GlobeNewswire•
NEW YORK, Sept. 16, 2019 (GLOBE NEWSWIRE) — Establishment Labs Holdings Inc. (ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced that the Company has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent application covering its proprietary implant surface technology. Acquired from the University of Manchester, this critical research and patent application was funded with the cooperation of Establishment Labs and is an important component of Motiva Implants®. The University of Manchester’s Institute of Inflammation and Repair is one of the world’s leading innovators of biocompatible surfaces within the human body.
“We are pleased that the USPTO recognized the unique attributes of our SmoothSilk® implant surface technology, which is a key differentiator of our Motiva Implants® relative to others on the market,” said Juan José Chacón-Quirós, Chief Executive Officer of Establishment Labs. “We will continue to strengthen our intellectual property, both in the U.S. and globally, to protect our innovations and pursue new advances in breast aesthetics and reconstruction.”
[huge_it_slider id=”15″]Additionally, the Company also announced the 510(k) submission for its SmoothSilk® anatomical tissue expander. The Company filed for CE Mark registration of its tissue expander during the fourth quarter of 2018.
“The 510(k) submission for our tissue expander is an important step forward in advancing our product portfolio and global reach and demonstrates our commitment to the breast reconstruction market. Patients undergoing breast reconstruction deserve significant improvement to safety and aesthetic outcomes and we are committed to delivering these results,” Mr. Chacón-Quirós concluded.
Patent Pending Applications:
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About Establishment Labs
Establishment Labs Holdings Inc. (ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in 75 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System and other products and services. Please visit the website for additional information: www.establishmentlabs.com.