Breast implant maker Establishment Labs yesterday registered for an initial public offering worth nearly $58 million, saying it plans to use the proceeds to fund a pre-market approval study of its Motiva implants.
The FDA granted an investigational device exemption in March for the PMA study and enrolled the first patient the next month, the company said.
Establishment Labs said that post-market data from sales of Motiva, which it’s sold outside the U.S. since October 2010, show “low rates of adverse events (including rupture, capsular contracture, and safety related re-operations) that we believe compare favorably with those of our competitors,” according to the filing.
“We believe the proprietary technologies that differentiate our Motiva implants enable improved safety and aesthetic outcomes and have helped drive our revenue growth. Our MotivaImagine platform enables surgical techniques that we promote as Motiva-branded surgeries. We have developed other complementary products and services on our MotivaImagine platform, which are aimed at further enhancing patient outcomes,” the company said.
Establishment Labs posted net losses of -$34.9 million last year, up 57%, on sales of $34.7 million, up 75.3% compared with 2016. First-quarter losses rose 30% to -$6.5 million on sales growth of 114% to $14.8 million, the company said.