CASIProject ID: 663879
Financé au titre de:
H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
AN INTEGRATED AUTOMATED ECG DIAGNOSTICS PLATFORM TO IMPROVE CARDIAC SAFETY IN CLINICAL DRUG TRIALS
Détails concernant le projet
Coût total:EUR 71 429
Contribution de l'UE:EUR 50 000
Sujet(s):PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices
Appel à propositions:H2020-SMEINST-1-2014See other projects for this call
Régime de financement:SME-1 - SME instrument phase 1
Vitalograph is a 50 year old company, that designs, manufactures and sells medical devices in clinical settings and clinical drug trials. This proposal focusses on the validation of a new dual-purpose 12 lead ECG diagnostics device incorporating an automated algorithm to be used in the regulatory mandated cardiac safety elements of clinical drug trials. Current solutions are expensive, introduce unnecessary analysis delays and have poor data consistency. The proposed solution can cut customer costs by 50% whilst at the same time improving Vitalograph’s margin from 25% to 70% as well as reducing the analysis time from several days to a few minutes. The target market has grown to be greater than €1.6Bn in 10 years with the targeted segment being one third of this. The target customers are pharmaceutical companies conducting drug trials.
The project fits well with Vitalograph’s product and market strategy to develop new medical devices for clinical drug trials and will increase the available market by a factor of 10. The company already operates successfully within the market having participated in over 50 trials totalling €56m in revenue since entering the market ten years ago. It has the R&D skills and bandwidth, operational capacity and commercial capability to fully exploit the resultant offering. Vitalograph has already established a market in cardiac safety in clinical trials by buying in other devices and services.
Vitalograph will work with the world-renowned Glasgow University ECG group as a 3rd party to validate their existing clinical algorithms for automated use in clinical drug trials. An IP licensing agreement is already in place and no IP issues are anticipated. The market is heavily regulated under medical device legislation in all jurisdictions (CE MDD, FDA, CSA, JPAL, CFDA etc.) but Vitalograph already has the necessary approvals, experience, regulatory knowledge and certifications to bring this product to the market.
Contribution de l'UE: EUR 50 000
MILL HOUSE HENRY STREET