Establishment Labs Chooses bioaccess™ for the Post-Market Clinical Trial of its Motiva Implants® in Colombia
[ORLANDO, FL, OCTOBER 13, 2019] Establishment Labs Holdings Inc. (Nasdaq: ESTA) (the “Company”) —a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market— has chosen bioaccess™ for its Motiva Implants® post-market clinical trial in Colombia. bioaccess™ will help the Company obtain institutional review board (IRB)/ethics committee (EC) approval at Hospital Universitario San Ignacio in Bogota to initiate its clinical trial and will also provide assistance in obtaining regulatory approval at Colombia's regulatory agency; INVIMA.
The Company has developed its Motiva Implants® by enhancing and creating novel product components for its implants and then combining these components into products that deliver improved aesthetic outcomes, increased patient satisfaction, and favorable safety profiles.
The Company launched its Motiva Implants® commercially in October 2010, and to date, it has sold over one million units in various countries outside the United States. Motiva Implants® incorporate a number of proprietary features that the Company believes contribute to Motiva Implants’ favorable safety profile as well as a natural appearance and feel. The Company's latest generation of Motiva Implants® utilizes its proprietary Ergonomix design, a round base implant that responds to gravity by shifting its maximum point of projection, offering the projection of a shaped implant without the malpositioning and rotation issues frequently associated with shaped implants. Furthermore, the Company Progressive Gel family of silicone gel rheologies consists of four highly purified biocompatible gels with specific visco-elastic properties that the Company believes enables Motiva Implants® to respond to the patient’s motion in ways that more closely mimic the appearance, feel and movement of natural breast tissue.
Colombia is an ideal location for clinical trials since its regulatory approval process is one of the fastest in Latin America, its hospital costs are about 30% less than in the US, and the country boasts great patient recruitment potential with a 50 million population with universal access to healthcare.
About Establishment Labs.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Read more at www.establishmentlabs.com.
About bioaccess.™
bioaccess™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research clients with support services to ensure their first-in-human trials are a success in Colombia (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). Read more at www.bioaccessla.com.
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Media Contact:
Julio G. Martinez-Clark
CEO, bioaccess™