Norwood Abbey's laser awaits FDA approval
Thursday, 18 April, 2002
Norwood Abbey (ASX:NAL) today announced it was awaiting FDA approval for its newly patented laser drug delivery system for anaesthesia.
The Melbourne company said it had submitted an application to the US drugs authority for approval to market the technology in that country.
In a statement to the ASX, marketing director Bernie Romanin said the submission of the application was a major milestone in the commercialisation of the technology.
"The use of Norwood's laser device to remove the stratum corneum (the outermost layer of skin) prior to application of the drug reduces substantially the time to onset of anaesthesia," he said.
"It is also a painless procedure."
The company said it had submitted a 510(k) application covering the use of the laser device together with local anaesthetic.
It explained that it had employed Washington-based consultants to review the submission and assist in its preparation in order to facilitate the process.
"The FDA application has also been framed to ensure that the greatest flexibility in marketing Norwood's laser device and the associated Norwood disposable tips is achieved," the statement said.
The company said the Australian Patent Office had recently issued a patent related to the use of the laser to deliver anaesthetic transdermally.
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