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Keraderm, which develops phototherapy treatments for infections, has announced it will introduce a $100 phototherapy treatment for onychomycosis in 2009, upon completion of current pivotal trials and pending marketing clearance from the Food and Drug Administration (FDA), PRNewswire reports.
Hampton, Va. — Keraderm, which develops phototherapy treatments for infections, has announced it will introduce a $100 phototherapy treatment for onychomycosis in 2009, upon completion of current pivotal trials and pending marketing clearance from the Food and Drug Administration (FDA), PRNewswire reports.
PRNewswire quotes Bill Cumbie, CEO of Hampton-based Keraderm, as saying, “Our pilot clinical trials have indicated the efficacy of the best oral medications with no significant side effects. We will establish the safety and efficacy of our treatment with our current pivotal clinical trials, which will be submitted to the FDA for approval as the first phototherapy treatment for onychomycosis. …
“We hope to introduce our treatment in 2009 at $100 for several treatments and continue to improve the technology so that eventually only one treatment in the $100 range will be necessary. We are also working to establish insurance reimbursement for our therapy, which will further reduce cost to the consumer.”
Keraderm research on this technology has been published in the British Journal of Dermatology and presented at the 2007 World Congress of Dermatology and the 2008 Annual Conference of the American Academy of Dermatology.