Energy-Based Feminine Rejuvenation March 2019 · 2019-06-19 · Energy-Based Feminine Rejuvenation March 2019 ... Product and corporate data can change very quickly and without notice

Energy-Based Feminine Rejuvenation March 2019

www.miinews.com Medical Insight, Inc. 2

M.I.I Disclaimer

Information in this study has been obtained by Medical Insight, Inc., from sources believed to be reliable. While Medical Insight believes the data provided herein to be accurate, no expressed or implied guarantees regarding accuracy or adequacy are made. Product and corporate data can change very quickly and without notice and Medical Insight continually updates its research products. Because of this, certain figures in Medical Insight reports may differ from corresponding figures in earlier reports, even if those reports were issued relatively recently. Furthermore, current economic conditions are contributing to a highly volatile market, in which actual results often diverge significantly from estimates developed by manufacturers, analysts and others, resulting in a revision of projections. Therefore, while Medical Insight will provide an explanation of figures in any of its reports, only the most recent reports contain Medical Insight’s latest estimates. This study is not intended as a substitute for proper due diligence. Although an attempt has been made to provide thorough coverage of the subject matter of this report, no guarantees regarding completeness or thoroughness are made. Medical Insight is not responsible for any errors, omissions, or results obtained from use of information provided herein. Any use which a reader makes of this report or any reliance on or decisions to be made based on it are the sole responsibility of such reader. Medical Insight accepts no responsibility for damages, if any, suffered by any reader as a result of decisions or actions taken based on this study. Medical Insight, Inc. reserves all rights to this copyrighted document. This study is protected by U.S. Copyright Law; Copyright 2019 Medical Insight, Inc. Unauthorized reproduction is strictly forbidden by law. This report may not be reproduced in part or in whole without written consent of a duly authorized officer of Medical Insight. Multiple copies of this report can be obtained at a nominal cost by contacting the publisher. Medical Insight, Inc. www.miinews.com Email: [email protected]



M.I.I Professional Biography

Michael Moretti President Medical Insight, Inc.

Michael Moretti has served as a medical industry analyst and strategic advisor for more than 25 years. As an industry consultant, Mr. Moretti specializes in strategic business development projects and high-growth, emerging market segments. He provides custom reports and confidential market studies for a variety of clients, including global medical and pharmaceutical companies.

In 1993, Mr. Moretti founded Medical Insight, Inc., the leader in focused aesthetic market

research offering comprehensive data on procedure volume and growth, revenue forecasts and new product introductions. Under Mr. Moretti’s leadership, Medical Insight publishes global market studies and forecasts for major industry sectors such as facial injectables, cosmeceuticals, body shaping procedures, skin rejuvenation technologies and home-use aesthetic products. Medical Insight also sponsors executive business forums to address scientific developments and market trends for the investment community.

Mr. Moretti is the founder of Aesthetic TV®, the first and only one-stop online resource for

current, reliable information about cosmetic and anti-aging treatments. Aesthetic TV offers expert advice for consumers via interviews with the top physicians in the field, and unprecedented access to the latest beauty-enhancing procedures and products created specifically to help people look and feel their absolute best.

Mr. Moretti is also founder of THE Aesthetic Guide® – a digital and print publication featuring

in-depth reports on new products, procedures and trends, reaching physicians, industry executives and investment analyst subscribers.

In 2007, Mr. Moretti debuted THE Aesthetic Show™, the first multidisciplinary annual business

to business trade show that brings thousands of the highest profile physicians and medical professionals together in Las Vegas to learn about the newest aesthetic procedures, products and technologies in a dynamic, interactive, educational format. For more information please visit: www.miinews.com. Contact Information: Michael Moretti Medical Insight, Inc. Email: [email protected] Or visit the Medical Insight website at: www.miinews.com



M.I.I Table of Contents Disclaimer 2

Professional Biography 3

Table of Contents 4

Table of Exhibits 6

1.0 Executive Summary 8

2.0 Background 10

2.1 Vaginal Atrophy 21

2.2 Vaginal Laxity 22 2.3 Labial Remodeling 25 2.4 Stress Urinary Incontinence 25

3.0 Energy-Based Feminine Rejuvenation Devices and Treatments 28 3.1 Overview of Energy Types and Treatments 28

3.1.1 CO2 Lasers 28 3.1.2 Er:YAG Lasers 29 3.1.3 Radiofrequency 29 3.1.4 High Intensity Focused Ultrasound 30 3.1.5 High Intensity Electromagnetic Fields (HIFEM) 30

4.0 Market Forecasts 31 4.1 Equipment Sales and Estimates 31 4.2 System Sales Estimates 34 4.3 Disposables Sales Estimates 36 4.4 Treatment Volume Estimates 38 4.5 Competitive Analysis and Market Share 40

5.0

Manufacturer Profiles 43 5.1 Alma Lasers 43 5.2 BTL Industries 45 5.3 Cutera 46 5.4 Cynosure 46 5.5 El.En. Group (Asclepion, DEKA, Quanta System) 48 5.6 Fotona 50 5.7 General Project 52



5.8 Hironic 52

5.9 Ilooda 53

5.10 InMode 54

5.11 Jeisys Medical 55

5.12 Lasering 56

5.13 Lumenis 56

5.14 Lutronic 57 5.15 NovaClinical 58 5.16 Perigee Medical 59 5.17 Sciton 60 5.18 Syneron Candela 63 5.19 Thermi, an Almirall Company 64 5.20 Venus Concept 65 5.21 Viora 66 5.22 Viveve 67



M.I.I. Table Of Exhibits Table 1 Top Energy-Based Feminine Rejuvenation Devices 20

Table 2 Total Worldwide Projected Dollar Sales for Top Manufacturers of Energy-Based Feminine Rejuvenation Devices (includes both platforms and consumables)

31

Table 3 Worldwide Projected Dollar Sales of Energy-Based Feminine Rejuvenation by

Region 32

Figure 1 Dollar Sales of Energy-Based Feminine Rejuvenation by Region 33

Table 4 Worldwide Projected Dollar Sales of Energy-Based Feminine Rejuvenation Platforms from Top Manufacturers 34

Figure 2 Worldwide Dollar Growth for Top Manufacturers of Energy-Based Feminine

Rejuvenation Device Platforms 35

Table 5 Worldwide Projected Dollar Sales of Consumables for Top Manufacturers of

Energy-Based Feminine Rejuvenation 36

Figure 3 Worldwide Dollar Sales of Energy-Based Feminine Rejuvenation

Consumables 37

Table 6 Worldwide Procedure Volume for Energy-Based Feminine Rejuvenation

Treatments 38

Figure 4 Worldwide Procedure Fees for Feminine Rejuvenation Treatments 39

Table 7 Market Shares of Top Manufacturers of Energy-Based Feminine Rejuvenation Platforms and Disposables 41

Figure 5 Market Shares of Top Manufacturers of Energy-Based Feminine Rejuvenation

Devices 42



i. Methodology This report was compiled from a wide variety of public and proprietary sources. Information

was cross-checked against other data, using Medical Insight’s proprietary forecasting models, and synthesized into both qualitative and quantitative analyses and projections, specifically covering

medical aesthetic products and equipment.

Public sources that were utilized for this report include:

- articles in trade publications and medical journals;

- articles in consumer magazines and newspapers; - company news releases, website information, marketing materials and financial filings;

- information from trade associations

Proprietary sources that were utilized include:

- Medical Insight’s extensive database of industry and product information;

- recent Medical Insight survey data; - industry analyst reports;

- exclusive interviews with company executives, researchers, sales representatives, physicians, patients, consultants and other industry experts

Additionally, feedback from Medical Insight product information is continually built back

into research products so that reports are updated with the most recent industry and market information on an ongoing basis.



Section

Executive Summary 1

Energy-based treatments for feminine rejuvenation and women’s health related medical

conditions has been a growing segment of the overall aesthetic device market sector for several years. These new technologies have emerged as a popular method of addressing a number of medical and

cosmetic needs across a wide-range of women’s age groups.

Until recently, the fast-growing market for in-office “vaginal rejuvenation” and related issues including incontinence had been a booming business for many aesthetic practitioners. It is an

expanding field of medicine and as society as a whole grows more open and expressive via social media, many women are no longer reluctant to discuss the intimate consequences that can arise from

childbirth, genetics or age-related hormonal changes.

In addition, women with aesthetic and medical issues that had been turned down by

gynecologists suddenly found plastic surgeons, cosmetic dermatologists and other aesthetic specialists willing to address their needs using these new technologies and techniques.

This new feminine rejuvenation treatment trend came with purported pain-free, no downtime

treatments that addressed the vaginal canal, introitus, vulva, labia majora and labia minora – while also including associated symptoms, such as stress urinary incontinence (SUI) or dyspareunia (painful

intercourse) that either presented singularly or as a combination of indications.

Some device manufacturers developed novel products and protocols focused on feminine

rejuvenation, while most companies simply added handpieces to existing energy-based platforms to exploit this newly formed market segment. Many suppliers started to embellish their marketing

campaigns with unsubstantiated treatment claims and terms like feminine health, feminine rejuvenation, vulvovaginal rejuvenation, women’s intimate wellness and vaginal restoration. While this

typical aggressive marketing approach may work in some poorly regulated countries, the U.S. FDA had an entirely different view and took strong definitive enforcement action in 2018 after several

manufacturers ignored their previous warning letters.



Many of the female patients attracted by providers marketing feminine rejuvenation over the

past few years were actually new to aesthetic procedures, as well, which signifies that the non-surgical feminine rejuvenation market has the potential to become another “gateway” channel for introducing

neophyte aesthetic patients to additional treatments, such as facial aesthetics and non-invasive energy-based body shaping solutions.

While this nascent market has the potential to expand the provider base among aesthetic

practitioners, OB/GYNs and urogynecologists would be the obvious adopters but have for the most part have stayed away from incorporating energy-based solutions to treat SUI and other medical

conditions. This is mostly due to the intimidating influence of the American College of Obstetricians

and Gynecologists (ACOG), the main gynecologic medical society that for years actively counseled its membership to avoid these devices due to a pervasive conservative culture of fear.

The expressed position of ACOG — as well as many OB/GYNs — is that these procedures

and devices have entered the market with tremendous fanfare but with little or no supporting clinical data. This led the FDA in July 2018 to issue a warning letter to most of the segment’s device

manufacturers, noting “deceptive health claims” and what it called “significant risks related to devices marketed for use in medical procedures for vaginal rejuvenation.”

In the U.S., the FDA’s action led to an almost immediate market contraction. Most of the manufacturers have responded with promises of implementing clinical studies. Meanwhile, the open

marketing of vaginal rejuvenation procedures has practically disappeared in the U.S.

Patients deserve well-made, approved technology from the clinical point of view, said Geoffrey Crouse, CEO of Syneron-Candela (Irvine, California, U.S.). “There has been a decent amount of

slightly better than anecdotal evidence that shows a direction, but the companies need to work collaboratively with the FDA to provide the appropriate body of evidence to support specific clinical

indications,” he reported.

As a result, we have lowered the forecasted annual growth rate for the non-surgical, energy-

based Feminine Rejuvenation market.

In 2018, total global sales reached $264 million and through 2023, sales are estimated to rise by 15% per year. On a regional basis, North America will be the largest market for energy-based non-

surgical feminine rejuvenation and is expected to expand by 16% per year through 2023. In North America energy-based feminine rejuvenation is a relatively new treatment option and could become



larger given the unmet demand – if manufacturers overcome regulatory and political hurdles. Asia is

the second largest market and will also expand by 16% per year, with growth supported by key markets. European and Latin American markets will exhibit growth of 13% and 9% per year,

respectively, as market penetration in these regions rises.

In 2018, there were close to 12,500 installed units globally and this number is expected to rise to about 23,800 by the end of the forecast period with an estimated compound annual growth rate of

14% and corresponding physician fees of nearly $2.9 billion by 2023.

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Energy-Based Feminine Rejuvenation March 2019 · 2019-06-19 · Energy-Based Feminine Rejuvenation March 2019 ... Product and corporate data can change very quickly and without notice