It is an adventure combining medical research and finance which has just taken an important step. The French company Carmat announced Thursday, July 15, the first human implantation of its artificial heart in the United States as part of a clinical study. The intervention was carried out at Duke University Hospital in Durham (North Carolina), one of the centers of excellence for cardiac surgery in the United States and one of the four American centers selected by Carmat after the green light from the Food and Drug Administration.
The company had to carry out tests across the Atlantic after having received the approval of the health authorities there in September 2019. This “The first American clinical study will be decisive for our development in the world’s largest medical device market”, underlines the Director General, Stéphane Piat. To date, ten patients eligible for transplantation should be recruited for this first phase.
The artificial heart, marketed under the Aeson brand, is intended for patients suffering from terminal biventricular insufficiency, and especially for patients awaiting a transplant, who often die for lack of a graft. “The primary endpoint of the study [américaine] is the survival of the patient 180 days after implantation or a successful heart transplant within 180 days after implantation, Carmat specifies. This is a step-by-step study with a report on the progress of the first three patients after sixty days, before the recruitment of the next seven patients. “
Its leaders themselves admit that the company launched on the basis of the work of surgeon and cardiologist Alain Carpentier has often been accused of making many promises without obtaining many results. Since the first operation, carried out at the end of 2013 at the Georges-Pompidou European Hospital, only nineteen patients have benefited from this last-chance prosthesis, implanted in France, but also in Kazakhstan, the Czech Republic and Denmark, with short and unequal survival times.
In the United States, the sale of the autonomous bioprosthesis is not envisaged before 2024. In Europe, it is now expected by the end of the year, after Aeson obtained the “CE mark” for the ‘indication of waiting for transplantation, end of December 2020.
The industrialization process is delicate, the part of manual labor in the manufacture of this very sophisticated device remaining important.
Initially, priority was given to France, where five CHUs were selected (Pitié-Salpêtrière in Paris, Lyon, Lille, Toulouse and Rennes), and to Germany, which alone accounts for 40% of the market for mechanical circulatory assistance devices in the European Union. Two countries where the waiting list for heart transplants was 900 and 700 patients respectively at the end of 2019.
The production of this total artificial heart, connected to a hospital establishment for the monitoring of high-risk patients (stroke, gastrointestinal bleeding, hemolysis, infections, etc.) will therefore have to keep pace. On the Bois-d’Arcy site (Yvelines), it has been accelerating for a few months, the company says. But the industrialization process is delicate, the part of manual labor in the manufacture of this very sophisticated device remains important.
Evaluate the cost-effectiveness ratio
The needs are however there. Around 5,500 heart transplants are performed worldwide each year and annual requirements are estimated at 100,000 in the United States and Europe alone. However, this activity is stagnating due to a shortage of organs. These trials should make it possible to assess the cost-effectiveness of the artificial heart compared to a transplant or to a non-transplanted patient making expensive stays in cardiology and intensive care. Their results will be used to set a price for its coverage by the health insurance funds.
The economic bet has still not been won, even if “medtech” is supported by powerful shareholders (Airbus Group, Bpifrance, Air Liquide, Truffle Capital and wealthy families, etc.) and helped by a long-term loan from the Bank. European investment (30 million euros). It has only burned cash since its creation in 2008. Listed on the stock market in 2010 at a price of 18.75 euros per share, the company has had an erratic course; the title is now worth 23 euros. Its managers and shareholders are counting on the beginnings of commercialization to finally make money.