FineHeart obtains approval to begin FIH clinical study
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Arnaud Mascarell: Trailblazing the Effective and Innovative Technology in Healthcare
Heart failure is one of the major diseases the current world faces. To avoid such mishaps, people nowadays are becoming more and more health-centric. The saying goes, “With a healthy heart, the beat goes on.” However, heart failure can lead to various dreadful consequences, and the treatment process is even more complex. To address the ongoing need for innovation, Medtech companies continue to develop devices to improve the heart’s pumping capacity. However, most options risk internal damage to the heart. FineHeart has developed an innovative device that provides temporary and permanent support for this crisis to prevent internal damage.
One of the brains behind FineHeart is Arnaud Mascarell, the Co-founder & Chief Executive Officer. Arnaud leads with a charge and has defined groundbreaking strategies to make FineHeart a well-known and esteemed organization in healthcare. He utilizes his immense experience to ensure the clinical development plans are on track to fulfill the FDA requirements and other competent authorities.
A Fine Journey to the Heart
When Arnaud received his Biomedical Engineer degree from UTC (Technological University of Compiègne, France), he started as a research engineer at Air Liquide Santé. After serving a brief period, he later joined Medtronic as a Field Clinical Engineer. He quickly realized that he would also have to explore the business side of medical operations to expand his skills. Arnaud went on to pursue an MBA from IAE Paris in 2000. His decision came to fruition as the degree reoriented his career, and he began to focus on sales and marketing. After a decade, he jumped into his entrepreneurial journey and co-founded FineHeart in 2010.
Utilizing Technology for Competitive Lead
According to the World Health Organization, heart disease has remained the leading cause of death globally for the past 20 years. Arnaud mentions that the second leading cause of death in the United States and Europe is heart failure. It has become a global pandemic affecting an estimated 64.3 million people worldwide, with a steadily rising incidence (over one million new cases in G8 countries). Heart Failure is a degenerative disease where the heartbeat weakens over time, becoming more and more severe. This results in reduced quality of life, frequent, costly hospitalizations, and early mortality. A quarter of problems are electrical, which can be treated with pacemakers. The other two-thirds are muscular, which can ultimately only be resolved with a heart transplant.
The shortage of donors limits heart transplants, so a device called an Left Ventricle Assist Device (LVAD) is implanted to improve the pumping capacity of the left ventricle. Despite the urgent need, current LVADs are bulky, which causes significant myocardial damage. They are associated with a risk of infection, bleeding, and thrombosis, which is why they are almost exclusively implanted on very severe patients with short life expectancy. In the event of a cardiogenic shock, it is often necessary to wait to decide whether to implant an LVAD and force physicians to resort to temporary circulatory assist solutions.
FineHeart has invented a breakthrough device called the ICOMS FLOWMAKER®. This device can provide both temporary support (with no time limit and preserving the patient’s mobility) and permanent support if the patient does not recover sufficiently from the shock, which constitutes a paradigm shift in how severe Heart Failure patients will be treated.
The ICOMS FLOWMAKER® is like an electric bicycle, as it increases the blood flow and is synchronized to the natural heartbeat.
The entire ICOMS FLOWMAKER® system is fully implanted in the left ventricle. It is powered by a miniaturized internal battery that is rechargeable by transcutaneous energy transfer (TET). It eliminates the risk of driveline infection, a significant determinant of post-VAD morbidity and mortality. Maintaining trans-aortic flow supports increases left ventricle unloading, improving myocardial recovery chances and faster device weaning possibilities. The wireless device is programmable, like a pacemaker, and the operating modes can be customized for individual hemodynamic requirements, which preserves pump efficiency in case of increased cardiac demand.
According to the patient’s point of view, ICOMS FLOWMAKER® is designed to deliver improved quality of life by providing untethered freedom and supporting the patients’ return to daily activities.
Overcoming Severe Challenges
One of the biggest challenges that doctors face is the lack of long-term treatments for heart failure patients, especially those who have progressed to the most severe stage of the disease. These patients bear the brunt of the economic burden, but most treatments do too little to help them.
FineHeart is determined to disrupt the deadly cycle of heart failure and address the unmet needs of patients. ICOMS FLOWMAKER is the only device that will preserve the heart’s natural pumping function, as it synchronizes with the heartbeat to augment blood flow.
Stepping Up in Tough Times
Discussing the impact of the COVID pandemic, Arnaud expresses that the issue with the pandemic is that it has monopolized the health community. However, with heart failure being a degenerative disease, patients’ treatment delays have worsened the condition.
Fortunatey, FineHeart has been able to continue developing its device through pre-clinical trials and has not been overly impacted. His concern with the pandemic is that numerous patients have suffered heart problems with severe forms of COVID-19, which could lead to a higher risk of severe heart failure in the future.
Over The Horizon
Moving ahead and chasing milestones, Arnaud’s efforts have helped FineHeart recently close an $18M series B funding. This financing was accomplished with a pool of industrial and independent investors. The collective action brought together know-how from the world of technological excellence and renowned medical expertise, shown by the substantial contribution from cardiologists, who individually invested. This consortium of shareholders represents a new approach, going beyond the cookie-cutter approach to secure financial support.
It is one example of how FineHeart will continue to push and find innovative ways to deliver the disruptive treatment that the ICOMS FLOWMAKER embodies. The organization now holds all necessary resources to ramp up development and is on track to target First-In-Human clinical trials next year.
Follow Your Heart
FineHeart faces all the challenges of a start-up in the Medtech Industry, from R&D and product trials to the difficulties of raising finance regularly. Arnaud understands the entrepreneurial drive and the challenges, so he advises up-and-coming entrepreneurs to believe in their products.
“If you believe in your product and the potential disruptive treatment it can bring to save patients’ lives, you must keep going and find solutions,” says Arnaud.