Patients are routinely advised that they should expect to have breast implants removed or replaced roughly every 10 to 15 years. Those rates are typically higher among women with silicone, rather than saline, implants and those with reconstructive, rather than augmentative, breast implant surgery.
 |
| Motiva implant--Courtesy of Establishment Labs |
Now, startup Establishment Labs has won more than $20 million in financing from private equity firms Crown Predator Holdings and JW Asset Management to market a next-gen breast implant that's supposed to be safer and more easily tracked.
"The investment and partnership from Crown Predator and JW Asset Management and the global relationships and experience they provide will enable us to accelerate investment in our technology, grow our customer base, and scale our business to meet growing demand," said Establishment Labs CEO Juan José Chacón-Quirós in a statement. "We are excited to officially begin the journey to bring our next generation Motiva implants to the United States, the largest market for breast aesthetics in the world."
Establishment's Matrix line of breast implants is designed to be safer in several ways including its TrueMonobloc high performance shell, which is supposed to improve the implant's mechanical qualities under stress; the BluSeal visual barrier-layer indicator that provides surgeons with a visual indicator to verify that the implant surface remains intact and is intended to reduce the risk of capsular contracture due to gel bleed; a nanotech-based surface that provides a high number of contact points--a feature that's intended to increase its biocompatibility; and an RFID microtransponder to enable a 15-digit product identification code to be read when a proprietary handheld reader is waved over the breast.
That RFID technology, dubbed VeriTeQ, is the first FDA-cleared microtransponder for use in humans--and the only one with a CE mark for breast implant use, the company said. The company reports complication rates of less than 1% after 5 years of implantation.
In an FDA postapproval analysis of marketed breast implants used for augmentation, the reoperation rate was 20% within 5 years and 36% within 10 years. In fact, the agency recommends that women with silicone gel-filled implants should have an MRI screening after 3 years with a new implant with repeated screening for implant rupture every 2 years after that.
"Establishment Labs is focused on delivering the highest quality products in the industry, including an advanced technology platform to provide a first class customer experience," Jason Wild, president and chief investment officer at JW Asset Management, added. "Establishment Labs is poised to become a market leader in breast aesthetics."
- here is the financing announcement