Israeli startup raises $10M to back transcatheter aortic valve stenosis treatment

Pi-Cardia has raised $10 million from a syndicate that includes a new, undisclosed strategic investor to address the burgeoning transcatheter aortic valve replacement (TAVR) market. The Rehovot, Israel-based startup anticipates that its Leaflex Catheter System could offer a less-invasive, less-expensive nonimplant option to both complement and potentially replace TAVR.

Rather than replace the valve, the procedure works to fracture valve calcification via mechanical energy--thereby helping to restore leaflet mobility. The catheter-based treatment requires only several seconds to apply once in place. It's expected to be useful in the facilitation of TAVR approaches, as well as to be sufficient in itself as an alternative to them. Existing balloon-based devices designed to do something similar can lead to short-term recoil, the company noted.

"Besides the typical case of an eighty-five-year-old patient with a tri-leaflet aortic valve, whom I will simply have more options to offer, there are also some common anatomies such as bicuspid aortic valves, where TAVR delivers suboptimal results," said Dr. Ganesh Manoharan, Consultant Cardiologist at the Royal Victoria Hospital in Belfast, Ireland, in a statement. "We believe that if a simpler, lower-cost alternative existed, which could offer patients a reasonable period of time without symptoms, such a technique could have an important role alongside TAVR."

Founded in 2009, Pi-Cardia has completed enrollment on the first set of patients for a European study. This financing is slated to allow the company to develop a second-gen device, as well as continue these clinical efforts toward gaining a CE mark.

In addition to the mystery strategic investor, the syndicate on this financing included Italian funds Innogest and Fondo Atlante Ventures, Chinese fund VI-Ventures as well as existing investors including Clal Biotechnology Industries and Anatomy Medical Technologies.

"As much as TAVR improves and becomes a routine procedure in lower surgical risk patients, it is still a relatively complex and expensive implantation procedure, which restricts its use to specific centers and specific cases" says Pi-Cardia founder and CEO Erez Golan. "In today's budget sensitive environment, waiting lists for TAVR are common even in the most developed countries, let alone in emerging markets, where TAVR may not be a viable option for a while."

- here is the announcement