Shares of med-tech firm Establishment Labs Holdings (NASDAQ:ESTA) soared 28% in premarket trading on Friday, reaching $52.75, after the company announced it had received U.S. FDA approval for its Motiva breast implants.
This milestone, hailed by TD Cowen analysts as the "most significant" in the company's history, opens the door for Establishment Labs to enter the $400 million to $500 million breast augmentation market in the United States.
Analysts at TD Cowen project that the company could generate $30 million in U.S. sales by 2025, capitalizing on this new market access.
The FDA approval follows a critical site inspection conducted in July, which Jefferies analysts described as a "clearing event."
Jefferies has also raised its price target for the stock from $61 to $67.
Establishment Labs shares have been on an impressive run this year, already up 59.1% year-to-date as of Thursday’s close, with this FDA approval likely to propel further growth