Investor Day
Welcome
Agenda Topic Presenter/Moderator Welcome; Logistics; Agenda Raj Denhoy Corporate Overview Peter Caldini Motiva® USA Business Updates Jeff Ehrhardt US Breast Aesthetic - Panel Ben Newcott Breast Reconstruction Opportunity in the USA Jeff Ehrhardt US Breast Reconstruction - Panel Ben Newcott Innovation Pipeline Roberto de Mezerville GLP-1s and Plastic Surgery Juan José Chacón-Quirós Unlocking New Markets - Panel Juan José Chacón-Quirós Management Q&A AgendaInvestors’ Day
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This presentation is not an offer to sell securities of Establishment Labs and it is not soliciting offers to buy securities of Establishment Labs in any jurisdiction where the offer or sale is not permitted.
Global Business Update Peter Caldini 01 Motiva US Business UpdateInvestors’ Day
90+ Establishment Labs® devices are approved COUNTRIES 4M+ Motiva® devices* in the market worldwide since 2010 DEVICES 210+ Applications approved/pending in over 20 jurisdictions PATENTS 140+ Science-based research PUBLICATIONS 20 Years of Global Innovation Global Business UpdateInvestors’ Day
Global Business UpdateInvestors’ Day Reconstruction Traditional Breast Augmentation Breast Tissue Preservation Motiva Flora® Motiva® JOY.(dot)® Preservé Mia® Motiva Flora® Tissue Expander Motiva® Round Ergonomix® Ergonomix2® Ergonomix® Ergonomix2® Ergonomix2® Diamond SmoothSilk® Non-Magnetic Infusion Port TrueFixation® System SmoothSilk® ProgressiveGel® Plus TrueMonobloc® BlueSeal® SmoothSilk® ProgressiveGel® Ultima® TrueMonobloc® BlueSeal® SmoothSilk® ProgressiveGel® Ultima® TrueMonobloc+® BlueSeal+® Motiva SuperSilicones® Woman’s Choice Program® SmoothSilk® ProgressiveGel® Ultima® TrueMonobloc+® BlueSeal+® Motiva SuperSilicones® Woman’s Choice Program® SmoothSilk® ProgressiveGel® Ultima® TrueMonobloc+® BlueSeal+® Motiva SuperSilicones® Woman’s Choice Program® Our Portfolio
Primary Augmentation (N=451) 2-year (95% CI) 3-year (95% CI) 4-year 95% CI 5-year 95% CI Capsular contracture (Baker Grade III/IV) 0.5% (N=2) 0.5% (N=2) 0.5% (N=2) 0.5% (N=2) Rupture, suspected or confirmed 0.6% (N=1) 0.6% (N=1) 0.6% (N=1) 0.6% (N=1) Breast pain 0.7% 0.7% 0.9% 1.2% Infection 0.9% 0.9% 0.9% 0.9% Implant removal, with or without replacement 1.6% 1.6% 1.8% 3.1% Any reoperation1 5.9% 6.6% 6.8% 8.8% Any complication2 8.4% 8.8% 9.6% 12.0% 5-year data is preliminary and does not reflect the final study results. Motiva® U.S. IDE Study 1. Any surgery on the breast or chest area, device or non-device related, including size change 2. Any device or non-device related event, including reoperation Global Business UpdateInvestors’ Day
Motiva® implants sold in 90+ countries Direct Distribution Near-term Opportunities Global Sales Footprint Investors’ Day Global Business Update
2025 Corporate Priorities Budget & Cash Management Revenue Target Efficiencies Identification Preservé Mia® Scaling up GEM® PMA Supplements New Technology Global Business UpdateInvestors’ Day US Launch InnovationDriving efficiencies & Profitability Minimally Invasive
•2025 revenue guidance: $205 to $210m •US to meaningfully exceed $35m • Including approx. $9.5m to $10m in 2Q •Mid-single digit growth outside the US •Underlying demand remains stable •Preservé Launch in EMEA and LATAM •Strong initial demand •Gross margins expected to trend higher •+200-300bp, driven by the US •Continue to drive efficiencies in OPEX •Reduced OUS & Corp expense by ~30% from 2023; Investing in US commercial operations •Leveraging stable OPEX in outer quarters •Expect to turn EBITDA positive in 2025 • Expect to grow at 20%+ for at least the next three years • Continued focus on efficiency and healthy growth • Expected to achieve cash flow positive in 2026 • On a clear path to become the global leader in breast aesthetics and reconstruction • Leading a transformation in minimally invasive Global Business UpdateInvestors’ Day 2025 Beyond 2025
Motiva® US Business Update 02 Motiva® US Business UpdateInvestors’ Day Jeff Ehrhardt
Key Priorities for the U.S. for 2025 Staff U.S. Organization with best in class, Plastic Surgery experienced talent • 42 Sales Representative, 4 Region Managers, 3 Strategic Acct. Mgrs., 1 NSD. • Customer Service & Support Team 01 Build out seamless, easy to navigate customer ordering platform and overall operating system 02 Build sufficient inventory and place permanent consignments in 200 targeted accounts • >100 Placed YTD 03 Focus Execution on Surgeon Training & Engagement and driving overall brand awareness 04 Achieves $35M+ revenue in 2025 05 • >1000 Surgeons have opened accounts • 5 billion+ Motiva impressions • Q1 $6.2M • Q2 ~$9.5M to 10.0M • Expecting to meaningfully exceed $35M Investors’ Day Motiva® US Business Update • >75% of orders via Motiva Portal • <25% via live agent
8 Sulàyöm Events In Costa Rica (120+ Surgeons) 8 Surgeon Lead Masterclasses (50+ Surgeons) Surgeon Training Investors’ Day Driving Surgeon Training and Engagement Motiva® US Business Update
Advisory Boards Driving Surgeon Training and Engagement Surgeon Engagement Sponsored Speaker Events All National & Regional Society Meetings • RASAPS • The Aesthetic Meeting • MiB Boards • ABAM • OCSPS • Atlanta Breast Symposium • The Aesthetic Meeting • PSTM Investors’ Day Motiva® US Business Update • The Aesthetic Society • ASPS • SESPERS • Atlanta Breast Symposium • ABAM • Mountain West Society • Northwest Society • RASAPS • SAPS • MiB • Breast Surgery & World Consensus • All State and Local
“Everyone” is talking about Motiva® on social @Motiva_USA 6,471+ 34,118+ 31,284,065+ Followers Interactions Impressions 750+ Organic Surgeon Posts 24 Motiva® Monday Emails 1,528 Social Post Downloads Investors’ Day Motiva® US Business Update
Influencer Program Patients are sharing their journey @_leslieperez 72.6K Followers Houston, TX @iamstephmurray 33.1K Followers Jacksonville, FL @daphnemarquez_ 114K Followers Houston, TX @ericapowell 19.8K Followers Ponte Vedra, FL @Mary_a_b 141K Followers Austin, TX @alexiusmariee 24.4k Followers Pfuglerville, TX Motiva US Business UpdateInvestors’ Day User Generated Content
Motiva®’s first A-list celebrity influencer MEGHAN TRAINOR is a grammy award winning A- list singer songwriter and television personality, most notable for her debut single "All About That Bass”. Meghan has sold millions of albums worldwide and has over 18M social media followers. Meghan announced on her podcast in late November 2024 that she was ready for a breast augmentation. She shared that she’s been considering the procedure since the age of 16 and was finally ready after breastfeeding and losing weight. Motiva US Business UpdateInvestors’ Day
Meghan’s Motiva® journey made headlines 90 Meghan X Motiva Mentions Impressions4.8 Billion 1.7M Video views Motiva US Business UpdateInvestors’ Day
Meghan Trainor Campaign Success Metrics 3,427+ Leads from Meghan Trainor’s landing page MT Campaign patients got surgery with Motiva® Implants700 + Motiva US Business UpdateInvestors’ Day
Driving Awareness 40% Increase in Motiva® Branded Searches Active Website Visitors130,000 Motiva US Business UpdateInvestors’ Day
Patients are looking for a Motiva® surgeon Patient Leads >5,000 Actions on Motiva Surgeon Locator >120,000 Motiva US Business UpdateInvestors’ Day
>1000 Surgeons Offer Motiva® : Patients have ready access to Motiva® Motiva US Business UpdateInvestors’ Day
Monthly Order Trends Steadily Increasing 0 30 60 90 120 150 OCT NOV DEC JAN FEB MAR APR A vg o rd er s pe r d ay Hospital accounts ordering Flora 700+ 60+ Aesthetic Accounts ordering Motiva Investors’ Day Motiva US Business Update
COMPANY CONFIDENTIAL. INTERNAL USE ONLY. DO NOT DISTRIBUTE. Investors’ Day Motiva US Business Update Extension of additional sizes Breast Tissue Preservation Current Portfolio Breast Reconstruction Beyond Ergonomix2® Platform & Mia Femtech Cycle of Innovation 2025+ Minimally Invasive Tools filed with FDA early June Early experience to begin 3Q25 US launch expected in 1H26 Supplement filed with FDA early June Reconstruction indication filing with FDA expected by end of 2025
Investors’ Day US Breast Aesthetics Panel 03 US Breast Augmentation Panel Ben Newcott Panelists Mark Epstein, M.D Anna Steve, M.D Troy Pittman, M.D.
Engineering Beautiful Durable Results with Motiva Implants My 7 Year Investigator Experience Center for Aesthetic Surgery Hauppauge, NYMark D. Epstein, MD, FACS Mark D. Epstein, MD, FACSInvestors’ Day
• Epstein Breast Retractors – ASSI (Royalties) • Epstein Breast Implant Retractor - Black and Black surgical • Vectra advisory board - Canfield Clinical Systems • Principal investigator - Motiva® US Clinical Breast Implant Trial • Stockholder – Establishment Labs® • Allergan- Consultant and speaker Relevant Disclosures Investors’ Day Mark D. Epstein, MD, FACS
Studied Biomedical/Electrical Engineering & Computer Science – Northwestern University About Me Board Certified – American Board of Plastic Surgery and American Board of Surgery 31 years of clinical practice Performed thousands of breast augmentation Employ both 2D and 3D imaging in my breast practice Performing One Day Recovery Breast Augmentation for 21 years Investors’ Day Mark D. Epstein, MD, FACS
Clinics of Plastic Surgery 42: 437 – 450, October 2015 Investors’ Day Mark D. Epstein, MD, FACS
How Did I Get Involved • 2017 – Invitation to become a principal investigator • Deep dive into the technology •SmoothSilk® •TrueMonobloc® technology• Novel approach to silicone rheology •QiD® Investors’ Day Mark D. Epstein, MD, FACS
Initial Observations Patients wanted the “little blue implant” Almost all new patients wanted to be in the study No issues with device usage and placement 100% of patients loved the way their breasts looked and felt Investors’ Day Mark D. Epstein, MD, FACS
Current Observations at Seven Years Follow Up Results are EXTREMELY stable Breasts feel more natural than with any other device 99% of patients thrilled with their results No patient has asked to have a competitive device placed Device related complications extremely low Investors’ Day Mark D. Epstein, MD, FACS
Sustaining Innovation – Motiva® technology - superior as compared to competitive devices New Market Disruption – Created two new markets utilizing minimally invasive technology •Small volume breast augmentation (Mia®) •Larger volume breast augmentation (Preserve ) Investors’ Day Motiva®: Disruption of the Market Mark D. Epstein, MD, FACS
Subpectoral breast augmentation Prepectoral breast augmentation •The “New Gold Standard” •Gold Standard > 30 years Investors’ Day Motiva®: Major Paradigm Shift Mark D. Epstein, MD, FACS
Motiva®: Advantages of Prepectoral Breast Augmentation Concern for the transition from chest wall to upper breast is no longer a concern with Motiva implants Can now perform this surgery in women with very thin tissue No animation deformities Can create narrower cleavage Faster recovery? 01 02 03 04 05 Investors’ Day Mark D. Epstein, MD, FACS
Case Studies Investors’ Day Mark D. Epstein, MD, FACS
Patient WS • 26 YO, 146 LBS • Primary Augmentation • Dual Plane I • Motiva® Ergonomix® ERSD R: 340 cc, L: 340 cc 6 Year Post-Op4 Month Post-Op1 Month Post-OpPre-0p 5/14/2018 6/4/2018 9/25/2018 6/17/2024 Investors’ Day Mark D. Epstein, MD, FACS 7 Year Post-Op 6/5/2025
Patient EJ • 40 YO, 118 LBS • Primary Augmentation • Dual Plane II • Motiva® Ergonomix® ERSD R: 230 cc, L: 230 cc 6 Year Post-Op4 Month Post-Op1 Month Post-OpPre-0p 7/2/2018 8/13/2018 10/29/2018 8/12/2024 Investors’ Day Mark D. Epstein, MD, FACS 7 Year Post-Op 5/29/2025
Patient FL • 34 YO, 122 LBS • Primary Augmentation • Dual Plane II • Motiva® Ergonomix® ERSD R: 265 cc, L: 265 cc 6 Year Post-Op4 Month Post-Op 10/8/2018 10/26/2018 2/25/2019 10/11/2024 Pre-0p 1 Month Post-Op Investors’ Day Mark D. Epstein, MD, FACS
Patient GD • 40 YO, 140 LBS • Primary Augmentation • Dual Plane I/II • Motiva® Ergonomix® ERSD R: 285 cc, L: 245 cc 6 Year Post-Op 10/10/2018 11/6/2018 2/18/2019 10/10/2024 4 Month Post-Op1 Month Post-OpPre-0p Investors’ Day Mark D. Epstein, MD, FACS
Patient HL • 39 YO, 135 LBS • Primary Augmentation • Dual Plane II • Motiva® Ergonomix® ERSD R: 285 cc, L: 285 cc 9/20/2018 10/18/2018 1/25/2019 9/29/2024 4 Month Post-Op1 Month Post-OpPre-0p 6 Year Post-Op Investors’ Day Mark D. Epstein, MD, FACS
Patient VC • 39 YO, 116 LBS • Primary Augmentation • Dual Plane III • Motiva® Ergonomix® ERSD R: 320 cc, L: 320 cc 12/3/2018 1/7/2019 4/15/2019 1/16/2025 6 Year Post-Op4 Month Post-Op1 Month Post-OpPre-0p Investors’ Day Mark D. Epstein, MD, FACS
Patient JK • 35YO • Primary Augmentation • Dual Plane I • Motiva® Ergonomix® ERSD R: 425 cc, L: 425 cc 6/24/2019 6/272019 10/28/2019 6/12/2023 4 Year Post-Op4 Month Post-Op3 Day Post-OpPre-0p Investors’ Day Mark D. Epstein, MD, FACS 6/92025 6 Year Post-Op
Patient AC • 40YO • Primary Augmentation • Dual Plane II • Motiva® Ergonomix® ERSD R: 265 cc, L: 265 cc 6/11/2018 7/302018 10/29/2018 8/8/2022 4 Year Post-Op4 Month Post-Op1 Month Post-OpPre-0p Investors’ Day Mark D. Epstein, MD, FACS 6/92025 7 Year Post-Op
Thank you mepstein@epsteinplasticsurgery.com 631 987 5001 Center for Aesthetic Surgery Hauppauge, NYMark D. Epstein, MD, FACS Investors’ Day Mark D. Epstein, MD, FACS
The New Era of Breast Aesthetics The Park Avenue Look and Experience Women Expect in my Practice Neinstein Plastic Surgery New York, New York Bigger isn't always better Anna Steve, MDInvestors’ Day Anna Steve, MD
Investors’ Day Anna Steve, MD
7% 93% Other Brand Motiva® (155) (12) Patient Preference for Implant Brands Investors’ Day Anna Steve, MD
Both patients here were only candidates for over the muscle implants because of Motiva® Investors’ Day Anna Steve, MD
Patient Testimonial Motiva® over the Muscle Other Brand Under the Muscle Preop Days after 6 months Investors’ Day Anna Steve, MD
Thank you Neinstein Plastic Surgery New York, New York Anna Steve, MD Investors’ Day Anna Steve, MD
The Quest for the Perfect Breast: Dogma, Devices and Drama New York, New York Washington, DC Troy Pittman, MD FACS Troy Pittman, MD FACSInvestors’ Day
Dr. Scott Spear Investors’ Day Troy Pittman, MD FACS
2014 Pre-Pectoral Reconstruction •Gamechanger in breast reconstruction •Does not disrupt the pectoralis • Implant anatomically replaces breast tissue •Faster post-op recovery / less pain •No animation deformity •Long term rippling? •Long term CC? •Requires ADM with strength yet compliance Investors’ Day Troy Pittman, MD FACS
Evolution Breast Augmentation Investors’ Day Troy Pittman, MD FACS
The FDA and Implants A Two-Part Mini Drama Investors’ Day Troy Pittman, MD FACS
Act I 1962 Cronin and Gerow begin the modern age of silicone breast implants 1976 Congress passed the Medical Device Amendment to The Food, Drug and Cosmetic Act, which empowered the FDA to regulate medical devices 1988 FDA classified Breast Implants as Class III devices, subject to stringent safety and effectiveness controls 1990 1991 FDA published a final 515(b) regulation requiring manufacturers to submit premarket approval applications (PMAs) for silicone-filled implants within 90 days Investors’ Day Troy Pittman, MD FACS
1992-2006 FDA Moratorium Investors’ Day Troy Pittman, MD FACS
CaseInvestors’ Day Act II – The Rising Storm 1997 • Keech and Creech report on BIA-ALCL 2011 • FDA alert 2016 • BIA-ALCL recognized by WHO 2019 • FDA hosts General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting • FDA orders a class I voluntary recall of all Allergan textured devices from the market. • Further fuels concern from patient advocacy groups, lobbyists, online chatter, etc. Investors’ Day Troy Pittman, MD FACS
Motiva® and The Tissue Preservation Revolution • Gamechanger in breast reconstruction augmentation • Does not disrupt the pectoralis • Implant anatomically replaces breast tissue • Faster post-op recovery / less pain • No animation deformity • Long term rippling? • Long term CC? • Requires ADM with strength yet compliance Investors’ Day Troy Pittman, MD FACS
Amimation Deformity Investors’ Day Troy Pittman, MD FACS
Preservation Breast Augmentation Investors’ Day Troy Pittman, MD FACS
Preservation Breast Augmentation Investors’ Day Troy Pittman, MD FACS
Investors’ Day US Breast Augmentation Q&A 04 Ben Newcott Panelists Mark Epstein, M.D Anna Steve, M.D Troy Pittman, M.D.
Breast Reconstruction Opportunity in the USA Jeff Ehrhardt Investors’ Day Breast Reconstruction Opportunity in the USA 05
• 85% of Device-Based Recons include Tissue Expanders plus Implants • Reconstruction Implant ASPs tend to be 25-30% higher than Augmentation Implants • Tissue expander ASPs can be nearly double than Augmentation Implants Reconstruction represents significant opportunity Device-Based Reconstruction Market Per Case Revenue can be as high as 3X of Augmentation • >100K procedures per year, with steady procedural growth ~2% • ~25% of total breast procedures • ~50% of total breast revenue • Mainly hospital based with legally mandated insurance coverage and strong reimbursement Investors’ Day Breast Reconstruction Opportunity in the USA
• Recently Published: Lower infection and device explantation demonstrated with Motiva Flora® at MD Anderson Cancer • Motiva Flora® has been approved and used in more than 60 institutions with more than > 100 pending Motiva® Implants and Motiva Flora® Tissue Expanders are well- differentiated Motiva Flora® Updates • Both are the only devices with SmoothSilk® surface technology for strong but pliable capsules • Motiva Flora® is the Only MRI Conditional Expander in the market, allowing: • Imaging during expansion process • More targeted treatment (radiation) protocols • 100% fill TrueMonobloc® implant is ideal for reconstruction patient where the main concerns are implant palpability and capsular contracture Investors’ Day Breast Reconstruction Opportunity in the USA Reconstruction represents significant opportunity
Investors’ Day Investors’ Day US Breast Reconstruction Panel 06 Ben Newcott Panelists Dennis Hammond, M.D. Nolan Karp, M.D.
The Motiva® Flora Tissue Expander Using Technology to Enhance Implant Based Breast Recon Partners in Plastic Surgery Grand Rapids, MichiganDennis C. Hammond, MD Investors’ Day Dennis C. Hammond, MD
• Anatomic shape • Shoulders resist rotation • Integrated valve, skirt • Fixation tabs • Orientation stripe • Low inflammatory surface • Soft feel • MRI compatible Design Breast Reconstruction Motiva Flora® Tissue Expander Investors’ Day Dennis C. Hammond, MD
Magnet-free Integrated Port Injection Dome RFID Coil Needle Stop Port Locator Investors’ Day Dennis C. Hammond, MD Design Breast Reconstruction
• Reader • Antenna • Emits Radio Waves • Air Wound Coil • Passive RFID Tag • Powered by the Reader Investors’ Day Dennis C. Hammond, MD Design Breast Reconstruction
https://radformation.com/blog/ezfluence-automates- planning-for-patients-with-aeroform-tissue-expander/ https://ro- journal.biomedcentral.com/articles/10.1186/s13014-020- 01501-x Investors’ Day Dennis C. Hammond, MD Rx Planning Breast Reconstruction Motiva Flora® Tissue Expander
Experimental set up to evaluate artifacts at 3T. T1- Weighted Spin Echo Pulse sequence, long and short axis. Source: Shellock Inc. Evaluation of Magnetic Field Interactions, Heating, and Artifacts for the Motiva Flora Tissue Expander. February 2019 Investors’ Day Dennis C. Hammond, MD MRI Breast Reconstruction Motiva Flora® Tissue Expander
Investors’ Day Dennis C. Hammond, MD MRI Breast Reconstruction
- Reconstruction Clemens MW, Mitchell MP, Christensen JM, et al. MRI-Conditional Tissue Expanders in Breast Reconstruction: Clinical Outcomes and Radiation Therapy Implications. Plast Reconstr Surg. Published online February 11, 2025. doi:10.1097/PRS.0000000000012029 Clinical Outcomes This retrospective, single center study explores and compares the clinical outcomes and radiation protocol impacts of MRI-Conditional Tissue Expanders (MRI-CTE’s) versus Traditional Tissue Expanders (TTE’s) in postmastectomy breast reconstruction. *Complications were tracked from expander placement to either exchange to a permanent implant or expander loss/removal. 867 tissue expanders patients559 456 706 tissue expanders 4.9 months mean follow-up 103 161 tissue expanders 4.7 months mean follow-up Complications* & Outcomes MRI-CTE (Motiva) (%) N=161 TTE (Mentor & Allergan) (%) N=706 Hematoma 2 (1.2%) 8 (1.1%) Seroma 3 (1.9%) 45 (6.4%) Infection/Cellulitis 3 (1.9%) 44 (6.2%) Malposition/Rotation 5 (3.1%) 26 (3.7%) Mastectomy Skin Flap Necrosis 7 (4.3%) 50 (7.1%) Mastectomy Skin Flap Necrosis Requiring Revision 2 (1.2%) 22 (3.1%) TE Exposure 0 (0%) 4 (0.6%) TE Removal with Immediate Replacement 1 (0.6%) 20 (2.8%) TE Removal without Replacement 2 (1.2%) 12 (1.7%) MRI Required During Expansion 3 (1.9%) 6 (0.8%) TE Removal Due to MRI 0 (0%) 6 (0.8%) patients Investors’ Day Dennis C. Hammond, MD
• In cases requiring MR imaging, 0/3 patients in the Flora® cohort required explantation to safely undergo scanning, whereas 6/6 patients in the TTE cohort required prior device removal. • During radiation planning, the Flora® cohort required less artifact management, with a mean artifact diameter of 1cm compared to 4cm in the TTE group. This reduction enabled more accurate radiation delivery (up to 75%) minimizing underdosing of the target and overdosing of adjacent healthy tissue. • The Motiva Flora® cohort group had a significantly lower rate of infection/cellulitis compared to the TTE cohort (1.9% vs. 6.2%) and showed a trend toward lower rates of seroma (1.9% vs. 6.4%). Results Key Takeaways • Motiva Flora® SmoothSilk® Tissue Expander may contribute to improved clinical outcomes with fewer surgical interventions and enhanced precision in radiation treatment planning. • Motiva Flora® demonstrated enhanced surgical outcomes in addition to providing improved accuracy in radiation dose calculations. • Reduced manual interventions for artifact adjustment decrease time and also the potential for human error, enhancing the overall precision of radiation treatment delivery. Clemens MW, Mitchell MP, Christensen JM, et al. MRI-Conditional Tissue Expanders in Breast Reconstruction: Clinical Outcomes and Radiation Therapy Implications. Plast Reconstr Surg. Published online February 11, 2025. doi:10.1097/PRS.0000000000012029 Investors’ Day Dennis C. Hammond, MD
TE, ADM, and Fat Grafting Breast Reconstruction Preop Investors’ Day Dennis C. Hammond, MD
TE, ADM, and Fat Grafting Breast Reconstruction Intraop Investors’ Day Dennis C. Hammond, MD
TE, ADM, and Fat Grafting Breast Reconstruction Result Investors’ Day Dennis C. Hammond, MD
TE, ADM, and Fat Grafting Breast Reconstruction Result Investors’ Day Dennis C. Hammond, MD
Breast Reconstruction Result TE, ADM, and Fat Grafting Investors’ Day Dennis C. Hammond, MD
TE, ADM, and Fat Grafting Breast Reconstruction Result - Motiva SilkSurface® Breast Implant - 380 cc ERSD - Fat 40 cc bilaterally F/U 6 Months Investors’ Day Dennis C. Hammond, MD
TE, ADM, and Fat Grafting Breast Reconstruction Result - Motiva SilkSurface® Breast Implant - 380 cc ERSD - Fat 40 cc bilaterally F/U 6 Months Investors’ Day Dennis C. Hammond, MD
My Investigator Experience: Motiva® Implants in Breast Reconstruction Hansjörg Wyss Department of Plastic Surgery Professor of Plastic Surgery NYU Grossman School of MedicineNolan S. Karp, MD Investors’ Day Nolan S. Karp, MD
In the Past…. I used to spend a great amount of time lowering the bar in breast reconstruction Trying to set realistic expectations This was disappointing to the patient But, also disappointing to me Investors’ Day Nolan S. Karp, MD
I started to compare my Reconstructive results to my Aesthetic results Is it realistic for me to make my Reconstructive breast surgery goals and expectations the same as Aesthetic? The patients expect this in reality These are the pictures that they see in magazines We are plastic surgeons The patient expects perfection for both reconstructive and aesthetic cases Investors’ Day Nolan S. Karp, MD
Aesthetic/ Reconstructive: Which is which? Investors’ Day Nolan S. Karp, MD
The Goal in 2025 and Beyond: Make the reconstructed breast as good or better than the native breast Investors’ Day Nolan S. Karp, MD
The Problem! Breast implant technology has not kept up with patient and market expectations We were stuck with implants that have not materially changed in 30 years or longer Investors’ Day Nolan S. Karp, MD
Until Now Investors’ Day Nolan S. Karp, MD
Motiva® Implants Feel more natural When I enrolled patients in the FDA study, I asked them to close their eyes. I put a Motiva® implant in one hand and our usual reconstructive implant in the other. 95% of patients picked the Motiva® implant. Enrolling patients in the study was easy Besides feeling better, Motiva® implants ripple less and have very rare capsular contracture. In addition, I have not seen a single rupture. Investors’ Day Nolan S. Karp, MD
United States Breast Reconstruction Market Over 100,000 cases a year 85% are implant based Concentrated in high volume centers When the Motiva® implants are approved we will switch at my institution immediately, and I expect most other institutions will switch as well Investors’ Day Nolan S. Karp, MD
Sample cases Investors’ Day Nolan S. Karp, MD
Reconstructed with Motiva® RSF 315 cc implants in the subpectoral position Post-OpPre-0p 41 year old with right breast cancer Investors’ Day Nolan S. Karp, MD
Post-OpPre-0p 40 year old with right breast cancer Reconstructed with Motiva® ERSF 550 cc. in the prepectoral position Investors’ Day Nolan S. Karp, MD
33 year old with BRCA1 mutation had a staged Breast reduction followed by Prepectoral Direct Implant placement with Motiva® ERSF 550cc Post-OpPre-0p Investors’ Day Nolan S. Karp, MD
Conclusions • We did 60 cases of breast reconstruction with Motiva® implants with the longest f/u now 54 months. • We had no complications specifically related to the implants themselves • Our complication profile was typical for what one sees in the breast reconstruction patient population • The patient satisfaction has been very high. • There were no cases of revision surgery related to pain or discomfort attributed to the implants Investors’ Day Nolan S. Karp, MD
Thank you Professor of Plastic Surgery NYU Grossman School of MedicineNolan S. Karp, MD Investors’ Day Nolan S. Karp, MD
Investors’ Day Ben Newcott Panelists Dennis Hammond, M.D. Nolan Karp, M.D. US Breast Reconstruction Q&A 07
Innovation Pipeline Roberto De Mezerville 08 Investors’ Day Innovation Pipeline
Motiva® Minimally Invasive Platform Roberto de Mezerville 08.1 Breast Tissue Preservation Investors’ Day Breast Tissue Preservation
Motiva Kaplan-Meier (KM) Key Complications 2-5 year including MRI cohort Primary Augmentation (N=451) 2-year (95% CI) 3-year (95% CI) 4-year 95% CI 5-year 95% CI Capsular contracture (Baker Grade III/IV) 0.5% (N=2) 0.5% (N=2) 0.5% (N=2) 0.5% (N=2) Rupture, suspected or confirmed 0.6%(N=1) 0.6%(N=1) 0.6% (N=1) 0.6% (N=1) Breast pain 0.7% 0.7% 0.9% 1.2% Infection 0.9% 0.9% 0.9% 0.9% Implant removal, with or without replacement 1.6% 1.6% 1.8% 3.1% Any reoperation1 5.9% 6.6% 6.8% 8.8% Any complication2 8.4% 8.8% 9.6% 12.0% Real World Data US-FDA Core Study Investors’ Day 1. Any surgery on the breast or chest area, device or non-device related, including size change. 2. Any device or non-device related event, including reoperation. Data from 5-year is preliminary and does not reflect the final study results. Breast Tissue Preservation FDA Approval
1-4 Year Follow-Up 13 Studies 4,784 Patients Motiva Minimally Invasive PlatformInvestors’ Day Real World Data Independent Meta - Analysis
Feeling and Geometry respecting surrounding breast tissue Surface for faster healing Immune response Minimizing implant manipulation (no touch techniques) Surgical Procedure Minimizing scaring Women Lifestyle Design with a Purpose SmoothSilk® 4 µm Average Roughness Investors’ Day Breast Tissue Preservation
T R U E M O N O B L O C + 32% higher elongation 23%+ Adaptability 45% Softer 60% higher performance B L U S E A L + Motiva Minimally Invasive PlatformInvestors’ Day
A Shell for Every Gel Shell Elongation Ergonomy Adaptability Softness Elongation Investors’ Day Breast Tissue Preservation
Our implant evolution Breast Tissue Preservation Platform Investors’ Day Breast Tissue Preservation
Motiva Minimally Invasive Technology Platform Investors’ Day The New Aesthetics Consumer Breast Tissue Preservation For the day-to-day Standardize Gluteal Enhancement Modeling Breast Tissue Preservation
Motiva® SmoothSilk Ergonomix Ergonomix2 Motiva® SmoothSilk Ergonomix2 Diamond Motiva® SmoothSilk Ergonomix2 Gluteal Diamond Motiva® Channel Separator Motiva® Inflatable Balloon Motiva® Insertion Sleeve Motiva® Pre-Op Marking Tool Motiva® InjectorMotiva® Consultancy Implant Selection Set Motiva® Tissue Separator Set of templates to guide the surgeon in selecting the Motiva Implant, under the consumers’ breast boundaries. Create a 3-dimensional breast pocket by an atraumatic controlled elongation of the breast tissue. Efficient deployment of the Motiva® Ergonomix2® with a “no-touch technique”. Facilitate the injection of the Motiva® Implant during the minimally invasive procedure. Creates a tunnel to the opposite border of the breast pocket to allow for the insertion of the inflatable balloon. Intended to act as an aid during the marking process. It separates the tissue, creating a pocket to allow the inflatable balloon to be inserted. G E M Investors’ Day Motiva® Minimally Invasive Technology Platform Breast Tissue Preservation
Investors’ Day Motiva Minimally Invasive Technology Platform The New Aesthetics Consumer Breast Tissue Preservation For the day-to-day Post Op Breast Tissue Preservation Courtesy of Dr Manuel Chacón Post Op
Investors’ Day Breast Tissue Preservation Breast Tissue Preservation Less invasive Surgery with Breast Tissue Preservation Minimally Invasive Experience with Breast Tissue Preservation • 1 to 2 cups up • No general anesthesia • No scars in the breast • Quick procedure and recovery • Up to 4 cups • With or without general anesthesia • Inframammary • Simple to more complex cases Traditional Breast Augmentation Leveraging Minimally Invasive Technologies to expand market opportunities
Investors’ Day Breast Tissue Preservation Mia Femtech Study Clinical Outcomes Primary Augmentation 1-year (N=100), 95% CI 2-year (N=100), 95% CI 3-year (N=100), 95% CI Capsular contracture (Baker Grade III/IV) 0.0% 0.0% 0.0% Rupture, suspected or confirmed* 0.0% 0.0% 0.0% Infection 0.0% 0.0% 0.0% Seroma 0.0% 0.0% 0.0% Hematoma 0.0% 0.0% 0.0% Rippling 0.0% 0.0% 0.0% Inferior malposition 0.0% 0.0% 0.0% Malposition/Displacement 1.0% 1.0% 1.0% Changes in Nipple Sensation 0.0% 0.0% 0.0% Changes in Breast Sensation 0.0% 0.0% 0.0% Any reoperation 0.0% 0.0% 1.0% Mia FemTech Kaplan-Meier Risk Complications Through 3-years (w/MRI Cohort) *Includes overall and MRI cohort (33 subjects/ 66 implants) combined. Establishment Labs, CLINR-001035. Fifth progress report for Minimally Invasive Breast Augmentation Traditional Feasibility Study (CLINP-001007). Data on file.
Motiva® Minimally Invasive Platform Roberto de Mezerville 08.3 GEM® Investors’ Day GEM
GEM® Gluteal Ergonomic Modeling GEM® Tissue Separator Balloon + Injector Post-Op Investors’ Day GEM
Pre-Op 6 Months GEM® Six Months Post-O Investors’ Day GEM
©2025 ESTABLISHMENT LABS. ALL RIGHTS RESERVED. New Generation for the Radio-Frequency Platform: •MR Conditional; no artifact effect outside of the implant •The Electronic Serial Number traceability feature •Passive device with no internal battery •With temperature sensor Investors’ Day GEM Zen® Technology Platform
Investors’ Day GLP-1s and Impacts on Plastic Surgery 09 Juan José Chacón-Quirós Panelists Sachin Sridharani, M.D. Johnny Franco, M.D.
Weight Loss Revolution Practice Integration Johnny Franco, MD FACS Johnny Franco, MD FACSInvestors’ Day
Weight Loss Revolution Roughly 2/3 Americans Are Overweight Or Obese Current pace (prior to GLP - 1): 80% of Americans would be obese by 2030 235 Million Americans are overweight or obese 45% of Americans Are Interested in a Weight Loss Drug 12% of America has or is taking GLP Medication Overweight In America Johnny Franco, MD FACSInvestors’ Day
Weight Loss Spend Patients in the office Continued Journey More then Skincare Ripple Effect Johnny Franco, MD FACSInvestors’ Day
Weight Loss Journey • GLP • Skin Laxity • Volume Loss • Weight Loss Surgery • Wellness • Energy Devices Johnny Franco, MD FACSInvestors’ Day
CaseInvestors’ Day
M Johnny Franco, MD FACSInvestors’ Day
Ozempification of Aesthetics • Young Patients • Weight Loss • New to Aesthetics • Evolving Needs • 20 - 30lbs Changes • Men Unique Patient Population • Modern Trends • Skin Laxity • Volume Issues • Combination Treatments • Unique Solutions • Pivotal Time New Challenges • Novel new technology • Enhance Surgical Results • Maintain Results • Future Treatments • Patient Journey Evolving Treatments Johnny Franco, MD FACSInvestors’ Day
Ozempification of Aesthetics Website 3 days National Media • Website • Social Media • Pop Culture Search Volume Johnny Franco, MD FACSInvestors’ Day
Search volume Johnny Franco, MD FACSInvestors’ Day
Aesthetic Naive Patients Johnny Franco, MD FACSInvestors’ Day
CaseInvestors’ Day Aesthetic Naive Patients https://www.mckinsey.com/industries/life-sciences/our-insights/glp-1s-are-boosting-demand-for-medical-aesthetics
Thank you www.austinplastsurgeon.com Austin Texas @austinplasticsurgeon jfranco@morebeautifulyou.com Johnny Franco, MD FACS Johnny Franco, MD FACSInvestors’ Day
Sachin M. Shridharani, MD FACS Glp-1S & Impacts On Plastic Surgery Sachin M. Shridharani, MD FACSInvestors’ Day
Founder – LUXURGERY Associate Clinical Professor - Washington Univ. – St. Louis Division of Plastic and Reconstructive Surgery Chief Medical Officer - SkinSpirit Board-Certified Plastic Surgeon Sachin M. Shridharani, MD FACS Disclosure Holds advisory and consultancy roles with multiple aesthetic medicine companies including Allergan, Establishment Labs, Evolus, Galderma, Merz, Prollenium, Revance, and Tiger Sachin M. Shridharani, MD FACSInvestors’ Day
Patient vs. Customer vs. Client What’s the difference? Patient Customer Client Sachin M. Shridharani, MD FACSInvestors’ Day
The Treatment Phase Patient experience in the treatment room • Patient vulnerability • Milestone to create bond or lose patient - In-room photography - Luxury robes and hotel slippers - Music reflective of LUXURGERY - Cleanliness and clutter-free - Familiar and trusted faces/staff members Sachin M. Shridharani, MD FACSInvestors’ Day
The Emerging Role of Injectable Weight Loss Medications in Plastic Surgery: A Systematic Review • 16 RCTs included • Total:10,492 patients Global Concern Study Overview • > 650 mn adults obese; 1.9 bn overweight (WHO, 2016) • Obesity → multifactorial ds w/ serious health implications Sachin M. Shridharani, MD FACSInvestors’ Day
Key Findings Conclusion & Future Directions • Consistent weight loss observed (1.5 to 5 kg) • Most common AE: mild to mod GI symptoms • GLP-1s show promise for non-surgical weight loss • Further RCTs needed to assess combination therapies and identify optimal agents Sachin M. Shridharani, MD FACSInvestors’ Day The Emerging Role of Injectable Weight Loss Medications in Plastic Surgery: A Systematic Review
B&A PICTURES • Age: 38 • Procedure: Aug/Pexy • Motiva® rnd 285cc HP • Approx: 6 months Before After Sachin M. Shridharani, MD FACSInvestors’ Day
• Age: 38 • Procedure: Aug/Pexy • Motiva® rnd 285cc HP • Approx: 6 months B&A PICTURES Sachin M. Shridharani, MD FACSInvestors’ Day Before After
• Age: 38 • Procedure: Aug/Pexy • Motiva® rnd 285cc HP • Approx: 6 months B&A PICTURES Sachin M. Shridharani, MD FACSInvestors’ Day Before After
• Age: 38 • Procedure: Aug/Pexy • Motiva® rnd 285cc HP • Approx: 6 months B&A PICTURES Sachin M. Shridharani, MD FACSInvestors’ Day Before After
Summary • GLP-1s → weight loss results • Non-surgical approach to weight mgmt & improve outcomes • AE’s generally mild to moderate, mainly GI, & often resolve w/ dosage adjustment • Future research → identify ideal GLP-1 agents and assess combo therapies for enhanced efficacy • LUXURGERY client-focused aesthetic practice • Priority: experience and trust Sachin M. Shridharani, MD FACSInvestors’ Day
Thank you New York, New YorkSachin M. Shridharani, MD FACS Sachin M. Shridharani, MD FACSInvestors’ Day
Investors’ Day Investors’ Day Unlocking New Markets 10 Juan José Chacón-Quirós Panelists Mark Epstein, M.D. Anna Steve, M.D. Troy Pittman, M.D. Sachin Shridharani, M.D. Johnny Franco, M.D.
Investors’ Day Management Q&A 11 Peter Caldini Juan José Chacón-Quirós Raj Denhoy Jeff Ehrhardt