Exilis ELITE FDA-Approved for Cellulite Reduction

The Exilis ELITE, a radiofrequency (RF)-based, skin-tightening platform, has been granted FDA approval for temporary reduction in the appearance of cellulite.

The monopolar focused RF device, which is engineered with advanced cooling, heats the dermis, causing collagen support tissues to remodel, tighten and firm. Using a new protocol to treat areas with underlying fat deposits, the device has...


Exilis ELITE FDA-Approved for Cellulite Reduction

The Exilis ELITE, a radiofrequency (RF)-based, skin-tightening platform, has been...

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FDA Approves PicoSure 532nm Delivery System

Cynosure has received U.S. Food and Drug Administration (FDA) clearance for its new 532nm laser delivery system for the PicoSure. The new wavelength is indicted for tattoo removal (all ink colors).

“The new 532nm Laser Delivery System further builds on the clinical and commercial success of the 755nm PicoSure for the removal of tattoos and benign pigmented lesions as well as the treatment of acne scars and wrinkles,” said Michael Davin, chairman and CEO of Cynosure. “We are pleased to offer this system as an upgrade to our current PicoSure customer base.”

Cynosure will debut the new delivery system at the American Academy of Dermatology (AAD) Annual Meeting in March and anticipate beginning intial shipments by the end of the second quarter of 2015.

Image courtesy of Cynosure.

ASAPS Releases Preliminary 2014 Stats

Though the American Society for Aesthetic Plastic Surgery (ASAPS) is still in the process of compiling its procedural statistical data for the 2014 calendar year, it has shared some distinct trends from the past year. Nonsurgical fat reduction procedures rose 43% in 2014 with more than 100,000 such procedures performed. Additionally, the number of buttock augmentations rose by 86% in 2014.

“Nonsurgical fat reduction is a new frontier in the realm of cosmetic procedures. The rise in its popularity is indicative of the public’s desire for nonsurgical alternatives in lieu of their invasive counterparts. Due to the technological advancement and efficacy of nonsurgical fat reduction devices, it’s not surprising that more people are opting to freeze or melt away stubborn body fat in the comfort of their surgeon’s office as opposed to undergoing surgery,” said Michael Edwards, MD, president of ASAPS, adding that physicians must also note that not all patients are good candidates for nonsurgical procedures—many will benefit more from surgical approaches.

ASAPS expects to release its full 2014 statistics in March 2015.

Cipher Acquires Three Astion Dermatology Products

Cipher Pharmaceuticals has acquired worldwide rights to three products—focused on inflammatory dermatological diseases—from Denmark-based specialty pharmaceutical company Astion Pharma:

  • Dermadexin, a barrier-repair topical with active ingredient P3GCM, which was approved by the EU in 2014 for the treatment of seborrheic dermatitis.
  • Pruridexin, a topical indicated for the treatment of chronic itching, which was submitted to the European Medicines Agency in 2014 and remains under active review (response expected within the first half of 2015).
  • ASF-1096, a product candidate in Phase 2 that is being investigated as a treatment for discoid lupus erythematosus and has been awarded orphan drug status in the EU.

According to Shawn O’Brien, president and CEO of Cipher Pharmaceuticals, the company plans to pursue an orphan drug indication for ASF-1096 and will submit Dermadexin and Pruridexin for U.S. and Canadian regulatory approval. Over time, Cipher anticipates out-licensing the products to partners in certain other regions.

Image copyright Getty Images.