Aesthetics Product News

Syneron(TM) Unveils Elegant, Portable eMatrix(TM) Skin Resurfacing System

Syneron(TM) Medical Ltd. has launched the sleek eMatrix(TM) treatment system, a portable touch-screen device that allows physicians to program dermatological procedures requiring skin resurfacing. An exciting advancement in aesthetic procedure technology that helps physicians to treat more patients in more locations, eMatrix utilizes Matrix RF(TM), the world’s first RF-only technology for fractional ablation and skin resurfacing, which was FDA-cleared and received the CE Mark for wrinkle reduction in August. The new eMatrix system uses fractional tissue heating to provide ablation and effective resurfacing.

Biocompatibles Filing For CE Mark Approval For Dermal Filler Bead

Biocompatibles has announced the filing for CE Mark approval by the Company’s development and marketing partner Merz Pharmaceuticals GmbH for the Cosmetic Dermal Filler Bead. The product has been licensed to Merz and will be manufactured by Biocompatibles’ German subsidiary, CellMed AG. The global market for aesthetic dermal filler products1 is at least $760m2. The current market consists mainly of products manufactured from collagen and hyaluronic acid. Biocompatibles’ subsidiary CellMed manufactures the Cosmetic Dermal Filler Bead from highly purified alginate material, using a proprietary manufacturing process.

Stiefel Laboratories Announces the Expansion of Its REVALESKIN(R) Skin Care Line

Stiefel Laboratories has announced the expansion of its REVALESKIN skin care line with three new products on the heels of the extraordinarily successful introduction of the core REVALESKIN(R) skin care system (Facial Cleanser, Day Cream with SPF 15 sunscreen and Night Cream). According to a Global Industry Analysis Report (March 2008), the market for anti-aging products is predicted to reach $115.5 billion by 2010. With the launch of these three new products, the REVALESKIN(R) skin care line will meet consumer demand for professional take-home beauty products designed for targeted treatment of problem skin areas.

FDA Issues Complete Response Letter For Ceftobiprole For Treatment Of Complicated Skin Infections

Johnson & Johnson Pharmaceutical Research & Development has announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked J&JPRD to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.

LEO Pharma unveils Xamiol® for scalp psoriasis

LEO Pharma has launched a new treatment gel Xamiol® for scalp psoriasis. This gel formulation contains the proven combination of the Vitamin D analogue calcipotriol 50 microgram/g (as monohydrate) and the corticosteroid betamethasone 0.5 mg/g (as dipropionate). It is indicated for once-daily topical treatment of scalp psoriasis in adults and is recommended for four weeks and thereafter repeat treatment can be initiated under medical supervision. Xamiol®, an almost clear and odourless gel, differs from traditional scalp psoriasis treatments.

Dermipsor’s combination drug can treat psoriasis efficiently

Dermipsor Ltd. has reported detailed analysis of the results for the Phase 2b clinical trial of its product DPS-101. To be used in the treatment of psoriasis patients, DPS-101 is a new topical non-steroidal combination drug. It is a mix of two active ingredients - calcipotriol and nicotinamide. The multi-centre trial included 168 bilateral patients. Each side of the body of these patients was treated separately to evaluate the effectiveness of various doses of the medication. At the end of this 12 week study, half of the patients who received the highest dose of the drug achieved a condition of “clear to almost clear”. This is a significant improvement as compared to placebo.

Obagi’s ELASTIderm™ increases skin elasticity in 6 weeks

Obagi Medical Products, Inc has announced the publication of a study of its copper-zinc malonate eye treatment ELASTIderm™ in the September 2008 issue of the dermatology journal, Experimental Dermatology. Findings of the study conducted at Jefferson Medical College suggest that six weeks of ELASTIderm treatment can boost the biosynthesis of elastin in skin helping to repair and regenerate the elastic fiber network. It reduces the number of visible wrinkles by restoring the skin’s elasticity. The product uses a bi-mineral complex technology.

Medivir submits application for marketing Lipsovir® in Europe

Medivir has submitted an application to the European medical regulatory authorities for marketing authorization for its product Lipsovir®. The cream, a patented combination of acyclovir (an antiviral agent) and hydrocortisone (an anti-inflammatory agent) is used for preventing as well as treating cold sores. None of the already existing products on the market that are indicated for the condition have the effect that Lipsovir promises.

FDA updates Raptiva’s labeling

The U.S. Food and Drug Administration has approved updated labeling changes for Genentech Inc.’s Raptiva (efalizumab) to warn of  the dangerous infection risks (like PML) associated to its usage. A once-weekly injection, Raptiva is approved for treatment of plaque psoriasis in adult candidates for phototherapy or systemic (whole body) therapy. Also, a risk of immune system’s permanent suppression with repeated administration of Raptiva has been indicated for kids below 14 years.

FDA clearance to Reliant Technologies’ new hand pieces

The U.S. Food and Drug Administration has given 510(k) clearance to Reliant Technologies Inc. for three novel Fraxel re:pair laser hand pieces. This enhanced potential of the Fraxel re:pair laser system will provide physicians with an option for surgical treatment and skin resurfacing. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all of the three surgical hand pieces can be used alone or along with each other, with no need to turn the system off for changing the hand pieces.

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