27th Apr 2015 07:00
FDA Approval for Silhouette Instalift®
London, 27 April 2015 - Sinclair IS Pharma plc (SPH.L) ("Sinclair" or "the Group"), the international specialty pharmaceutical company, announces that it has received US FDA approval for Silhouette Instalift®.
Silhouette Instalift®, Sinclair's patented, reabsorbable, PLGA suture with bi-directional cones was filed with the FDA in July 2014. The FDA has now accepted the Group's application with an approved label stating "The Silhouette Instalift device is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position". FDA approval means Sinclair is now free to sell Silhouette Instalift® in the US market with immediate effect.
Based on independent market research management expect that annual peak sales for Silhouette Instalift®in the US will be in excess of $200 million five years post launch, equivalent to approximately 300,000 patient treatments per year. The distribution model for Silhouette Instalift® in the US is currently being evaluated as part of the strategic review process announced on 25 November 2014.
Chris Spooner, CEO, commented: "I am delighted with today's announcement which represents the biggest growth opportunity in the Company's history. Sinclair's strategy is to build a world leading aesthetic portfolio based on innovative and minimally invasive treatments, supported by extensive physician training. Silhouette Instalift® is a unique anti skin sagging cones-on-suture device. A combination of safety, rapid procedure time and strong physician economics has already led to dynamic growth in several markets. FDA approval brings further credibility to this worldwide franchise."
Ends
Sinclair IS Pharma plc Tel: +44 (0) 20 7467 6920
Chris Spooner
Alan Olby
Peel Hunt LLP Tel: +44 (0) 20 7418 8900
James Steel
Clare Terlouw
Notes to Editors:
About Sinclair IS Pharma plc - see www.sinclairispharma.com
Sinclair IS Pharma is an international specialty pharmaceutical company centred on Dermatology, in particular - Aesthetics, Wound care, and Skin care. The Group has a direct sales and marketing presence in the top five European markets and a rapidly growing International division concentrated on the Emerging Markets through long term multi-product, multi-country, sales, marketing and distribution deals with key strategic partners.
"Safe Harbor" Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward‐looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward‐looking statements due to a variety of factors.
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