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Estamentment Labs, a Costa Rican company focused on aesthetic wellness and breast reconstruction, is in the final stages of obtaining approval from the U.S. Food and Drug Administration (FDA) to sell Motive in the country.
The company’s general manager, Juan José Chacón, announced this last Tuesday, August 6, during the presentation of the second half financial results.
“Late last month, the FDA completed its pre-approval inspection of our manufacturing facilities. We expect Motiva implants to be approved in the U.S. very soon. Our launch in the U.S. will be a defining event on our path to revolutionize aesthetics and breast reconstruction,” the businessman said during his presentation.
Chacón said the company is on a clear path to global market leadership and has many years of solid growth ahead.
“The new standards we have set for clinical and aesthetic outcomes in these categories will now be available to women and surgeons in the world’s largest markets,” he said.
Motiva implants will be available in additional markets in Europe and Japan from 2021.
In terms of financial performance, Establishment Labs’ total revenue for the quarter ended June 30 was $44.1 million, a decrease of $4.5 million compared to $48.6 million in the same period of 2023.
Juan José Chacón said: “Our efforts to reduce our expense base have yielded tangible results, with an adjusted Ebitda loss of $4.3 million, less than half of the loss in the same period last year.”
According to data released by the company, the performance of this indicator in the second quarter of last year was US$9.2 million.
Last July, the company opened the Sulàyöm Innovation and Manufacturing Center in the Coyol Free Trade Zone in Alajuela, with an investment of US$45 million.
The expansion includes 9,300 square meters (m²) of manufacturing space, medical research space, offices and a global learning center, including operating rooms and surgery suites for medical education and training.
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