Establishment Labs Holdings, Inc. (NASDAQ:ESTA) was founded on October 9, 2013, and its predecessor was Establishment Labs, SA, a Costa Rica registered company established on January 18, 2004, headquartered in the British Virgin Islands, the company Its US agent is its wholly-owned subsidiary-Motiva USA LLC. Establishment Labs Holdings Inc. is a medical technology company focused on improving patient safety and aesthetics, focusing on the breast beauty and breast plastic surgery market.
Establishment Labs Holdings (ESTA):
Establishment Labs Holdings is a global medical technology company dedicated to improving patient safety and aesthetics. It initially focused on the breast beauty and reshaping market. Through the design, development, manufacturing and marketing of innovative silicone gel breast implant product portfolios: brands It is MotivaImplants®, the core component of the MotivaImagine® platform.
MotivaImplants® is produced in the company’s two production bases, in compliance with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and is currently sold in more than 60 countries through exclusive distributors or direct sales teams. In addition to MotivaImplants®, Establishment Labs’ product and technology portfolio also includes Divina® 3D Simulation System, Puregraft and MotivaImagine® Centers.
Motiva Implants’ post-marketing monitoring data (not FDA data, but the company’s own customer tracking data) and third-party data show that Motiva Implants shows a low incidence of adverse events (including breast prosthesis rupture, package Membrane shrinkage and safety-related re-operations, etc.), this is a significant competitive advantage of the product.
Establishment Labs Holdings believes that its Motiva Implants unique proprietary technology can improve safety and aesthetics, and help drive the company’s revenue growth. The company’s MotivaImagine platform provides strong technical support for the promotion of its Motiva Implants brand products. The company has also developed other complementary products and services on the MotivaImagine platform to further improve the treatment effect of patients.
To date, most of the revenue of Establishment Labs Holdings, Inc. comes from the sale of Motiva Implants. The company began selling Motiva Implants outside the United States in October 2010. Since then, Establishment Labs has launched four generations of Motiva Implants. Motiva Implants are now sold in more than 60 countries, including the “2016 International Society of Aesthetic Plastic Surgery (ISAPS)” counted nine of the “Top Ten Breast Augmentation Countries”.
Establishment Labs holding company currently sells its products through exclusive distributors, and in some countries/regions also sells products through direct sales.
Establishment Labs Holding Company received the FDA-approved Research Device Exemption (IDE) in March 2018 to initiate its Motiva Implant clinical trial in the United States. The first volunteer in the study was registered in April 2018, and the company expects to complete enrollment in early 2019. The results of the study are expected to support the submission of premarket approval (PMA) to the FDA.
Establishment Labs Holdings (ESTA) investment:
Establishment Labs Holdings, Inc. (NASDAQ:ESTA) submitted its IPO prospectus on 6/21/2018, and listed on NASDAQ on 7/19/2018. The issue price was US$16, 3.1 million shares were issued, and US$49.6 million was raised. , Jefferies / Cowen joint underwriting.