Aesthetic Devices - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 9

1.2 List of Figures 15

2 Introduction 16

2.1 Aesthetic Devices Overview 16

3 Products under Development 17

3.1 Aesthetic Devices-Pipeline Products by Stage of Development 17

3.2 Aesthetic Devices-Pipeline Products by Segment 18

3.3 Aesthetic Devices-Pipeline Products by Territory 19

3.4 Aesthetic Devices-Pipeline Products by Regulatory Path 21

3.5 Aesthetic Devices-Pipeline Products by Estimated Approval Date 23

3.6 Aesthetic Devices-Ongoing Clinical Trials 24

4 Aesthetic Devices-Pipeline Products under Development by Companies 25

4.1 Aesthetic Devices Companies-Pipeline Products by Stage of Development 25

4.2 Aesthetic Devices-Pipeline Products by Stage of Development 28

5 Aesthetic Devices Companies and Product Overview 32

5.1 Acelity L.P. Inc. Company Overview 32

5.2 Aeon Astron Corporation Company Overview 33

5.3 Aesthetic Medical Device Company Overview 34

5.4 Aesthetics Point Ltd. Company Overview 36

5.5 Allergan Inc Company Overview 37

5.6 Allergan Plc Company Overview 39

5.7 Almirall Ltd Company Overview 47

5.8 Ambicare Health Ltd Company Overview 48

5.9 Andrew Technology LLC Company Overview 49

5.10 Anika Therapeutics Inc Company Overview 50

5.11 Avita Medical Ltd Company Overview 51

5.12 BioPhotas, Inc. Company Overview 54

5.13 Biosculpture Technology, Inc. Company Overview 55

5.14 BioTime Inc Company Overview 57

5.15 Bioxis Pharmaceuticals Company Overview 61

5.16 Bovie Medical Corp Company Overview 66

5.17 Celltrix AB Company Overview 69

5.18 CollPlant Ltd Company Overview 70

5.19 Cutera Inc Company Overview 71

5.20 Cytori Therapeutics Inc Company Overview 76

5.21 Cytrellis Biosystems Inc Company Overview 77

5.22 Dermele Skin Care, LLC Company Overview 80

5.23 Eclipse Aesthetics LLC Company Overview 81

5.24 Ellman International Inc Company Overview 82

5.25 Emory University Company Overview 83

5.26 Erchonia Corp Company Overview 84

5.27 Eternity Healthcare Inc. Company Overview 85

5.28 EternoGen Aesthetics LLC Company Overview 86

5.29 Forticell Bioscience Inc Company Overview 87

5.30 Fourth State Medicine Ltd Company Overview 88

5.31 Genzyme Corp Company Overview 89

5.32 ImpLite Ltd. Company Overview 90

5.33 Innova Medical Design Company Overview 91

5.34 Innovia LLC Company Overview 92

5.35 IonMed Ltd. Company Overview 94

5.36 Juvenis Ltd Company Overview 95

5.37 Keraderm LLC Company Overview 96

5.38 Khorionyx SA Company Overview 97

5.39 Medifirst Solutions Inc Company Overview 98

5.40 Medixsysteme Company Overview 100

5.41 Merz Pharma GmbH & Co KgaA Company Overview 102

5.42 Moma Therapeutics, Inc. Company Overview 104

5.43 N8 Medical Inc Company Overview 105

5.44 NanoVibronix Inc Company Overview 106

5.45 Neosthetic, LLC Company Overview 107

5.46 Northwestern University Company Overview 108

5.47 Nu Skin International Inc. Company Overview 109

5.48 Oligo Medic Inc Company Overview 111

5.49 PetVivo Holdings Inc Company Overview 112

5.50 PhotoDerma SA Company Overview 114

5.51 PhotoMedex Inc Company Overview 116

5.52 PhotoSonix Medical, Inc. Company Overview 118

5.53 Pinnacle Therapeutics Company Overview 119

5.54 PolyNovo Biomaterials Pty Ltd Company Overview 120

5.55 PS Advanced Engineering Company Overview 123

5.56 Regen Lab SA Company Overview 125

5.57 Regenscientific Company Overview 128

5.58 Samyang Biopharmaceuticals Corp Company Overview 129

5.59 SANUWAVE Health Inc Company Overview 130

5.60 Sebacia Inc Company Overview 133

5.61 Sekisui Medical Co Ltd Company Overview 134

5.62 Serene Medical, Inc. Company Overview 135

5.63 Shanghai Haohai Biological Technology Co Ltd Company Overview 136

5.64 Shin Poong PharmCo Ltd Company Overview 138

5.65 Sienna Biopharmaceuticals Inc Company Overview 139

5.66 Sinclair Pharma PLC Company Overview 142

5.67 Slender Medical Ltd. Company Overview 149

5.68 Sofregen Medical Inc Company Overview 151

5.69 Southern Illinois University Carbondale Company Overview 152

5.70 Syneron Medical Ltd Company Overview 153

5.71 TEI Biosciences Inc Company Overview 154

5.72 University of California Irvine Company Overview 155

5.73 University of California Santa Barbara Company Overview 156

5.74 Valeant Pharmaceuticals International Inc Company Overview 157

5.75 Zeltiq Aesthetics Inc Company Overview 160

6 Aesthetic Devices- Recent Developments 162

6.1 Jul 16, 2018: Cutera Launches truSculpt iD, Personalized Body Sculpting: The Next Evolution 162

6.2 Jul 12, 2018: InMode Introduces Triton: The World's First and Only Simultaneous Multi-Wavelength Hair Removal 162

6.3 Jul 09, 2018: Solsys Medical Appoints Dr. Arti Masturzo As Chief Medical Officer 163

6.4 Jul 05, 2018: Sinclair Pharma: Trading Update for the 6 months to 30 June 2018 164

6.5 Jul 02, 2018: Lumenis Unveils NuEra tight , Its High Power, Temperature-Controlled Top to Toe Radio Frequency Skin Laxity and Cellulite Treatment, at the 2018 Aesthetic Show 165

6.6 Jun 25, 2018: Zimmer Biomet Update on Warsaw North Campus FDA Inspection 166

6.7 Jun 19, 2018: STRATA Skin Sciences Announces 510(k) Submission for its Multi Micro Dose Tip Accessory for the XTRAC 308nm Excimer Laser 166

6.8 Jun 12, 2018: AirXpanders Appoints Frank Grillo As New CEO 167

6.9 Jun 11, 2018: Quantel Medical creates a new subsidiary in Poland 167

6.10 Jun 06, 2018: InMode Aesthetic Solutions Launches A New Concept for Subdermal Adipose-Remodeling of the Face, EmbraceRF and Morpheus8 168

6.11 Jun 06, 2018: Sciton Announces New HALO 2.0 and New FDA Indications 169

6.12 Jun 04, 2018: SWAG Penis Enhancement Procedure Developed by Top Plastic Surgeon Achieving Optimal Results 169

6.13 Jun 04, 2018: SANUWAVE Health Names Shri Parikh As President For Global Healthcare Division 170

6.14 Jun 04, 2018: Viveve Announces Settlement of Patent Infringement Litigation with Thermi 171

7 Appendix 352

7.1 Methodology 352

7.2 About GlobalData 355

7.3 Contact Us 355

7.4 Disclaimer 355

List of Figure

1.2 List of Figures

Figure 1: Aesthetic Devices-Pipeline Products by Stage of Development 19

Figure 2: Aesthetic Devices-Pipeline Products by Segment 20

Figure 3: Aesthetic Devices-Pipeline Products by Territory 21

Figure 4: Aesthetic Devices-Pipeline Products by Regulatory Path 23

Figure 5: Aesthetic Devices-Pipeline Products by Estimated Approval Date 25

Figure 6: Aesthetic Devices-Ongoing Clinical Trials 26

List of Table

1.1 List of Tables

Table 1: Aesthetic Devices-Pipeline Products by Stage of Development 19

Table 2: Aesthetic Devices-Pipeline Products by Segment 20

Table 3: Aesthetic Devices-Pipeline Products by Territory 21

Table 4: Aesthetic Devices-Pipeline Products by Regulatory Path 23

Table 5: Aesthetic Devices-Pipeline Products by Estimated Approval Date 25

Table 6: Aesthetic Devices-Ongoing Clinical Trials 26

Table 7: Aesthetic Devices Companies-Pipeline Products by Stage of Development 27

Table 8: Aesthetic Devices-Pipeline Products by Stage of Development 30

Table 9: Acelity L.P. Inc. Pipeline Products & Ongoing Clinical Trials Overview 34

Table 10: Strattice For Facelift-Product Status 34

Table 11: Strattice For Facelift-Product Description 34

Table 12: Aeon Astron Corporation Pipeline Products & Ongoing Clinical Trials Overview 35

Table 13: BioDermal Filler-Product Status 35

Table 14: BioDermal Filler-Product Description 35

Table 15: Aesthetic Medical Device Pipeline Products & Ongoing Clinical Trials Overview 36

Table 16: Alluris-Product Status 36

Table 17: Alluris-Product Description 36

Table 18: Skinlumina-Product Status 36

Table 19: Skinlumina-Product Description 37

Table 20: Aesthetics Point Ltd. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 21: Juvence Implant-Product Status 38

Table 22: Juvence Implant-Product Description 38

Table 23: Allergan Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 24: JUVEDERM Volbella-Product Status 39

Table 25: JUVEDERM Volbella-Product Description 39

Table 26: VYC-25L Hyaluronic Acid Injectable Gel-Product Status 40

Table 27: VYC-25L Hyaluronic Acid Injectable Gel-Product Description 40

Table 28: Allergan Plc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 29: Botox-Forehead Lines-Product Status 41

Table 30: Botox-Forehead Lines-Product Description 42

Table 31: Botox-Masseter-Product Status 42

Table 32: Botox-Masseter-Product Description 42

Table 33: earFold-Product Status 42

Table 34: earFold-Product Description 43

Table 35: Eplica Silk-Product Status 43

Table 36: Eplica Silk-Product Description 43

Table 37: HA Threads-Product Status 44

Table 38: HA Threads-Product Description 44

Table 39: Juvederm Volift-Nasolabial Folds-Product Status 44

Table 40: Juvederm Volift-Nasolabial Folds-Product Description 44

Table 41: MicroCell-Breast Augmentation-Product Status 45

Table 42: MicroCell-Breast Augmentation-Product Description 45

Table 43: Phoenix-Breast Augmentation-Product Status 45

Table 44: Phoenix-Breast Augmentation-Product Description 45

Table 45: SeriGel-Product Status 46

Table 46: SeriGel-Product Description 46

Table 47: Skin Quattro Device-Product Status 46

Table 48: Skin Quattro Device-Product Description 46

Table 49: Allergan Plc-Ongoing Clinical Trials Overview 47

Table 50: earFold-Long Term Prospective Uncontrolled Study of Earfold or the Treatment of Prominent Ears: FOLD 48

Table 51: Almirall Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Table 52: Hyaluronic Acid Facial Filler-Product Status 49

Table 53: Hyaluronic Acid Facial Filler-Product Description 49

Table 54: Ambicare Health Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

Table 55: Ambulight Rejuvenate-Product Status 50

Table 56: Ambulight Rejuvenate-Product Description 50

Table 57: Andrew Technology LLC Pipeline Products & Ongoing Clinical Trials Overview 51

Table 58: HydraSolve Lipoplasty System-Visceral Fat-Product Status 51

Table 59: HydraSolve Lipoplasty System-Visceral Fat-Product Description 51

Table 60: Anika Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 61: Next Generation ELEVESS Dermal Filler-Product Status 52

Table 62: Next Generation ELEVESS Dermal Filler-Product Description 52

Table 63: Avita Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

Table 64: ReNovaCell-Aesthetics And Repigmentation-Product Status 53

Table 65: ReNovaCell-Aesthetics And Repigmentation-Product Description 53

Table 66: Avita Medical Ltd-Ongoing Clinical Trials Overview 54

Table 67: ReNovaCell-Aesthetics And Repigmentation-Autologous Cell Suspension Grafting Using ReNovacell in Non-segmental Vitiligo Patients: A Randomized Controlled Study 55

Table 68: BioPhotas, Inc. Pipeline Products & Ongoing Clinical Trials Overview 56

Table 69: Celluma-Skin Rejuvenation And Sun Spots-Product Status 56

Table 70: Celluma-Skin Rejuvenation And Sun Spots-Product Description 56

Table 71: Biosculpture Technology, Inc. Pipeline Products & Ongoing Clinical Trials Overview 57

Table 72: Airbrush Liposculptor IIE-Product Status 57

Table 73: Airbrush Liposculptor IIE-Product Description 57

Table 74: Airbrush Liposculptor IIIE-Product Status 58

Table 75: Airbrush Liposculptor IIIE-Product Description 58

Table 76: BioTime Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Table 77: Renevia-Product Status 59

Table 78: Renevia-Product Description 60

Table 79: BioTime Inc-Ongoing Clinical Trials Overview 61

Table 80: Renevia-A Randomized, Evaluator-blinded, Delayed-treatment-controlled Study of the Effectiveness and Safety of Renevia, A Resorbable Matrix for the Delivery of Autologous Adipose Derived Cells to treat Subcutaneous Facial Lipoatrophy Defects Arising from HIV 62

Table 81: Bioxis Pharmaceuticals Pipeline Products & Ongoing Clinical Trials Overview 63

Table 82: CYTOSIAL Deep Wrinkle-Product Status 63

Table 83: CYTOSIAL Deep Wrinkle-Product Description 63

Table 84: CYTOSIAL Medium-Product Status 64

Table 85: CYTOSIAL Medium-Product Description 64

Table 86: Cytosial Volume-Product Status 64

Table 87: Cytosial Volume-Product Description 64

Table 88: Cytosmile-Product Status 65

Table 89: Cytosmile-Product Description 65

Table 90: MTI-12-Product Status 65

Table 91: MTI-12-Product Description 66

Table 92: MTI-12-Aesthetic Device-Product Status 66

Table 93: MTI-12-Aesthetic Device-Product Description 66

Table 94: MTI-12-Surgical Repair-Product Status 66

Table 95: MTI-12-Surgical Repair-Product Description 67

Table 96: Bovie Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 68

Table 97: Renuvion-Dermal Resurfacing-Product Status 68

Table 98: Renuvion-Dermal Resurfacing-Product Description 68

Table 99: Bovie Medical Corp-Ongoing Clinical Trials Overview 69

Table 100: Renuvion-Dermal Resurfacing-A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma for Dermal Resurfacing 70

Table 101: Celltrix AB Pipeline Products & Ongoing Clinical Trials Overview 71

Table 102: Credurance-Product Status 71

Table 103: Credurance-Product Description 71

Table 104: CollPlant Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

Table 105: Next Generation Dermal Filler-Product Status 72