Entries by Mario

Establishment Labs Announces Motiva® Implants IDE Clinical Trial Underway with First Patient Enrolled and Surgery Completed

NEW YORK, April 27, 2018 (GLOBE NEWSWIRE) Establishment Labs Holdings Inc., a global medical device company focused on breast aesthetics and reconstruction technologies, today announced the enrollment and successful completion of implant surgery on the first patient in its U.S. investigational device exemption (IDE) clinical trial of its Motiva®

Establishment Labs Receives IDE Approval from U.S. FDA to Initiate Clinical Trial of Motiva Implants

NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) Establishment Labs Holdings Inc., a global medical device company focused on breast aesthetics and reconstruction technologies with a strong emphasis on product development and innovation, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a clinical […]

Establishment Labs Appoints Dennis Condon to the Board of Directors

NEW YORK, Jan. 8, 2018 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on breast aesthetics and reconstruction technologies with a strong emphasis on product development and innovation, announced today that Dennis Condon has been appointed to the Board of Directors. Mr. Condon brings years of experience in the breast implant market from […]

Establishment Labs and OBP Medical Announce Partnership to Deliver Innovative New Tool for Advanced Breast Aesthetics Procedures

NEW YORK, Nov. 29, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today the launch of the MotivaImagine Ultralight LED in partnership with OBP Medical, creators of the award winning ONETRAC Retractor family. Surgical kits designed to support placement […]

Establishment Labs Announces Positive Clinical Study Results for its Motiva Implants® Published in the Aesthetics Surgery Journal

NEW YORK, September 14, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today that the results of a three-year, retrospective clinical study using the Company’s Motiva Implants® were published in the peer-reviewed Aesthetic Surgery Journal. The study evaluated the […]

Establishment Labs Announces $55 Million Combined Debt and Equity Financing

NEW YORK, August 28, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today that it has closed a $55 million combined secured credit facility and equity investment with Madryn Asset Management. “This transaction allows us to finance our research […]

Establishment Labs Announces Leadership for Energy and Environmental Design (LEED) Gold Certification on its Headquarters in Costa Rica

NEW YORK, August 10, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation announced today that it has received U.S. Green Building Council’s (USGBC) Leadership for Energy and Environmental Design (LEED) Gold Certification on its new headquarters in Costa Rica. “This […]

Establishment Labs Submits Investigational Device Exemption (IDE) Filing for Prospective Clinical Trial of Motiva Implants

NEW YORK, August 7, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today that it has submitted an Investigational Device Exemption (IDE) filing to the U.S. Food and Drug Administration (FDA) for its Motiva Implants®, the lead product in […]

Establishment Labs Obtains Medical Device Single Audit Program (MDSAP) Regulatory Certification

Certification Assures Compliance with FDA Quality Management System (QMS) Regulation NEW YORK, July 25, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation announced today that it has received the Medical Device Single Audit Program (MDSAP) regulatory certification of its two […]

Establishment Labs Announces the Appointment of Renee Gaeta as Chief Financial Officer

NEW YORK, July 12, 2017 (GLOBE NEWSWIRE) Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation announced today that Renee Gaeta has been appointed Chief Financial Officer, effective immediately. “We are delighted to welcome Renee to our team. Her impressive background in finance and […]