First US implant for Ventracor

Sydney-based Ventracor (ASX:VCR) has implanted its first VentrAssist left ventricular assist system (LVAS) in the United States.

The implant is part of an FDA-approved feasibility study in ten patients at up to five hospitals across the United States. The procedure was performed by a team led by Prof Bartley Griffith at the University of Maryland Medical Center in Baltimore.

"The patient came through the operation well," said Ventracor's CEO Colin Sutton.

Sutton said that Ventracor had anticipated beginning the feasibility study by the middle of the year, and the first US implant means the company has achieved that milestone. It is expected that the feasibilty study will be completed by the end of the year.

"Once that's done then we would hope to monitor those patients, and then write up the results and send it into the FDA and wait for their approval to start off on the pivotal trial, which we think all and all that might be this time next year," he said.

Ventracor expects bridge to transplant trials and alternative to transport (or destination therapy) trials to begin in the US sometime next year, said Sutton.

Sutton said that the US presents a harder "regulatory hurdle to jump" but the offsetting factor is that Ventracor expects reimbursement for the implants which currently cost approximately AUD$100,000 each.

Ventracor has a market capitalisation of AUD$265 million and as at June 30, had $33 million in cash and a burn rate of $2.4 million a month. "If you do those sums, it means that we'll have to do a capital raising in the reasonable future," said Sutton.