BORDEAUX, France–(BUSINESS WIRE)–FineHeart SA, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully implantable cardiac output management system designed to address the unmet needs of patients with severe heart failure, announced today today the grant from USPTO (United States Patent and Trademark Office) in the United States, of their new patent United States 11 097093.
The patent named “Method of managing a heart pump” covers various therapeutic modes of the ICOMS FLOWMAKER®, the world’s first and only fully implantable electrophysiological cardiac assist device for the treatment of severe heart failure.
In addition to being totally adaptable, the mini intracardiac pump developed by FineHeart is the only circulatory assist device capable of synchronizing with the opening of the aortic valve to increase native cardiac function with each heartbeat. Algorithms used in ICOMS FLOWMAKER® represent the true intelligence of the device. Like the algorithms used in pacemakers, they can recognize patient effort, identify arrhythmias and adjust the level of assistance provided in real time.
This key patent adds to FineHeart’s strong international portfolio of over 72 patents in 18 diverse areas of expertise ranging from design, control, to surgical implantation of the ICOMS FLOWMAKER®.
Designed by renowned electrophysiologists, the ICOMS FLOWMAKER® offers great autonomy to patients with severe heart failure. It requires little energy: its 70g battery is recharged through the skin via a wireless transcutaneous energy transfer (TET) system, avoiding any risk of infection.
For Dr Stéphane Garrigue, CSO Cardiologist and co-Designer of the ICOMS Flowmaker: “The ICOMS FLOWMAKER® began as a vision and culminated in the development of a totally disruptive approach to the treatment of severe heart failure. It is the first physician-programmable smart heart mini-device, regardless of the characteristics of the diseased heart and the rhythm of the heart.It preserves and supports the normal function of the heart to optimize the therapeutic effect and help its progression, in a personalized way for each implanted patient.It is the first device to produce blood flow in strict accordance with cardiac physiology.This allows the heart to increase its chances of spontaneous recovery, and the patient to avoid a vital dependence on cardiac assistance, a major drawback of all current cardiac assistance devices. to its unprecedented functionality, the ICOMS FLOWMAKER® brings hope to doctors and thousands of patients suffering from severe heart failure, whose only solut current therapeutic ion is a transplant.”
For Arnaud Mascarell, CEO and co-founder of Fineheart: “Even if the technologies developed over the last decades allow patients to recover their vital functions and regain a certain autonomy, there are still limits and constraints that prevent them from leading a normal life. With ICOMS FLOWMAKER®our ambition is to enable patients with severe heart failure to return to a normal life.
Severe heart failure is the second leading cause of death worldwide after cancer. It is a degenerative disease that progresses to a severe form and results in the heart’s inability to pump normally. Every year, 200,000 patients cannot be treated appropriately due to a lack of therapeutic solutions.
With its unique characteristics, the ICOMS FLOWMAKER® represents an effective therapeutic alternative for all these patients.
About ICOMS FLOWMAKER
The ICOMS FLOWMAKER® is the first completely intraventricular wireless flow accelerator that provides physiological support synchronized with the natural contractions of the heart. It respects the natural blood flow and does not require an aortic bypass. This is the first miniaturized device – barely 10 cm – which adapts to the needs of patients, like a pacemaker, to treat more or less severe patients. It has no external transmission as it is recharged via a wireless transcutaneous energy transfer (TET) system. The device is implanted using a minimally invasive beating-heart procedure, commonly performed by cardiac surgeons, which takes an average of 90 minutes.
FineHeart is a medical device company developing its innovative product, ICOMS FLOWMAKER®, with the potential to treat 200,000 patients with severe heart failure each year. The first human trials are expected in 2023. FineHeart will initially target the 50,000 most severe patients eligible for cardiac support. Initial estimates put this market segment at over US$5 billion.
Created in 2010, FineHeart is based in Bordeaux and employs nearly 50 people. It is led by a team of internationally renowned cardiac surgeons and electro-physiologists: Dr Stéphane Garrigue, PhD, CSO, co-inventor of ICOMS FLOWMAKER®; Dr. Philippe Ritter, MS, co-inventor of cardiac resynchronization (CRT); and Arnaud Mascarell, CEO of FineHeart. The company holds a portfolio of 72 patents in 18 families.
FineHeart is supported by a large pool of industrial and independent public and private investors: Lauak Group, Doliam, Med-INNOV, FineHeart Founders’ Holding representing national and international private investors, mainly from the cardiology sector, and the European investment Verve Ventures as well as historical shareholders Irdi, Aquiti, Galia, Broadview Ventures and M Capital. FineHeart also benefits from the financial support of the European Union, Bpifrance, the New Aquitaine Region and the Center Region.