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Establishment Labs Submits Module Four to U.S. FDA for Premarket Approval of Motiva and Reports Record Fourth Quarter and Full Year 2022 Financial Results
NEW YORK--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and
About this update from Establishment Labs Holdings Inc.
[{"type":"text","content":" NEW YORK--(BUSINESS WIRE)--\nEstablishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced that it has submitted the fourth and final module of its modular submission to the FDA for premarket approval of Motiva Implants® in the United States. The company also provided unaudited financial results for the fourth quarter and full year ended December 31, 2022 and provided 2023 guidance.\n\nFourth Quarter Highlights and Outlook\n\n\nFourth and final module submitted to U.S. FDA for premarket approval of Motiva Implants®.\n\n\n2023 guidance of $200 million to $210 million, an increase of 24% to 30% over 2022.\n\n\nFourth quarter worldwide sales of $43.8 million, consistent with preannouncement on January 9, 2023; fourth quarter sales increased 24.1% year-over-year and were a new quarterly record; excluding the impact of foreign currency changes, revenue growth in the fourth quarter would have been 27.7%.\n\n\nFourth quarter net loss from operations of $13.6 million compared to a net loss of $14.2 million in the year-ago period.\n\n\nCash balance of $66.4 million as of December 31, 2022.\n\n\nMia Femtech™ commercialization on track.\n\n\nMotiva Flora® tissue expander global rollout ongoing.\n\n\n“Based on the strong results we are reporting today and the continued momentum in our business, 2023 will be a groundbreaking year on our road to $500 million by 2026,” said Juan José Chacón-Quirós, Chief Executive Officer. “This conviction is reflected in our 2023 revenue guidance of $200 million to $210 million. Preparations for commercial sales of Mia Femtech are progressing and approval in China is also expected in the first half of 2023, gaining us entry into the second largest global market. And in a major milestone for Establishment Labs, we have submitted module four of our modular PMA to the U.S. FDA, bringing us closer to approval of Motiva in the United States.”\n\n“We are putting in place the infrastructure to support this growth and more,” Mr. Chacón-Quirós continued. “Our new Sulàyöm campus will undergo validation and begin manufacturing this year; this facility also brings us significant new capabilities in R&D, medical education, and media. We are defining every day what a women’s healt...