EXECUTIVE SUMMARY …………………………………………………………………………. ES-1
i. Methodology ……………………………………………………………………….. ES-5

Exhibit ES-1: Global market for female urinary incontinence devices, combined market forecast ($m), 2015-20 ………………………………… ES-2
Exhibit ES-2: Global market for female urinary incontinence devices, share by product type, 2015 ………………………………………………….. ES-4

1. FEMALE URINARY INCONTINENCE CLINICAL OVERVIEW ………………. 1-1
1.1 Anatomy of the Urinary System ………………………………………………… 1-1
1.2 Types of Urinary Incontinence ………………………………………………….. 1-2
1.2.1 Stress urinary incontinence ……………………………………….. 1-2
1.2.2 Overactive bladder and urge incontinence …………………… 1-3
1.3 Treatment for Urinary Incontinence …………………………………………… 1-4
1.4 Stem Cell Research ………………………………………………………………… 1-7
1.5 Bibliography …………………………………………………………………………… 1-9

Exhibit 1-1: Estimated worldwide prevalence of overactive bladder, 2008, 2013, and 2018 ……………………………………………………………………… 1-5

2. INJECTABLE URETHRAL BULKING AGENTS FOR STRESS URINARY INCONTINENCE ……………………………………………………………………………… 2-1
2.1 Reimbursement ……………………………………………………………………… 2-2
2.2 Safety and Effectiveness …………………………………………………………. 2-3
2.3 Contraindications ……………………………………………………………………. 2-4
2.4 Selected Products ………………………………………………………………….. 2-5
2.4.1 Carbon Medical Technologies ……………………………………. 2-5
2.4.2 Cogentix …………………………………………………………………. 2-6
2.4.3 Merz Aesthetics/Merz Pharma …………………………………… 2-7
2.4.4 Other urethral bulking agents not yet approved in the US . 2-8
2.4.4.1 Bulkamid ………………………………………………….. 2-9
2.4.4.2 Urolastic …………………………………………………. 2-10
2.4.4.3 Urolon …………………………………………………….. 2-10
2.4.5 Alternative agents being researched …………………………. 2-16
2.5 Market Analysis ……………………………………………………………………. 2-16
2.6 Competitive Analysis …………………………………………………………….. 2-17
2.7 Bibliography …………………………………………………………………………. 2-21

Exhibit 2-1: Analysis of selected urethral bulking agents, 2016 …………………….. 2-11
Exhibit 2-2: Injectable urethral bulking agents, global market forecast ($m), 2015-20 …………………………………………………………………………………. 18
Exhibit 2-3: Global urethral bulking agents market, share by supplier, 2015 …… 2-20

3. URETHRAL SLING SYSTEMS FOR STRESS URINARY INCONTINENCE ………………………………………………………………………………… 1
3.1 Safety Concerns and Legal Issues ………………………………………………. 6
3.1.1 US safety reviews ……………………………………………………….. 6
3.1.2 Safety reviews outside the US …………………………………….. 10
3.1.3 Mesh lawsuits …………………………………………………………… 10
3.1.4 Conclusions ……………………………………………………………… 13
3.2 Selected Products …………………………………………………………………… 14
3.2.1 CR Bard …………………………………………………………………… 14
3.2.2 Boston Scientific ……………………………………………………….. 18
3.2.3 CL Medical ………………………………………………………………. 19
3.2.4 Caldera ……………………………………………………………………. 20
3.2.5 Coloplast …………………………………………………………………. 20
3.2.6 Cousin Biotech …………………………………………………………. 21
3.2.7 Ethicon/Johnson & Johnson ……………………………………….. 21
3.3 Market Analysis ………………………………………………………………………. 23
3.3.1 Procedure volumes …………………………………………………… 23
3.3.1.1 US ……………………………………………………………. 23
3.3.1.2 EU ……………………………………………………………. 24
3.3.1.3 Japan ……………………………………………………….. 25
3.3.1.4 Rest of world ……………………………………………… 26
3.3.2 Market forecast …………………………………………………………. 27
3.3.2.1 US ……………………………………………………………. 32
3.3.2.2 Five major EU markets ………………………………… 34
3.3.2.3 Rest of world ……………………………………………… 35
3.3.3 Competitive analysis …………………………………………………. 35
3.4 Bibliography ……………………………………………………………………………. 41

Exhibit 3-1: The three main types of midurethral slings for SUI ………………………. 3-4
Exhibit 3-2: Retropubic and transobturator approaches ………………………………… 3-5
Exhibit 3-3: Ongoing postmarket studies of single-incision sling systems for urinary incontinence …………………………………………………………… 3-9
Exhibit 3-4: Independent reviews conducted outside the US of the evidence for the safety and efficacy of urogynecologic surgical mesh implants ……………………………………………………………………… 3-11
Exhibit 3-5: Selected synthetic urethral sling systems, 2016 ………………………… 3-15
Exhibit 3-6: Urethral sling placement, procedure volumes forecast, 2015-20 ….. 3-28
Exhibit 3-7: Urethral sling systems, market forecast ($m), 2015-20 ………………. 3-30
Exhibit 3-8: Urethral slings market, global share by supplier, 2015 ……………….. 3-37
Exhibit 3-9: Urethral slings market, US share by supplier, 2015……………………. 3-38
Exhibit 3-10: Urethral slings market, 5EU share by supplier, 2015………………….. 3-39
Exhibit 3-11: Urethral slings market, rest of world share by supplier, 2015 ………. 3-40

4. NEUROMODULATION SYSTEMS TO TREAT OVERACTIVE BLADDER ………………………………………………………………… 4-1
4.1 Sacral Nerve Stimulation …………………………………………………………. 4-1
4.2 Percutaneous Posterior Tibial Nerve Stimulation ………………………… 4-2
4.3 Selected Neuromodulation Systems for Overactive Bladder …………. 4-3
4.3.1 Axonics Modulation Technologies ………………………………. 4-3
4.3.2 Bioness…………………………………………………………………… 4-6
4.3.3 BlueWind Medical …………………………………………………….. 4-7
4.3.4 Cogentix …………………………………………………………………. 4-7
4.3.5 FemPulse ……………………………………………………………….. 4-8
4.3.6 Medtronic ………………………………………………………………… 4-9
4.3.6.1 InterStim …………………………………………………… 4-9
4.3.6.2 NURO …………………………………………………….. 4-11
4.3.7 Nuvectra ……………………………………………………………….. 4-12
4.3.8 StimGuard …………………………………………………………….. 4-12
4.4 Market Analysis ……………………………………………………………………. 4-13
4.5 Competitive Analysis …………………………………………………………….. 4-17
4.6 Bibliography …………………………………………………………………………. 4-18

Exhibit 4-1: Selected neuromodulation systems for the treatment of overactive bladder ………………………………………………………………. 4-4
Exhibit 4-2: Neuromodulation systems for the treatment of overactive bladder, global market forecast ($m), 2015-20 ………………………………………. 4-15

5. OTHER TECHNOLOGIES FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE ………………………………………………… 5-1
5.1 Artus Active Implant ………………………………………………………………… 5-1
5.2 Lyrette Transurethral Radiofrequency System ……………………………. 5-2
5.3 Vesair Bladder Control System ………………………………………………… 5-3
APPENDIX: COMPANY LISTING ……………………………………………………………… A-1