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Radiancy Receives FDA Clearance For The ClearTouch(TM) Light Unit Assembly


10/19/2005 5:09:31 PM

ORANGEBURG, N.Y., Dec. 15 /PRNewswire/ -- Radiancy, Inc., the global leader in light-based skin therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted it clearance to market the company's unique ClearTouch(TM) Light Unit Assembly (LUA) for the treatment of acne vulgaris. With the new clearance, the Radiancy technology becomes the first light-based therapy in the world to be indicated for the treatment of pustular inflammatory acne. The ClearTouch LUA expands the treatment applications available with Radiancy's phototherapy systems, including SkinStation(R), the company's flagship product in the U.S.

(Photo: http://www.newscom.com/cgi-bin/prnh/20031215/LAM092 )

As a result of the indication, physicians now have a new, safe and effective phototherapy modality to combat acne. By allowing patients to enjoy faster treatment results and freedom from medications, SkinStation with ClearTouch represents a significant medical advance in professional skin care.

Acne vulgaris is the most commonly treated skin condition in the U.S., afflicting 17 million people, according to the National Institutes of Health, and accounts for approximately 30 percent of all dermatology visits. An estimated $5 billion is spent annually in the U.S. on topical preparations, oral medications and other acne treatments.

According to Fabian Tenenbaum, vice president of marketing and sales for Radiancy, "This breakthrough provides clear benefits to both physicians and patients. SkinStation with ClearTouch optimizes the synergy of light and heat energy (LHE) to create the next generation in light-based therapy for acne. ClearTouch was designed to penetrate deeper than first-generation systems that employ only blue light. As a result, SkinStation with ClearTouch has demonstrated its effectiveness in the treatment of acne, including the treatment of pustular inflammatory acne."

To treat acne, ClearTouch delivers penetrating green-yellow light that activates a photothermal reaction in the porphyrin molecules, causing the release of free oxygen to destroy P. acnes bacteria. Direct heat delivered to the skin accelerates the photothermal reaction and bacteria destruction. Pulsed light in the red spectrum further activates the porphyrin, and also helps reduce the inflammation associated with active acne.

"We now have another modality to use while dealing with the growing antibiotic resistance of acne," says Barry Ginsburg, M.D., a dermatologist in private practice in Birmingham, Ala. "I would expect long-lasting results. ClearTouch is a very safe, easy advance in acne treatment. It's also suitable for any age and any gender."

Physicians in the U.S. have already gained significant clinical experience with SkinStation. Since 2002, under the National Acne Research Project (NARP), investigational use of the modality for the treatment of severe acne vulgaris has been conducted in 70 U.S. clinical sites. Using the ClearTouch LUA, physicians have achieved up to 90 percent clearance of inflammatory acne lesions in one month.

"During the study, we treated 40 patients with ClearTouch and saw good results when dealing with inflammatory acne," states Dr. Neal Gregory, a dermatologist in private practice in Chatam, N.Y., and a primary NARP investigator. "Over the length of the protocol, nearly all patients improved. Then after the protocol, when combined with other modalities, including glycolic peels, patients showed excellent improvement quickly. Further, throughout the study and in subsequent usage, patients experienced virtually no side effects. Based on our experience, I think ClearTouch is a good therapy that a lot of people will benefit from."

According to Steven Shapiro, M.D., a dermatologist in Palm Beach Gardens, Fla., "Sometimes patients don't respond to topical and oral medications when treating acne. ClearTouch provides us with an entirely new mechanism of treatment. We've seen either significant improvement or clearing, which has now lasted for several months. Patient satisfaction has been great in that it is a very simple treatment for them. An added benefit is that the texture of their skin appears to improve as well. Discolored scars also tend to lighten."

ClearTouch causes light activation of the natural porphyrins of the P. acnes according to Ava Shamban, M.D., a clinical assistant professor of dermatology at the University of California School of Medicine, Los Angeles, and a NARP investigator. "The light and heat appear to stimulate some kind of a photochemical reaction within the skin itself that helps normalize or reverse some of the inflammatory process of the acne," says Shamban.

"Internationally, SkinStation with ClearTouch accounts for 50 percent of all light-based acne treatments," notes Tenenbaum. "Unlike older technologies, SkinStation can be used to successfully treat a variety of conditions, including vascular and pigmented lesions, and hair removal, using a single phototherapy system. This new acne indication underscores the versatility of SkinStation, powered by LHE, as well as Radiancy's commitment to provide exceptional value in products that deliver unparalleled safety and efficacy in the treatment of a wide variety of dermatological conditions," says Tenenbaum.

About Radiancy

Founded in 1998, Radiancy, Inc., leads the world in developing unique professional and consumer medical products employing its proprietary Light Heat Energy (LHE) technology. The company's mission is to deliver light-based therapeutic systems that improve the lives of people while enhancing clinical practice. Radiancy serves a worldwide clinical community from its headquarters in Orangeburg, New York, and from offices in Europe, Asia and Latin America.

For more information about SkinStation with ClearTouch, please contact Fabian Tenenbaum at 845-398-1647 or visit http://www.radiancy.com/.

SkinStation and LHE are registered trademarks of Radiancy, Inc. ClearTouch is a trademark of Radiancy, Inc.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031215/LAM092AP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comRadiancy, Inc.

CONTACT: Fabian Tenenbaum of Radiancy, Inc., +1-845-398-1647


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