NEW YORK - Establishment Labs Holdings Inc . (NASDAQ: NASDAQ:ESTA), a medical technology firm specializing in women's health, announced the U.S. Food and Drug Administration (FDA) has approved its Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for both primary and revision breast augmentation procedures.
Juan José Chacón-Quirós, Founder and CEO of Establishment Labs, expressed that the FDA's approval marks a significant milestone for breast aesthetics in the United States, offering women access to advanced implant technology supported by extensive scientific research. The company upholds its commitment to women's health and is poised to introduce this technology across the U.S.
The Motiva implants are noted for their innovative design, featuring patented SmoothSilk® surfaces that aim to enhance biocompatibility and minimize inflammation. The Ergonomix® model is particularly unique, claiming to be the first breast implant to incorporate ergonomic principles, allowing it to mimic the natural movement and feel of breast tissue.
Dr. Caroline A. Glicksman, the Medical Director of the Motiva U.S. IDE Study and an investigator, highlighted the trial's stringent methodology and its findings, which demonstrated low rates of common complications such as capsular contracture and rupture. The three-year study, which reported a high patient compliance rate, was conducted across 32 centers in the U.S. and three in Western Europe.
Board-certified plastic surgeon Dr. M. Bradley Calobrace also commented on the lack of innovation in the U.S. breast implant market and anticipates that Motiva implants will significantly enhance clinical and aesthetic outcomes for augmentation procedures.
Since their initial launch in 2010, nearly four million Motiva® devices have been distributed globally, backed by a robust portfolio of patent applications and clinical studies. The recent FDA approval is the first for a new breast implant in the U.S. since 2013.
Dr. Kamakshi R. Zeidler, a board-certified plastic surgeon and member of the Establishment Labs Femtech Advisory Board, praised the Motiva implants for their natural feel and low complication rates, emphasizing the impact this technology may have for women in the United States.
Establishment Labs has been recognized for its contributions to Femtech, with a range of solutions for breast health, aesthetics, and reconstruction. The company operates under strict regulatory standards and is supported by a comprehensive array of scientific and clinical research.
The information presented in this article is based on a press release statement from Establishment Labs Holdings Inc.
In other recent news, Establishment Labs Holdings Inc. announced the appointment of Fillipo "Peter" Caldini as the new President. Caldini brings extensive experience to the role, having served in leadership positions at Acreage Holdings (OTC:ACRGF), Bespoke Capital Acquisition Corp., Pfizer (NYSE:PFE) Consumer Healthcare, and Bayer AG (ETR:BAYGN). In line with his appointment, Caldini will receive a base salary of $415,000, with eligibility for bonuses and equity awards.
On the financial front, Establishment Labs reported a revenue increase of 18.7%, reaching $44.1 million in the second quarter of 2024. Despite soft demand in Latin America, the company demonstrated stable results in Europe and signs of recovery in other regions. The company's 2024 revenue guidance is set at $174 million to $184 million.
Citi has reiterated a Neutral rating on Establishment Labs' stock, focusing on the company's advancements toward FDA approval for its Motiva product. The FDA recently completed its inspection of the manufacturing facility, marking a significant step for Establishment Labs. Citi has initiated a 90-day Positive Catalyst Watch for the company, monitoring the stock closely for any positive developments, particularly in relation to the FDA's decision-making process regarding Motiva.
These recent developments underline Establishment Labs' strategic positioning and growth trajectory. The company is preparing for entry into the US market, with strong interest noted from US plastic surgeons. The market is keenly awaiting further updates, especially regarding the FDA approval for Motiva implants, which is expected to have a significant impact on Establishment Labs' global sales and adoption of its products.
InvestingPro Insights
In light of the recent FDA approval of Establishment Labs Holdings Inc.'s (NASDAQ: ESTA) Motiva® breast implants, investors and stakeholders may find the following metrics and tips from InvestingPro insightful for evaluating the company's financial health and market position:
InvestingPro Data reveals that Establishment Labs has a market capitalization of $1.15 billion, indicating a robust size within the medical technology sector. Despite this, the company's Price/Earnings (P/E) ratio stands at -13.39, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at -13.84, suggesting that the company is currently not profitable. Moreover, the Price/Book (P/B) ratio is quite high at 25.57, which may raise concerns about the stock being overvalued relative to its book value.
Revenue for the last twelve months as of Q2 2024 is reported at $151.35 million, with a negative revenue growth of -14.56%, indicating a contraction in sales. Nevertheless, the company maintains a strong Gross Profit Margin of 66.04%, which reflects the company's ability to retain a significant portion of sales as gross profit.
Two InvestingPro Tips that may be particularly relevant to investors are:
- Analysts have recently revised their earnings expectations downwards for the upcoming period, which could signal potential headwinds for the company's financial performance.
- Despite the challenges, the company's liquid assets exceed its short-term obligations, indicating a stable liquidity position that could support its operations and strategic initiatives.
Investors seeking additional insights on Establishment Labs can find more InvestingPro Tips at https://www.investing.com/pro/ESTA, with a total of 9 tips listed to help inform their investment decisions.
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