France’s Carmat, a company that is building an entirely artificial human heart, is planning an initial public offering on the Alternext market of NYSE-Euronext Paris in June. The company, co-founded by renowned French heart surgeon Alain Carpentier, is leveraging the aerospace industry’s expertise in modeling, stress testing, miniaturization and design for severe environments as well as the latest advances in software, medicine, biology and materials science. Click to read the story and see the video.
Carmat aims to secure €15 million in its initial public offering. It has already raised €42.70 million, including €2.25 million from the Professor Alain Carpentier Foundation and European Aeronautics Defense & Space (EADS), the parent company of passenger jet maker Airbus, €33 million from OSEO, the French state innovation agency, €5 million from Paris-based venture capital firm Truffle Capital , plus another €950,000 in a share capital increase.
The money raised in the initial public offering will be used by the company to commercialize a prototype that has been under development for some 15 years. This year Carmat plans to produce 25 prostheses for preclinical trials and implantation in humans. The goal is to conduct clinical trials with humans in 2011, after obtaining the permission of the AFSSAPS, the French government agency for healthcare product safety. Commercial launch in Europe and the U.S. is expected in mid-2013, says Carmat chief executive Marcello Conviti.
The Carmat artificial heart is intended for patients who have suffered a massive heart attack or those with late-stage heart failure. Cardiac failure is the leading cause of death worldwide. In Europe and North America alone it is responsible for around 100,000 deaths per year. Less than 4,000 people a year are lucky enough to get human heart transplants. “More than 95% of those people currently have no alternative, so this is our potential market,” says Conviti, who has over 25 years experience in cardiovascular medical devices, most recently as senior vice president strategy and new business development at Edwards Lifesciences. (To hear more about Carmat’s plans click on Informilo’s interview with Conviti below)
Work on the artificial heart began, at the prompting of heart surgeon Carpentier, in the labs of Matra, a French engineering company which was absorbed into EADS in 2000. The project, which involves combining the latest developments in aerospatial technology with cutting-edge heart surgery, was kept secret until October 2008, when EADS spun it off, creating Carmat. (Informilo editor-in-chief Jennifer L. Schenker first wrote about Carmat in an October, 2008 article in BusinessWeek. She also interviewed investor Philippe Pouletty about the Carmat project on stage at the DLD conference in Munich in January 2009)
Recent high-tech advances, including medical imaging and computer modeling, combined with cutting edge systems design, biocompatible materials, polymers and electronics, have helped the project make some major breakthroughs. Among the hearts advantages over earlier devices – such as the famous Jarvik artificial heart first implanted in humans in the early 1980s – is that the Carmat device employs two internal pumps to move blood to the lungs and into the body, rather than the single pump typical of earlier designs.
Other prototype artificial hearts that have been developed are based on pneumatic or mechanical devices which are made from materials that are not compatible with human blood and can not self-regulate. The new Carmat design, which is based on a portfolio of 10 worldwide patents, also promises to resolve three other major issues that have held back development to date: risk of blood clots, inability to mimic the human heart’s capacity to adapt according to a patient’s level of physical exertion and unreliability.
The Carmat heart uses cutting-edge biopolymer materials that are compatible with human blood. The design of Carmat’s heart promises to reduce the formation of dangerous blood clots – a persistent problem with early artificial hearts – and could also spare patients from dependence on anticoagulant drugs.
Feedback sensors and software in the Carmat device can adjust the heart’s speed and pressure depending on exertion level, permitting patients to engage in normal, variable levels of activity. An external battery pack, which can be worn on a belt, is attached via a plug implanted behind a patient’s ear. The plug sends power through a wire implanted inside the body which is connected to the artificial heart. Patients can go for up to five hours before having to recharge or change batteries, a major improvement over current devices which typically allow patients only a half-hour of freedom to take a shower or perform other limited tasks before they have to recharge a battery sewn under their skin or connect to an external energy source.
And, the Carmat heart is designed to last about five years or 230 million heart beats without system failure, having gone through some of the same rigorous testing used in aerospace projects, including thousands of hours of simulations and wear and test tests. The artificial hearts will include external remote diagnostic software for monitoring the patient’s status and alerting medical staff in the event of a problem. Doctors will also be able to update some of the heart’s software remotely.
The first clinical trial in 2011 will involve implanting the hearts into patients and monitoring them for 180 days to measure short term safety and efficacy, the company said. The second trial will include 22 patients, including six from the first trial, to test for long term use. The cost of the operation is expected to be roughly equivalent to that of a human heart transplant but follow-up care, which adds up to around €50,000 per year for patients with transplanted human hearts, will be significantly reduced as the artificial hearts are expected to require less doctor visits, re-hospitialization and drugs.
The heart is likely to be the first human organ to be successful replaced with “bio body parts,” says Philippe Pouletty, a trained medical doctor and a general partner at Truffle Capital, a Carmat investor. He predicts that artificial kidneys and livers may be next.
The introduction of completely artificial organs will require the advent of a new type of healthcare professional, says Dr. Piet Jansen, Carmat’s chief medical officerf. Cardio engineers, rather than cardiologists, will have to be trained to fix broken hearts, he says.
Commercialization of an artificial human heart is the realization of a life long dream for Carpentier, the heart surgeon who helped co-found Carmat. Carpentier is the inventor of the first biomedically engineered heart valves. Today the annual replacement valve market is worth $800 million and an estimated one out of every two procedures worldwide uses a Carpentier valve or ring, says Conviti.
Some 30 years ago when Carpentier sought to finance and produce his breakthrough invention he had to get U.S. financial backing , creating a partnership with Edwards Lifesciences. The phenomenal success of the heart valves prompted Professor Carpentier to go back to the drawing board and try to design an entire heart that could be implanted in humans, this time with European backing.