21 CFR 820

Establishment Labs Announces Japanese Regulatory Approval and Reimbursement for Motiva Implants and the Motiva Flora Tissue Expander for Use in Post-Mastectomy Reconstruction

Retrieved on: 
Thursday, November 10, 2022
General Health, Health, Telemedicine, Virtual Medicine, Medical Devices, Establishment, Motiva, Implant, 21 CFR 820, Nasdaq, Diversified Specialty Institute Holdings, Inc., IDE, Pharmaceuticals and Medical Devices Agency, RFID, ESTA, Medicines and Healthcare products Regulatory Agency, PMDA, Clinical trial, MDSAP, Woman, U.S. FDA, Spanish National Health System, Medication, FDA, Pharmaceutical industry, Medical imaging, Medical device

The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System.

Key Points: 
  • The products have also received reimbursement for post-mastectomy reconstruction under the Japanese National Health System.
  • The first reconstruction patient in Japan was successfully treated with Motiva in early November at Nagoya University Hospital.
  • Launching Motiva Flora with Motiva Implants in the Japanese market is a significant step in changing the global standard in breast reconstruction, said Juan Jos Chacn-Quirs, Founder and Chief Executive Officer.
  • Motiva Implants and the Motiva Flora tissue expander are currently not approved for commercial distribution in the United States.

Establishment Labs Reports Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 7, 2022
Medical Devices, Health, Consumer, Surgery, Women, Health Technology, Environment, MDSAP, Mia, U.S. FDA, Risk, U.S. Securities and Exchange Commission, Growth, FDA, GAAP, SEC, Adoption, Company, Investor relations, Private Securities Litigation Reform Act, Clinical trial, Securities Exchange Act of 1934, ESTA, Trial of the century, Securities Act of 1933, IDE, Borrowing base, Total, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., 21 CFR 820, Goal, PMA, Investment, Nasdaq, Woman, Marketing, Annual report, Form 10-K, Security (finance), Time, Video game, Medical device, Lithium, Food delivery, Pharmaceutical industry, Bank, Motiva

Establishment Labs Holdings Inc. (Nasdaq: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the third quarter ended September 30, 2022.

Key Points: 
  • Establishment Labs Holdings Inc. (Nasdaq: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the third quarter ended September 30, 2022.
  • Third quarter operating expenses of $36.6 million, an increase of 27.5% compared to the third quarter of 2021.
  • The significant momentum in our business continued in the third quarter of 2022 and we expect our strong financial results will continue into the fourth quarter and into 2023, said Juan Jos Chacn-Quirs, Founder and Chief Executive Officer.
  • Establishment Labs will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its financial results.

Establishment Labs Announces Participation in Two Upcoming Investment Conferences

Retrieved on: 
Tuesday, November 1, 2022
Medical Devices, Health, Consumer, Women, Health Technology, Biotechnology, Motiva, IDE, Founder, MDSAP, Conference, Clinical trial, Diversified Specialty Institute Holdings, Inc., 21 CFR 820, NASDAQ, FDA, ESTA, Nightclub

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in two upcoming investment conferences.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in two upcoming investment conferences.
  • Mr. Chacn-Quirs and Mr. Denhoy are scheduled to speak in person to conference attendees on Tuesday, November 15 at 5:00 PM GMT.
  • Mr. Denhoy will also participate in the Stephens Annual Investment Conference, being held on November 15-17, 2022.
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

Establishment Labs to Announce Third Quarter 2022 Financial Results on November 7

Retrieved on: 
Monday, October 24, 2022
Biotechnology, Medical Devices, Women, Consumer, Health, MDSAP, International, NASDAQ, Clinical trial, Motiva, ESTA, Diversified Specialty Institute Holdings, Inc., FDA, IDE, 21 CFR 820, Medical device

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended September 30, 2022 after the market closes on Monday, November 7, 2022, and will host a conference call at 4:30 pm ET that day to discuss those results.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended September 30, 2022 after the market closes on Monday, November 7, 2022, and will host a conference call at 4:30 pm ET that day to discuss those results.
  • To participate in the conference call, dial (877) 407-8037 (U.S. and Canada) or (201) 689-8037 (International) and use conference ID number 13733889.
  • The call will also be available via live or archived webcast on the Investor Relations section of the Establishment Labs website at www.establishmentlabs.com .
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

Establishment Labs to Host Investor Event for Mia Femtech on October 5, 2022

Retrieved on: 
Tuesday, September 20, 2022
Medical Devices, Health, Consumer, Surgery, Women, Health Technology, Securities Exchange Act of 1934, Adoption, Risk, Time, U.S. FDA, FDA, IDE, Securities Act of 1933, Company, Form 10-K, Private Securities Litigation Reform Act, Environment, U.S. Securities and Exchange Commission, Program, Clinical trial, Motiva, ESTA, Goal, 21 CFR 820, NASDAQ, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Security (finance), SEC, Annual report, MDSAP, Medical device, Risk management, Mia

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on womens health, initially in the breast aesthetics and reconstruction market, today announced that it will host an investor event on October 5, 2022 to discuss Mia Femtech (Mia).

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on womens health, initially in the breast aesthetics and reconstruction market, today announced that it will host an investor event on October 5, 2022 to discuss Mia Femtech (Mia).
  • Mia Femtech is Establishment Labs minimally invasive breast aesthetics experience.
  • The Company will provide an overview of Mia as well as updates on the progress to date in development and commercialization.
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

Establishment Labs Announces Hani Zeini has Joined the Company as Exclusive Advisor in Anticipation of US Launch

Retrieved on: 
Monday, September 12, 2022
Medical Devices, Health, Consumer, Surgery, Women, Health Technology, Securities Exchange Act of 1934, Adoption, Risk, Time, Medication, Breast augmentation, University, Stanford Graduate School of Business, Woman, FDA, Computer, IDE, Securities Act of 1933, Medicine, Electrical engineering, Growth, Form 10-K, Private Securities Litigation Reform Act, Industry, Labs, Environment, Business, U.S. Securities and Exchange Commission, Clinical trial, Motiva, ESTA, Stanford University, Goal, 21 CFR 820, NASDAQ, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Security (finance), SEC, Annual report, Medical device, Aesthetics, MDSAP, Risk management, Inam Kulathur

In 2017, Mr. Zeini founded a boutique advisory firm, Elissar Advisors, focused on providing commercial expertise in aesthetics medicine.

Key Points: 
  • In 2017, Mr. Zeini founded a boutique advisory firm, Elissar Advisors, focused on providing commercial expertise in aesthetics medicine.
  • With our launch in the US drawing closer, we have considered a variety of approaches to enter the market.
  • Hanis experience and wisdom will be vital to those efforts, said Dr. Heather Brennan, Global Head of Markets at Establishment Labs.
  • I am beyond excited to help Establishment Labs usher in a new era in plastic surgery, something to which I have dedicated my career, said Hani Zeini.

Establishment Labs Reports Record Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 8, 2022
Health, Consumer, Women, Surgery, Health Technology, General Health, Biotechnology, FDA, Woman, U.S. Securities and Exchange Commission, Securities Act of 1933, Risk, Investor relations, Trial of the century, Technology, Private Securities Litigation Reform Act, Growth, Motiva, SEC, Investment, Clinical trial, Zeltiq Aesthetics, Securities Exchange Act of 1934, Security (finance), Environment, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Marketing, Company, 21 CFR 820, Form 10-K, MDSAP, ESTA, GAAP, U.S. FDA, IDE, PMA, Goal, Nasdaq, Time, Annual report, Total, Health, Borrowing base, Adoption, Video game, Pharmaceutical industry, Bank, Tutoring

Establishment Labs Holdings Inc. (Nasdaq: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the second quarter ended June 30, 2022.

Key Points: 
  • Establishment Labs Holdings Inc. (Nasdaq: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the second quarter ended June 30, 2022.
  • Second quarter operating expenses of $37.9 million, an increase of 45.0% compared to the second quarter of 2021.
  • The strong momentum in our business continued in the second quarter of 2022, said Juan Jos Chacn-Quirs, Chief Executive Officer.
  • Second quarter revenue of $41.2 million was up 28.7% from the second quarter of 2021; excluding the impact of the stronger U.S. dollar, which reduced reported revenue by approximately $1.5 million, growth in the second quarter would have been 33.3%.

Establishment Labs Announces Complete Enrollment in Motiva US IDE Study

Retrieved on: 
Wednesday, August 3, 2022
Medical Supplies, Medical Devices, Health, Surgery, Other Health, Clinical Trials, Plastic surgery, Drug Quality and Security Act, PMA, Form 10-K, Breast cancer, Goal, Department, Private Securities Litigation Reform Act, Security (finance), Annual report, Investigational device exemption, Woman, Rupture, Securities Act of 1933, Trial of the century, Securities Exchange Act of 1934, Risk, Patient, Food, Northwestern Memorial Hospital, MRI, U.S. Securities and Exchange Commission, Safety, 21 CFR 820, FDA, Safety of magnetic resonance imaging, Magnetic resonance imaging, Diversified Specialty Institute Holdings, Inc., Time, Plastic, IDE, ESTA, Adoption, Augment, CEO, Environment, Food and Drug Administration Amendments Act of 2007, MDSAP, Clinical trial, NASDAQ, Pharmaceutical industry, Medical imaging, Medical device, Motiva

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced it has completed enrollment in the Motiva US IDE clinical study.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced it has completed enrollment in the Motiva US IDE clinical study.
  • The Augmentation cohort, which finished enrollment in August of 2019, will complete its third year of study follow-up this month.
  • The Motiva US IDE study enrolled 827 patients at 32 centers in the US, Germany, and Sweden.
  • Having completed full enrollment in the IDE study across all patient groups, we are diligently working with the plastic surgeons in the trial to maintain high patient follow-up, said Juan Jos Chacn-Quirs, Founder and CEO of Establishment Labs.

Establishment Labs to Announce Second Quarter 2022 Financial Results on August 8

Retrieved on: 
Monday, July 25, 2022
Surgery, Medical Devices, Other Health, Health, Medical Supplies, NASDAQ, ESTA, Motiva, MDSAP, IDE, Clinical trial, International, 21 CFR 820, FDA, Diversified Specialty Institute Holdings, Inc., Medical device

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended June 30, 2022 after the market closes on Monday, August 8, 2022, and will host a conference call at 4:30 pm ET that day to discuss those results.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended June 30, 2022 after the market closes on Monday, August 8, 2022, and will host a conference call at 4:30 pm ET that day to discuss those results.
  • To participate in the conference call, dial (877) 407-8037 (U.S. and Canada) or (201) 689-8037 (International) and use conference ID number 13731615.
  • The call will also be available via live or archived webcast on the Investor Relations section of the Establishment Labs website at www.establishmentlabs.com .
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

Establishment Labs Releases 2021 Sustainability Review

Retrieved on: 
Tuesday, July 19, 2022
Environment, Surgery, Medical Devices, Women, Professional Services, Sustainability, Health, Consumer, Environmental, Social and Governance (ESG), Research, Global, CEO, IDE, Woman, Security (finance), Risk, GRI, U.S. Securities and Exchange Commission, Form 10-K, Freedom, Time, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Annual report, Private Securities Litigation Reform Act, Securities Exchange Act of 1934, Carbon, 21 CFR 820, Health, Adoption, Breast cancer, Health and Safety Executive, United Nations, Environment, Sustainable Development Goals, Goal, Exercise, Securities Act of 1933, List of Nature Research journals, NASDAQ, Harwell Science and Innovation Campus, Industry, COVID-19, Motiva, MDSAP, ESTA, FDA, Clinical trial, Sustainable Development Goals and Lebanon, Awareness, Medical device, Risk management, Pharmaceutical industry

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced publication of its 2021 Sustainability Review to coincide with the fourth anniversary of the companys public listing on NASDAQ.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced publication of its 2021 Sustainability Review to coincide with the fourth anniversary of the companys public listing on NASDAQ.
  • We are presenting our 2021 Sustainability Review as an exercise in transparency, so that all of our stakeholders can review our progress with this vision and our efforts in support of environmental and social issues in our communities.
  • Among the topics included in the 2021 Sustainability Review are:
    References to the Global Reporting Initiative (GRI) Standards for Energy Consumption, Emissions, and Health and Safety topics as well as the Sustainable Development Goals (SDGs) outlined in the United Nations resolution The 2030 Agenda.
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.