Premier Bionics claims sleep trial success

Premier Bionics has announced a successful clinical trial for its AirwayClear device for non-invasive detection and diagnosis of obstructive sleep apnoea (OSA), providing support for commercial discussions and laying the groundwork for a larger trial.

The device, developed by scientists at Premier Bionics' subsidiary Pulmosonix, was compared in a small study at the Monash Medical Centre's Sleep Unit to the current standard diagnostic method for OSA, polysomnography. A high correlation was found between results obtained using the two methods, suggesting that the rapid and non-invasive method may be useful in diagnosing the sleep disorder.

"Before we had completed twenty patients, at 16 patients, we had very strong... very significant data," said Premier CEO Dr Martin Soust. "The sensitivity of the device is more considerable that we initially thought, and may be able to detect partial obstructions of the airway."

Dr Philip Berger, one of the inventors of the device, and scientific director of the Ritchie Centre for Baby Health Research at Monash University, said that the device not only improved diagnosis, but also provided information with the potential to improve treatment of OSA.

The company now plans to expand the trial into a larger multi-centre study to look at the findings in more detail. Soust said he expected a multi-site trial would not begin until early 2004, due to the time required to recruit sleep centres, build more device prototypes and complete the regulatory requirements for the trial. Although trial sites in Australia would be sought, he did not rule out the possibility of conducting part of the trial offshore.

According to Soust, Premier Bionics will continue to look for a commercialisation partner for the Pulmosonix technology, but said the expanded trial program would not be dependent on having a partner.