Xcell collaborators earn $1m NIH grant

Collaborators of Perth devices company Xcell Diagnostics (ASX:XEL) have received a US NIH grant worth more than AUD$1 million (US$702,000) to perform clinical studies on Xcell's Funhaler paediatric asthma spacer device.

The grant, made to researchers at the University of Western Australia and the TVW Institute of Child Health led by Prof Peter LeSouef, will be used to test the performance of the Funhaler to FDA standards, specifically looking at whether previously observed effects of the device on the adherence of paediatric medication is sufficient to result in an improved deposition in the airways of asthmatic children.

Xcell CEO Dr Saliba Sassine said it was pleasing to see successful funding of Australian research by the US NIH.

"It takes the pressure off us as well, as we would have had to fund the study ourselves," he said.

Sassine said that the clinical program would commence shortly, and was expected to run for up to three years. However the trial results would not be required for US FDA approval of the device, and the company was expecting to submit a 510K application early next year.

"In practical terms we will be able to apply to the FDA before the study is completed, but it is always good to keep providing information to physicians," Sassine said.

Xcell also plans to file for European approval for the Funhaler at the same time as the FDA filing. The device has already been listed on the Australian Therapeutic Goods Register.