Establishment Labs’ Motiva Implants Approved in China

Establishment Labs Holdings Inc. has received National Medical Products Administration (NMPA) approval in China for its Motiva Implants.
 
“Our approval in China marks Establishment Labs’ entry into the second largest global and most dynamic market for breast aesthetics in the world,” Establishment Labs CEO Juan José Chacón-Quirós said. “This is the first breast implant technology approved in China in more than a decade. Many Chinese plastic surgeons are familiar with Motiva Implants from other Asian countries where we have leading market shares, and we expect they will adopt our technology as their first choice.”

Establishment Labs’ Motiva silicone gel-filled implants are currently not approved for U.S. commercial distribution. The company’s implants are undergoing PMA clinical investigation pursuant to U.S. Food and Drug Administration (FDA) regulations for investigational medical devices.
 
“We transformed the breast aesthetics market in South Korea with Motiva, and we are excited to replicate that success in China,” added John Lim, founder/CEO of Motiva China Ltd., Establishment Labs’ exclusive distribution partner in the market. “Three years after launching in Korea in 2016, we became the market leader. Today, Motiva is far and away the most chosen and most recognized brand in Korea. Most importantly, we changed the perception of our industry. Chinese plastic surgeons and consumers are highly attuned to the latest innovations in science and technology, and, just like the Koreans, we expect they will recognize Motiva as truly innovative and differentiated.”
 
Establishment Labs Holdings Inc. is a global medical technology company offering Femtech solutions for breast health, breast aesthetics, and breast reconstruction. The more than 3 million Motiva devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available, according to the company. The Motiva Flora tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MRI conditional. Mia Femtech, Establishment Lab’s minimally invasive experience for breast harmony, is the company’s most recent innovation. These solutions are supported by more than 200 patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants and began a clinical trial to support regulatory approval in the United States.