Dive Brief:

• Establishment Labs received Food and Drug Administration approval for its Motiva breast implants for primary and revision breast augmentation.
• Motiva is the first new breast implant to receive U.S. premarket approval since 2013, according to Establishment Labs’ Thursday announcement. Since then, the market has been reshaped by safety problems that led to the withdrawal of Allergan’s Biocell textured breast implant.
• Motiva devices have a surface designed to enhance biocompatibility and promote low inflammation, according to the company. Establishment Labs won approval on the strength of three-year clinical data.

Dive Insight:

The clinical trial enrolled patients at 32 centers in the U.S. and three sites in Western Europe. Three years after implantation, compliance among the 451 participants in the primary augmentation cohort of the trial was 92.4%. The rate of capsular contracture, the hardening of scar tissue around the implant, was 0.5%. The rate of confirmed or suspected rupture was 0.6%. 

Establishment Labs said 6.1% of patients underwent a reoperation, in some cases to change the implant size. The authors of a paper about the study said the data suggests “the leading cause of revisional surgery has shifted from capsular contracture and rupture to more subjective indications for reoperation such as malposition and size change.” The complication rate, including reoperations, was 8.4%.

Generating the data has enabled Establishment Labs to bring Motiva to the U.S. market 14 years after the device became commercially available overseas. The company said it has delivered nearly four million Motiva devices to plastic and reconstructive surgeons in more than 85 countries. 

Establishment Labs has forecast global revenue in a range of from $174 million to $184 million for this year, representing year-over-year growth of from 5% to 11%. BTIG analysts forecast U.S. revenue of $1.1 million in the fourth quarter, $19.3 million in 2025 and $55.8 million in 2026.

Establishment Labs included U.S. sales in its forecast after the FDA made three observations in a report when inspecting the company’s manufacturing facility, according to the firm’s August earnings call. The FDA previously said it would approve the breast implants pending a satisfactory inspection.

The company ended June with a cash balance of $54.6 million but can access $25 million from its debt facility now that it has FDA approval. Establishment Labs will gain access to another $25 million if it achieves $195 million in trailing 12-month sales.