BORDEAUX, France--(BUSINESS WIRE)--FineHeart S.A, a medical device company developing the FLOWMAKER®, a fully implantable cardiac output restoration system (ICOMS) to address the unmet needs of patients suffering from severe heart failure, announced today that its first two patents have been granted in China by the CNIPA - China National Intellectual Property Administration -.
These new patents complement the company's strong international portfolio of 20 families and more than 78 patents covering the concept, design, production and surgical implantation of the FLOWMAKER®, the world's first physiological heart assist device for the treatment of severe heart failure, designed by French rhythm and electrophysiology cardiologists.
In line with FineHeart's strategy to offer a minimally invasive, effective and durable implantable solution to the largest number of patients suffering from severe heart failure, these first Chinese patents open the doors to a vast and rapidly expanding market.
With a 360% growth in medical device imports over the past 10 years, the Chinese healthcare market is undergoing a profound transformation to meet the growing needs of its aging population. With more than 200 million people over 65 years old, they are becoming the largest consumers of healthcare products. Cardiovascular diseases are the leading cause of death, affecting more than 300 million Chinese patients, of whom approximately 14 million suffer from severe heart failure.
With a favorable economic and regulatory environment for medical device innovation, both domestic and international, and attractive reimbursement opportunities, FineHeart's FLOWMAKER® perfectly meets the needs of the Chinese mechanical ventricular assist market.
With its radically innovative design, the FLOWMAKER® is much easier to manage than LVADs. Using the native contraction of the heart, this miniature heart pump operates physiologically, without intraventricular bypass; its 70 g battery requires little energy and is recharged through the skin, avoiding any risk of infection. The FLOWMAKER® can be implanted with a beating heart, thanks to a minimally invasive surgical procedure well mastered in China, thus limiting physiological modifications. The FLOWMAKER® assists the heart, adapts to the evolution of the pathology, and can be easily removed, without critical risk for the patient.
For Dr. Stéphane Garrigue, cardiologist, CSO, co-founder of FineHeart and co-inventor of the FLOWMAKER®: "Our miniature, mini-invasive, fully implantable left ventricular assistance system represents hope for thousands of patients with severe heart failure. With the FLOWMAKER®, our ambition is to enable them to recover their vital functions and regain significant autonomy, while freeing them from the constraints and complications associated with current devices or those under development.”
“We are extremely proud of being granted these patents in China, where the aging population is facing a resurgence of cardiovascular diseases. It highlights the technological advances of our device and allows us to envisage an effective treatment for patients with severe heart failure in this country, once we have completed the clinical steps that will start soon. Our intellectual property portfolio is a key asset for our future development. We will continue to put in place strong barriers to entry to protect our market from competition," said Arnaud Mascarell, CEO and co-founder of FineHeart.
About The FLOWMAKER®
The 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, which, on average lasts 90 minutes.
Second cause of death in the world after cancer, severe heart failure is a degenerative disease that progresses to a severe form, resulting in an inability of the heart to contract effectively. Each year, 200,000 patients are not effectively managed due to lack of treatment.
About FineHeart
FineHeart is a medical device company that is developing its innovative ground-breaking product, FLOWMAKER®, with the potential to treat 200,000 patients with severe heart failure each year. First-In-Human trials are expected in 2023. FineHeart will initially target the 50,000 most severe patients who are eligible for cardiac assistance. Initial estimates value this market segment to be worth over US$5 billion.
Founded in 2010, FineHeart is based in Bordeaux employing close to 50 employees. It is led by a team of internationally renowned cardiac surgeons and electro-physiologists: Dr. Stéphane Garrigue, PhD, CSO co-inventor of the FLOWMAKER®; Dr. Philippe Ritter, MS, co-inventor of cardiac resynchronization (CRT); and Arnaud Mascarell, FineHeart's CEO. The company holds a portfolio of 78 patents in 20 families.
FineHeart is supported by a wide pool of public and private industrial and independent investors: Lauak Group, Doliam, Med-INNOV, FineHeart Founders' Holding representing domestic and international private investors, mainly from the cardiology sector, and the European investment fund 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 Centre Region
