Patients will help document treatment efficacy in innovative, decentralised trials project

Patients will help document treatment efficacy in innovative, decentralised trials project

In collaboration with leading researchers and the pharmaceutical industry, the PhaseV innovation project will set new standards for how the effects of treatment can be documented so that patients are offered the right treatment. Patients and healthcare professionals will thus provide data that can help shed light on whether the treatment is working when Monsenso’s digital platform is used to support decentralised trials in the project.

To date, medical treatments have been tested primarily in long-term, randomised clinical trials to determine treatment effects and side-effects, with limited measurement of long-term effects when treatment is provided in clinical practice.

Often, drug trials take 6-15 years before a new drug can be released on the market, and 80 percent of trials fail to recruit and retain a sufficient number of patients in the trials within the set timeframe. This means that the benefits for patients and healthcare systems are often delayed. However, with digital developments, it is possible for clinics, hospitals, and patients alike to play a more active role in documenting the impact of treatments.

The new PhaseV (Phase five) innovation project, in which Innovation Fund Denmark is investing DKK 24 million (of which DKK 8,3 million goes to Monsenso), aims to develop and validate a scalable digital platform for efficient, decentralised patient recruitment, patient data collection and study execution. This is done by engaging patients and clinicians in the monitoring of treatment effects over longer periods of time based on patients’ own feedback, digital biomarkers from smartphones and wearables, as well as registry data.

With this project, we want to show that it is possible to engage and motivate patients and healthcare professionals to collect continuous data from patients over time. PhaseV will set new standards for how the efficacy and safety of new treatments can be documented in a scalable way in the future, so that patients are offered the right treatment“, says Thomas Lethenborg, CEO of Monsenso.

Digitizing the effect of patient treatments can be of decisive importance for our insight into the effects of the treatment of severely overweight people as well as for future clinical studies, where the goal is to make it easier for both patients and healthcare personnel to participate“, says Daniel Vega Møller, Vice President Medical & Science Obesity, NASH and Devices Novo Nordisk A/S.

Country Manager for Novartis in Denmark, Peter Drøidal, also sees great potential in the PhaseV project: “The healthcare system lacks resources and therefore we all need to think in new ways. This project’s combination of public and private partners offers unique opportunities to develop new digital solutions that can help improve patient care and free up personnel time“.

Severe obesity, urticaria and diabetic foot ulcers
The PhaseV project will develop a platform with three apps to collect data on patients with severe obesity, diabetic foot ulcers and urticaria – all of which are costly chronic conditions. For example, annual treatment costs for severe obesity alone are estimated to exceed DKK 15 billion for Danish municipalities and regions.

More than 800,000 Danes live with severe obesity, and associated diseases are very common. As severe obesity causes both direct and indirect costs to society, there is a significant need for good and well-documented weight loss treatments“, says Jens Meldgaard Bruun, clinical professor at Aarhus University and Steno Diabetes Center Aarhus and part of PhaseV.

Urticaria affects 15-20 percent of the population, and in about 1 percent it occurs chronically and causes a severely reduced quality of life.

Thorough monitoring and efficient data collection on symptom development are crucial for correct and effective future treatment“, says Simon Francis Thomsen, Professor and Chief Physician at Bispebjerg Hospital.

22.000 Danes live with diabetic foot ulcers and treatment costs society more than DKK 5 billion annually.

For a patient with diabetes, a foot ulcer can become critical within days, and in exceptional cases amputation may be necessary. Hence, time is of the essence, and we want to prevent serious complications“, says Klaus Kirketerp-Møller, senior physician at Bispebjerg Hospital and Steno Diabetes Center Copenhagen.

The PhaseV project is expected to bring value to patients, regions, and municipalities, as well as to the institutions and companies involved.

Attractive new market opportunity for Monsenso
“We are further developing Monsenso’s digital health platform to improve the support of decentralised trials across chronic conditions, where behaviour and ongoing follow-up play a major role in patients’ quality of life. We see both the development work and the partnerships as very interesting for Monsenso, because it opens up a new, attractive market opportunity“, says the CEO of Monsenso, Thomas Lethenborg.

The consortium behind the project, which is supported by the Innovation Fund, includes Novo Nordisk, Novartis, Aarhus University, the Research Unit for General Practice, Aarhus Municipality, Bispebjerg Hospital, the Danish Technological Institute, the Danish Life Science Cluster, Steno Diabetes Center Aarhus, the Copenhagen Institute for Future Studies and Monsenso.

Financial expectations
The project does not change Monsenso’s financial expectations for H2 2022 but is expected to contribute to increased growth in 2023 and beyond.

Facts
Innovation Fund investment: DKK 24.3 million (of which DKK 8.3 million is for Monsenso).
Total project budget: DKK 48.2 million.
Duration: 3 years
Official title: PhaseV

Further information
CEO, Monsenso
Thomas Lethenborg
Tel. +45 21 29 88 27
E-mail: lethenborg@monsenso.com

Chairman of the board, Monsenso
Peter Mørch Eriksen
Tel. +45 29 00 35
E-mail: petermorcheriksen@outlook.com

Certified Adviser, Monsenso
Norden CEF A/S
John Norden
Tel. +45 20 72 02 00
E-mail: jn@nordencef.dk
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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence and behavioural data. It connects individuals, carers and health care providers to enable personalised treatment, remote care and early intervention. We collaborate with health and social care, pharmaceuticals and leading researcher worldwide in our endevaours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com

 
Monsenso expands to Israel as part of a real-world evidence project in pharma

Monsenso expands to Israel as part of a real-world evidence project in pharma

Monsenso is translating its digital health app to Hebrew and Russian as part of a real-world evidence project with a pharmaceutical customer in Israel.

Monsenso’s digital health solution is translated to Hebrew and Russian and will be implemented in Israel as part of a project, where it will be used to collect real-world patient-reported health data and data from connected wearables to support evidence generation for a specific drug.

With these recent additions, Monsenso’s digital health solution is now available in 19 countries and 12 languages.

The project is a great example of the relevance of Monsenso’s solution to help pharmaceuticals generate the evidence necessary to support regulatory approval and reimbursement dialogues. It helps pave the way to provide Monsenso’s solution internationally to customers wishing to collect valuable, longitudinal patient data via daily self-reports, periodic clinical questionnaires as well as sensor data from phones and connected wearables to support studies and clinical practice.

CEO Thomas Lethenborg says: “We are excited to continue our success in the pharmaceutical market and offer our digital health solution in more languages and countries going forward, thus enabling even more individuals globally to better take care of their mental health”.

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About Monsenso
Monsenso is a digital health company that enables better outcomes for patients and clinicians through data-driven decisions. We are focused on mental health and user-centred in designing our solutions for patients and clinicians. Our cloud-based platform is a CE-marked medical device (Class 1, pending Class 2a and MDR certification) that is HIPAA compliant, with certifications in ISO 13485, ISO 27001, Cyber Essentials, and TGA. Our solution has been clinically and scientifically validated by over 70+ peer-reviewed studies and can be configured for applications across mental health conditions. We work with healthcare systems, life sciences, and research organisations globally. Book a demo to learn more.

Monsenso will be working with Australian mental health clinic

Monsenso will be working with Australian mental health clinic

Monsenso will be working with the mental health clinic Aware Family Wellness in Australia.

Aware Family Wellness focuses on providing outpatient treatment to individuals in all age groups across a broad range of mental disorders, such as depression and perinatal depression, anxiety, eating disorders, complex trauma, and others.

Patients will be offered the Monsenso digital health solution as part of the treatment at the clinic, with the overall aim to better prepare patients for consultations, enhance the probability of correct and timely diagnosis and treatment, and thereby reduce the number of admissions and the probability of serious illness.

Founder and Accredited Mental Health Social Worker, Amy Ware says: “We are looking forward to using the Monsenso digital health solution to support our patients even more actively, and offering them a solution that provides them with self-help tools and psychoeducational material, enabling them to take better care of their mental health outside of treatment sessions”.

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About Monsenso
Monsenso is a digital health company that enables better outcomes for patients and clinicians through data-driven decisions. We are focused on mental health and user-centred in designing our solutions for patients and clinicians. Our cloud-based platform is a CE-marked medical device (Class 1, pending Class 2a and MDR certification) that is HIPAA compliant, with certifications in ISO 13485, ISO 27001, Cyber Essentials, and TGA. Our solution has been clinically and scientifically validated by over 70+ peer-reviewed studies and can be configured for applications across mental health conditions. We work with healthcare systems, life sciences, and research organisations globally. Book a demo to learn more.

Monsenso enters partnership with psychiatric clinic in Greece

Monsenso enters partnership with psychiatric clinic in Greece

Monsenso has entered into a partnership agreement with the Greek psychiatric clinic Tzeranis Psychis Omma to deploy the solution in their clinic from Q2 2022 and drive market expansion of the Monsenso solution on the Greek market.

In 2019, 18% of the Greek population was living with a mental illness [1] – since then, the Covid-19 pandemic has led to a significant rise in mental health problems [2]. At the “Meeting of Minds on Quality of Care” conference hosted by WHO/Europe in Athens in December 2021, the necessity to “improve the quality of mental health care for children and adolescents” was emphasised, particularly in light of the Covid 19 pandemic [3]. Greek officials have further highlighted the significance of patient-centricity in mental health services in particular [2].

Psychis Omma has supported individuals with psychological and psychiatric illnesses for over 50 years, aiming at “offering a better life for people suffering from mental disorders, both to themselves and their families” [4]. The clinic provides both inpatient hospitalisation in their facilities in Nea Penteli, close to Athens, as well as (online) psychological support services and external observation [4]. 

The Monsenso Digital Health Solution will be implemented in Psychis Omma’s clinical practice as a tool to support patients in their treatment pathway and to facilitate early intervention and crisis reduction. Moreover, Psychis Omma Mental Health Solutions will act as a partner of Monsenso in Greece, advocating for the benefits of using digital support tools in mental health settings and actively marketing the Monsenso solution on the Greek market.

The Monsenso app for individuals helps patients to keep track of their well-being, symptoms, and medication intake through self-reported data, as well as their behaviour through sensor data collected on mobile phones. The historical data is visualised and helps individuals remember how they have been doing, e.g. between support sessions. It also helps them gain better insight into the behaviours that trigger their symptoms, empowering them to better manage their condition. Healthcare providers access the user data via a web portal for professionals, enabling them to see fluctuations in the mental state of the patients. This can help to predict relevant outcomes and reduce potential relapses and readmissions.

We are excited to bring the Monsenso Solution to Greece and work with Psychis Omma as a partner who values enabling people with mental illnesses to live better, more independent lives as highly as we do.”, says Thomas Lethenborg, CEO of Monsenso.

We are looking forward to working with Monsenso as a partner in Greece and to using their digital health solution to offer improved treatment support to more patients. Remote patient monitoring will open new doors to us in terms of our capabilities to actively support individuals outside of treatment sessions.”, says Spyros Tzeranis, Scientific Director of Tzeranis Psychis Omma.

About Tzeranis Psychis Omma 
Tzeranis Psychis Omma is a Greek Neuropsychiatric Clinic founded in 1971, providing specialist health services and supporting individuals with various psychological and psychiatric illnesses. Working with highly experienced and trained nursing and medical staff, the clinic offering both inpatient care and external psychological support aims at enabling more individuals suffering from mental illness to live better lifes.
To learn more visit tzeranis.gr.

About Monsenso
Monsenso is an innovative technology company offering a medical grade digital health solution. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment. To learn more, visit www.monsenso.com

[1] Stewart, C. (2021). Europe: mental disorders among adolescents in 2019, by country. Statista. https://www-statista-com.esc-web.lib.cbs.dk:8443/statistics/1273254/mental-disorders-among-adolescents-in-europe-by-country/

[2] WHO (2021). Athens Mental Health Summit – Ministers and representatives renew commitment to prioritize mental health in the WHO European Region.
https://www.euro.who.int/en/countries/greece/news/news/2021/8/athens-mental-health-summit-ministers-and-representatives-renew-commitment-to-prioritize-mental-health-in-the-who-european-region

[3] WHO (2021). WHO/Europe and Greece put quality of care at the top of the health agenda. https://www.euro.who.int/en/countries/greece/news/news/2021/12/whoeurope-and-greece-put-quality-of-care-at-the-top-of-the-health-agenda

[4] Psychis Omma Tzeranis Clinic (n.d.). Our Clinic. https://tzeranis.gr/en/our-clinic/

Norddjurs municipality in Denmark joins a successful back-to-work program supported by the Monsenso digital health solution

Norddjurs municipality in Denmark joins a successful back-to-work program supported by the Monsenso digital health solution

Norddjurs Municipality in the Central Jutland region joins the successful Return-to-Work program, facilitated by several partners including Empano, Sundinvest, Den Sociale Kapitalfond, AS3, PWC and supported by Monsenso’s digital health solution. From February 2022, Monsenso’s digital health solution will be deployed in Norddjurs Municipality to support individuals during their return-to-work process, while collecting real-world insights on outcomes.

The impact of COVID -19 on social care.
The disruption or shutdown of critical mental health services during the COVID -19 pandemic has led to the rapid adoption of technology-enabled care (TEC) in both health care and adult social care (ASC). Today, there is no doubt that digital technologies offer the potential to improve social care, from targeting resources where they are most needed to promote independence in the community through remote care and treatment support.

Commissioning beyond COVID -19
The adoption of technology-enabled care (TEC) also provides an opportunity to move towards a more person-centered and evidence-based model of commissioning that focuses on service delivery outcomes.

Three forward-thinking municipalities in Denmark implement an outcome-based back-to-work service provided by Empano and Monsenso

To date, two forward-thinking municipalities in Denmark (Guldborgsund and Slagelse) have implemented an outcome-based back-to-work service provided by Empano and Monsenso.

The back-to-work services are designed to help citizens with mental illness return to the labour market faster and consist of coping and motivational courses provided by Empano, offered in conjunction with the Monsenso digital health solution for remote treatment support and real wold data collection on outcomes to validate and demonstrate program effectiveness. 

Since February 2022, Norddjurs municipality in the Central Jutland region has also joined the successful program and more municipalities are expected to follow during the year.

About Monsenso
Monsenso is an innovative technology company offering a medical grade digital health solution. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment.

To learn more, visit www.monsenso.com

Monsenso has signed an agreement with Awakn Life Sciences, a global biotech company

Monsenso has signed an agreement with Awakn Life Sciences, a global biotech company

Monsenso has signed an agreement with, a global biotech company, to support the company’s medical psychedelic treatments. Awakn Life Sciences is a global biotech company that leads the field of psychedelic medicine for the treatment of addiction. In October 2021 commenced the implementation of the Monsenso Digital Health Solution in Awakn Life Sciences clinical practice as a tool for supporting patients throughout their treatment while capturing real-world patient insights to inform clinical decision-making and personalised treatment.

Mental illness and addiction are some of the biggest public health challenges facing the global community.

Nearly one billion people worldwide suffer from mental illness, for which there are too few effective treatments available beyond coping strategies and treating symptoms. With global spending on mental health estimated to reach $16 trillion by 2030 (as measured by lost economic output)[1], it is critical that effective new treatments are developed to address the current gaps. Psychedelic-assisted therapy has emerged as a potential solution to this treatment vacuum. In the early 20th century, these substances were severely restricted and had a negative connotation. Today, however, a growing body of evidence and urgent unmet patient needs have led clinicians and regulators to consider them as a viable treatment option.

Psychedelic-Assisted Psychotherapy represents a paradigm shift in psychiatric treatment

Psychedelic drugs are substances that alter perception and mood and affect various cognitive processes. When used in conjunction with psychotherapy, they can put patients in a temporary state where they can better process memories, emotions, and past traumas[2], allowing for processing that enables subjects to let go of things that have previously troubled them[3]. For the same reason, psychedelic-assisted psychotherapy has shown effective in treating historically difficult-to-treat illnesses[4] and is today considered a promising game-changer in psychiatric treatment[5,6,7].

While psychedelics have spurred great interest in the life science industry, only a few psychedelic companies are currently treating patients in the clinical setting. Awakn Life Sciences launched the UK’s first psychedelic-assisted clinic in Bristol, followed by London and Manchester, offering evidence-based psychedelic therapies for addiction and other mental health indications, and has also opened a clinic in Oslo, Norway with plans to scale across Europe quickly.

In October 2021, Awakn Life Science commenced implementation of the Monsenso Digital Health Solution in its clinical practice to support patients throughout their treatment journey and to capture real-world data to inform clinicians’ decision making for personalised patient support and management.

“We are excited to work with Awakn Life Science to support new treatment options for people who have experienced insufficient treatment results. We look forward to partnering with Awakn Life Sciences and be part of their growth journey” says CEO of Monsenso, Thomas Lethenborg.

Awakn’s CEO, Anthony Tennyson added “There’s such a critical need to provide solutions and hope to people suffering from mental illnesses and addiction. We’re excited to partner with Monsenso to better engage with clients throughout their treatment, gain insights to help inform clinical decisions and improve health outcomes, and generate insights that inform our research and treatment development programs”.

About Awakn Life Science Awakn Life Sciences is a publicly-traded (NEO: AWKN) (OTCQB: AWKNF) biotechnology company with clinical operations; researching, developing, and delivering psychedelic medicine to better treat Addiction. Awakn’s team consists of worldleading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies and enabling technologies to treat Addiction.

About Monsenso Monsenso is an innovative technology company offering a digital health solution for mental health and behavioral disorders. Our mission is to help provide better mental health to more people at lower costs. Our solution helps optimise the treatment of mental disorders and gives a detailed overview of an individual’s mental health through the collection of outcome, adherence and behavioural data. It connects individuals, carers and health care providers to enable personalised treatment, remote care and early intervention. Based on continuous research and development, our team is committed to developing solutions that fit seamlessly into the lives of individuals, increase their quality of life and improve the efficacy of mental health treatment. To learn more visit www.monsenso.com

For additional information contact:
Bettina van Wylich-Muxoll
Chief Marketing Officer
marketing@monsenso.com
Monsenso

Sources:

[1] https://www.weforum.org/agenda/2020/10/mental-health-day-covid19-coronavirus-global/

[2] https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

[3] Jennifer Mitchell, neuroscientist and professor in the departments of neurology, psychiatry and behavioral sciences at the University of California San Francisco.

[4] Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development

[5] https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

[6] https://www.scientificamerican.com/article/a-renaissance-for-psychedelics-could-fill-a-long-standing-treatment-gap-forpsychiatric-disorders/

[7] Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development