Associated tags: Patent, IDE, Breast cancer, U.S. FDA, Safety, Publication, 21 CFR 820, Science, PMA, Engineering, Clinical trial, MDSAP, Motiva, FDA, Establishment, Medical device
Locations: UNITED STATES, NORTH AMERICA, CALIFORNIA, JAPAN, ASIA PACIFIC, COSTA RICA
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s 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 women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in two upcoming investment conferences.
- Juan José Chacón-Quirós, Chief Executive Officer and Founder, and Raj Denhoy, Chief Financial Officer, will participate in the 2024 Jefferies Global Healthcare Conference being held June 5-6, 2024.
- Mr. Chacón-Quirós and Mr. Denhoy are scheduled to speak to conference attendees on Wednesday, June 5, 2024 at 8:30 a.m.
- Live webcasts of the presentations will be available on the Establishment Labs investor relations website at https://investors.establishmentlabs.com/ .
Health Technology,
Health,
Surgery,
FDA,
Total,
ESTA,
Investment,
Breast,
IDE,
Rupture,
U.S. FDA,
Video game Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced financial results for the first quarter ended March 31, 2024.
Key Points:
- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced financial results for the first quarter ended March 31, 2024.
- First quarter loss from operations was $8.8 million compared to a loss of $22.1 million in the fourth quarter of 2023 and $8.2 million in the year-ago period.
- SG&A expenses for the first quarter decreased approximately $2.8 million to $28.9 million compared to $31.7 million in the first quarter of 2023.
- Establishment Labs will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its financial results.
Surgery,
Medical Devices,
Women,
Clinical Trials,
Other Health,
Health,
Cosmetics,
Consumer,
Retail,
FDA,
Investigational device exemption,
Motiva,
Breast,
Patient,
Rupture,
Clinical trial,
Woman,
Labs,
MRI Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort.
Key Points:
- Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort.
- Relative to historic benchmarks, patient follow-up remains very high and the rates of complication remain very low.
- Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States.
- This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial.
Health,
Medical Devices,
Consumer,
Women,
Surgery,
Health Technology,
General Health,
Xavier University,
FDA,
University,
ESTA,
American Cyanamid,
Woman,
Regenerative medicine,
Breast augmentation,
Johnson & Johnson,
U.S. FDA,
Science,
Marketing,
MBA,
PMA,
Organization Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced today that Jeff Ehrhardt has joined the company as General Manager of North America.
Key Points:
- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced today that Jeff Ehrhardt has joined the company as General Manager of North America.
- “Jeff is the ideal person to introduce Motiva to the United States,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs.
- Mr. Ehrhardt was most recently General Manager for Plastic Surgery & Regenerative Medicine at Allergan Aesthetics.
- "Joining Establishment Labs is in many ways the culmination of the last 25 years of my career,” said Jeff Ehrhardt.
Retrieved on:
Wednesday, April 24, 2024
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended March 31, 2024 after the market closes on Wednesday, May 8, 2024, 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 women’s health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended March 31, 2024 after the market closes on Wednesday, May 8, 2024, 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 +1 (201) 689-8037 (International) and use conference ID number 13746251.
- 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 .
Retrieved on:
Wednesday, April 17, 2024
Medical Devices,
Health,
Consumer,
Surgery,
Women,
Health Technology,
FDA,
ESTA,
Aesthetics,
U.S. FDA,
Motiva,
Clinical trial,
PMA,
Medical director,
Labs Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in The Aesthetic Meeting 2024, which is being held May 2-5 in Vancouver, BC Canada.
Key Points:
- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in The Aesthetic Meeting 2024, which is being held May 2-5 in Vancouver, BC Canada.
- At the meeting, Dr. Caroline Glicksman, the Medical Director and an Investigator in the Motiva US IDE Study, will present an update on the clinical trial after completion of four-year follow-up.
- The presentation, Motiva US Core Clinical Study Update, is part of an investigator research update session scheduled for approximately 6:30 p.m. PT on May 2.
- Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States.
Retrieved on:
Wednesday, February 28, 2024
General Health,
Surgery,
Medical Devices,
Health,
Health Technology,
ESTA,
Total,
Investment,
FDA,
Expander,
Video game Fourth quarter net loss from operations of $22.1 million compared to a net loss of $13.2 million in the year-ago period.
Key Points:
- Fourth quarter net loss from operations of $22.1 million compared to a net loss of $13.2 million in the year-ago period.
- Total operating expenses for the fourth quarter were $42.7 million, an increase of $1.4 million compared to $41.3 million in the fourth quarter of 2022.
- SG&A expenses for the fourth quarter increased approximately $2.1 million to $36.9 million compared to $34.8 million in the fourth quarter of 2022.
- Establishment Labs will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its financial results.
Retrieved on:
Friday, February 23, 2024
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s 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 women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in two upcoming investment conferences.
- Juan José Chacón-Quirós, Chief Executive Officer and Founder, and Raj Denhoy, Chief Financial Officer, will participate in Citi’s 2024 Unplugged Medtech and Life Sciences Access Day.
- Mr. Chacón-Quirós and Mr. Denhoy are scheduled to speak to conference attendees on Thursday, February 29, 2024 at 2:30–3:10 p.m.
- Live webcasts of the presentations will be available on the Establishment Labs investor relations website at https://investors.establishmentlabs.com/ .
Retrieved on:
Thursday, February 22, 2024
Medical Devices,
Health,
Consumer,
Surgery,
Women,
Health Technology,
ESTA,
FDA,
Oaktree Capital Management,
Form,
Interest,
Motiva,
Security (finance),
Tranche Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced that it has amended its $225 million term loan facility with funds managed by Oaktree Capital Management, L.P. (“Oaktree”).
Key Points:
- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced that it has amended its $225 million term loan facility with funds managed by Oaktree Capital Management, L.P. (“Oaktree”).
- The terms on the two tranches already drawn under the facility, which total $175 million, are unchanged.
- “This amended facility provides access to additional capital, should we need it, to ensure our successful launch of Motiva Implants in the United States,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs.
- We look forward to continuing our long-term relationship with Establishment Labs and are excited for what lies ahead.”
A Form 8-K outlining the full terms of the credit facility will be filed with the Securities and Exchange Commission.
Retrieved on:
Wednesday, February 14, 2024
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended December 31, 2023, after the market closes on Wednesday, February 28, 2024, 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 women’s health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended December 31, 2023, after the market closes on Wednesday, February 28, 2024, 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 +1 (201) 689-8037 (International) and use conference ID number 13744589.
- 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 .
