Establishment Labs Announces Regulatory Clearances in Brazil

Establishment Labs Announces Regulatory Clearances in Brazil

NEW YORK, NY (PRWEB) MARCH 31, 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 received regulatory approval from the Brazilian National Health Surveillance Agency (ANVISA) to market Motiva Implants® and Puregraft®.

According to a survey by the International Society of Aesthetic Plastic Surgery (ISAPS), there were over 166,000 breast augmentation procedures performed in Brazil in 2015, the world´s second largest market after the United States. Having more than 5,500 board certified plastic surgeons, Brazil is also one of the largest markets for fat grafting with more than 110,000 procedures performed in face, breast and body contouring in 2015.

“Regulatory clearance to market Motiva Implants® and Puregraft® in Brazil is an exciting milestone for Establishment Labs,” said Juan José Chacón Quirós, Chief Executive Officer of Establishment Labs, “Brazilian surgeon interest and support has been very high pre-launch, and we’ve seen enough demand to validate our commercialization strategy for Motiva Implants® and Puregraft® through our own direct sales network.This commitment to Brazil should position our company as a leader in the Brazilian market.”

Establishment Labs had already received the GMP (Good Manufacturing Practices) certification from Brazil’s National Health Surveillance Agency (ANVISA) following an inspection and audit of its manufacturing facility in San José, Costa Rica. Brazil’s GMP regulations, which closely resemble the internationally recognized ISO 13485 standard, require medical device manufacturers to have a quality system for the design, manufacture, packaging, labeling and storage of their products. “We are pleased with the successful completion of the ANVISA clearance for our products and GMP certification, which is evidence of our commitment to produce innovative products in strict adherence to our quality system,” said Salvador Dada, Chief Operating Officer of Establishment Labs.

According to Eddie de Oliveira, Vice-President of Sales for Latin America, “We are honored to begin our sales efforts in one of the most dynamic aesthetic markets in the world. The Brazilian plastic surgeon is known for their skill, expertise and innovative surgical techniques. We hope to win their confidence with our advanced line of surgical products.”

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.

Establishment Labs Announces Opening of New Medical Device Manufacturing Facility

Investment of $16.5M in the new manufacturing facility will support its growing international market presence

NEW YORK, NY (PRWEB) DECEMBER 15, 2016

Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation,
announced today the opening of a state of the art silicone medical device manufacturing facility in Costa Rica.
Luis Guillermo Solís, President of Costa Rica, inaugurated the Manuel E. Chacon B. Center for Advanced Silicone Technologies, commenting, “The growth of Establishment Labs demonstrates the great capacity and skills of our people and is an incentive for other national companies to seek insertion and link with this sector. We are very pleased with this news.”
Establishment Labs invested $16.5M in the 40,570 square foot facility and is currently scheduled to begin commercial-scale production by early 2017. The investment in the new facility was financed by a $15M debt facility from Perceptive Advisors and from its own capital.
“This new facility will support a multi-year effort to increase our manufacturing capabilities alongside our existing facility in Costa Rica, and will help us to achieve even greater operational excellence,” said Juan José Chacón Quirós, CEO and founder of Establishment Labs. “This new facility will allow us to meet growing demand from current markets, as well as expected demand as we enter new markets. As we develop our commercial footprint globally, we expect to increase customer responsiveness, improve inventory turns, and support our commercialization time and R&D efforts.”
According to Salvador Dada, COO of Establishment Labs, “at capacity, the new facility is expected to employ approximately 350 full-time, high-tech positions, including engineers and skilled operators, as well as process development and validation specialists who will work with the company´s research, development, and innovation teams to optimize and accelerate product launches. This new facility will house state-of-the-art equipment, including a fully equipped 3D lab as well as 16,000 square feet of ISO Class VII clean-room operations.”
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 approximately 50 countries worldwide.
About Perceptive Advisors:
Founded in 1999, Perceptive Advisors is focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. Its dedicated team of industry experts uses a unique balance of scientific, technical and investment expertise to identify opportunities. Perceptive seeks to evaluate opportunities without biases by analyzing and weighing critical data and catalysts assessing the balance between market perception and reality. Perceptive manages approximately $2 billion across our strategies and has a long and successful track record.

New Technology by Establishment Labs Results in Increased Safety for Patients Seeking Breast Augmentation

Patient centric innovation is cornerstone of new Safety Campaign

NEW YORK, NY (PRWEB) OCTOBER 17, 2016

Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation, today announced the launch of the Motiva Safety Campaign featuring Motiva Implants® with Q Inside Safety Technology™. The campaign will focus on tools that empower women to be in charge of their health through advanced technology and enhanced warranty options.

“Our mission is to make breast aesthetics safer and better for women worldwide by delivering a world class technology platform that promotes women’s health and lifestyle choices,” said Juan José Chacón-Quirós, CEO of Establishment Labs. “We are constantly evaluating and expanding our program to allow women to be in control of their health by leveraging the most advanced tools and warranty options available in breast aesthetics.”
The cornerstone of the safety campaign is the Q Inside Safety Technology™, a biosensor that is accessed via a proprietary handheld reader when waved over the breast area. This easy method allows doctors to non-invasively retrieve specific information on each implant, even years from now when patients may have misplaced their paperwork.
Highlights of the technology are:
World’s first FDA-cleared and CE-approved biosensor solution that allows plastic surgeons to connect patients through both the MotivaImagine™ App and the Motiva website (MotivaImplants.com)
Q Inside Safety Technology™ is an electronic passport containing all relevant information about implants

Increased peace of mind in the unlikely event of a safety issue or device recall
Helps ensure patient safety and well-being Non-invasive verification of its unique electronic serial number within the body
15-digit serial number delivered to the reader corresponds with a secure, online database that can be accessed only via the Internet by authorized persons
Another unique benefit for patients is the ability to register their implants via an App,

MotivaImagine™. The App will:
Store their serial number to ensure it is always available
Offer the opportunity for an extended warranty which not only covers the replacement cost of the implants, but also offers financial assistance applicable to revision surgery costs
Provide reminders concerning breast health
Dr. Marcos Sforza, Plastic Surgeon at The Hospital Group states, “Our patient’s safety is our top priority. In the United Kingdom, thousands of women suffered the stress of not knowing the information of their implants when a French manufacturer had a troubling market recall. Therefore, we now only offer Motiva Implants® with Q Inside Safety Technology™ as it provides our patients control and verification of their implant for their safety and well-being.”.

“Motiva’s Q Inside Safety Technology™ offers patients a safety benefit, unlike any other breast implant in the world. I look forward to the time when we will be able to utilize the Motiva Implants in the United States,” said Scott Spear, MD, Plastic Surgeon, Washington DC.

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). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implants® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.

Establishment Labs and Puregraft Announce Strategic Partnership

An exclusive international distribution transaction marries advanced breast implants and autologous fat transfers

NEW YORK, NY (PRWEB) SEPTEMBER 14, 2016

Establishment Labs, a global medical device company focused on next-generation breast implants and other innovative medical device technologies, announced today that it has entered into an exclusive agreement to distribute Puregraft’s® line of autologous fat transfer products. The agreement also includes an additional option to distribute the Puregraft® products in the United States and Canada.

“We are very proud of this partnership with Puregraft®, a brand that has been at the cutting edge of technology in cell therapies,” said Juan José Chacón Quirós, Chief Executive Officer of Establishment Labs. “Puregraft® autologous fat transfer has demonstrated long term natural tissue retention, and will enable advanced cell-and-implant hybrid aesthetic and reconstructive treatments in combination with our innovative line of Motiva Implants®. We believe that incorporating the latest technologies into breast aesthetics, breast reconstruction and body contouring will improve patient outcomes significantly and we are continuing to invest to bring an entirely new generation of products and therapies to market.”

Used in combination, Motiva Implants® and Puregraft® autologous fat transfer allows plastic surgeons to balance volume between silicone breast implants and subcutaneous tissue volume, for a more natural look and feel using the patient’s own cells.
“We are delighted to work with Establishment Labs to advance the state of the art Plastic Surgery procedures,” said Brad Conlan, CEO of Puregraft, and LLC. “We are enthusiastic about the opportunities in the international market, and anticipate that hybrid procedures will become the new standard for breast augmentation, breast reconstruction and body contouring.”

“There is a critical, unmet need in breast aesthetics and breast reconstruction surgery for consistent, reproducible treatments using silicone implants in combination with purified fat grafts in breast and body contouring. These are both best-of-breed companies in their respective fields,” said Professor Marcos Sforza, one of the leading voices in combination techniques and advanced technologies in Plastic Surgery. “This partnership will provide surgeons with additional tools and elevate the standard of care for patients.”

About Establishment Labs:
Establishment Labs is an innovator in implantable medical devices. Their Motiva Implants® line of silicone breast implants are approved for sale in over 60 countries.
Motiva Implants® combine several proprietary technologies to improve safety and patient satisfaction, including SilkSurface® hierarchical micro-nano structures, Ergonomix™ the world’s first breast implant with ergonomic characteristics, and the QInside™ RFID microtransponder technology. QInside™ is- also cleared for sale in the U.S. via FDA’s 510(k) pathway. Establishment Labs manufactures its own products in state-of-the-art ISO 13485-certified facilities.

About Puregraft:
Puregraft, LLC is a global medical device company owned by Bimini Technologies. In 15 minutes or less, 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. Puregraft, LLC is positioned to continue its leadership in the rapidly expanding, fat transfer marketplace. The company was founded in 2013 and is based in San Diego, California.

Establishment Labs Announces Completion of a $28 Million Financing

NEW YORK, NY (PRWEB) JULY 20, 2016

Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation, announced that existing investors exercised their option to invest an additional $6.84 Million, completing a $28 Million financing. Investors in the financing include Crown Predator Holdings (CPH), JW Funds, and Perceptive Advisors.

“This additional investment allows us to continue our rapid pace of innovation and commercialization,” said Juan José Chacón Quirós, CEO of Establishment Labs, “as well as complete our new GMP compliant, state of the art facility. This facility quadruples our production capacity, and readies us for regulatory clearance in the United States.”

“Less than a year after our original investment, the exercise of our investor option shows our confidence in the management team and the business,” said Nick Lewin, Partner at CPH. “There is a real opportunity to be the market leader, not only in patient satisfaction and safety, but also in sales volume, and transform the market in the process.”

According to Jason Wild, Founder and Chief Investment Officer of JW Asset Management, LLC, “Establishment Labs is quickly becoming the premier company in Breast Aesthetics, as they continue to innovate with the best minds in biomedical engineering and Plastic Surgery. The rapid industry acceptance and usage by key opinion leaders, scientists, and surgeons shows that Establishment Labs has figured out how to make a meaningful difference in this industry.”

Joseph Edelman, Chief Executive Officer and Portfolio Manager of Perceptive Advisors added, “This investment is based not only on what Establishment Labs has accomplished but what we believe they are going to accomplish in the future. Our diligence in the space suggests that Motiva-branded implants are a transformational product in the industry, and that Establishment Labs should become the outright market leader.

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). Utilizing only the highest quality of medical grade silicones, CE-marked Motiva Implants® are rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.

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.

About JW Asset Management, LLC:
JW Asset Management is a New York based fund manager for five investment partnerships. Jason Wild, a registered pharmacist, is the firm’s founder and chief investment officer. JW Asset Management has a strong history of finding opportunities within the specialty pharmaceutical sector. The firm is active in both the public and private equity markets.

About Perceptive Advisors:
Founded in 1999, Perceptive Advisors is focused on supporting the progress of the life sciences industry by identifying opportunities and directing financial resources to the most promising technologies in healthcare. Our dedicated team of industry experts uses a unique balance of scientific, technical and investment expertise to identify opportunities. Perceptive seeks to evaluate opportunities without biases by analyzing and weighing critical data and catalysts assessing the balance between market perception and reality. Perceptive manages approximately $2 billion across our strategies and has a long and successful track record.

Establishment Labs Receives Korean Regulatory Approval for Motiva Implants

Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation, announced today that it has received approval from the Korean Food & Drug Administration (KFDA). Establishment Labs also announced a 10 year distribution agreement with Seoul-based Human Wellness Corporation (HWC) to market Motiva Implants® and the MotivaImagine™ platform, combining the latest breast implant technology with integrated 3D capabilities and the latest surgical and consultation tools.

“I am thrilled to announce approval from the KFDA for Motiva Implants®,” said Juan José Chacón Quirós, Founder and Chief Executive Officer of Establishment Labs, “This is a crucial step in Establishment Labs becoming the worldwide market leader in breast implant technology. Given the product safety record, Motiva Implants® have quickly become the breast implants of choice for patients who are seeking the most advanced devices for breast aesthetics.”

“As we expand to new markets globally,” Mr. Chacón Quirós added, “we will continue to invest in research and development, intellectual property and clinical studies that create innovative product and platform technologies. South Korea is a very important market for both us and the industry, and I expect we will have continued regulatory approvals globally throughout this year.”

Worldwide, there have been over 150,000 implantations performed with Motiva Implants® with an unparalleled safety record. Motiva Implants® are available with the Q Inside Safety Technology™, an FDA cleared and CE approved RFID solution that allows Plastic Surgeons to connect patients through the MotivaImagine™ App to an electronic passport that contains all of the relevant information about their breast implants for increased safety and peace of mind.

According to John Lim, Chairman of HWC, “Korea is the largest market for breast aesthetics in Asia. We are honored to be the long term partner of Establishment Labs, with a mission of bringing next generation breast implant technology to Korean women. With KFDA clearance, we believe that Motiva Implants® and MotivaImagine™ will provide best-in-class technology for the sophisticated Korean consumer.”
The KFDA approval in Korea is the most recent of regulatory clearances for Motiva Implants®, adding to its existing regulatory approvals in over 60 countries worldwide.

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). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implants® line is rigorously scrutinized by professional quality engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.

JAMM Technologies Acquires the Veriteq RFID Technology Platform and Enters into Supply Agreement with Establishment Labs

MINNEAPOLIS, MN (PRWEB) APRIL 04, 2016

JAMM Technologies, LLC announced today that it has purchased a portfolio of assets from Veriteq Corporation, including its implantable RFID solutions, UDI business and intellectual property. The company also disclosed that it has entered into a long term supply agreement with Establishment Labs to provide implantable micro-transponder technology for their current and next generation family of silicone breast implants.
JAMM Technologies has begun implementing its vision to become an identification and reference platform for implantable medical devices. “All long term implantable devices should have RFID technology to provide key information on the safety and functionality of these devices,” said Randy Geissler, Chief Technology Officer of JAMM Technologies. “The ability for doctors to identify and communicate with implantable medical devices will allow for the development of smart devices that increase both safety and health.”

Juan Jose Chacón Quirós, CEO of Establishment Labs, added, “Implantable RFID technology is one of the most exciting technologies in medical devices. Our agreement with JAMM secures the supply of Q Inside Safety Technology™ and the future development of diagnostic capabilities in biosensors for the next generation of Motiva breast implants.”
There have been over 40,000 implantations of Motiva Implants® with Q Inside Safety Technology™ in the European Union and Japan. Q Inside Safety Technology™ is a FDA cleared and CE approved RFID solution that allows plastic surgeons to connect patients through the MotivaImagine™ App to an electronic passport that contains all the relevant information about the breast implant for increased safety and peace of mind.

About JAMM:

JAMM Technologies is a hardware and service provider to the medical device industry, offering a complete solution for the wireless, external identification of implanted medical devices, as well as key information about the device and performance. Its proprietary RFID implantable components are the only safe and non-invasive method of identifying medical devices from outside the human body and provide unique biosensing and diagnostic capabilities. JAMM technologies is focused on continued innovation, and all profits are reinvested into research and development of next generation technology.
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). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implants® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.

Establishment Labs Announces the Appointment of Dr. Brian Kinney to its Scientific Advisory Board

NEW YORK, NY (PRWEB) MARCH 29, 2016

Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation, announced today that Brian Kinney, MD, FACS has joined its Scientific Advisory Board to assist the company in the advancement of its research and development of the next generation of Motiva breast implants. He will collaborate with experts recently appointed to the Medical Advisory Board.

In December 2015, Establishment Labs formalized its Scientific Advisory Board to continue and strengthen innovation across its Breast Implant portfolio and associated technologies. Innovation is at the foundation of Establishment Labs’ global strategy, and the company believes it will be a key factor in its efforts to bring the next generation of Motiva Implants to the United States.
Establishment Labs CEO, Juan José Chacón Quirós stated, “Dr. Kinney has unique expertise as a Plastic Surgeon and as an M.I.T educated Biomechanical Engineer. We are the first company in the world to incorporate super-silicones and biosensors in breast implants and with Dr. Kinney’s assistance, we will develop these technologies to extend product lifetime and prevent unnecessary operations to replace ruptured implants.”

Dr. Kinney added, “I am humbled and honored by the invitation to join the Scientific Advisory Board of Establishment Labs. Focusing on innovation should result not only in higher degrees of safety but also create a more natural look and feel that is desired by all patients. Neither patients nor surgeons should have to choose between safety and outcome.”

He continued, “While I believe that Establishment Labs’ most recent line of Ergonomix Implants are advanced and highly respected in the industry, I look forward to working with the Scientific Advisory Board innovation team to incorporate the state-of-the-art in biomaterials to further improve safety, performance of the implants and develop next generation technology.”
According to Rudy Mazzocchi, Executive Chairman of Establishment Labs, “Dr. Kinney’s knowledge is at the crossroads of Plastic Surgery and Biomechanical Engineering, precisely where our innovation team has been working to improve the safety and performance of silicone implants. Dr. Kinney will be a wonderful addition to our team and I am looking forward to working with him on our future product innovations.”

Dr. Kinney has a Bachelor of Science in Biomedical Engineering and a Master of Science in Mechanical Engineering from the Massachusetts Institute of Technology. He finished his Chief Residencies in General Surgery and Plastic Surgery at the University of California at Los Angeles. A Former President of the Plastic Surgery Educational Foundation and Chairman, Board of Trustees of the American Society of Plastic Surgeons, he is also member of the American Association of Plastic Surgeons (AAPS), the American Association for the Advancement of Science (AAAS), the American Cleft Lip and Palate Association (ACPA), the American College of Surgeons (ACS), the American Institute of Physics (AIP), , the American Society for Aesthetic Plastic Surgery (ASAPS), the American Society of Mechanical Engineers (ASME), the Institute of Electrical and Electronic Engineers (IEEE), the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Educational Foundation (PSEF).

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). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implant Matrix® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.

Establishment Labs Announces Senior Executive Hires to its Global Sales Team

NEW YORK, NY (PRWEB) MARCH 17, 2016

Establishment Labs, a global medical device company focused on breast implant technologies with a strong emphasis on product development and innovation, announced two additional hires to its senior executive sales team today. The enhanced international sales team and structure shall become effective on April 1st of this year.

Juan José Chacón Quirós, CEO of Establishment Labs, commented, “We continue to expand our very experienced team of executives, skilled at managing and growing a global sales structure while continuing to drive innovation, both of which are prerequisites for future success. Combined with our industry transforming Motiva breast implants, this global team will play a key role in solidifying our position as the market leader in breast implant technologies and continue our rapid year over year growth in every market.

“Already known as an innovation leader, Motiva is quickly becoming the prominent brand sold in markets across Europe, Asia, and the Americas,” Juan José Chacón Quirós continued, “We expect both our current product portfolio and continued innovation to attract plastic surgeons worldwide who are committed to best practices.”

This global sales structure will be divided into three regions. Each region will have full responsibility for launching, in collaboration with strategic partners, Motiva’s third and fourth generation breast implant families, both in new markets and through the existing distribution network. Each region will be led by a Vice President of Sales reporting directly to the Chief Executive Officer.

Based on his successful experience in opening new markets, Mr. Olivier Tourniaire will now serve as Vice President of Sales for Asia Pacific, Middle East and Africa. These markets are of particular importance to the growth of Motiva given the brand’s potential in this region to serve patients better than any other products on the market. Mr. Tourniaire, who has been with Establishment Labs since 2011, has been instrumental in positioning Motiva as the fastest growing brand in the European market. Mr. Tourniaire has over 20 years of sales experience in the breast implant market and was one of the founders of Laboratoires Eurosilicone. During his tenure as Export Manager, he grew that brand to the third position in sales worldwide. Mr. Tourniaire is based in Dubai, UAE.
Erik Vogelenzang will become Vice President of Sales for Europe. Mr. Vogelenzang will lead the continuing development of Motiva in Europe with special focus on the creation of Centers of Excellence and direct-to-patient targeted initiatives that will be instrumental for growth in that region. Mr. Vogelenzang is an accomplished executive with over 25 years of experience in building brands across the surgical aesthetics industry. Mr. Vogelenzang spent 12 years at INAMED (purchased by Allergan), the majority of which were leading the international expansion of breast, facial and obesity products. Most recently, he was one of the co-founders of Global Consolidated Aesthetics (GCA). Mr. Vogelenzang is based in Dusseldorf, Germany.

Eddie de Oliveira is joining the company as Vice President of Sales for Latin America. Mr. de Oliveira will be in charge of launching the new generations of Motiva implants in this region. Further, he will act as President of Motiva Brasil, a subsidiary recently created by Establishment Labs to launch Motiva in the world’s second largest market for breast implants. Until recently, Mr. de Oliveira was the Executive Country Director in Brazil for GCA, where he led their subsidiary to a leadership position in the Brazilian market. Prior to that, Mr. de Oliveira was involved in the setup of the GCA subsidiaries in France and Spain and served as Manager for International Marketing for Eurosilicone and Nagor. Mr. de Oliveira is based in Sao Paulo, Brazil.

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). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implant Matrix® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.

Establishment Labs Announces the Appointment of Dr. David Hung to Its Board of Directors

NEW YORK, NY (PRWEB) FEBRUARY 09, 2016

Establishment Labs, a global breast implant and medical technology company, is pleased to announce the appointment of Dr. David Hung to the company´s Board of Directors.

“We are honored to welcome David to our Board of Directors. He is a world class scientist and an exceptional entrepreneur.” said Juan Jose Chacon Quiros, CEO of Establishment Labs. “David’s knowledge and experience will be invaluable to our company as we expand into new markets and develop innovative products that improve patient outcomes.”
Dr. David Hung is the Founder, President, and CEO of Medivation, a San Francisco-based life sciences company. Dr. Hung first identified and in-licensed enzalutamide, a novel androgen receptor antagonist, in 2005, and led the development of enzalutamide from discovery and preclinical testing to approval for human use as Xtandi. Today, Xtandi is approved for the treatment of metastatic castration resistant prostate cancer in more than 55 countries, with worldwide net sales exceeding $2 billion on an annualized basis.

“Establishment Labs is taking a rigorous approach to innovation in an industry where it is much needed,” said David Hung. “Establishment has already created a product portfolio that I believe will set new standards in the industry, and they are well-positioned to deliver next generation products that will further address unmet medical needs and improve patient outcomes.”
Ed Schutter, Director at Establishment Labs and CEO of Arbor Pharmaceuticals, commented, “We welcome David to the Board of Directors and greatly respect his accomplishments at Medivation developing Xtandi. The talent and knowledge at Establishment Labs is remarkable for this industry, and the cross disciplinary approach will lead to better and safer options across breast reconstruction and aesthetics.”

Prior to Medivation, Dr. Hung was President and CEO of Pro-Duct Health, a venture capital-backed company focused on the early detection of breast cancer. Dr. Hung was the inventor of the Pro-Duct catheter which enabled the detection of early cellular atypia in women at high risk for breast cancer and he led the development of the catheter which resulted in its FDA clearance. Three years after raising a total of $22M in venture funding, the company sold for $168M in 2001 to Cytyc Corporation, one of the world’s largest makers of cervical pap smears. Prior to Pro-Duct Health, Dr. Hung was Vice President of Lead Discovery and Development at Chiron Corporation. Dr. Hung received an M.D. Alpha Omega Alpha from the University of California, San Francisco, and an A.B. summa cum laude from Harvard University.

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). Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implant Matrix® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All of its products are manufactured in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC.