* To test heart in Belgium, Poland, Saudi Arabia, Slovenia
* Could gain approval in France and other countries soon
* Shares rise 25 percent
PARIS, May 14 France's Carmat has won
approval to proceed with the first human implantations of its
artificial heart in four countries, the company said on Tuesday,
sending its shares up 25 percent.
The approval were given by the four international cardiac
surgery centres in Belgium, Poland, Saudi Arabia and Slovenia,
where the tests will be carried out, but not in France, where
Carmat's artificial heart is still to gain approval from the
drug safety agency, ANSM.
Shares of Carmat rose 24.56 percent at 12.12 GMT to 129.5
euros, valuing the company at 535 million euros ($694.56
Among Carmat's competitors are privately-held SynCardia
Systems and Abiomed Inc., both of the United States.
The approval is "good news" that allows the French medical
devices maker "to make progress on the subject of human
implantation despite the growing demands of the ASNM,"
Portzamparc analysts wrote in a note.
The French regulator has asked Carmat to test the device on
animals before it can allow implantation in humans.
"The patient selection process and the training of the
clinical teams are ongoing in these four countries (...)
Implantations could start shortly following the completion of
the training," Carmat said in a press release.
Developed by a team of engineers from Airbus parent company
EADS, the Carmat devices - expected to cost 150,000
euros ($193,600) each - mimic heart muscle contractions with two
micro pumps, one for each ventricle or heart chamber.
"Carmat expects to receive additional approvals in a near
future, potentially in France and in other countries," Chief
Executive Marcello Conviti said in the press statement.
Last October, Carmat had said it expected to seek approval
for its artificial heart from French authorities by the end of
the year, enabling it to carry out its first implant in early