Digital Therapeutics (DTx) Acceleration Program for Obesity.
Are you a startup or an academic project leader? Have you developed a digital solution aimed at improving obesity management?
Join our acceleration program and benefit from a unique support system to fast-track the development and market launch of your DTx.
Fostering the market launch of digital therapies in obesity
Prevalence of obesity
Obesity affects a growing portion of the French population, with over 18% of adults impacted in 2023, according to data from Santé publique France.
This prevalence has almost doubled since the 1990s, reflecting changes in lifestyles, diet and sedentary lifestyles.
Moreover, obesity is associated with a significant increase in comorbidities, such as type 2 diabetes, cardiovascular diseases, and certain cancers.
Innovation needs
Digital therapeutics (DTx) are medical devices based on mobile applications, scientifically validated, and often used as a complement to traditional care
DTx can play a crucial role in helping patients make long-term behavioral changes through personalized programs focused on nutrition, physical activity, or emotional management. These tools often incorporate approaches based on cognitive-behavioral therapies to encourage engagement and adherence to treatment.
Market access complexity
The market introduction of DTx presents several specific challenges, particularly in the European context where CE marking is mandatory.
Reimbursement by the healthcare system is a key factor to ensure patient access to DTx. This often requires demonstrating, through rigorous clinical trials, the solution’s effectiveness in addressing targeted medical needs.
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Finally, raising awareness among healthcare professionals about these new approaches is essential to encourage their adoption and prescription.
About the program
The DTx Obesity Acceleration Program is the result of a collaboration between Novo Nordisk and Agora Health, aimed at supporting startups and academic project leaders developing digital solutions for obesity management.
Over a period of six months, the selected participants will benefit from tailored support provided by the partners' teams, covering areas such as existing solutions analysis, regulatory strategy, clinical evaluation strategy, and market access strategy.
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This program is designed to help innovations overcome the complex challenges of market entry and achieve sustainable integration into care pathways.
Program Partners
Agora Health is a startup studio dedicated to digital medical devices. Its goal is to facilitate the emergence and market entry of innovative solutions by de-risking their development during all pre-commercialization phases.
Novo Nordisk is a pharmaceutical company specializing in the development and commercialization of treatments for chronic diseases, including diabetes, obesity, bleeding disorders, and growth disorders.
AppThera is a platform designed for healthcare professionals, simplifying the selection and prescription of digital therapies (DTx) for their patients. These therapies are mobile applications certified as medical devices, with their clinical efficacy demonstrated through randomized controlled trials.
The program's partner teams will support the selected participants in addressing all the challenges related to bringing their innovation to market.
ποΈ Regulatory, clinical and market access strategy
Review and monitoring of the market access strategy, in particular through the reimbursement of the digital solution.
π Deployment strategy
Support in developing the commercialization plan, with or without a partner.
π° Budget estimate and roadmap
Support in optimizing costs and timelines for the implementation of the selected projects.
π¨βοΈ Visibility among healthcare professionals
Showcasing the selected projects to French healthcare professionals involved in the care pathways of patients with obesity.
π€ Access to a network of experienced experts
The expert network is made up of consulting firms with expertise in digital medical devices.
β¨ Partnership opportunities
Each selected participant will have the opportunity to engage in partnership discussions with the teams at Novo Nordisk and AppThera.
Schedule
Informative webinar
ποΈ February 4, 2025
closing date for applications
ποΈ February 14, 2025
Pitching sessions
ποΈ March 4 and 5, 2025
Launching of the program
ποΈ March 26, 2025
Selection criteria
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Digital therapeutics (DTx)
Software application (mobile, web, VR, etc.) intended for patients and with a therapeutic aim.
Having or aiming for CE marking.
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Existing project
Existing project (TRL 5 minimum) and wishing to be part of a regulatory and clinical approach.
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Evidence of effectiveness in obesity
Whatever the mode of action (nutrition, physical activity, psychology, etc.), the project must include a clinical demonstration for patients suffering from obesity.
This program may under no circumstances constitute a direct or indirect advantage to the persons mentioned in Articles L.1453-3 et seq. of the French Public Health Code (Loi Encadrement des Avantages). Any application that could fall within the scope of these articles will be rejected.
FAQ
How much does the program cost?
The program is free for selected candidates.
I don't have a company yet, can I apply?
Yes, if your project is sufficiently advanced (TRL 5), you can apply, with or without a incorporated company.
Who will select the projects?
The jury consists of members from AppThera and Novo Nordisk.
What will the program consist of?
The program will take place in several individual working sessions aimed at challenging the solution, refining its positioning in the care pathway and working on market access.