a global leader in robotic therapeutic ultrasound

A Global Leader in Robotic Therapeutic Ultrasound

(NASDAQ: EDAP)

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©2021 EDAP TMS S.A. All rights reserved. Confidential.

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context. Unless the context requires otherwise, references to “EDAP,” “EDAP TMS,” “the Company,” “we,” “us” and “our,” refer to EDAP TMS S.A., Inc.

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information incorporated by reference into the Prospectus. No reliance may be placed for any purposes whatsoever on the information contained in this

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This presentation contains, in addition to historical information, forward-looking statements that involve risks and uncertainties. These include statements

regarding the Company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of

uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Factors that may cause such a

difference include, but are not limited to, the clinical status and market acceptance of our HIFU devices, the sustained activity of our lithotripsy and distribution

business, as well as the length and severity of the recent COVID-19 outbreak, including its impacts across our businesses on demand for our devices and

services. Factors are also those described in the Company's filings with the Securities and Exchange Commission, including under “Cautionary Statement on

Forward-Looking Information”, “Risk Factors” and “Operating and Financial Review and Prospects” in the Company’s annual reports on Form 20-F filed with the

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Forward Looking Statements & Disclaimer

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Innovative minimally-invasive diagnostic and therapeutic robotic platforms using ultrasound-based technologies

Investment Highlights

Global presence in more than 50 countries:

• 5 commercial subsidiaries (USA, Germany, Japan, Malaysia,

South Korea)

• 2 representative offices (Russia, Emirates)

• worldwide network of distributors 5 continents

EDAP Subsidiaries Distributors

EDAP Headquarters EDAP Representative offices

Designs, produces and markets

medical equipment dedicated to

minimally invasive therapies

based on robotic therapeutic

ultrasound

Lead product, Focal One®,

combines the latest technologies

in imaging and treatment

modalities

Global distribution agreement

with Exact Imaging creates the

most complete end-to-end

offering for the management of

prostate cancer

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Investment Highlights – HIFU Expansion

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Robust HIFU Pipeline

Complete offering in

prostate cancer

management …

… from targeted

diagnostic to

treatment

Large & Growing

WW Prostate Cancer

Market Opportunity

Accelerated Market Access Model Focused On

Surgical Market Trends:

Minimally-invasive, Robotic,

Energy-based Ablation,

Quality of Life Preservation Technology

Expanding Private and Public Covered Lives

Investing in Product Innovation to Expand Indications

Growing U.S. Organization and Direct Sales

Building a Robust Clinical Data Compendium

Leveraging Marquee Commercial Relationships


Endometriosis PancreasBreast Liver

Manufactured by EDAP TMS

Prostate Cancer

Micro-Ultrasound

Diagnostics

BPH and Lithiasis

Holmium and Thulium

Lasers for vaporization /

Enucleation of Prostate

and Urinary Stones

Urodynamics

UroFlow /

PressureFlow and

Filling Cystometry

Minimally-Invasive

HIFU treatment for

Prostate Cancer and HIFU

developments on other

pathologies

HIFU Division ESWL Division

Urinary Stones

(ESWL)

Non-Invasive treatment for

Urinary Stones

DISTRIBUTION Division

Distributed by EDAP TMS

Three Business Divisions

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HIFU (High Intensity Focused Ultrasound) =

Acoustic pressure or vibrations delivered to targeted cells. Intense immediate tissue

heating at focal point (+85°C) creates cavitation i.e. tissue necrosis and cellular ablation

HIFU strongly addresses

medical needs for tissue ablation

while preserving healthy

surrounding tissue

EDAP’s HIFU platform is a robotic

device with highly precise

mechatronics, providing image

guidance with motion tracking

and real-time treatment planning

What is HIFU

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Superior HIFU Expertise + Strong EDAP IP Portfolio

=

Multi-application HIFU platform vision

HIFU principles are similar to sun beams going through a magnifying glass


HIFU Management of Prostate Cancer

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+ Localization

MRI and biopsy fusion for

precise targeting

Real time and 3-D imaging

+ Validation

Confirmatory imaging

+ Ablation

Dynamic Focusing patented

technology for conformational

treatment

50,000+ Prostate cancer treatments

performed worldwide

100+ peer-reviewed publications

300+ HIFU centers in the world

Focal One: The Ultimate Robotic HIFU Tool for Focal Ablation


Prostate Cancer Management: Distinctive Offering

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A Complete End-to-End Urology Solution from Diagnosis to Focal HIFU Treatment

Exclusive WW distribution agreement with

Exact Imaging creates a synergistic

combination

Combined with EDAP’s Focal One, we believe

this is the only end-to-end solution that offers

urologists complete control of the prostate

cancer workflow

Adds screening, diagnostic and active

surveillance capabilities to EDAP’s focal

therapy

ExactVu’s ability to locate more treatable

cancers can drive Focal One sales and

procedure growth


Prostate cancer in the World

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1 Million biopsies(1)

248,530 new cases diagnosed (#1 cancer in men)(2)

34,130 deaths (#2 cancer in men)(2)

3.1 Million American men living with prostate cancer(2)

Localized PCa Treatment patterns

Active Surveillance

Radiation Therapy

Radical Prostatectomy

US Key market figures (yearly)


(1) Loeb et al. Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011 Nov;186(5):1830-4.(2) 2021 estimates from American Cancer Society (https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html)

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G 6 G7 (3+4) G7 (4+3) G8 G9/T3

Active

Surveillance

Wholegland

treatmentSurgery, Radiotherapy, HIFU

Agressive radical

treatmentSurgery+ radiotherapy

Radiotherapy+ hormonal therapyFocal treatment

Focal Therapy represents a strong balance between the stressful “wait-and-see” approach of

Active Surveillance and the morbid radical surgery or radiotherapy

Active Surveillance Whole-gland treatment(Surgery, Radiotherapy, HIFU)

Combined Therapies(Surgery + Radiotherapy,

Radiotherapy + Hormones)

Focal Treatment

(*) Based on Mygatt et al., Prostate Cancer and Prostatic Disease 2013 and Sivaraman et al., European Urology 2016

Apex

20% of cases

Posterior / Lateral

70% of cases

Anterior

10% of cases

Index tumor localization(*)

Transperineal and Transurethral approach:

Cryotherapy, IRE, TULSA, etc.

Transrectal approach:

Focal One HIFU

Precision approach:

Brachytherapy, Focal One

Focal One is ideally positioned for focal treatment in the majority of the cases

(1) Thuroff et al. J. Urol. 2013 Feb; (2) Ganzer et al. – BJUI 2013; (3)Crouzet et al. – 2013 Eur. Urol.; (4)Rischmann et al. – Eur. Urol. 2016;

(5) Donovan et al. – NEJM 2016; (6) Sponsor Executive Summary PMA P13003 (www.fda.gov); (7)Crouzet et al. – 2017 Eur. Urol.

Patient Benefits – Quality of Life

LOW MORBIDITY

97% preservation of continence(4)

78% preservation of erectile function(4)

HIGH EFFICACY

97-99% cancer specific survival at 10 years(1,2,3)

94-95% metastasis-free rate at 10 years(1,2,3)

ALSO AVAILABLE FOR SALVAGE TREATMENT (Recommended by NCCN Guidelines)

82% cancer specific survival(7)

81% metastasis free rate at 7 years(7)

Minimally-invasive therapy that preserves Quality of Life

Clinically-proven

No incision, no scar, no radiation

Typically less time away from work and leisure activities

Low risk of side effects, such as incontinence or erectile dysfunction

Ultra-precise ultrasound technology

The Paradigm shift in the Management of Prostate Cancer

Robotic HIFU for Prostate Cancer

Morbidity comparison at 2 years


4%

20%

3%

22%

4%

34%

11%

44%

19%

47%

Incontinence Incidence Erectile Dysfunction Incidence

Active Surveillance (ProtecT)

Hemi HIFU (AFU Trial)

Radiotherapy (ProtecT)

Whole Gland HIFU (FDA Trial)

Prostatectomy (ProtecT)

(5)

(5)

(5)

(4)

(6)

0

200 000

400 000

600 000

800 000

1 000 000

1 200 000

1 400 000

1 2 3North America Europe ROW

New

cases:

1,275,000

HIFU

potential:

220,000

Focal One

Potential:

165,000

30%75%

PCa Market and Assumptions

Business Model

Machine Sales Price $650k

Number of cases per machine 40 (US) – 60 (OUS)

Service contract Price$80k (US)

$60k (OUS)

FocalPak single-use disposable Price$1,200 (US)

$1,000 (OUS)

Potential Market in Revenues (US$)

Annual Revenue

Machine Revenue

(10% renewal rate)$205 Million

Service contract Revenue $215 Million

FocalPak single-use disposable Revenue $175 Million

Total Revenue WW $595 Million

US Revenue $250 Million

And when Endometriosis will be available …

3,000 EDAP HIFU devices

is equivalent to

$2 Billion in machine sales20%

10%

North America;

1 322

Europe; 1 125

ROW; 738

TOTAL NUMBER OF EDAP HIFU DEVICES REQUIRED TO COVER THE MARKET

Focus on US HIFU Adoption Plan


1. Establish Commercial Excellence

– Revamped Capital Sales Structure (1 to 8)

– Build Sustainable Pipeline

– New Pricing Models

– Add Clinical Sales Structure

2. Focus on Reimbursement Roadmap

– Coding

– Payment

– Coverage

• Fund raise of $28 Million done in April to support the Plan

• Recruitment of Top Medtech Industry Veteran Ryan Rhodes as CEO of EDAP’s US

subsidiary to design and execute the Plan

• 4 Key Areas of Priority :

3. Develop & Deliver Marketing Effectiveness

– Updated Messaging to Key Stakeholders (Physician, Patient, Hospital)

– Patient Activation Strategy & Tactics

– Clinical Positioning Beachhead

4. Leverage Education & Training

– Create Focal One Training Centers

– Support Peer to Peer Instruction

– Influence Residents and Fellows

U.S. Reimbursement Strategy - Focal One®

Focal One® Installs at Tier-1 Institutions

HCPCS Code C9747: Temporary C-code awarded by CMS on 7/1/2017

CPT® 55880: Cat. 1 Code effective 1/1/2021

Secured Physician and Hospital Payment levels

Salvage HIFU Coverage: Medicare (10 states) + Aetna, Cigna (nationwide)

Reimbursement Achievements

Individual claims support: HIFU Coverage Hotline

MACs coverage: Medicare nationwide coverage

Commercial Insurances: Nationwide coverage from United Healthcare,

BlueCross/BlueShield, Aetna, Cigna, Humana, etc.

Reimbursement Next steps

Universal HIFU Coverage: Obtain universal coverage

from Medicare and Commercial Payors

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Treatment Type CPT Code RVUs* Avg. ($)*

Procedure

Time /

Recovery

Cryotherapy 55873 22.28 $777Home

same day

HIFU (FocalOne) 55880 28.57 $997Home

same day

Radical Prostatectomy 55840 34.06 $1,1883 mo.

recovery

Laparoscopic Radical

Prostatectomy55866 41.95 $1,464

2-6 wk.

recovery

Favorable Physician Economics

* Source: CMS, EDAP TMS

Reimbursement Update

Unanimous Vote at HOP Panel recommending upgrade from

APC level 5 to level 6 : if confirmed by CMS final rule this

would bring the average payment of HIFU from $4500 to $8500

Commercial and Clinical Strategy to Address WW Market Opportunity

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Accelerated US Marketing Plan:

Accelerated US Clinical Plan:

• Patient Marketing

• Digital Marketing

• Expand Marketing Team

• Urologists Events

• Clinical Studies / Data

Management

• Expand Clinical Team

• Endometriosis US Clinical

Study Expenses

Accelerated Europe Go-to-Market Strategy:

• Patient Marketing

• Support Level I and initiated Additional Studies

• Support Reimbursement Strategy

• Provide Clinical Guidance and Recommendations

Accelerated Asia Go-to-Market Strategy

• Expand on Regulatory Programs

• Build Awareness of HIFU in the Region

• Increase Sales Support and Initiative (HIFU

Business Developer)

HIFU beyond Prostate Cancer

Phase I study: study to confirm feasibility (20 patients)

Phase II multicentric study: Confirmatory safety and efficacy study (38 patients).Initiated in 09/20.

Phase III randomized study: to be initiated based on Phase II results.

Multi-application platform to treat various conditions requiring soft tissue ablation

Prostate Endometriosis

Pancreas

Breast

LiverProstate

OB/GYN

Pathologies

Today Tomorrow Future

Focal One® HIFU Platform

Focus on Rectal EndometriosisMinimally invasive alternative to invasive rectal surgery

HIFU

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Stone ManagementA steady Cash generator

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Exclusive and Patented Technologies

Electroconductivity

latest and most efficient

shockwave technology with

Automatic Pressure Regulation

Visio-Track

User-friendly and radiation-free 3D ultrasound,

proprietary, localization system

Strategic pivot of ESWL research and

development resources toward emerging

HIFU opportunities

Will continue to support lithotripsy

installed base

Lithotripsy division generates revenue as

well as steady and predictable cash flow

to fund other corporate strategic

initiatives

60K+ / year procedures

700+ Installed devices

86Countries

Financial Highlights


Key Financial Data

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Six Months Ended

June 30,

Twelve Months Ended

December 31,

(in €Millions except

per share data)2021 2020 2020 2019 2018

Revenue €20.7 €16.9 €41.7 €44.9 €39.2

Gross Profit 8.6 7.4 18.4 21.0 16.9

Gross Margin 41.6% 43.9% 44.1% 46.8% 43.2%

Operating Profit (Loss) (0.2) (1.2) 0.3 2.2 (1.3)

Net Income (Loss) 0.4 (1.5) (1.7) 1.5 (0.3)

Earnings (Loss) Per

Share0.01 (0.05) (0.06) 0.05 (0.01)

Revenue

Q2 2021: U.S. HIFU treatment volumes increased +79% over same 2020 period

H1 2021: Total Revenue increased by 22.5% vs H1 2020

Q4 2020: Record quarter revenue level with 51% growth in HIFU

FY 2020: Despite Covid-19 adverse impact, €41.7 million revenue and profitable operating result

Full Year

2019

(+15%)

Full Year

2020

(-7%)

€44.9M

€14.1M(+28%)HIFU

€14.2M(-2%)ESWL

€16.6M(+22%)Distribution

€41,7M

€11.4M(-19%)HIFU

€12.9M(-9%)ESWL

€17.3M(+5%)Distribution

€39.2M

€11.0MHIFU

€14.5MESWL

€13.7MDistribution

Full Year

2018

Balance Sheet Highlights

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Robust financial profile

Strong cash position of

€45.0 Million ($53.3 Million)

as of June 30, 2021,

Balance Sheet As Of:

(in €Million)June 30,

2021

December 31,

2020

December 31,

2019

Cash and cash equivalents 45.0 24.7 20.9

Other current assets 20.4 20.7 21.2

Fixed and other non current assets 9.2 9.8 11.0

74.6 55.2 53.1

Current liabilities 15.3 21.5 17.5

Non current liabilities 11.1 7.4 8.2

Shareholders' equity 48.2 26.2 27.4

74.6 55.2 53.1

High Intensity

Focused

Ultrasound

(HIFU)

Robust HIFU

PipelineExact Imaging

Platform offers a

minimally invasive

robotic tool for soft

tissue ablation,

currently approved

for use in the

treatment of prostate

cancer

Opportunities to

expand HIFU

applications to treat

endometriosis, liver

cancer and

pancreatic cancer

Distribution

agreement adds

complementary

capabilities

leveraging the very

latest technologies

Company Summary

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Innovative minimally-invasive diagnostic and therapeutic robotic tools using ultrasound-based technologies

THANK YOU!


a global leader in robotic therapeutic ultrasound

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