Establishment Labs Announces Motiva® Implants IDE Clinical Trial Underway with First Patient Enrolled and Surgery Completed

NEW YORK, April 27, 2018 (GLOBE NEWSWIRE)

Establishment Labs Holdings Inc., a global medical device company focused on breast aesthetics and reconstruction technologies, today announced the enrollment and successful completion of implant surgery on the first patient in its U.S. investigational device exemption (IDE) clinical trial of its Motiva®®® in female patients who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. With a population size of approximately 750 patients over 22 years of age, at up to 40 study sites in the United States, Canada, Sweden, and Germany, all subjects will be selected according to a strict protocol established by FDA regulations.

Patients meeting the inclusion and exclusion criteria may be enrolled in the study. The primary safety endpoint is based on the incidence, severity, method of resolution, and duration of all complications on a “per-implant” and “per-subject” basis. The use of 3D imaging systems, such as Divina®, performed pre-operatively and at 1-10 year visits, will supplement the data and corroborate the manual measurements performed. An MRI sub-study will be done in parallel to determine the percentage of ruptures, with a subset of the treated population selected to obtain MRIs at 1,2,4,6,8 and 10 years.

Additional information regarding the trial will be available on clinicaltrials.gov and www.motivaimplants.com/UStrial

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 strict quality assurance testing throughout the manufacturing process. Motiva Implants are sold in more than 60 countries worldwide. All of Establishment Labs’ manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Investor Relations Contact
Lynn Pieper Lewis or Leigh Salvo
Gilmartin Group
(415) 937-5404
leigh@gilmartinir.com

Establishment Labs Receives IDE Approval from U.S. FDA to Initiate Clinical Trial of Motiva Implants

NEW YORK, March 22, 2018 (GLOBE NEWSWIRE)

Establishment Labs Holdings Inc., a global medical device company focused on breast aesthetics and reconstruction technologies with a strong emphasis on product development and innovation, announced today that it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial for its Motiva Implants, the lead product in its portfolio of innovative aesthetic technologies.

The IDE approval enables Establishment Labs to move forward with a single arm, multi-center study investigating female patients receiving primary breast augmentation, primary breast reconstruction, or revision surgery. The results of the study are expected to support a Pre-Market Approval (PMA) submission to the FDA.

“I’m delighted to have the opportunity to participate in a study that has the potential to bring new insights to the breast aesthetic and reconstruction industry. Motiva Implants are innovative and differentiated, and we hope that these innovations will show significantly improved patient outcomes,” said Dr. Caroline Glicksman, a board certified plastic surgeon and Medical Director of the Motiva Implants clinical trial. “Considerable time was taken to create a robust protocol that studies the safety and efficacy of Motiva Implants, and we have worked closely with the FDA to design a state of the art trial. Our investigators include experienced, knowledgeable, and caring surgeons from the United States, Canada, Sweden, and Germany. The safety of our patients remains our primary goal and we look forward to a successful trial that collects valid scientific data and advances the breast aesthetic and reconstruction industry.”

Juan Jose Chacon Quiros, CEO and Founder of Establishment Labs added, “Patient safety is Establishment Labs’ highest priority. Our implants are engineered with the latest scientific understanding in material sciences and surface technologies, and our advances in biocompatibility have demonstrated a favorable safety profile for patients worldwide. The start of this trial is an important milestone in our global commercialization strategy, and only adds to our leadership position as the innovator in this industry. Our decision to pursue a trial in the United States with such a rigorous study design reflects the confidence we have in both the superiority of our product and our manufacturing processes. There is a tremendous opportunity to materially improve the safety and satisfaction of patients seeking breast augmentation or reconstruction surgery.”

Motiva Implants are designed with a TrueMonobloc® shell that results in a strong and durable breast implant with exceptional elasticity for ease of insertion and small incisions. The cell-friendly surface technology behind Motiva Implants has demonstrated low complication rates in recent publications. For better aesthetic outcomes, the soft, form-stable filling gel allows for optimal shape retention, a natural look, and comfortable feel for women. Establishment Labs maintains strict manufacturing practices and adherence to both United States and European standards.

Roberto de Mezerville, Chief Technology Officer of Establishment Labs, commented, “Establishment Labs is committed to bringing enhanced safety and innovative products to the breast aesthetics and reconstruction fields. Motiva Implants® have a strong and rapidly growing following around the world, and the data is suggestive that they represent a meaningful advance to the industry. I have the highest expectations for this trial, and its impact on surgeons and patients alike.”

About the Motiva Implant Trial
The Motiva Implants clinical study is a single arm, multi-center trial, designed to measure the safety and effectiveness of the Motiva Implants SmoothSilk®/SilkSurface® and Ergonomix® in subjects who are undergoing primary breast augmentation, primary breast reconstruction, or revision surgery. It is scheduled to start in the second quarter of 2018, pending Institutional Review Board approvals at all selected clinical sites. With a population size of approximately 750 patients over 22 years in age and in up to 40 study sites in the United States, Canada, Sweden, and Germany, subjects will be selected per a strict protocol according to FDA regulations.

Patients meeting the inclusion and exclusion criteria may be enrolled in the study. The primary safety endpoint is based on the incidence, severity, method of resolution, and duration for all complications on a “per-implant” and “per-subject” basis. The use of 3D imaging systems, such as Divina®, performed pre-operatively and at 1-10 years visits, will supplement the data and corroborate the manual measurements performed. An MRI sub-study will be done in parallel to determine the percentage of ruptures, with a subset of the treated population selected to obtain MRIs at 1,2,4,6,8 and 10 years.

Additional information regarding the trial will be available on clinicaltrials.gov and www.motivaimplants.com/UStrial

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 strict quality assurance testing throughout the manufacturing process. Motiva Implants are sold in more than 60 countries worldwide. All of Establishment Labs’ manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Investor Relations Contact
Lynn Pieper Lewis or Leigh Salvo
Gilmartin Group
(415) 937-5404
leigh@gilmartinir.com

Establishment Labs Appoints Dennis Condon to the Board of Directors

NEW YORK, Jan. 8, 2018 (GLOBE NEWSWIRE)

Establishment Labs, a global medical device company focused on breast aesthetics and reconstruction technologies with a strong emphasis on product development and innovation, announced today that Dennis Condon has been appointed to the Board of Directors.

Mr. Condon brings years of experience in the breast implant market from his role as President of Mentor Aesthetics from 1990 to 1998.

On his appointment, Mr. Condon commented, “It is very exciting to see the extraordinary progress that Establishment Labs has brought to the field of breast aesthetics and the much needed innovation they have successfully developed and commercialized. The vastly improved patient outcomes is the first true differentiator in the market in decades, and I am very much looking forward to helping the company scale their business and help patients and plastic surgeons alike.”

Mr. Condon continued, “Establishment Labs has taken up the mantle of being the leader and innovator in this industry, and they are accomplishing much of what the industry should have been thinking about to improve safety and patient satisfaction. With this foundation, I think we can build the franchise and the products that can change and grow the industry in a way that has never been possible to date.”

Most recently, Condon was the CEO and President of Nuvesse Skin Therapies, a venture-backed cosmeceutical skincare company serving the U.S. medical device and retail skin care markets, until its sale to a Korean pharmaceuticals company in 2016. Previous to Nuvesse, he was CEO and President of Merz Aesthetics, Inc. and President and Chief Business Officer of BioForm Medical. BioForm was acquired by Merz Pharma in January 2010. Dennis has also lead other aesthetic companies, acting as CEO of a cosmetic laser company and CEO of a national chain of cosmetic surgery centers.

Dennis currently serves on the boards of two other companies in the aesthetic medical field: AirXpanders Inc., a unique breast reconstruction device, and Suneva Medical Inc., which commercializes the longest lasting dermal filler for facial fine lines and wrinkles. Mr. Condon has a BS in Biological Sciences from the University of California, Davis.

Juan Jose Chacon Quiros, CEO and Founder of Establishment Labs, commented, “We welcome Dennis to our Board. He brings 35 years of experience in key executive roles in the plastic surgery market, and his knowledge, insight, and executive leadership experience are a great fit with our team. I look forward to his help in building a new standard for Breast Aesthetics and Reconstruction.”

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.

Investor Relations Contact
Lynn Pieper Lewis or Leigh Salvo
Gilmartin Group
(415) 937-5404
leigh@gilmartinir.com

Establishment Labs and OBP Medical Announce Partnership to Deliver Innovative New Tool for Advanced Breast Aesthetics Procedures

NEW YORK, Nov. 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 today the launch of the MotivaImagine Ultralight LED in partnership with OBP Medical, creators of the award winning ONETRAC Retractor family.

Surgical kits designed to support placement of Establishment Labs’ next-generation Motiva Implants® will now include the MotivaImagine Ultralight LED, a single-use, cordless surgical retractor and measurement device with integrated LED light source and smoke evacuation channel. The unique design and features make it an ideal tool for plastic surgeons performing Motiva MinimalScars breast augmentation. It delivers unmatched functionality, clinical efficiency and infection prevention for Motiva users in countries across the globe. No assembly, additional parts/components, or fiber-optic cable are required.

“We are delighted to launch the MotivaImagine Ultralight LED with OBP Medical to increase the safety and efficacy profile of our Motiva Implants. With the launch of Motiva MinimalScars breast augmentation we will deliver added value to plastic surgeons and their patients,” said Juan José Chacón Quirós, CEO and founder of Establishment Labs. “The MotivaImagine Ultralight LED is an evidence-based tool that eliminates the risk of cross contamination and integrates seamlessly into our implantation protocol for advanced breast aesthetics procedures.”

“OBP Medical is committed to developing products that improve patient care and increase patient safety,” said Jason Swift, CEO of OBP Medical. “The clinical, operational and safety benefits of ONETRAC technology embodied in the MotivaImagine Ultralight LED make it the perfect choice for advanced procedures using Motiva Implants. Our partnership with Establishment Labs helps us meet demand for ONETRAC in new regions and we look forward to working together to put innovative surgical solutions into the hands of surgeons around the world.”

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.

About OBP Medical:

OBP Medical is the leading global developer of single-use, self-contained, illuminating medical devices. We create simple and effective single-use solutions by integrating medical devices with LED light sources, making them one. At OBP Medical, we illuminate the everyday. Our innovative products are in use at more than 6,000 physician offices, surgery centers and hospitals throughout the U.S., as well as healthcare facilities worldwide. For more information about OBP Medical and our line of self-illuminated medical devices, please visit www.obpmedical.com, check out our Simple.Bright.Ideas.BLOG or follow us on Twitter. OBP Medical is proud to be ISO13485 certified.

Establishment

Investor Relations Contact
Lynn Pieper Lewis or Leigh Salvo
Gilmartin Group
(415) 937-5404
leigh@gilmartinir.com

Establishment Labs Announces Positive Clinical Study Results for its Motiva Implants® Published in the Aesthetics Surgery Journal

NEW YORK, September 14, 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 the results of a three-year, retrospective clinical study using the Company’s Motiva Implants® were published in the peer-reviewed Aesthetic Surgery Journal.

The study evaluated the experience of 5,813 consecutive female patients receiving Motiva Implants for breast augmentation, from 2013 to 2016 at Dolan Park Hospital in Bromsgrove, England. The study, based on the experience of 16 board-certified plastic surgeons, evaluated rates of complications and reoperation following the procedure, with postoperative follow-up care over the three-year period. Two surface technologies of Motiva Implants were investigated: SilkSurface® and VelvetSurface®.

Clinical highlights of the clinical study included:

  • Total reoperation occurred at a rate of 0.76% (95% confidence interval)
  • No serious adverse events or cases of implant rupture for device failure were observed
  • No incidences of capsular contracture in primary cases, late seroma, asymmetry, persistent swelling, breast pain or rippling
  • Low rates of early complications with no late complications reported
  • Motiva SilkSurface® resulted in lower complication rates compared to Motiva VelvetSurface® implants

“These findings help validate the differentiated safety profile of Motiva Implants,” said Juan José Chacón Quirós, CEO and founder of Establishment Labs. “We expect this to be the start of many peer reviewed articles that suggest a truly differentiated product and competitive advantage. Establishment Labs does not believe that industry, doctors, or patients need to accept the complication rates associated with the majority of implants today, and that high complication rates do not have to be endemic to breast augmentation. This paper is a credit to the commitment that Establishment Labs has made to innovation in breast augmentation and reconstruction, and reaffirms our belief that our commitment to technological development can vastly improve many of the problems that have plagued this industry.”

“Motiva Implants demonstrated low reoperation rates that are encouraging considering there remains a clear unmet need for improved safety and durability of silicone breast implants,” stated Dr. Marcos Sforza, Scientific Medical Director of the Hospital Group and Medical Advisory Board member of Establishment Labs.

“After 10 years as the scientific Medical Director of the largest hospital for cosmetic surgery in Europe, and having used all the available brands of implants, I had become increasingly disappointed with industry and the lack of new solutions and technologies for breast augmentation and reconstruction. We commenced using Motiva in 2013 because of their commitment to innovation and patient-centric approach, and our belief that we could do better has been validated by our results. Using Motiva Implants has revolutionized our practice across the board, and we can proudly confirm with this publication that we have not seen one double capsule or late seroma in over 12 thousand implants used in breast augmentation. Compared to our previous experience in breast augmentation, revision rates have been reduced more than 10 times with higher patient satisfaction rates. These results are good for the breast augmentation and reconstruction markets, they are good for patients, plastic surgeons, and industry alike, and I look forward to future innovations and a revitalized aesthetic industry,” stated Dr. Sforza.

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 aesthetic and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.

Contact
Lynn Pieper Lewis or Leigh Salvo
Gilmartin Group
(415) 937-5404
leigh@gilmartinir.com

Establishment Labs Announces $55 Million Combined Debt and Equity Financing

NEW YORK, August 28, 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 closed a $55 million combined secured credit facility and equity investment with Madryn Asset Management.

“This transaction allows us to finance our research and development into next generation implants for breast augmentation and reconstruction surgeries, pursue expanded commercialization opportunities in markets where our Motiva Implants® have been approved, and support our proposed FDA Trial and entrance into the US Market,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs.

“As we continue our efforts to be a leader in breast aesthetics—not only in terms of innovation, but also in global sales—we are delighted to have the support and confidence of Madryn. Along with our other institutional shareholders, they have taken the time to understand what an extraordinary opportunity is in front of us, and they believe we are the company to drive this transformation in the medical aesthetics industry,” Chacón-Quirós concluded.

“We see tremendous value in Establishment Labs as a leader and an innovator in the global medical technology industry and are pleased to support the company in achieving its growth plans,” said Avinash Amin, Co-Founder and Managing Partner of Madryn. “There is a wide unmet need for new technologies in breast aesthetics, with a specific focus on improved safety, better outcomes, and greater satisfaction. We believe that the Company’s Motiva Implants together with its associated suite of breast augmentation products and services will bring advances to an industry that has seen little innovation in many decades.”

About Madryn Asset Management, LP
Madryn Asset Management is a leading alternative asset management firm that invests in innovative healthcare companies specializing in unique and transformative products, technologies, and services. The firm draws on its extensive and diverse experience spanning the investment management and healthcare industries, and employs an independent research process based on original insights to target attractive economic opportunities that deliver strong risk-adjusted and absolute returns for its limited partners while creating long-term value in support of its portfolio companies. For additional information, please visit www.madrynlp.com.

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.

Contact
Lynn Pieper Lewis or Leigh Salvo
Gilmartin Group
(415) 937-5404
leigh@gilmartinir.com

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.