MELBOURNE, Australia, Jan. 15 -- The US Food and Drug Administration (FDA) has granted 510(k) marketing approval for Norwood Abbey Ltd.'s laser-assisted drug delivery (LAD) device for "ablation of the outer layer of the skin prior to the application of OTC topical 4 percent lidocaine cream, for local dermal anesthesia."
The LAD, compromising a laser device and single-use disposable tips, is designed to painlessly and temporarily alter the stratum corneum, or outer layer of skin, for more effective delivery of topically applied drugs.
Norwood's North American marketing partner for the LAD, Ferndale Laboratories Inc., will package Norwood disposable LAD tips with its over-the-counter topical anaesthetic, Ela-Max. Mark McLoughlin was appointed a vice-president for the laser project in North America.
The primary market for the product is expected to be patients undergoing various procedures requiring needle-sticks, including injections, intravenous insertions and blood donations. The company is targeting clinicians in dermatology/plastic surgery, oncology pediatrics, and blood donation facilities.; Norwood said it expects to sell or place 10,000 devices by the end of 2005.
For more information, visit: www.norwoodabbey.com