Light Age Inc. receives FDA approval for the treatment of onychomycosis -- MEDICA - World Forum for Medicine


Light Age Inc.

Light Age Inc. receives FDA approval for the treatment of onychomycosis

Clearance by the Food and Drug Administration provides a new, effective way of treating infected nails using
laser therapy.
September 28, 2011 – Light Age Inc., a Somerset, NJ based private developer and manufacturer of laser
products, has received US FDA marketing approval for its Q-Clear™ laser systems for the treatment of
onychomycosis. Onychomycosis, more commonly known as nail fungal infection, is caused by common
dermatophytes, such as Trichophyton rubrum, that infect the nail bed and matrix. Because the infection
resides in areas that are hard to access, such as the underside of the nail plate, it has been historically difficult
to treat. Onychomycosis affects tens of millions of people in the United States and many more worldwide. In
addition to causing disfigurement and discomfort, the resulting lesions provide access for other opportunistic
diseases that can result in severe medical problems, especially for people with circulatory issues in their
extremities, including diabetics, paraplegics, and the elderly. The Q-Clear™ laser system provides a
revolutionary, minimally invasive and highly effective treatment for onychomycosis. With it, fast, effective,
low cost treatments can now become commonly available through dermatologists, podiatrists, and other
professional healthcare providers.
“Onychomycosis has long caused both physical harm and emotional distress to millions of people. Its
treatment has been challenging: topical therapies have had limited efficacy and systemic medications have
had significant and potentially serious side effects. As a result, treatment options have been limited and
courses of treatment long, expensive, and frustrating,” commented Dr. Donald Heller, CEO of Light Age
Inc. “Lasers provide a unique capability in penetrating the nail plate and dermal tissues and directly treating
the infection, without causing significant side effects or pain.”
Dr. James Holfinger, of Southwest Foot and Ankle Associates, Inc. in Cleveland, Ohio, primary investigator
for the 12 month randomized clinical study, added, “lasers now provide a superior option for treatment of
onychomycosis. The Q-Clear laser system provides highly effective treatment for many patients without the
need for use of systemic medications which often require blood testing to monitor for potentially serious
complications”. Since pioneering the use of the Q-Clear™ laser system in the field of podiatry, Dr.
Holfinger states “the unique characteristics of this laser provide advantages not associated with any other
treatment or laser system currently available.”
The Q-Clear™ is the only q-switched laser system that has received FDA approval specifically for the
clearance of nails infected by onychomycosis.
Ms. Betsy Reddington, Director of Regulatory Affairs at Light Age Inc. mentioned, “The Q-Clear™ has had
FDA approval for general surgery and dermatology since 2003 and has been shown to be safe and effective
in treating multiple indications for use in surgery, dermatology, and now in podiatry. In our 12-month
randomized clinical study following subjects of both genders, including Caucasian, Asian, African
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American, and Latino subjects, the Q-Clear™ laser system has proven to be substantially effective in
clearance of dystrophic nails having a clinically apparent diagnosis of onychomycosis. Statistical analysis
of results indicates significant apparent clearing in 97% of the subjects treated with an average clearance of
affected areas of 56±7% at 98% level of confidence. The protocol employed was extremely well tolerated
by patients; no pain was reported, although some patients reported feeling a low-level sensation on some
involved nails. Reported patient satisfaction was 100%. No significant adverse reactions or responses were
observed or reported. We are very proud to receive FDA approval specifically for the treatment of
onychomycosis. We are even more happy to know our laser has been found to be safe and effective in
treating a disease that affects so many people and which can be most troubling for individuals with
compromised circulation in their extremities.”
About Light Age, Inc.
Since its founding in 1986, Light Age, Inc. has been the inventor, innovator, and preeminent developer of
alexandrite laser technology as well as a pioneer in the development of many other advanced laser
technologies. Additionally, Light Age has played a major role in creating and establishing numerous
advanced applications based on solid-state laser media and nonlinear optical processes. Today, Light Age is a
leading supplier of advanced laser systems worldwide for almost every application from fundamental research
to medical diagnostics and therapeutics to aesthetic laser procedures. Its products are sold under its own name
brands and in OEM and embedded products distributed by other device manufacturers. In addition to its
commercial manufacturing, Light Age develops custom laser systems and new laser capabilities under contract
and in strategic partnerships. Light Age frequently develops and engineers laser systems with flexible and/or
highly specialized capabilities for applications requiring new, difficult, and sometimes seemingly impossible
laser characteristics.