GC Aesthetics (“GCA”), a medical technology company providing healthcare aesthetic solutions for global healthcare markets, announced today several recent positive developments for the Company, demonstrating continued progress on its U.S. and international growth strategy.
Initiating Clinical Study to Support FDA Approval.
On December 31, 2018, GCA signed a letter of intent with ICON Clinical Research Limited (ICON), a global Clinical Medical Research Organization, whereby ICON will provide clinical and regulatory services to support a FDA Pre-Market Approval for GC Aesthetics breast implants for both aesthetic and reconstructive indications within the United States. The agreement is linked to a multi-year GC Aesthetics Silicone Gel Breast Implant Pivotal Study. GCA expects to submit an Investigational Device Exemption application to the FDA in the second half of 2019.
Appointment of U.S. Leadership
In conjunction with the Company’s engagement with ICON, GCA also recently announced the appointment of Ron Cosmas as U.S. Project Manager. In this position, Mr. Cosmas will establish a local presence for GCA in the United States, and will be responsible for cultivating brand awareness, instituting a key opinion leader network and spearheading the FDA approval process for GCA breast implant products in the United States. Mr. Cosmas has over 20 years of experience working with aesthetic medical device companies in the U.S. with key players such as McGhan Medical, Allergan, Sientra, Keller Medical and OBP Medical. He has significant experience with, and expertise in, the U.S. FDA regulatory approval process.
Appointment to the Board of Directors.
GCA is also excited to announce the appointment of Mariano García-Valiño to the Company’s Board of Directors. Mr. García-Valiño has been active at the intersection of healthcare, strategy and entrepreneurship for over 25 years. Most recently, Mr. García-Valiño was CEO of GBT (B3:GBIO33), a biopharmaceutical company with presence in the 10 largest Latin American markets that he helped to build and then took public in 2017. Prior to GBT, Mr. García-Valiño led the Latin-American business for Bausch+Lomb, and had various senior executive roles with Pfizer, Eli Lilly, McKinsey, Advent International and Warburg Pincus in Europe, the United States and Latin-America. Mr. Garcia-Valiño holds an engineering degree from Universidad de Buenos Aires and an MBA from the Harvard Business School. He is based in Montevideo, Uruguay.
“We are thrilled about the recent developments and progress at GC Aesthetics.”
Said Carlos Reis Pinto, Chief Executive Officer of GC Aesthetics.
“We are committed to advancing our products for women seeking safe, empowering breast augmentation or reconstruction solutions. The combination of adding aesthetic industry veteran Ron Cosmas to our team and our partnership with global clinical research leader ICON will help us in achieving our strategy of bringing our new generation of breast implant technology to the United States. I also welcome Mariano García-Valiño to our board. Mariano brings invaluable experience in the healthcare aesthetics industry, and his insights in scaling operations in fast-growing international aesthetics markets will be essential as we expand our market leadership and build the new standard in helping women around the world be their best-self.”
About GC Aesthetics
GC Aesthetics (“GCA”) is an established global medical technology company that develops, manufactures in-house and markets a comprehensive range of proprietary aesthetic products that empower patients to feel safe and confident on their personal journey. Through 30 years of commercial presence, GCA has been dedicated to advancing the science of medical aesthetics and delivering high-quality products under its premium Nagor and Eurosilicone brands, primarily for breast augmentation and breast reconstructive surgery. More than 2.5 million women and men across 70 countries have trusted GCA products, which are supported by published 10-year clinical data demonstrating compelling safety and clinical effectiveness. The Company’s vertically-integrated strategy enables exceptional clinical, operational and commercial performance, which allows GCA to provide competitively differentiated products to physicians and patients. Through a culture of continuous innovation and dedication to customer-responsiveness, GCA has established itself as a leading provider of medical aesthetics solutions and the partner-of-choice for patients seeking to improve their lives.