New Member Spotlight Keraderm LLC
Keraderm LLC is a medical device company with proprietary, patented, platform technology that can effectively and safely treat a wide variety of infections. This innovative light-based technology has the potential to effectively treat infections without the serious side effects that many medications have and to effectively treat infections caused by drug resistant organisms such as MRSA. Keraderm has obtained patents on its key technologies to treat infections and has a number of additional patent applications pending on refinements of its technology. Published laboratory and clinical studies indicate that the technology has great potential to effectively and safely treat infections.
Keraderm is well on the way to be the first phototherapy treatment approved by the FDA for onychomycosis (fungal nail infections) with its research published in the prestigious peer-reviewed British Journal of Dermatology and presented at the 2007 World Congress of Dermatology and the 2008 Annual Conference of the American Academy of Dermatology. Keraderm also has a growing portfolio of national and international patents that protect key aspects of its proprietary platform technology to treat infections.
Onychomycosis affects approximately 36 million Americans and the current treatment market is approximately $1.5B although there is currently no safe and effective treatment available.
“Our goal,†states Keraderm CEO Bill Cumbie, “is to develop a safe and efficacious treatment for onychomycosis that can be accessed by a large number of people at a low cost. Many people cannot use current medications due to their high cost, significant side effects, and contraindications with taking other medications. Our pilot clinical trials have indicated a safety profile as good as the best topical treatments with the efficacy of the best oral medications. We hope to establish the safety and efficacy of our treatment with the completion of our current pivotal clinical trials which will be submitted to the FDA for approval as the first phototherapy treatment for onychomycosis. The beauty of our treatment is that it can be delivered easily and inexpensively.â€
Prior clinical trials have shown this novel phototherapy treatment has the efficacy of the best oral medications with the safety profile of the best topical medications. Pivotal trials to support a 510k application to the FDA are currently being concluded and it is expected that FDA clearance will be obtained in mid-2009. Currently, Keraderm is seeking its first round of venture capital to commercialize its treatment in 2009.
