Xcell appoints regulatory team for US, Europe push

Perth-based devices group Xcell Diagnostics (ASX: XEL) has gathered up a specialised regulatory affairs team to drive United States and European registration of its Funhaler product.

The paediatric inhalation device is intended to make medications less fearful for children through the use of breath-driven incentive toys attached to it, such as whistles and spinning discs, to encourage the child to inhale more.

The developer, InfaMed, was acquired by Xcell late last year and subsequently attracted a $470,000 National Health and Medical Research Council Development Project Grant over three years.

In March, Xcell announced that a commissioned report on the rollout of the Funhaler had recommended against devoting resources to a limited commercial release in Australia, which has just 2 per cent of the world market.

Instead, it advised the company to fast track its application for registration in the US and Europe, which would give it access to more than 75 per cent of the world market.

In the latest news, Xcell said US-based FDA expert Dr Ken Collins would lead the company's preparations and lodgement of documentation for the product's registration.

Newly appointed CEO Dr Saliba Sassine said Collins was currently vice-president of regulatory affairs at Alsius Corporation in the US, before which he worked as corporate vice-president and technical advisor at Boston Scientific Corporation.

Collins will be assisted by Lorraine Glover, an Australian commercial biotechnology industry specialist, who has been named manager for regulatory affairs.

Sassine said Xcell aimed to have the Funhaler approved for sale in the US and Europe within nine months.