NEW YORK - Establishment Labs Holdings Inc . (NASDAQ:ESTA), a medical technology company focused on women's health, particularly in breast aesthetics and reconstruction, announced positive preliminary results from a clinical study of its Mia Femtech product at the 9th Annual World Symposium on Ergonomic Implants held this week in Barcelona, Spain.
The Mia Femtech Clinical Study, which is IRB-approved and began enrolling participants from December 2020 to April 2021, reported no instances of capsular contracture (Baker Grade III/IV), ruptures, infections, hematomas, or seromas requiring medical intervention among the 100 subjects over the three-year period. Additionally, no changes in nipple or breast sensation were noted, with a follow-up compliance rate of 93%.
Juan José Chacón-Quirós, CEO of Establishment Labs, stated, "The Mia results being shown this week are among the best breast implant data reported at three years." He emphasized that the technology points toward a minimally invasive future for breast aesthetics. Chacón-Quirós also highlighted the growing demand for Mia and mentioned the recent FDA approval of Motiva implants, indicating plans to introduce Mia Femtech to the U.S. market.
The symposium in Barcelona, which runs from October 31 to November 2, serves as a platform for over 500 plastic surgeons, researchers, and commercial partners to discuss advancements in ergonomic implants, with a focus this year on breast tissue preservation.
Establishment Labs has delivered nearly four million Motiva devices globally since 2010, aiming to set a new standard for safety and patient satisfaction. The company also produces the Motiva Flora tissue expander for breast reconstruction post-breast cancer, noted for being the only expander with an integrated port compatible with MRI conditional radio-frequency technology.
The data presented at the symposium is preliminary and does not reflect the complete study results or establish the ultimate safety or effectiveness of the Mia Femtech procedure. This announcement is based on a press release statement from Establishment Labs Holdings Inc.
In other recent news, Establishment Labs has made significant strides with the U.S. Food and Drug Administration (FDA) granting market clearance for its Motiva SmoothSilk Ergonomix & Round breast implants. This approval has led to a surge in endorsements from analyst firms. Mizuho Securities and TD Cowen have maintained their Outperform and Buy ratings, respectively, while Citi has reiterated a Neutral rating and initiated a 90-day Positive Catalyst Watch.
The FDA clearance is expected to help Establishment Labs capture an additional 10% of the U.S. market share annually, potentially boosting its revenues. In the second quarter of 2024, the company reported a revenue increase of 18.7%, reaching $44.1 million.
The company has also recently strengthened its leadership team with the appointment of Fillipo "Peter" Caldini as the new President. These are the latest developments in Establishment Labs' journey, highlighting the company's progress and the positive outlook from various analyst firms.
InvestingPro Insights
As Establishment Labs Holdings Inc. (NASDAQ:ESTA) reports positive clinical results for its Mia Femtech product, investors may be interested in additional financial insights. According to InvestingPro data, ESTA's market capitalization stands at $1.22 billion, reflecting the company's significant presence in the medical technology sector focused on women's health.
Despite the promising clinical outcomes, it's worth noting that ESTA is currently not profitable, with a negative P/E ratio of -15.24 over the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company to be profitable this year. However, this is not uncommon for medical technology companies investing heavily in research and development.
On a positive note, ESTA has shown strong performance in the stock market, with a 73.7% year-to-date price total return and a 53.59% return over the past year. This impressive growth suggests investor confidence in the company's potential, possibly fueled by developments like the Mia Femtech study results and the recent FDA approval of Motiva implants.
An InvestingPro Tip highlights that ESTA's liquid assets exceed its short-term obligations, indicating a solid financial position to support its ongoing research and market expansion plans, including the potential introduction of Mia Femtech to the U.S. market.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for ESTA, providing a deeper understanding of the company's financial health and market position.
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