HAMPTON, Va., Sept. 9 Is it possible to use the healingpower of light to treat infections? Keraderm, a leader in the development oflight-based treatments for infections, thinks so. Keraderm today announcedfull enrollment for pivotal trials to obtain FDA clearance of its phototherapytreatment for onychomycosis (fungal nail infections). The objectives of thepivotal trials are to confirm the efficacy and safety of Keraderm's treatmentfor patients with onychomycosis.
Eighty-five subjects with confirmed onychomycosis have been enrolled inthe prospective, placebo controlled, double blind, multi-site trial. Studyobjectives include assessing safety, clinical improvement, mycological cureand visual improvement of the treated nail. Patients will receive four twenty-minute treatments over a four-week period and will be followed up to assesssafety and efficacy of the treatments after several months.
Keraderm's germicidal light technology has been clinically shown tosuccessfully inactivate the organisms that cause onychomycosis. The results ofKeraderm's collaboration with the Wellman Center for Photomedicine, anaffiliate of Harvard Medical School, on a grant from the National Institute ofHealth have recently been published in the prestigious peer-reviewed BritishJournal of Dermatology. The data indicate that Keraderm's treatment iseffective at penetrating the nail and also inactivating the organisms thatcause onychomycosis. Additionally, results of Keraderm's successful pilotclinical trials at Brigham and Women's Hospital, an affiliate of HarvardMedical School, have been presented at the 2007 World Congress of DermatologyConference and the 2008 American Academy of Dermatology Conference. Thesepilot clinical trials indicated significant improvement in 73% of subjectstreated with its proprietary technology with no significant side effects.Keraderm anticipates an increased improvement rate in the current pivotaltrials due to further enhancements of its technology.
Keraderm LLC is a medical device company with proprietary, patented,platform technology for a wide variety of skin and nail infections. Thistechnology has the potential to effectively treat infections without theserious side effects that many medications have and to effectively treatinfections caused by drug-resistant organisms such as MRSA. Keraderm hasobtained patents on its key technologies to treat infections and has a numberof additional patent applications pending on refinements of its technology.Published laboratory and clinical studies indicate that the technology hasgreat potential to effectively and safely treat infections.
Statements in this press release containing the words believe, may,expect, project and other similar expressions are forward-looking statementsthat are not definite and have a number of risks and uncertainties.Representative factors that can cause actual results to differ from thoseprojected include the following: regulatory clearance of products, marketacceptance; financial constraints; government regulations; obtaining andenforcing intellectual property rights; attracting and retaining keyemployees; developing partnership opportunities; timing of commercial productlaunches; and other similar internal and external risks factors.
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SOURCE Keraderm LLC