Establishment Labs Announces Leadership for Energy and Environmental Design (LEED) Gold Certification on its Headquarters in Costa Rica

NEW YORK, August 10, 2017 (GLOBE NEWSWIRE)

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation announced today that it has received U.S. Green Building Council’s (USGBC) Leadership for Energy and Environmental Design (LEED) Gold Certification on its new headquarters in Costa Rica.

“This distinction is a great honor for our company and partners worldwide, built on the legacy of Costa Rica as an advocate for the preservation of natural resources,” said Juan José Chacón Quirós, founder and CEO of Establishment Labs. “As part of our strategy to bring Motiva Implants® to the U.S. market, we believe patients and doctors alike will appreciate our unique industry goal to meet the highest standards in the world for environmental and medical device regulatory compliance.”

LEED certification, established by U.S. Green Building Council and verified by the Green Building Certification Institute, is the worldwide preeminent program for the design, construction and operation of high performance green buildings. The Manuel E. Chacon B. Center for Advanced Silicone Technologies was unveiled on December 15, 2016 and serves as the headquarters for Establishment Labs. The facility includes state-of-the-art manufacturing facilities, innovation labs and corporate offices. The facility is located in the Coyol Free Zone in Costa Rica, one of the largest and most modern high-tech business parks in Central America, hosting medical device companies including Abbott, Medtronic, Philips, Smith & Nephew, and Cooper Vision, among others.

“LEED certification is another significant milestone in establishing operations that meet the highest standards for state-of-the-art, efficient, and sustainable infrastructure,” said Salvador Dada, Chief Operating Officer. “As a global medical technology company, making a positive impact on humanity with our environmental initiatives is at the core of our company values. We are pleased with this important validation as we pursue opportunities to adopt green solutions and strive to manufacture the highest quality aesthetic products for patients.”

The project used advanced energy modeling during the design. Some of the highlights of this LEED-Gold Certified facility include:

Energy Efficiency

  • Ice Bank system for cooling the controlled air in the clean room and support areas instead of traditional energy-powered chillers.
  • Energy micro-grid comprised of solar panels and energy-storage batteries that generates up to 80% of the total energy consumption of the building, including manufacturing areas, allowing for efficiently more air exchanges in the clean rooms for less particulates in the production areas.
  • The Chilled-Beams system for soft cooling administrative areas -instead of traditional air conditioning systems- reduce at least 30% of energy consumption and eliminate the use of refrigerants.
  • Efficient lightning, movement sensors and Energy-Star appliances and equipment in all administrative areas to reduce 50% of energy consumption compared to traditional designs.

Environment

  • Oil-less air compressors for cleaner air throughout the facility.
  • Rain-water recovery systems for the irrigation systems and toilets.
  • Water efficient systems for administrative areas to reduce 49% of water consumption in comparison with traditional designs.
  • Non-volatile organic compound (VOC) paints, coatings, adhesives and other external materials that reduce CO2 emissions and heat.
  • Local materials used for energy saving during the construction process.
  • 57% of construction waste materials were recycled instead of sending to landfills areas.

Native plantings in the landscaped areas reduce fertilization and water usage.
Preferred parking for low emitting (hybrid) and fuel efficient vehicles and carpooling.

About Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Motiva Implants and Divina are registered trademarks of Establishment Labs.

Establishment Labs Submits Investigational Device Exemption (IDE) Filing for Prospective Clinical Trial of Motiva Implants

NEW YORK, August 7, 2017 (GLOBE NEWSWIRE)

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today that it has submitted an Investigational Device Exemption (IDE) filing to the U.S. Food and Drug Administration (FDA) for its Motiva Implants®, the lead product in its portfolio of innovative aesthetic technologies. Upon acceptance, the IDE would enable the Company to initiate a clinical study in the U.S. to assess the safety profile and patient satisfaction of Motiva Implants.

“This is a very significant milestone for Establishment Labs and patient safety, and hopefully the start of many technologies that we can bring to market in the United States,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs. “Motiva Implants are already sold in over 60 countries worldwide and have been implanted more than 300,000 times over the past seven years. We are confident that a clinical study in the United States will confirm the safety profile we are seeing in all of our markets.”

The IDE submission for this Motiva Implants study proposes a single arm, multi-center study investigating female patients receiving primary breast augmentation, primary breast reconstruction, or revision surgery. Upon acceptance of the IDE, Dr. Caroline Glicksman, a board-certified plastic surgeon in the U.S., has agreed to lead the study as the principal investigator. The results of the study are expected to support a Pre-Market Approval (PMA) submission to the FDA.
“This is a big day for technological improvement in our industry,” said Roberto de Mezerville, VP of Research, Development & Innovation of Establishment Labs. “The science and technology behind Motiva Implants was developed with enhanced patient safety as a priority, and we look forward to demonstrating that a commitment to innovation in this industry can lead to safer and better patient outcomes in both the aesthetics and reconstruction fields.”

About Establishment Labs:
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction.  All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.
Motiva Implants and Divina are registered trademarks of Establishment Labs.

Establishment Labs Obtains Medical Device Single Audit Program (MDSAP) Regulatory Certification

Certification Assures Compliance with FDA Quality Management System (QMS) Regulation

NEW YORK, July 25, 2017 (GLOBE NEWSWIRE)

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation announced today that it has received the Medical Device Single Audit Program (MDSAP) regulatory certification of its two manufacturing sites in Costa Rica which are now in compliance with five regulatory bodies including the United States Food and Drug Administration (FDA).

“Establishment Labs is the first company in the aesthetics industry to obtain the MDSAP certification, which is a testament to the regulatory strength of our Quality Management System (QMS) in both manufacturing facilities in Costa Rica,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs. “Now FDA compliant, these facilities will supply Motiva Implants® for our clinical trial programs in the United States and support our global expansion efforts.”

MDSAP was established by a coalition of international medical device regulatory authorities including Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and PMDA and the United States FDA. The goal of MDSAP is to allow a single regulatory audit of a medical device manufacturer’s QMS to satisfy the needs of the participating regulatory jurisdictions. This program enables the manufacturers to contract with an authorized third-party Auditing Organization to conduct a single audit to satisfy the relevant regulatory requirements of the participating regulatory authorities including the FDA, which recognizes MDSAP audit reports as a substitute for FDA Establishment Inspection Reports (EIRs).

According to Salvador Dada, COO of Establishment Labs, “Certification of dual-production capabilities under MDSAP will help ensure continuity of supply for our customers and brings large scale capacity to support the growing demand for our Motiva Implants worldwide by achieving economies of scale as we expand our global offerings.”

By obtaining this certification, Establishment Labs’ QMS has been found to conform with ISO 13485:2003 (Medical devices – Quality management systems); Australia’s Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding 1.6); Brazil RDC ANVISA N. 16/2013 (Good Manufacturing Practices for Medical Devices), RDC ANVISA n. 23/2012 (Reporting of Field Actions), RDC ANVISA n. 67/2009 (Post-market surveillance); Canada Medical Devices Regulations – Part 1 – SOR 98/282; Japan – MHLW Ministerial Ordinance 169 (Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents), Article 4 to Article 68, Pharmaceutical and Medical Device Act (PMD Act); and USA – 21 CFR 820 (Quality System Regulation), 21 CFR 803 (Medical Device Reporting), 21 CFR 806 (Reports of Corrections and Removal) – Subparts A to D, 21 CFR 821 (Medical Device Tracking Requirements), for the design, production and distribution of silicone components and silicone implantable medical devices.

Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Motiva Implants and Divina are registered trademarks of Establishment Labs.

Establishment Labs Announces the Appointment of Renee Gaeta as Chief Financial Officer

NEW YORK, July 12, 2017 (GLOBE NEWSWIRE)

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation announced today that Renee Gaeta has been appointed Chief Financial Officer, effective immediately.

“We are delighted to welcome Renee to our team. Her impressive background in finance and complex transaction management, including the past three years in the aesthetics market, made her an ideal candidate for this key position in our organization,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs. “I am confident in Renee’s ability to guide and implement our financial strategy and high-growth initiatives as we move towards becoming a global leader in the aesthetic space.”

Ms. Gaeta brings more than a decade of financial leadership experience to Establishment Labs. She recently served as Vice President, Corporate Controller at Sientra, Inc., a Nasdaq listed (SIEN) aesthetics company. At Sientra, she served as a member of the executive team and headed the finance department. She was instrumental in preparing the company during its pre-IPO stage establishing compliant systems and controls, and played a key role in Sientra’s successful Initial Public Offering (IPO) and Follow-On Offering. Prior to Sientra, Ms. Gaeta spent ten years with KPMG, LLP, rising through the organization to the role of Director, Transaction & Restructuring. In this capacity, she managed multiple global clients and specialized in complex transaction and restructuring deals with a focus on evaluation and application of technical accounting.

“I am excited to join a team full of passionate and dedicated individuals who take pride in the design and delivery of high performance aesthetic products to patients,” said Ms. Gaeta. “I look forward to contributing my expertise to the leadership team of Establishment Labs and advance the company’s vision to expand the Motiva Brand and drive long-term growth and value.”

Ms. Gaeta holds a Bachelor of Science in Accounting from Loyola Marymount University and is a Certified Public Accountant in the State of California.

About Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Establishment Labs Announces Initial Data Regarding Its SilkSurface® Technology as Presented by Professor Robert Langer at the Recent Beauty Through Science (BTS) Congress

NEW YORK, July 10, 2017 (GLOBE NEWSWIRE)

Establishment Labs, a global medical technology company focused on aesthetic technologies with a strong emphasis on product development and innovation, today announced that Professor Robert Langer, Chairman of its Scientific Advisory Board, presented initial data highlighting the benefits of the company’s proprietary SilkSurface® technology at the recent, 13th Annual Beauty Through Science (BTS) Congress held in Stockholm, Sweden on June 1-3, 2017. BTS is considered one of the premier events worldwide in the field of plastic surgery.

“At Beauty Through Science, we look to bring the highest levels of science to plastic surgery, and we are honored that Professor Robert Langer accepted our invitation as keynote speaker,” said Dr. Per Héden, BTS President. “The latest advances in material sciences and biomedical engineering need to be incorporated into everything we do as plastic surgeons, and his lecture spoke to the rigorous scientific approach we must demand from ourselves and from industry. His commitment to understanding the biocompatibility of implant surfaces is of the utmost importance to our field.”

“Published studies determine macrophages to be the sole immune population necessary for inflammation and fibrosis. In our pilot study, we were able to prove that, compared to a smooth surface control, Establishment Labs’ SilkSurface decreases fibrosis-dependent-innate immune macrophages,” said Professor Langer. “We will continue to work in collaboration with the scientists at Establishment Labs to further evaluate the fibrotic response mechanism in breast implant surfaces,” he added.

Professor Langer’s discoveries have created meaningful advancements in the fields of engineering, science, and medicine. In addition to serving on Establishment Labs’ Scientific Advisory Board, Professor Langer is one of 13 designated Institute Professors at MIT, the highest honor awarded to a faculty member. Professor Langer also holds over 1,250 issued and pending patents which have been licensed or sublicensed to over 350 companies. Professor Langer has also previously served as a Chairman of the Federal Drug Administration’s Science Board. Professor Langer’s full bio can be referenced at http://web.mit.edu/langerlab/langer.html.

About Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Establishment Labs Announces the Addition of Professor Alexandre Mendonça Munhoz, M.D., Ph.D., to its Medical Advisory Board

Company Announces the Commercial Launch of Motiva Implants® in Brazil

NEW YORK, June 29, 2017 (GLOBE NEWSWIRE)

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced the addition of Alexandre Mendonça Munhoz, M.D., Ph.D., to the company’s Medical Advisory Board. The appointment was announced during the 37th Jornada Paulista de Cirurgia Plastica in São Paulo, Brazil simultaneously with the commercial launch of Motiva Implants® in Brazil.

“We are pleased to have Dr. Munhoz join our Medical Advisory Board,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs. “Our mission is made possible by bringing leading minds of the industry together to solve problems that have plagued breast aesthetic and reconstructive surgery for decades. Dr. Munhoz has been a leader in the pursuit of excellence in breast surgery, and as we expand into the world’s second largest market, we welcome a prominent member of the Brazilian school of Plastic Surgery to our Medical Advisory Board.”

Dr. Munhoz is currently a Professor of Plastic Surgery, Breast Surgery Division of Plastic Surgery at the University of São Paulo School of Medicine in São Paolo, Brazil, and is a full member of the Brazilian Society of Plastic Surgery (SBCP), which coordinates the Scientific Department in the São Paulo region. Dr. Munhoz participated as a guest member of the international consultants of Plastic and Reconstructive Surgery (PRS) and Breast Journal since 2006. In 2016, he assumed the position of Associate Editor of PRS-Global Open Journal. His achievements include 25 scientific awards related to plastic surgery research, 115 published scientific papers, with 81 indexed in PubMed platform and first author on 76 studies.

“Motiva Implants are truly innovative and are designed with cutting-edge research from the material science, incorporating advances and understanding from both the surface technology and physiology disciplines. For years, I have been searching for the solutions that Establishment Labs’ scientists have developed in the design of Motiva. Professor Scott Spear, an international leader in the field of plastic surgery, and one of my mentors in academic life, introduced me to their advances and technologies and I am grateful for the opportunity to join the Medical Advisory Board and continue to advance the work of my mentor,” said Dr. Munhoz. “I am excited to bring these state-of-the-art technologies and implants to the community of plastic surgeons and patients in Brazil.”

“We are thrilled to officially launch our Motiva Implants in Brazil, a key market in surgical aesthetics, during Jornada Paulista de Cirurgia Plastica,” said Eddie De Oliveira, Latin America Vice President of Sales at Establishment Labs. “The excitement of plastic surgeons around the launch of our products is palpable, and we are humbled to see our science reach broad commercialization.”

About Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®‘s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Establishment Labs Strengthens Leadership Team with the Appointment of Nicolas Maurer as Chief Commercial Officer

NEW YORK, NY (PRWEB) JUNE 12, 2017

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today that Nicolas Maurer has been appointed Chief Commercial Officer effective immediately. Maurer will oversee the company’s commercial sales and marketing initiatives, establishing Motiva Implants® as one of the most vibrant brands in the industry.

“Nicolas brings extensive business expertise and innovative marketing leadership to Establishment Labs,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs. “He is well recognized for building some of the most successful brands in global cosmetics. I am confident that Nicolas’ insight and industry knowledge will help us elevate the Motiva brand, increase both plastic surgeon and consumer specific requests for Motiva products, and drive revenue growth over the long term. We are delighted to welcome his inspiration and leadership to our team.”

Maurer’s career includes several entrepreneurial start-up ventures as well as 17 years with German cosmetics corporation Beiersdorf AG, which owns globally recognized brands such as NIVEA, Eucerin, LaPrairie, Elastoplast and Aquaphor, where he managed multiple product launches and led the development of strategies across a number of marketing channels.

As Corporate Vice President of Marketing at Beiersdorf AG, Maurer was responsible for growing the skincare product portfolio worldwide. Prior, he managed Beiersdorf’s U.S. brand portfolio. His award-winning campaigns led to numerous recognitions from Walmart, CVS, Target and Rite Aid as well as professional organizations such as the American Association of Dermatology and the Skin Cancer Foundation. Maurer also served internationally in various capacities at Beiersdorf in Germany, Sweden, Denmark, East Africa and Asia.

“I look forward to contributing to the leadership team of Establishment Labs. The achievements of the company to date demonstrate its innovative and entrepreneurial culture. We plan to continue to bring new products to market to expand the Motiva brand and drive long-term growth and value,” said Maurer. “There is an immense opportunity to provide plastic surgeons with truly innovative technologies, products and techniques to address patient concerns around the aesthetic look and feel of their procedure. These practices will have the potential to transform the cosmetic industry.”

Maurer holds a Master’s Degree in Marketing and Controlling from IPAG in Paris and graduated from Lycee Phillibert Dessaignes in Blois, France with a Baccalaureate C (A-Level) in Mathematics and Physics.

About Establishment Labs:
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Establishment Labs Announces Certification of its Second Facility in Costa Rica

Second manufacturing facility in Costa Rica has received certification and begun shipping units to Europe and around the world. This new site, in combination with the company’s existing facility, extends manufacturing capacity by 4X and enables the company to expand its distribution capability.

NEW YORK, NY (PRWEB) JUNE 02, 2017

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today that its second manufacturing facility in Costa Rica has received its EC Certificate – Full Quality Assurance System from BSI and has begun shipping units from the new facility to Europe and around the world. This new site, in combination with the company’s existing facility, extends manufacturing capacity by 4X and enables Establishment Labs to expand its distribution capability.

“Full Quality Assurance System certification of our new, state-of-the-art facility is an important milestone, as it not only reinforces the high quality standards of our entire organization, but also meaningfully increases manufacturing capacity, and enables us to fully supply expanding demand,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs. “This certification is instrumental to our long-term strategic plans, provides compliance with key regulatory authorities, and adds significantly more flexibility to our current manufacturing and distribution operations. Our focus on product quality, state-of-the-art facilities, and deep technological know-how continues to establish and maintain our brand of consistency, quality and safety,” concluded Chacón-Quirós.

“Designed and built with advanced, environmentally beneficial techniques, the building’s infrastructure is supported by systems that are sustainable, renewable, and cost effective over the long term, such as a solar and battery microgrid, as well as an ice bank system that supports the clean room air systems,” said Salvador Dada, Chief Operating Officer. “These were important considerations for us, and I am pleased that we were able to build a modern, environmentally friendly facility that meets the highest quality of standards.”

The 40,000-square foot complex was completed in December 2016 and will serve as the company’s corporate headquarters, hosting more than 300 people, including manufacturing, research & development, regulatory affairs, finance, customer service, and other operational functions. The facility is located in the Coyol Free Zone of Costa Rica, considered the largest and most modern high-tech business park in Central America, hosting medical device companies including Abbott, Medtronic, Philips, Smith & Nephew, and Cooper Vision, among others.

About Establishment Labs:
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities have been successfully inspected according to the MDSAP program for compliance with 8 of the most stringent standards and regulations, including ISO 13485 and FDA 21 CRF Parts 820 and 821.

Establishment Labs Expands Management Team with Key Addition in Quality Assurance and Regulatory Affairs

NEW YORK, NY (PRWEB) MAY 26, 2017

Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today the expansion of its leadership team with the addition of Alberto Quesada as Vice President of Quality Assurance & Regulatory Affairs.

“We are pleased to add a senior executive with Alberto’s deep expertise during this exciting stage of our growth. His background and track record of achievement within high-profile healthcare companies, such as Boston Scientific and Allergan, will add great value as we expand,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs.
“Alberto’s drive for organizational excellence and standard of quality aligns perfectly with our goal of becoming a global leader in aesthetic and reconstructive devices technology, while improving patient safety through product innovation.”

Alberto Quesada brings more than two decades of experience in quality assurance, quality control, and regulatory affairs to Establishment Labs. He will lead all activities related to the design, manufacture and distribution of quality products with the highest industry standard, as well as compliance with the company’s Quality Management System and applicable regulations. In addition, Mr. Quesada will lead all regulatory aspects of the business to support appropriate and timely introduction of products as well as a continuous state of compliance with markets’ regulatory requirements.
“The current regulatory framework requires not only a best-in-class product but a methodical approach to continuously improve quality at all levels,” stated Mr. Quesada. “Our plan is to deepen our competitive advantages by building a stronger set of capabilities in our Quality Management System.”

Prior to joining Establishment Labs, Mr. Quesada served as a Quality Director and later as a Management Representative at Boston Scientific in Costa Rica. Previously, he spent nearly a decade with Allergan Corporation, where he served in senior quality management roles. He also held roles at Baxter Healthcare Corporation, Kativo Chemical Industries and GTE Sylvania. Mr. Quesada received his MBA from Universidad Estatal a Distancia (UNED), Costa Rica and his undergraduate degree in Industrial Engineering from the University of Costa Rica.

About Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Establishment Labs Announces Close of $18M Financing Round

The funding will be used primarily to support the international launch of Motiva Implants® and Puregraft® in new markets

NEW YORK, NY (PRWEB) APRIL 17, 2017

Establishment Labs, a global medical device company focused on breast surgery technologies with a strong emphasis on product development and innovation, announced today that it has closed an $18 million financing round. Multiple investors participated, including Kilowatt Capital and Florence Capital Advisors.
“We are thrilled with the enthusiasm of the investment community in this oversubscribed round of funding,” said Juan José Chacón Quirós, CEO of Establishment Labs. “This round of investment will support the process of launching Motiva Implants® and Puregraft® in some of the largest markets worldwide. We are grateful for the backing from our new and existing investors.”

According to Nick Lewin from Crown Predator Holdings, “Our new partners join Perceptive Advisors and JW Funds with the same shared vision of Establishment Labs bringing innovation to market in the surgical aesthetics field. The company continues to rapidly scale, and this investment provides us the opportunity to build for the future and help Establishment Labs continue its high level of growth.”

Over the last six months, Establishment Labs has received regulatory clearances in Russia, Australia, Saudi Arabia, Israel, Vietnam and Brazil -among others- and is currently in the process of scaling up production capacity at its new state of the art manufacturing plant in Costa Rica.

About Establishment Labs:
Establishment Labs is a global, privately held, breast implant and medical technology company that designs, develops, manufactures and markets an innovative product portfolio consisting of advanced silicone-filled breast and body shaping implants (http://www.motivaimplants.com). Its CE-marked Motiva Implants® line of silicone breast implants utilizes medical-grade silicone and is subject to rigorous quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®’s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field. The Puregraft® technology is used in hospitals and clinics around the world and provides physicians with confidence and convenience in fat grafting surgical procedures.

About CPH:
Crown Predator Holdings (CPH) invests in early and growth stage companies with an interest in special situations that do not easily fit into traditional investment categories. CPH leads and co-invests in transactions across all industries, capital structures, and styles. Through an extensive and global network of relationships and support, CPH seeks to add value as partners, not just as investors. Founded in 2006 and based in New York City, CPH is a family office led investment firm.