30-day preclinical study successfully completed: ICOMS FLOWMAKER® demonstrated very good clinical tolerability
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STARTING THE CLINICAL
PHASE IN 2022
The momentum of safe and efficient pre-clinical testing brings FineHeart’s ICOMS FLOWMAKER® closer to the start of human trials for 2022
SIGNIFICANT MARKET POTENTIAL
FineHeart is initially targeting the 50,000 most severe patients who are eligible for cardiac support but are not being treated with current LVADs*. This represents an initial potential market of more than US$5 billion per year.
* Left Ventricular Assist Device
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patients
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ROADMAP
Successful testing of the implantable wireless transcutaneous energy transfer (TET) system to power the ICOMS FLOWMAKER®
Several preclinical studies programmed Final developments in the production and manufacturing process
Start of First In Human clinical trials 1st Europe Study: ICOMS FLOWMAKER® BRIDGE Trial : 3 patients
Certification ISO 13485 for Quality Management System
FDA filing – application for Breakthrough designation Transfer and validation of the ICOMS FLOWMAKER® for industrialization
2nd Study: ICOMS FLOWMAKER® CONFIRM Trial - USA Early Feasibility Study 10 patients. NYHA IV
3rd Study: ICOMS FLOWMAKER® EXPAND Trial EU & US - 30 patients NYHA IV Destination Therapy
EU approval
FDA approval
Production and marketing