Norwood leaps to market as FDA approves device

Nine months of waiting with bated breath ended this week when Norwood Abbey finally received 510(k) approval from the US Food and Drug Administration (FDA) to begin marketing its laser-assisted drug delivery device as a means to quickly and efficiently deliver local anaesthetic to the skin.

The announcement has driven Norwood's share price (ASX: NAL) up 13 cents this week to settle around 65 cents.

"We're pretty excited, it's a great way to start the year," said Bernie Romanin, director of marketing at the Melbourne-based biotechnology and devices company. "This is really the platform technology that Norwood Abbey was established on two years ago."

Norwood's device uses a laser to temporarily alter the surface of the skin, allowing more efficient application of topical drugs such as the local anaesthetic lidocaine, the first drug to be approved for use with the device.

"The FDA approval was pivotal as it validates the base technology," said Romanin. He noted that while 510(k) approval for medical devices was usually granted in three or four months, the Norwood application was complicated by being a device/drug combination.

The device as approved will be used to provide local anaesthesia for procedures requiring needle-sticks, such as injections and insertion of intravenous devices, as well as blood donations.

But Norwood also believes that the device's use goes beyond the application of local anaesthetics to the effective delivery of a large range of drugs across the skin, including vaccines and anti-inflammatory drugs.

While the company plans to begin marketing the laser system in the US by the middle of the year, there is a lot to do before it officially launches the device on the US market, said Romanin. First and foremost on the list will be finalising the manufacturing contracts.

"Within the next week, we'll be selecting companies to manufacture the device and the tips," said Romanin. Norwood already has a relationship with Ferndale Laboratories, a US-based pharmaceutical company who will work with Norwood on sales, distribution and marketing, as well as provide disposable tips packaged with its local anaesthetic Ela-Max.

And the company has appointed Mark McLoughlin as vice-president for the laser project in North America. McLoughlin's responsibilities include coordinating all aspects of the laser project including manufacturing, market development, sales, marketing and distribution.

In addition, Norwood plans to have European CE Mark approval by the end of the year, to allow them to begin marketing the device there.

"The next key milestone for Europe is to lock in a partner like Ferndale. We expect to be in Europe by the beginning of next year," said Romanin.

Although Norwood has estimated that around 10,000 of the devices will be in use in the US by the end of 2005, generating approximately $AUD20 million for the company per annum primarily in sales of the disposable tips used with the device, Romanin said that the company hopes to have 1000 units in place by the end of this year. He noted that requests had already been coming in from interested clinicians and healthcare professionals.