Xeltis said yesterday that the FDA designated the bioresorbable replacement pulmonary valve it’s developing as a humanitarian use device, granted for device designed to treat rare diseases.
The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer structure with naturally regrown tissue; CEO Laurent Grandidier told MassDevice.com last year that the company is also looking at the aortic valve replacement and vascular markets.
Xeltis hopes to bring a pulmonary valve to the market by the end of 2018, Grandidier told us.
“FDA HUD designation represents an important step for Xeltis and may help expedite the time when bioabsorbable valves become a real, available treatment option for patients that need RVOT reconstruction in the U.S.,” he said yesterday in prepared remarks.
Last December, Xeltis closed an over-subscribed Series B round worth about $32 million.