Jenavalve ploughs on alone

Jenavalve Technologies’ latest funding round provided $50m for the development of a catheter-mounted aortic valve. But it also highlighted the fact that the company, unlike many of its peers, has been unable to find a buyer. Jenavalve, New Valve Technology and Meril Life Sciences are the three groups whose transcatheter aortic prostheses have been approved in Europe but which have not been taken out by one of the big players here. Meril, owned by a single family and self-funding, does not want a buyout; but Jenavalve’s management has made no secret of its desire for an exit – and since its product was CE marked far earlier than these others its investors must be getting restive. Still, a consortium led by Bain Capital appears to have faith that it will get there in the end, presumably buoyed by the FDA awarding breakthrough device designation to the device last month. A US filing for humanitarian device exemption is planned for the second half of this year, as are supplementary EU filings.