03/12/2007 - 11:52

Visiomed takes major step into US market

03/12/2007 - 11:52


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Nedlands-based Visiomed Group Ltd has secured United States FDA clearance for its redesigned and improved 'Funhaler' paediatric asthma incentive spacer.

Visiomed takes major step into US market

Nedlands-based Visiomed Group Ltd has secured United States FDA clearance for its redesigned and improved 'Funhaler' paediatric asthma incentive spacer.

FDA notification of pre-market clearance allows Visiomed to market and sell the improved Funhaler into the US, the world's biggest market for medical devices.

The achievement is timely for fledging UK-based biomedical company Clinical Cell Culture Ltd (C3), given the announcement last month that it was planning to merge with Visiomed.

The improvements to the Funhaler design evaluated by the FDA included a redesigned incentive module, a redesigned and patent-pending low-flow valve controlling delivery of medication and a number of improved manufacturing processes.

Visiomed chief executive Dr William Dolphin said the recently introduced design changes to the Funhaler significantly improved performance and the FDA determined that the implemented changes modified the existing device sufficiently to warrant 510(k) submission.

"FDA clearance of the improved device was extremely rapid" Dolphin noted.

"We received notification of 510(k) clearance from the FDA less than 60 days following submission. We're very pleased with the rapid and positive response from the FDA as 510(k) clearance is required for the Funhaler spacer product to be sold into the US market."

The Company has recently appointed Alliance Tech Medical (ATM), a pre-eminent distributor of respiratory products in the US healthcare industry, as distribution partner for the US market.

ATM has four regional headquarters located in California, Texas, Delaware and Illinois with over 30 direct sales representatives and a partnership with a nationwide group of distribution outlets.

"The US is the world's major market for medical products and is a key market for Visiomed." said Dr Dolphin.

"510(k) clearance gives us a green light to go after this important market. With a population of over 300 million there are an estimated 42 million asthmatics in the US of which approximately 10 million are under the age of nine. "

In conjunction with ATM, in the coming months Visiomed is initiating an advertising campaign in leading US respiratory journals and participating in several key respiratory and paediatric conferences throughout the US.

The company is working closely with key influencers - physicians, respiratory therapists and asthma support groups - to ensure a high level of acceptance and uptake of the Funhaler product.

Visiomed has recently completed distribution agreements in Europe, South America and the Middle East and continues discussions with key distributors in other major European and Asian markets.

The Company's spacer products - the Funhaler directed at the paediatric market and the Breath-A-Tech addressing the needs of the adolescent and adult markets - collectively account for approximately 80 per cent of spacers sold in Australia.

"We are the market leader in Australia, and as we continue to expand our global market presence Visiomed is being recognised as a significant player in the large and growing respiratory care market." Dr Dolphin said.


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