{"id":722,"date":"2011-09-28T00:00:00","date_gmt":"2011-09-28T05:00:00","guid":{"rendered":"http:\/\/lightage.com\/web\/uncategorized\/september-28-2011-light-age-inc-receives-fda-approval-for-the-treatment-of-onychomycosis-using-its-q-clear-q-switched-ndyag-laser-system\/"},"modified":"2017-09-06T09:31:55","modified_gmt":"2017-09-06T14:31:55","slug":"september-28-2011-light-age-inc-receives-fda-approval-for-the-treatment-of-onychomycosis-using-its-q-clear-q-switched-ndyag-laser-system","status":"publish","type":"post","link":"https:\/\/lightage.com\/web\/press-release\/september-28-2011-light-age-inc-receives-fda-approval-for-the-treatment-of-onychomycosis-using-its-q-clear-q-switched-ndyag-laser-system\/","title":{"rendered":"September 28, 2011 \u2013 Light Age Inc. receives FDA approval for the treatment of onychomycosis using its Q-Clear\u2122 q-switched Nd:YAG laser system"},"content":{"rendered":"[vc_column_text disable_pattern=”true” align=”left” margin_bottom=”0″ width=”1\/1″ el_position=”first last”]\n

Clearance by the Food and Drug Administration provides a new, effective way of treating infected nails using\u00a0<\/strong><\/em>laser therapy.<\/strong><\/em><\/p>\n

September 28, 2011 \u2013 Light Age Inc., a Somerset, NJ based private developer and manufacturer of laser\u00a0products, has received US FDA marketing approval for its Q-Clear\u2122 laser systems for the treatment of\u00a0onychomycosis. Onychomycosis, more commonly known as nail fungal infection, is caused by common\u00a0dermatophytes, such as Trichophyton rubrum, that infect the nail bed and matrix. Because the infection\u00a0resides in areas that are hard to access, such as the underside of the nail plate, it has been historically difficult\u00a0to treat. Onychomycosis affects tens of millions of people in the United States and many more worldwide. In\u00a0addition to causing disfigurement and discomfort, the resulting lesions provide access for other opportunistic\u00a0diseases that can result in severe medical problems, especially for people with circulatory issues in their\u00a0extremities, including diabetics, paraplegics, and the elderly. The Q-Clear\u2122 laser system provides a\u00a0revolutionary, minimally invasive and highly effective treatment for onychomycosis. With it, fast, effective,\u00a0low cost treatments can now become commonly available through dermatologists, podiatrists, and other\u00a0professional healthcare providers.<\/p>\n

\u201cOnychomycosis has long caused both physical harm and emotional distress to millions of people. Its\u00a0treatment has been challenging: topical therapies have had limited efficacy and systemic medications have\u00a0had significant and potentially serious side effects. As a result, treatment options have been limited and\u00a0courses of treatment long, expensive, and frustrating,\u201d commented Dr. Donald Heller, CEO of Light Age,\u00a0Inc. \u201cLasers provide a unique capability in penetrating the nail plate and dermal tissues and directly treating\u00a0the infection, without causing significant side effects or pain.\u201d<\/p>\n

Dr. James Holfinger, of Southwest Foot and Ankle Associates, Inc. in Cleveland, Ohio, primary investigator\u00a0for the 12 month randomized clinical study, added, \u201clasers now provide a superior option for treatment of\u00a0onychomycosis. The Q-Clear laser system provides highly effective treatment for many patients without the\u00a0need for use of systemic medications which often require blood testing to monitor for potentially serious\u00a0complications\u201d. Since pioneering the use of the Q-Clear\u2122 laser system in the field of podiatry, Dr.\u00a0Holfinger states \u201cthe unique characteristics of this laser provide advantages not associated with any other\u00a0treatment or laser system currently available.\u201d<\/p>\n

The Q-Clear\u2122 is the only q-switched laser system that has received FDA approval specifically for the\u00a0clearance of nails infected by onychomycosis.\u00a0Ms. Betsy Reddington, Director of Regulatory Affairs at Light Age Inc. mentioned, \u201cThe Q-Clear\u2122 has had\u00a0FDA approval for general surgery and dermatology since 2003 and has been shown to be safe and effective\u00a0in treating multiple indications for use in surgery, dermatology, and now in podiatry. In our 12-month\u00a0randomized clinical study following subjects of both genders, including Caucasian, Asian, African\u00a0American, and Latino subjects, the Q-Clear\u2122 laser system has proven to be substantially effective in\u00a0clearance of dystrophic nails having a clinically apparent diagnosis of onychomycosis. Statistical analysis\u00a0of results indicates significant apparent clearing in 95% of the subjects treated with an average clearance of\u00a0affected areas of 56\u00b17% at 98% level of confidence. The protocol employed was extremely well tolerated\u00a0by patients; no pain was reported, although some patients reported feeling a low-level sensation on some\u00a0involved nails. Reported patient satisfaction was 100%. No significant adverse reactions or responses were\u00a0observed or reported. We are very proud to receive FDA approval specifically for the treatment of\u00a0onychomycosis. We are even more happy to know our laser has been found to be safe and effective in\u00a0treating a disease that affects so many people and which can be most troubling for individuals with\u00a0compromised circulation in their extremities.\u201d<\/p>\n

For more information contact Light Age\u2019s marketing department at 732-563-0600<\/p>\n

or email us at\u00a0sales@192.163.194.50<\/a>.<\/p>\n[\/vc_column_text] [mk_button dimension=”three” size=”small” bg_color=”#0b1fb8″ text_color=”light” icon=”moon-file-pdf” url=”http:\/\/192.163.194.50\/~lightag3\/web\/wp-content\/uploads\/Q-Clear\u2122-Onychomycosis-Press-Release.pdf” target=”_blank” align=”center” margin_top=”0″ margin_bottom=”15″ animation=”fade-in” width=”1\/1″ el_position=”first last”]\n

Click here to view or download the press release as a PDF file<\/p>\n[\/mk_button]\n","protected":false},"excerpt":{"rendered":"

[vc_column_text disable_pattern=”true” align=”left” margin_bottom=”0″ width=”1\/1″ el_position=”first last”] Clearance by the Food and Drug Administration provides a new, effective way of treating infected nails using\u00a0laser therapy. September 28, 2011 \u2013 Light Age Inc., a Somerset, NJ based private developer and manufacturer of laser\u00a0products, has received US FDA marketing approval for its Q-Clear\u2122 laser systems for the […]<\/p>\n","protected":false},"author":2,"featured_media":720,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7],"tags":[27,28,18,29,30,31,32,33,34,35,36,37,25],"class_list":["post-722","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-release","tag-fungal-nails","tag-fungus","tag-laser","tag-nail","tag-nail-funus","tag-onychomycosis","tag-podiatric","tag-podiatry","tag-q-clear","tag-q-switched","tag-qclear","tag-toenail","tag-treatment"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/lightage.com\/web\/wp-content\/uploads\/2017\/09\/Admin-Login-Logo.png","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p8ffg7-bE","jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/posts\/722","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/comments?post=722"}],"version-history":[{"count":0,"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/posts\/722\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/media\/720"}],"wp:attachment":[{"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/media?parent=722"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/categories?post=722"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lightage.com\/web\/wp-json\/wp\/v2\/tags?post=722"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}