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 Carmat won clearance from the French medicines agency to resume an
implant trial in May after a suspension following the death of a
fifth patient in October.
Chief Executive Stephane Piat, who took over in September, told
Reuters that lessons from previous failures had been learned and
Carmat was tightening its clinical trials procedure.
"There was a need to better oversee the clinical trial. We are in
the process of doing that, and today everything is back to normal,"
he said during an interview.
Carmat has hired Wenzel Hurtak, a Dutch national who has held top
positions at U.S firm Johnson & Johnson, for the newly created post
of director of manufacturing.
"This will enable us to separate production from research and
development and better work on the future generations of our
products," Piat said.
Carmat says more than 100,000 patients in the United States and
Europe could benefit from its artificial heart in the coming years,
a market worth more than 16 billion euros ($18 billion).
The company hopes to bring its existing battery-powered product to
market in the European Union from 2019.
The device is designed for people with end-stage heart failure, a
fatal condition where the heart is unable to pump blood adequately
around the body. It aims to be an alternative to heart transplants
where there is a shortage of donor organs.
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Privately-held SynCardia Systems and Abiomed, both U.S. companies,
are among Carmat's competitors, with SynCardia's artificial heart
the only one approved for use both in North America and the EU.
Piat said Carmat had been slow to develop a marketable product for a
number of reasons but it expected to be able to develop prototypes
more quickly using 3D printing.
"We are already working on a simpler, more energy-efficient heart,"
he said.
The company, which has teamed up with tire maker Michelin and
aerospace and defence group Airbus, has said it plans to open a new
factory near Paris with more automated processes at the end of 2017.
($1 = 0.8831 euros)
(Editing by Andrew Callus and Alexander Smith)
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