The first commercialization of artificial heart in France, capital influx into "mechanical heart"

French medical technology company Carmat announced on Monday that the Aeson system for the artificial heart, which took more than a decade to develop, was successfully implanted in a hospital in Italy, achieving the company's first commercial application of an artificial heart.

In recent years, the technological breakthrough of artificial heart has brought good news to tens of millions of heart failure patients, and has also become a track for capital to chase madly. However, the research and development of artificial heart products still has the characteristics of high risk and high barriers, which need to be tested by the market for a long time.

The "last battlefield" in the cardiovascular field

Heart failure is also known as the "last battleground" in the cardiovascular field, and although humans have made significant progress in the treatment of heart disease over the past few decades, the incidence and mortality of heart failure are still increasing year by year. Especially in high-risk coronary interventional surgery, due to the ventricular pumping insufficiency of patients with heart failure, interventional surgery will aggravate myocardial ischemia, resulting in unstable blood flow motility, greater surgical risk, and higher mortality.

Compared with heart transplantation, artificial heart provides patients with a greater range of choices, has great clinical significance, and in recent years, the technical path has gradually become clear, which is expected to become an inflection point in the heart failure treatment market.

According to a team of heart surgeons at Duke University Hospital, the number of new heart failure cases in the U.S. is estimated at around 100,000 each year, and only 3,000 to 4,000 of these patients could benefit from a heart transplant. Artificial hearts break through the limit on the number of heart transplant donors and are expected to benefit a large proportion of patients who remain.

Carmat CEO Stéphane Piat said the manufacturing cost of the artificial heart amounted to about 200,000 euros and the production cycle was about three months. "Now we have two goals: to increase sales efforts and to reduce production costs as soon as possible." Piat explained.

The United States is one of Carmat's clinical research sites and a major market for the company's commercialization of artificial hearts. Last week, Carmat's artificial heart also had its first patient implant at Duke University Hospital in Durham, North Carolina.

For now, however, artificial hearts can only be used as a bridge for heart transplantation, which means that they can be used as a transition period waiting for a heart donor. "All artificial hearts are transitional at present, and there is no technology that can make artificial hearts provide permanent power in the human body." Academician Ge Junbo, director of the Department of Cardiology of Zhongshan Hospital affiliated to Fudan University, told the first financial reporter.

In addition, the issue of blood compatibility is also a major challenge facing the industry. All blood-contact artificial organs face blood damage. Blood destruction can cause hemolysis or thrombosis and complications, such as stroke caused by blood clots, which can cause fatal harm to patients.

Carmat's artificial heart addresses these challenges to some extent. The device consists of implantable biological valves and a portable external power supply system, using highly biocompatible materials, which can provide a unique self-regulating system with pulsating properties that promise to reduce or eliminate the risk of rejection in the patient's body.

One of Carmat's two founders is the inventor of the world's most used Edward heart valve, the French cardiologist Alain Carpentier, and the other is a technologist at The Airbus Group.

China's R&D benchmarks the world's leading technology

Artificial hearts, like heart valves, have become one of the most concerned areas in the cardiovascular field at present, attracting a large amount of money in recent years, and medical device companies in the global cardiovascular field are competing for this fledgling track.

In June this year, Weiwu Capital's tens of millions of dollars strategic restructuring of Yongrenxin; Lanfan Medical has also strategically invested in Tongxin Medical, a magnetic levitation artificial heart development enterprise; core medical care of ultra-small magnetic levitation artificial heart development enterprise, completed 100 million yuan of financing last year; at the beginning of this year, Xinqing Medical, a research and development company for in vitro artificial heart devices, also received more than 100 million yuan of financing, including Northern Light Venture Capital.

There are two types of artificial hearts, one is a complete artificial heart (TAH), and Carmat's Aeson belongs to TAH. The other is the left ventricular assistive device (VAD), which is currently being developed by most companies. Compared with the complete artificial heart, the market application of this left ventricular artificial heart assist device is more mature, and companies including Medtronic and Abbott have developed market-oriented products.

Multiple teams in China are also promoting the development of interventional artificial heart products. Minimally invasive interventional artificial heart can provide rapid, injury-free circulation assistance in the event of pump failure in patients with peripheral vascular interventional surgery that inserts a miniaturized blood pump into the patient's aorta. This technique provides intraoperative cardiac protection for high-risk coronary interventional surgery.

In September last year, the minimally invasive interventional artificial heart jointly developed by the team of academician Ge Junbo of Zhongshan Hospital affiliated to Fudan University and Xinqing Medical was officially launched, which has completed many animal experiments in one year and is expected to fill the gap of domestic artificial heart.

At present, the only successful market in the world of such interventional artificial heart enterprises only the United States Abiomed company, its minimally invasive interventional artificial heart product Impella series in 2015 for the first time by the UNITED States FDA approval listed, so far more than 100,000 patients around the world have received Impella series product treatment, but the product has not yet entered the Chinese market.

According to reports, the interventional artificial heart of Xinqing Medical is directly benchmarked against Abiomed's Impella ECP, and the indication is heart protection in high-risk coronary intervention surgery, with smaller intervention size, larger flow, and cost advantages.

Although the artificial heart is a blue ocean with great application prospects, experts also warn that the entire artificial heart industry is still in its infancy, the product has the characteristics of high risk, high barriers, etc., and the approval of the product is not the end, and it still needs to be tested for a long time in the clinic.