€6 million of further funds raised in addition to the €15 million in June
Clinical trials expected in 2022
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, today announced further funding of €6 million bringing the Series B total to €21 million, giving FineHeart a cash runway until the end of 2023. This financing comes in addition to the €15 million raised in June 2021 with the pool of industrial and independent investors: Lauak Group, Doliam, FineHeart Founders’ Holding which brought together international private investors, mainly from the cardiology sector and the European investment fund Verve Ventures. They joined historical shareholders Irdi, Aquiti, Galia, Broadview Ventures, and M Capital.
“I am extremely pleased with the interest our project is attracting from new investors who are joining the original and innovative consortium, which we brought together in previous rounds. This further sign of confidence in our strategy allows us to move ahead with the next steps in the development of the ICOMS FLOWMAKER® and the First In Human clinical trials in 2022”, declared Arnaud Mascarell, CEO & Co-founder of FineHeart. “Our goal is to bring an effective treatment to thousands of patients suffering from severe heart failure as quickly as possible, thanks to our disruptive, fully implantable device, with no external wires or batteries, which will enable them to lead a normal life again.”
Sylvain Famier, President of Med-INNOV, one of the investors in this new round of financing, said:
“We are delighted to add FineHeart to our portfolio of highly innovative French companies that are inventing the healthcare of tomorrow. The ICOMS FLOWMAKER® technology is revolutionary and unique. We are convinced that it has all the functionalities to effectively treat severe heart failure effectively”.
The ICOMS FLOWMAKER® is the world’s first physiological cardiac assist device. FineHeart has successfully completed all the critical pre-clinical trials required to programme First In Human clinical trials. The in-vivo studies validate the therapeutic potential of the device and have been welcomed by the international medical community, who await an effective solution for the treatment of severe heart failure.
I would like to highlight the remarkable and unprecedented pre-clinical advances that have been made, making ICOMS FLOWMAKER® a potential first-in-class treatment for thousands of patients with severe heart failure.” said Jean-Luc Boulnois, Chairman of FineHeart’s Board of Directors.
With this latest round of financing, FineHeart has now raised €46 million since since its inception in 2010.
Today the company has a staff of 45, essentially focused on R&D and expertise in quality and regulatory affairs. FineHeart has an international Scientific Medical Board of world-renowned key opinion leaders.
About the ICOMS FLOWMAKER®
The ICOMS FLOWMAKER® is the first fully intraventricular, wireless flow accelerator that provides physiological support synchronized with the heart’s natural contractions. It respects the natural blood flow and does not require aortic bypass surgery. It is the first miniaturized device – barely 10 cm in size – that is adjustable to patients’ needs, like a pacemaker, to treat patients with varying degrees of severity. It has no external driveline as it is recharged via a wireless transcutaneous energy transfer system (TET). The device is implanted using a minimally invasive beating-heart procedure, commonly performed by cardiac surgeons, and lasts on average 90 minutes. FineHeart demonstrates that the protocol for implanting and removing the ICOMS FLOWMAKER® resolves the severe complications associated with implantation of left ventricle assist device (LVAD) surgery, which deteriorates the fragile cardiovascular condition of the treated patients. Within two years of the implantation of a classic LVAD, 80% of patients develop a severe complications that make them dependent on their assistance device.
About FineHeart – www.fineheart.fr
FineHeart is a French medical device company headquartered in Bordeaux. Its patented ICOMS innovation holds the potential to treat 200,000 severe heart failure patients annually, with FineHeart initially targeting the 50,000 patients who are eligible for hemodynamic support but today are not treated by current LVADs; a $5B unmet market need. FineHeart was founded in 2010 by a team of internationally renowned cardiac surgeons and cardiologists, led by Stephane Garrigue, MD, PhD, CSO, Philippe Ritter, MD, MS, co-inventor of cardiac resynchronization therapy (CRT), and FineHeart CEO, Arnaud Mascarell. The company benefits today from 17 patent families. FineHeart is supported by major U.S. venture capital firms specializing in the cardiovascular space, prime French investors, the European Union, and Region Nouvelle Aquitaine and Region Centre. It has been recognized by FierceMedTech as one of its “Fierce 15,” designating it as one of the most promising private MedTech companies in the industry.
Contacts
FineHeart Communications
James Palmer
j.palmer@orpheonfinance.com
+33 (0) 7 60 92 77 72
Media Relations
Annie-Florence Loyer
afloyer@newcap.fr
+33 (6) 88 20 35 59
