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Establishment Labs Holdings Idea Proposal (ESTA)

Establishment Labs Holdings Idea Proposal (ESTA)
 

What competitive advantage will Establishment Labs bring to the U.S. breast implant market, if any? Will ESTA challenge for meaningful share?

Report Available: October 21, 2021

 

Blueshift Research found ESTA preparing for its entrance into the U.S. breast augmentation and reconstruction market with the hiring of a U.S. commercialization executive and the expansion of its manufacturing and R&D capabilities. The company is also adding to its product portfolio with new minimally invasive breast implants and state-of-the-art tissue expanders. With ESTA’s timeline for launch in the U.S. set for late 2022, how its products are perceived by the plastic surgery community is not completely clear. However, the expectation on the Street regarding the potential for success is high.

 

Observations

  1. ESTA is global med-tech company in the breast aesthetics and reconstruction market. Founded in 2004 with an IPO in 2018, ESTA produces and distributes Motiva implants and tissue expanders in 80 countries, but not yet in the U.S. To date, the company has delivered 1.6 million Motiva implants to plastic surgeons by using an innovative production method which employs nanotechnology and 3D printers to create an exacting surface and a more biocompatible product that improves safety and outcomes. The next major step for ESTA is to navigate the FDA trial and approval process and commercialize its Motiva brand in the U.S., which is on target for late 2022.
  2. ESTA’s FDA U.S. investigational device exemption (IDE) Motiva implant clinical trial has been underway since April 2018 with an initial portion of the primary data completed in March 2021. The trial is a single arm, multi­center trial designed to measure the safety and effectiveness of Motiva’s SmoothSilk and Ergonomix implants in female patients who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. The results of the study are expected to support a Pre-Market Approval (PMA) submission to the FDA and lead to commercialization of Motiva implants in the U.S. in late 2022.
  3. Recent ESTA highlights and accomplishments:
  • 7: Launch of the Motiva Flora tissue expander in Europe and other CE Mark countries. Motiva Flora offers several notable advances, including ESTA’s patented SmoothSilk surface technology as well as an RFID enabled non-magnetic integrated port, that offers potential improvements in imaging, treatment, and overall clinical outcomes and patient satisfaction.
  • June 24: ESTA completed the enrollment of its 100th patient in the Motiva Mia case series. The single-center study is a prospective, interventional, single-arm feasibility study of women 18 years or older in primary minimally invasive breast enhancement. The Motiva Mia system is designed to provide a minimally invasive breast enhancement procedure in less time and with faster recovery than traditional breast surgery.
  • June 23: ESTA broke ground on its third facility that will double its manufacturing capability and provide for additional R&D and medical education. The facility is needed to support the company’s planned growth and eventual expansion into the U.S. and China markets.
  • June 21: Nature Biomedical Engineering published a landmark study that demonstrates that the patented Motiva SmoothSilk surface significantly reduces the foreign body response compared to implants with high degrees of roughness or completely smooth surfaces that were included in the study. The unique and patented SmoothSilk surface includes a number of elements purposefully designed to improve biocompatibility, including a topography of only 4 microns on average and specific characteristics around skewness and the number, distribution, and size of contact points.
  • June 1: ESTA announced the appointment of Heather Brennan as Head of U.S. Commercial Operations. Her initial responsibilities will be to prepare for the commercialization of Motiva implants in the U.S.
  1. ESTA reported record Q2 sales, which increased 205.5% YY to $32 million and a lower-than-expected EPS loss. Based on the strength of the first half of 2021, ESTA raised its full-year guidance to $122 million to $126 million in revenue, ahead of the consensus of $121 million.
  2. As ESTA makes plans to enter the highly competitive breast implant market in the U.S., it will be challenged by med-tech giants including Allergan (ABBV) and Mentor (JNJ) that dominate the market. ESTA will also have to compete against SIEN which has a strong and growing market position because of it broad implant size portfolio.
  3. Blueshift Research’s July 7 report found that SIEN was on track for steady gains despite a highly competitive market. Sources, particularly in the breast implant sales channel, noted that despite not being FDA approved for the U.S., ESTA’s products were generating high interest levels. Sources highlighted the company’s well-respected, time tested, and broad product portfolio outside the U.S. They also said ESTA had secured key U.S. opinion leaders that are expected to help drive a successful launch when and if its products are approved by the FDA.

 

How is ESTA’s portfolio differentiated from what is available in the U.S. market today? What makes them unique? Does this create any advantage for ESTA? Is ESTA poised to compete for meaningful share in the U.S. market? Is ESTA’s history and successful product performance an indicator of success in the U.S. market? What headwinds will ESTA face as it enters the U.S. market? Which competitor is most at risk of losing share to ESTA? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Plastic surgeons and their teams in the U.S. and Europe, Breast implant sales channel, and Industry specialists. 

 

Companies: AbbVie Inc (ABBV), Johnson and Johnson Co. (JNJ), Establishment Labs Inc. (ESTA), Sientra Inc. (SIEN)

 

Research Begins: October 4, 2021

 

 

To see other ideas Blueshift Research is currently working on, please click here.

 

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