FineHeart

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.

patients

0
patients

Market potential

0
$ bn p.a.

Regular price*

0
Regular price*

Potential Gross margin

0 - 75%
patients

* In line with LVAD reimbursement prices.

80 000 - 120 000€ per unit

RoadMap

30-day preclinical study successfully completed: ICOMS FLOWMAKER® demonstrated very good clinical tolerability

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