EIT Health-supported Vitadio earns permanent DiGA status

EIT Health-supported start-up, Vitadio, based in the Czech Republic, has officially become the first digital health application for type 2 diabetes to obtain a permanent DiGA status in Germany. This means their innovative app which supports the treatment of type 2 diabetes, a condition which affects nearly 10% of the German population,[1] is now officially recognised as a reimbursable digital health application by the German government.

A regulatory framework to approve digital health solutions for reimbursement came into force in Germany in 2019, as part of a broader Digital Healthcare Act. Under the framework, approved digital health applications, known as DiGA, can be prescribed by healthcare providers to German patients. Patients are then reimbursed for the cost by health insurers. The framework ensures that the 73 million people insured in Germany’s statutory health insurance system[2] can access digital treatment.

Vitadio’s achievement of DiGa status follows the soon to be published results of the important clinical study, EIVEL, which showed that people using Vitadio achieved recommended blood sugar levels (HbA1c) 4.1x more often than those using standard treatment. Thanks to these results, the German Federal Institute for Drugs and Medical Devices (BfArM) granted the company the listing.

Lenka Röhryová, co-founder of Vitadio, said: “We are excited to see such good results not only in improving metabolic parameters but also in increasing patients’ ability to self-manage and lower diabetes distress. We are now focused on rolling out the therapy to patients across Germany.” She added: “EIT Health programmes have helped us with the initial market expansion.”

Vitadio’s journey with EIT Health began in 2019 when they participated in the Smart Ageing Camp, focusing on products for Europe’s ageing population and Health Venture Lab. The same year they leveraged EIT Health’s Bridgehead programme to support their expansion into new European markets. They joined the programme again in 2021.

Founded in 2019, Vitadio, led by CEO Jan Šomvársky, with Boleslav Kristián leading the technical development, and Lenka Röhryová serving as Chief Commercial Officer, is a medtech company specialising in developing prescription digital therapeutics for lifestyle-related conditions. Their international team, spanning offices in Prague and Berlin, consists of 30 dedicated individuals.

The company’s app for iOS and Android is approved to support the treatment of type 2 diabetes and is fully covered by health insurers in Germany. Vitadio recently launched in Italy together with its strategic partner Theras.

The company plans to launch new therapies and expand internationally to realise its vision of helping patients live free of chronic conditions.

Is your start-up looking for support to grow? Discover EIT Health’s portfolio of programmes.

[1] Tamayo, T. et al. (2016) The prevalence and incidence of diabetes in Germany, Deutsches Arzteblatt international. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4850517/ (Accessed: 14 May 2024).

[2] thelawreviews.co.uk. (n.d.). The Law Reviews – The Healthcare Law Review. [online] Available at: https://thelawreviews.co.uk/title/the-healthcare-law-review/germany. Accessed May 2024.