Avastra trial delayed

The clinical trial being run by Sydney biomaterials company Avastra (ASX:AVS) for its BioWeld device has been delayed by six months due to severe post-operative complications experienced by the first patient.

"There was a post-operative complication which wasn't device-related," said Avastra's managing director Paul Ralph.

Avastra's BioWeld device is being developed as an alternative to sutures. It uses a protein solder which is activated by laser light to join arteries and veins.

The patient was undergoing free flap surgery where the failure rate is between 5 - 30 per cent, said Ralph. He could not provide more information as to what condition the patient was suffering due to the restrictions of the Medical Privacy Act and because the company is sponsoring the trial rather than conducting the trial itself.

"This has put us behind by at least six months," said Ralph.

"The initial trial schedule was very tight and optimistic, which is good," said the trial's principal investigator, Dr Peter Maitz. "It made the team work harder."

"Whilst the initial application of the BioWeld device on the first patient was a success, we experienced severe postoperative complications unrelated to the BioWeld device but patient-related, which led to the need for revision surgery," he said. "There was no adverse outcome for the patient...The patient has been disqualified from the study."

The trial could not continue until the Clinical Trail Oversight Committee had fully assessed the situation.

"We're basically starting again," said Ralph. "It's put a real hole in our timetable."

The next patient has been enrolled and Maitz is confident that patient recruitment should be completed by the end of 2005.

"The trial is back on this week," Maitz said.

However, the delay will impact on Avastra's commercialisation schedule of the BioWeld tube and also lead to delays in its European and US trials' schedules.