Trial report sparks Ventracor trading halt

Ventracor (ASX:VCR) called a trading halt this morning in the wake of a newspaper report the company said "could be misinterpreted" to suggest a pilot trial of its VentrAssist heart device would be delayed.

The article in the Sydney Morning Herald said the trial, at Melbourne's Alfred Hospital, had been delayed while the hospital reviewed the device after one of the trial's patients died earlier this month.

The article quoted a hospital spokesperson as saying that "the review could take as long as a coronial inquest -- up to two years -- although it would probably be less."

The Alfred's public affairs manager, Trisha Lee, today confirmed that she had made the comments, adding that "I was being flippant when I said two years, [it is] a matter of waiting and seeing."

"Certainly about the halfway mark it is an appropriate time for review, but also because there have been two deaths," Lee said. " It is not unexpected that some of the patients might die. It is very important that we review carefully whether the device works and whether it is safe. The decision to conduct the review was made by ethics committee and the surgeon. It is a normal process."

Lee said that the hospital did not get involved in the company's continuous disclosure obligations to the Australian Stock Exchange.

Ventracor called a trading halt at 10:15 this morning, citing the SMH article "which contained information that could be misinterpreted to suggest a delay in the pilot trial of its VentrAssist device."

"Ventracor is currently seeking clarification from the Alfred hospital," the company said in a statement. At press time a meeting between management from both Ventracor and the Alfred was still underway.

Ventracor has stated repeatedly over the 14 months since the first patient received the 'artificial heart' implant that in order to be eligible for the experimental therapy, patients must be gravely ill, not eligible for heart transplantation and no longer responding to optimal medical therapy.

Of the five patients who have taken part in the trial, two have died. Following the first death in January, Prof Don Esmore, the trial's chief medical investigator, said that the VenrAssist device had "functioned well". On March 10 Ventracor informed the ASX that the device implanted in the second patient to pass away had "performed as expected".

Stockbroker Glenn Crichton, of Baillieu Polkinghorne, told his clients in an email today that he thought the way the story had been reported was "disturbing". He said the company had not been notified of any decision to suspend the trial, and suspension of the trial would not have occurred without robust debate with the surgeons and Ventracor executives.

"The appearance of the news article reflects a serious breach of confidentiality at the Alfred Hospital," Crichton wrote. "I find it very hard to believe that a major decision such as a trial suspension was made without informing the company. Clearly, there is a real risk of there being a sell-off when the stock is resumes trading... I remain confident in their product and its commercial potential." When the first VentrAssist trial patient died in January, the company was criticised for not making a statement until two days later.

Shares in the company have been falling steadily since their peak last year, closing yesterday at AUD$1.60.