Establishment Labs is having a standout year as it executes a global launch of its Mia Femtech procedure. The company's latest catalyst is CE mark approval for the tools used in the minimally invasive breast procedure.
The Santa Barbara, CA-based company's Mia Femtech is designed to increase breast shape by one to two cup sizes in 15 minutes without general anesthesia. The company recently launched the procedure in Japan and has announced partnership agreements with four European clinics and a clinical chain in France.
"We continue to view Mia favorably for its short procedure and recovery times, impressive aesthetic and safety outcomes, and significant market opportunity," Marie Thibault, a medtech analyst at BTIG, wrote in a report Tuesday.
Additional centers are expected to be onboarded throughout the year as the company expands the launch throughout Japan and Europe. In February, Establishment Labs provided 2023 revenue guidance of $200 million to $210 million, which represents growth of 24% to 30% over 2022.
The company's latest CE marking under the European Medical Device Regulation (MDR) is for the Motiva injector, the Motiva inflatable balloon, and the Motiva channel dissector. These surgical tools are all designed to be used in the company's next-generation aesthetic procedures.
“The approval in Europe of our minimally invasive tools is an important step in the evolution of plastic surgery,” said Juan José Chacón-Quirós, founder and CEO at Establishment Labs. “Innovations that improve both the experience and outcome of a medical procedure can expand markets. This minimally invasive technology platform can help change perceptions and overcome reservations — opening aesthetics to the many women who would not consider a traditional surgery. We are also extremely gratified that all Motiva implants and tools have now received certification under the new European MDR standard.”
Interestingly, Establishment Labs is launching Mia Femtech through a business model without sales reps. Instead, as the CEO has previously explained, the company is creating partnerships with selected clinics that already have good marketing assets that can be mixed with the company's technologies that are embedded into the Mia Femtech procedure.
Upcoming regulatory catalysts for the Mia Femtech procedure includes market approval in China, which is expected soon, and FDA approval, which is expected later this year.