MEDICAL devices developer Visiomed Group has secured the crucial regulatory clearance that paves the way for the commercialisation of its Funhaler asthma spacer into the lucrative US market.
MEDICAL devices developer Visiomed Group has secured the crucial regulatory clearance that paves the way for the commercialisation of its Funhaler asthma spacer into the lucrative US market.
The company has also cleaned up its product portfolio, selling its microDERM product back to the company it bought from to free up resources to concentrate on its microEYE project.
The Food and Drug Administration approval clears the way for Visiomed to start selling its Funhaler into the US, which is the world’s biggest market for medical devices, in the June quarter.
The Funhaler, which incorporates whistles and spinning disks to encourage children to take their asthma medication properly, is protected by international patents.
Visiomed CEO Saliba Sassine said of about 120,000 units a year to break even.
“Global annual sales of about 500,000 units would bring a positive cash flow in excess of $3 million,” he said.
Dr Sassine said the company had opted not to sell its Funhaler anywhere, including Australia where it has Therapeutic Goods Administration approval, until the FDA approval came through.
“We thought it better to wait until we could go into the US, rather than going into smaller markets such as Australia on a piecemeal basis,” he said.
The company appointed Austrade last year to help it find distributors in the US, Canada, Japan, the UK, Italy, France, Spain, Germany and Sweden.
It has also appointed ABX Logistics to manage its supply chain deliveries and Australian company ITL to manufacture its device at its Malaysian facility.
Dr Sassine said the company had just taken delivery of its first run of Funhalers and was undergoing 100 per cent inspection.
“You have to be very careful because while it has a fun aspect, it is a drug delivery device,” he said.
Dr Sassine said the sale of its German skin cancer and dermatological imaging business microDERM back to its original owner ZN GmbH came after an internal review.
“We looked at it and noticed nobody in that space was making significant headway,” he said.
That sale is expected to reap at least $1.15 million, in the form of the cancellation of ZN GmbH’s existing debt and all the shares and unlisted options it holds in Visiomed.
Visiomed has decided to concentrate on its microEYE product which is aimed at developing computer-based imaging systems for the diagnosis of a number of eye diseases including glaucoma, diabetic retinopathy, trachoma and cataract.
The $1.15 million for the microDERM sale comes courtesy of debt cancellation.
