In a sign that European tech IPOs are warming up, French startup Carmat, a pioneering designer of an entirely artificial human heart, is planning a €15 million initial public offering on the Alternext market of NYSE-Euronext Paris this month. Co-founded by French heart surgeon Alain Carpentier, the company has tapped the latest technological advances in software, materials science, and aerospace (including stress-testing, miniaturization, and design for severe environments) to devise an artificial heart that avoids problems plaguing earlier such devices.
Carmat has already raised €42.70 million from private backers, including €2.25 million from the Professor Alain Carpentier Foundation and European Aeronautic Defence & Space Co. (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; and €950,000 from a share capital increase.
The money raised in the IPO will be used to commercialize a prototype device that has been under development for 15 years. This year Carmat plans to produce 25 prostheses for preclinical trials and implantation in humans. The goal is to conduct full 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 and is responsible for around 100,000 deaths per year in Europe and North America alone. Yet fewer than 4,000 people per 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 more than 25 years experience in cardiovascular medical devices, most recently as senior vice president strategy and new business development at Edwards Lifesciences (EW).
Work on the Carmat artificial heart began under Carpentier in the labs of Matra, a French engineering company that was absorbed into EADS in 2000. The project was kept secret until October 2008, when EADS spun it off.
Protected by 10 global patents, the Carmat heart offers numerous advantages over earlier devices such as the famous Jarvik artificial heart first implanted in humans in the early 1980s. To start with, it uses two internal pumps to move blood to the lungs and into the body, rather than the single pump typical of earlier mechanical or pneumatic designs.
Secondly, thanks to advances in biopolymer science, the Carmat heart is far more compatible with human blood than predecessors. This greatly reduces the risk of blood clot formation—a persistent problem with early artificial hearts—and could also spare patients from dependence on anticoagulant drugs.
Thirdly, the Carmat heart is fitted out with feedback sensors and cutting-edge software that allow it to adjust its speed and pressure depending on the patient's exertion level. This permits patients to engage in variable levels of activity and live more normal lives. What's more, the heart can be powered for up to five hours off a portable battery pack—compared with as little as a half-hour for earlier artificial hearts—allowing for a much greater degree of freedom and mobility.
Last but not least, the Carmat heart is designed for much greater durability than earlier devices, with a projected lifetime of about five years or 230 million heart beats. To boost reliability, it includes diagnostic software that allows doctors to monitor the device remotely and be alerted in the event of problem. They can even download software upgrades into the heart from a distance.
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 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 fewer doctor visits, re-hospitalizations, and drugs.
The human heart is likely to be the first organ to be successful replaced with "bio body parts," says Philippe Pouletty, a trained medical doctor and a general partner at Carmat investor Truffle Capital. Pouletty predicts that artificial kidneys and livers may be next. The introduction of completely artificial organs, adds Piet Jansen, Carmat's chief medical officer, also will require the evolution of new healthcare professions: in addition to cardiologists, he says, there will be "cardio engineers" who treat heart failure.
Commercialization of an artificial human heart is the realization of a lifelong dream for Carpentier, who invented of the first biomedically-engineered heart valves in the 1980s. The replacement valve market is now worth $800 million annually, and one out of every two procedures worldwide uses a Carpentier valve or ring, according to Carmat CEO Conviti.
Three decades 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. Looks like his dream is on the verge of coming true.
Guest blog post from Jennifer L. Schenker.
This blog post was adapted from www.informilo.com. Click here to read the original posting, provided courtesy of Informilo.
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