Fineheart successfully completes study of its implantable device for treating severe heart failure – BioWorld Online

PARIS Fineheart SA, of Bordeaux, France, reported the success of a seven-day preclinical study to evaluate its Implantable Cardiac Output Management System (ICOMS), the first fully Intra-Ventricular Flow Accelerator synchronized to the native heartbeat to restore natural heart pumping capacity. Following multiple short-term studies conducted over years of development, this first long-term study confirms promising results for the ICOMS in overcoming many of the challenges associated with LVADs currently on the market, Arnaud Mascarell, CEO and co-founder of Fineheart, told BioWorld.

Heart failure affects 220,000 patients

Heart failure (HF) is the second leading cause of death in the US. and Europe. Each year, 200,000 patients suffer from severe heart failure, requiring a heart transplant or placement of left ventricular assist devices (LVADS). Only 12,000 have treatment: 5,000 through heart transplant and 7,000 through LVADS. Current LVADs are still cumbersome and remain associated with significant myocardial injury and a high risk of complications and thrombosis, said Mascarell.

Seventy percent of patients return to the hospital within one year, due to infection, gastrointestinal bleeding, thrombosis or even cardiac problems. Twenty percent of patients die from one of these complications in the first year after implantation, fifty percent in year four. The FDA highlights these adverse events with current durable LVADs and underlines the importance of restricting current device use. In fact, less than 10% of patients eligible for an LVAD are currently treated.

$16M invested so far in the technology

Heart surgeons and electrophysiologists led by Stphane Garrigue inventor of ICOMS and Philippe Ritter co-inventor of cardiac resynchronization therapy (CRT) had the idea of inventing a miniature smart intracardiac impeller pump, capable of synchronizing with the heartbeat, and restoring natural heart function. It is a case of providing assistance, and supporting basic cardiac contractility, like a sort of electric bicycle for the heart, said Mascarell.

Formed in 2010, the company, based within the Biomedical Technology Innovation Platform (PTIB) in Bordeaux, has invested $16 million in this new medical device. Under the direction of Mohammad Haddadi, Fineheart's chief research and development officer, 25 engineers in mechanical fluids, electronics and artificial intelligence have developed a miniature pump, implantable in the heart. Sixteen patent families protect the impeller pump, the design of the pump, its placement within the heart and the control algorithms.

ICOMS component parts

The ICOMS system includes a cylindrical titanium pump less than 10 cm long. This pump houses a 75-gram micro-impeller powered by an implantable 100 cm3 battery giving five hours charge from full.

A transcutaneous energy transfer (TET) system, 4 cm in diameter and implanted under the skin, means the battery can be charged over a wireless connection.

Finally, the ICOMS program hosted on a computer allows the cardiologist to modify the pump rotation speed, the synchronization with the patient's heart rhythm and the operating mode based on heart rate.

The system, which produces 1.5 watts power, similar to a beating heart, is implanted in the left ventricle via a left lateral mini-thoracotomy and anchored in the apex of the left ventricle using a specially designed delivery system.

The initial prototypes for the implantable miniature impeller were developed and put through bench testing in 2013, and the proof of concept was established in 2015 with the first preclinical tests performed on sheep. Biocompatibility testing on animal subjects was carried out in 2018. The recent seven-day preclinical study was carried out on three calves, into which the ICOMS was implanted via mini-thoracotomy through a transapical approach into the beating heart without cardiopulmonary bypass.

Promising results

This preclinical study has shown that the Fineheart system preserves the integrity of blood cells. With a pump outlet positioned entirely inside the ventricle, ICOMS has shown less shear stress being applied to red blood cells and preserved pulsatility, which therefore should result in lower incidence of gastrointestinal bleeding, said University of Michigan Professor of Cardiac Surgery, Francis Pagani director of the Cardiovascular Center and member of the Fineheart scientific advisory board.

The exceptionally low level of hemolysis measured during the trial confirmed performance and reliable hemocompatibility. Finally, the ICOMS supported and preserved native cardiac cycles hemodynamically, maintaining a regular heartbeat and healthy blood flow throughout the seven days of follow-up. The results of this preliminary long-term study are extremely promising and set the stage for the next phase in the products development said Harvard Medical School Professor Mandeep Mehra, from the Division of Cardiovascular Medicine at the Brigham and Women's Hospital, Boston, and member of the Fineheart scientific advisory board.

A market worth $5B

Fineheart is now preparing for longer-term preclinical trials for a study that will last 60 days. These strong initial long-term results open the door to longer preclinical trials already in preparation and to a phase I trial within 18 months, said Mascarell. The company is seeking U.S. FDA pre-market approval. That is why Fineheart has been in discussion for three years with the American authorities, as part of the pre-submission program, and holding meetings with the FDA. Fineheart is initially targeting the 50,000 patients eligible for hemodynamic assistance but who are not currently being treated using LVADs, a market it said is worth $5 billion.

The company said Finehearts technology has three major advantages over LVADs: no wires coming out of the body, reducing the risk of severe infection; a hemolysis level of just one third; and a thoracotomy with just two small incisions and no need for extracorporeal incision.

Fineheart is being supported by Broadview Ventures Inc. and Longview Ventures LLC, two major U.S. venture capital firms specializing in the cardiovascular field; by leading French investors such as Sofimac SAS, Galia Gestion SAS, M Capital Partners SAS; by the industrial investor Doliam SA, and by the European Union, Region Nouvelle Aquitaine and Region Centre de France. The company has already raised $14 million since it was formed. We are now entering the validation stage, with the continuation of preclinical tests, and pre-manufacturing, which should take between 24 and 36 months, said Mascarell, who is this year working on a $24 million series B round with the support of its historical investors.

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Fineheart successfully completes study of its implantable device for treating severe heart failure - BioWorld Online