Oculus Innovative Sciences, Inc., a specialty pharmaceutical company, announced that the company's Microcyn-based antimicrobial wound solution and wound hydrogel dressing have received Class IIb medical device registrations from the Australian Government Department of Health as well as Class IIb registrations from the New Zealand Medicines and Medical Devices Safety Authority.
The registrations, similar in substance, provide for the Microdacyn60 wound care products to be used in the debridement and moistening of chronic wounds, ulcers, cuts, abrasions and burns including those located in any human cavity such as the oral, nasal and ear. By reducing the microbial load via a local antimicrobial effect, these products assist in creating a moist environment, enabling the body to perform in its own healing process.
"Australia and New Zealand are two of the more challenging countries in terms of securing medical device registration," said Bruce Thornton, Oculus VP for international marketing/sales. "They set the bar high relative to validating both product safety and efficacy. For that reason, we recognize these registrations as continued substantiation of the Microcyn Technology's unparalleled performance in the treatment of wounds, rashes and skin infections. With these two new registrations in hand, the Microcyn Technology is now approved in over 45 countries worldwide."
For the next four months, the Microdacyn60 products will be in pre-marketing mode with various sampling programs deployed for healthcare professionals in both countries. The planned commercial launch is scheduled for January 2017 with the Microcyn-based products being distributed exclusively by Oculus' Australian/New Zealand partner, Te Arai Biofarma Limited.
Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care.