Pulmosonix brings forward clinical trials
Tuesday, 12 November, 2002
Melbourne devices company Pulmosonix is planning to start clinical trials for its two medical devices earlier than originally foreshadowed, according to a recent announcement by parent company Premier Bionics.
Premier Bionics CEO Martin Soust said that the possibility of accelerating the clinical programs was highlighted during a recent technical review.
"During the course of the discussions it was obvious that certain things could be achieved faster," Soust explained. A further incentive, which allowed Premier Bionics to provide additional resources to Pulmosonix, was a $250,000 Biotechnology Innovation Fund grant that Pulmosonix received in August, he said.
As a result, Pulmosonix now plans to commence clinical trials earlier than originally scheduled for the two products it currently has in development.
First off the blocks will be the upper airway patency monitoring (UAPM) diagnostic device for diagnosis of obstructive sleep apnoea, which is expected to be first used in clinical trials in December. Soust said that results from this initial trial, which would probably include around 20-24 patients, would probably be available in the second quarter of next year.
"It's fundamentally a tool that should simplify the diagnosis of obstructive sleep apnoea," said Soust. The non-invasive device essentially monitors airflow through the patient's airway using acoustic technology developed at Monash University's Ritchie Centre for Baby Health Research.
Close on the heels of the UAPM will be clinical trials of Pulmosonix's second application based on the acoustic platform technology, a device that enables monitoring of the lungs in infants with respiratory distress. The lung inflation monitor (LIM) is designed to work as an add-on to ventilation machines and determines the extent that lungs are being inflated.
According to Soust, this clinical trial will probably start in the middle of 2003 and data from the first series of patients will be available towards the end of 2003.
The company will be looking at performing the early clinical trials in Melbourne, and possibly other Australian centres, depending on required institutional approvals and patient enrolments.
But Premier Bionics has plans to licence or partner out the technology before larger trials are required for the devices.
"We think there are companies that are better placed to go through the regulatory process, manufacturing and distribution of medical devices," explained Soust. "We would hope to talk to potential partners in the first part of next year."
He said that Premier Bionics was keeping an open mind about opportunities for licensing and partnering, with the possibility of one or more companies being approached.
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