

Brain+ is expecting results from 5 Pilot and Proof of Concept (PoC) studies in H2 2022 on the 3 core technologies, and 1 additional study in 2023. 4 trials (1 Pilot, 3 PoC) have been successfully concluded as of February 2022, with positive results for all three technologies.

POTENTIAL:

Currently, 50 million people are diagnosed with dementia globally, and this number is expected to triple to more than 150 million people by 2050. In the US, 1 in 3 seniors dies with or of dementia.

 In 2030, the global costs of dementia are expected to be $2 trillion (or equal to 2/3rds of the entire health care budget of the USA), prospectively 1 in 3 people will die from dementia and the estimated market potential for digital dementia treatments approximately $2-5 billion. Tapping into this market with effective digital solutions has the potential to generate revenue of hundreds of millions $. Brain+ aims to commercialize its products based on licensing deals with strategic commercial partners for faster market penetration and global scaling.

TEAM:

We have built our knowledge base, know-how, and network of global expert collaborators over 10 years, and our technology portfolio is the results of R&D investments of over €10 million, which puts us in a unique position to become a global market leader in digital therapeutic solutions for dementia and Alzheimer's. We have a senior management team with a combined 100 years of track-record, with backgrounds from companies such as Coloplast, Lundbeck, Novartis, and GN Hearing. This provides us the solid backbone needed, to change the way we treat and deal with dementia on a global scale.

PARTNERS & COLLABORATORS:

We believe collaborations give the best outcomes, and so we partner with the best minds and hearts in our eco-system; pharmaceutical leaders in Alzheimer's, such as Biogen and Rox Health, a subsidiary of Roche Germany; academic & clinical partners, such as universities of Oxford, Nottingham, Aarhus, Gothenburg; patient organizations and NGOs, such as Alzheimer Europe, Alzheimer's disease international, and the European Brain Council.