AN INTEGRATED AUTOMATED ECG DIAGNOSTICS PLATFORM TO IMPROVE CARDIAC SAFETY IN CLINICAL DRUG TRIALS

Projektinformationen

CASI

ID Finanzhilfevereinbarung: 663879

DOI 10.3030/663879

Abgeschlossenes Projekt

EK-Unterschriftsdatum 5 Februar 2015

Startdatum 1 März 2015

Enddatum 31 August 2015

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten € 71 429,00

EU-Beitrag € 50 000,00

Koordiniert durch

VITALOGRAPH (IRELAND) LIMITED
Ireland

Ziel

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.

Wissenschaftliches Gebiet

• natural sciences › computer and information sciences › databases
• natural sciences › computer and information sciences › software › software applications

Programm/Programme

• H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
• H2020-EU.3.1.3. - Treating and managing disease

Thema/Themen

• PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Aufforderung zur Vorschlagseinreichung

H2020-SMEInst-2014-2015

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEINST-1-2014

Finanzierungsplan

SME-1 - SME instrument phase 1

Koordinator

VITALOGRAPH (IRELAND) LIMITED

• Netto-EU-Beitrag: € 50 000,00
• Adresse: MILL HOUSE HENRY STREET ; V94 Limerick ; Irland
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Region
  Ireland › Eastern and Midland › Dublin
• Region: Ireland › Eastern and Midland › Dublin
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 71 429,00