US approves Kiwi asthma inhaler

Auckland medical devices company Nexus6 has gained American Food and Drug Administration approval for one of its products, enabling it to sell into the United States for the first time.

Nexus6 is the company behind the Smartinhaler technology, developed by company founder and asthma sufferer Garth Sutherland nine years ago.

It puts a microprocessor into an asthma or other type of inhaler, recording up to a year's worth of dosage information which can then be downloaded by doctors, hospitals and researchers.

The technology allows better management of patients' conditions and provides realtime data for research.

Nexus6 has been following a fast growth plan since graduating from Auckland University's Icehouse business incubator programme in 2003.

It has gone through two rounds of angel investment funding and has been exporting for some time.

However, its SmartTrack product is the first to gain FDA 510(k) marketing clearance.

Garth Sutherland said Nexus6 had customers waiting for the product and without FDA approval the company wasn't free to operate in the US.

"It really is a major milestone for a developing medical device company."

The approval covers the SmartTrack device, docking station and software.

SmartTrack can be used to manage asthma and chronic obstructive pulmonary disease, which an estimated 44 million Americans suffer from.

It allows doctors to see when patients' conditions are not under control because they are not taking their medication correctly, and lets researchers determine how effective the medication is.

This year Nexus6 signed a deal with a New Jersey company, MicroDose Technologies, to apply Smartinhaler technology to an electronic dry powder inhaler it makes.

However, it did not need FDA approval for this because it was a co-development agreement, Sutherland said.

Nexus6 was now seeking more partnerships with US companies, particularly those with channels in to the American respiratory research market, he said.

Nexus6 made a profit for the first time this year, but the challenge was to balance growth with profitability, Sutherland said.

"It's always a question of how quickly can you grow.

"We could load up on resources and quickly go back to where we were before."

Sutherland praised government agencies the Foundation for Research, Science and Technology and New Zealand Trade and Enterprise for their help with the FDA approval and the company's entry into the United States.