PARIS- Artificial heartmaker Carmat will begin sales of its devices from the second quarter of this year after a long-awaited European Commission approval, in a boost to its shares.
Given recurring shortages of donors, Carmat's device aims to give patients with end-stage biventricular heart failure, a deadly condition where the heart is no longer able to pump blood adequately around the body, an alternative to hospital stays.
Although France's Carmat has yet to generate any significant revenue, its devices could represent a major breakthrough as heart diseases represent a leading cause of death worldwide.
Last month, Carmat secured European regulatory approval for its product in a so-called "bridge-to-transplant", although the European Commission however did not approve its artificial heart as a permanent implant.
Several estimates put at around 2,000 the number of patients in France, Germany, Italy, Spain and Britain with this specific condition on waiting lists for a heart.
"Our ambition to treat all patients in need for a heart is still there," Carmat's Chief Executive Stephane Piat told a briefing, adding that the number of potential recipients for which it had received approval was large.
Carmat shares were up 8% at 1300 GMT, giving it a market capitalisation of around 400 million euros ($493 million).
Airbus' subsidiary Matra Defense owns a 13% stake in Carmat, while the ALIAD venture capital unit of Air Liquide has a 0.6% stake.
Piat said Carmat's device, to be marketed under the brand name Aeson, would be made available from the second quarter in Germany, possibly followed by France and other countries.
A challenge lies ahead with reimbursement by social security systems for the device whose price per unit, Piat said, will top 150,000 euros.
Carmat, which has suffered setbacks with the death of patients in past trials, is conducting several studies to convince governments to buy its product.
It is also launching a study in the United States this quarter with the hope of getting approval from the Food and Drug Administration for its device by 2024.
Among Carmat's competitors are privately-held SynCardia Systems and Abiomed, both companies based in the United States. ($1 = 0.8108 euros)
(Reporting by Sudip Kar-Gupta; Writing by Matthias Blamont; Editing by Louise Heavens and Alexander Smith) ((sudip.kargupta@thomsonreuters.com; +33 1 49 49 53 84;))
