gdme001mfr-medical devices for the treatment of obesity ...allergan sees decline in sales as new...

15
Medical Devices for the Treatment of Obesity GDME001MFR / Published May 2013

Upload: others

Post on 02-Oct-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

XX XX

GDHC00PIDR / Published XXX

XX XX

GDHC00PIDR / Published XXX

Medical Devices for the Treatment of Obesity

GDME001MFR / Published May 2013

Page 2: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 2 GDME001M FR / Published MAY 2013

Medical Devices Strive to Fill Void in Obesity

Treatment

The o besity medi cal device ind ustry is exp ected to

experience significant change in the n ear future, a s new

products come to market, older p roducts see a decline in

sales, physi cian a doption increa ses world wide, and

supporting d evice reim bursement is p ut in place. While

bariatric surg ery te chniques have demonstrated not able

improvements in safety and efficacy compared with years

prior, aversi on to inte rvention has curbed operation

prevalence to less than 1% of suitable obese candidates.

Moreover, di abetes indi cations fu rther drive ob esity

medical devi ces sal es by loweri ng th e thre shold body

mass in dex for patie nts to receive i mplantation, and

comorbidities like this can o ften necessitate intervention.

With limited options in re gards to ph armacotherapy, and

near-unanimous disinclination to surgery, there i s a void

in treatment options, an d medical d evices are u p for

substantial adoption.

Allergan Sees Decline in Sales as New Devices Enter

the Market

Whereas th e obe sity treatment d evice in dustry has

previously been dominated by restrictive devices such as

the Lap-Band (Allergan) and artificial fullness devices like

the Orbe ra (Allerga n), Global Data now ex pects

noteworthy adoption of malabsorption devices, including

the EndoB arrier (GI Dynamics) an d the soon -to-be-

approved ValenTx (ValenTx), in lieu of wani ng interest in

gastric banding and no n-adjustable intragastric balloons,

which h ave seen a suggestive de cline in po pularity as

long-term outcomes have been published, demonstrating

lack of efficacy and frequent explantations.

Improvements in Gastric Electrical Stimulation

Long-sought gastric electrical stimulation technology has

advanced sig nificantly in re cent years, and t wo d evices

available on the market today, the Abiliti (IntraPace, Inc.)

and DIAMOND Ta ntalus (Meta Cure, Inc.), have bee n

gaining phy sician inte rest inte rnationally. Besi des

targeting the stoma ch, similar stimulation tech nologies

have be en developed fo r the hypothalamus, utili zing

deep brain stimulation, including the NeuroSigma device,

a device that is currently in preclinical testing. In addition,

matching advancements in neuronal blocking technology

have ena bled patient-sp ecific vag al blockin g therapy,

with o ne device al ready app roved, the Vblo c Ma estro

System (E nteroMedics), and add itional products

expected to enter development in the future.

Endoscopic Approaches Increasingly Popular

Among Patients

Other d evice techn ologies which have und ergone

noteworthy i mprovement inclu de endoscopic suturing

and stapling tools, capable of stomach reduction surgery

via transoral, inci sionless access, which is in creasingly

popular fo r those strongl y oppo sed to sca rs. Lastly,

despite a rtificial fulln ess device s seeing a de cline in

sales, phy sicians a re n onetheless e xcited ab out the

development of the Tran sPyloric Shuttle (Baronova) and

Full Sense Device (BFKW), whi ch are both still in

development, but tout next-gene ration technolo gy and

could potenti ally see widespread ad option. Num erous

other devices are in d evelopment as the obesity medical

device industry continues to grow.

 

Page 3: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 3 GDME001M FR / Published MAY 2013

What do Physicians Think?

While surgi cal procedu re volume s remain l ow, the

number of physicians performing these surgeries is small

as well, which will drive minimally invasive device sales.

Device use is ideal for trea ting patients who wish to lose

weight, but are not morbidly obese surgical candidates.

“The incapability of surgeons to operate on the numbers

that they want to will drive device sales … there is still a

very important gap for patients who have a BMI between

30 and 40, because they are not surgical candidates

…THERE is the endoscopic [device] field.”

Key Opinion Leader, April 2013

While d evice use h as increa sed in re cent years,

procedures are still expensive and reim bursement is still

lacking, which h as been a maj or barrier to d evice

adoption.

“Most people can’t afford to pay for a device out of

pocket, so insurance reimbursement is a pretty critical

issue with [treatment of obesity]. A lot of [device

adoption] has to do with reimbursement issues.”

Key Opinion Leader, April 2013

Despite mini mal reim bursement cu rrently, Global Data

expects com pensation fo r medical dev ices in the near

term, a s efficacy im proves and lon g-term out comes are

published.

“When [insurers] incorporate the coverage of the surgery,

they have to include all the different risks of surgery, so

for the insurance companies, device use is cheaper and

better. They know that, but they are not forced by law

now [to provide reimbursement], so it’s a matter of time.”

Key Opinion Leader, April 2013

Open surg ery and la paroscopic p rocedures l eave scars

and can be complicated with bleeding and infection; as a

result, transoral, inc isionless devic es have seen a

dramatic rise in use.

“I think there’s been some desire to have procedures that

are less invasive, don’t leave scars, have lower

complication rates than current procedures. I think that’s

what’s driving [sales].”

Key Opinion Leader, April 2013

New device sale s are driven by waning inte rest in

currently app roved d evices, su ch a s th e non -adjustable

intragastric balloon, which has mixed effectiveness in the

long term.

“The balloon isn’t going to be effective in overly obese

patients, not in this lifetime.”

Key Opinion Leader, April 2013

Next-generation te chnologies in g astric stim ulation

previously showed po or effica cy, but re cent

improvements in de sign are ma king the se devices

increasingly competitive.

“I think if we can progress with gastric stimulation, it

probably is one thing that could pick up in the future. If

gastric stimulation already worked, it would probably be

[the preferred] procedure…”

Key Opinion Leader, April 2013

Page 4: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 4 GDME001M FR / Published MAY 2013

1 Table of Contents

1 Table of Contents ................................................................................................................... 4

1.1 List of Tables ................................................................................................................... 8

2 Introduction ........................................................................................................................... 13

2.1 Catalyst ......................................................................................................................... 13

2.2 Related Reports ............................................................................................................ 14

2.3 Upcoming Related Reports ........................................................................................... 14

3 Market Overview ................................................................................................................... 15

3.1 Background ................................................................................................................... 15

3.1.1 Overfed and Under-nurtured .................................................................................. 15

3.1.2 Pharma Fails to Seize the Obesity Market, Leaves Void for Med-Tech to Fill ....... 16

3.1.3 Surgery Remains the Gold Standard for Now ........................................................ 17

3.1.4 Diabetes Indications Further Fuel Obesity Medical Device Industry Growth ......... 19

3.1.5 New Indications in Pediatrics ................................................................................. 20

3.1.6 International Market Growth ................................................................................... 20

3.1.7 High Costs and Evolving Reimbursement .............................................................. 21

3.1.8 Drivers Behind Device Adoption ............................................................................. 22

4 Competitive Assessment ...................................................................................................... 24

4.1 Overview ....................................................................................................................... 24

4.2 Artificial Fullness Devices ............................................................................................. 26

4.2.1 End Ball (Endalis Laboratory) ................................................................................. 28

4.2.2 Obalon (Obalon Therapeutics) ............................................................................... 29

4.2.3 Orbera (Allergan) .................................................................................................... 31

4.2.4 Heliosphere (Helioscopie) ...................................................................................... 34

4.2.5 ReShape Duo (ReShape Medical) ......................................................................... 36

4.2.6 SatiSphere (EndoSphere) ...................................................................................... 37

4.2.7 Spatz 3 (Spatz Medical) ......................................................................................... 39

4.3 Endoscopic Surgical Devices........................................................................................ 42

Page 5: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 5 GDME001M FR / Published MAY 2013

4.3.1 Intraluminal Stapler (Ethicon) ................................................................................. 42

4.3.2 OverStitch (Apollo Endosurgery) ............................................................................ 44

4.3.3 StomaphyX (EndoGastric Solutions) ...................................................................... 46

4.4 Gastric Electrical Stimulation ........................................................................................ 48

4.4.1 Abiliti (IntraPace, Inc.) ............................................................................................ 50

4.4.2 DIAMOND Tantalus (MetaCure Inc.)...................................................................... 52

4.5 Gastric Emptying Aspiration Tools ................................................................................ 54

4.5.1 AspireAssist (Aspire Bariatrics, Inc.) ...................................................................... 54

4.6 Malabsorption Devices .................................................................................................. 56

4.6.1 EndoBarrier (GI Dynamics, Inc.) ............................................................................ 56

4.7 Neuronal Blocking Technology ..................................................................................... 59

4.7.1 Vbloc Maestro System (EnteroMedics) .................................................................. 59

4.8 Restrictive Devices ....................................................................................................... 60

4.8.1 AMI Band (Agency for Medical Innovation) ............................................................ 62

4.8.2 Bioring (Cousin Biotech) ......................................................................................... 64

4.8.3 Heliogast (Helioscopie) .......................................................................................... 66

4.8.4 Lap-Band (Allergan) ............................................................................................... 68

4.8.5 Midband (Medical Innovation Development) .......................................................... 72

4.8.6 MiniMizer Extra (Bariatric Solutions) ...................................................................... 73

4.8.7 Swedish/Realize Band (Ethicon-Endosurgery) ...................................................... 75

5 Pipeline Products .................................................................................................................. 78

5.1 Overview ....................................................................................................................... 78

5.2 Artificial Fullness Devices ............................................................................................. 79

5.2.1 Full Sense Device (BFKW) ..................................................................................... 79

5.2.2 TransPyloric Shuttle (Baronova) ............................................................................ 80

5.3 Deep Brain Stimulation ................................................................................................. 82

5.3.1 Deep Brain Stimulation Device (NeuroSigma) ....................................................... 82

5.4 Endoscopic Surgical Devices........................................................................................ 84

Page 6: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 6 GDME001M FR / Published MAY 2013

5.4.1 ACE Stapler (BaroSense) ...................................................................................... 84

5.4.2 RS2 Restore (CR Bard) .......................................................................................... 85

5.5 Malabsorption Devices .................................................................................................. 86

5.5.1 ValenTx (ValenTx) .................................................................................................. 86

5.6 Restrictive Devices ....................................................................................................... 88

5.6.1 AMI B-Band (Agency for Medical Innovation) ........................................................ 88

5.6.2 AMI Basket (Agency for Medical Innovation) ......................................................... 89

5.6.3 TERIS (BaroSense, Inc.) ........................................................................................ 91

6 Current and Future Players .................................................................................................. 93

6.1 Overview ....................................................................................................................... 93

6.1.1 Medical Device Companies have Opportunity to Incorporate Lifestyle Programs . 93

6.2 Company Profiles .......................................................................................................... 95

6.2.1 Allergan .................................................................................................................. 95

6.2.2 Apollo Endosurgery, Inc. ........................................................................................ 97

6.2.3 Aspire Bariatrics, Inc. ............................................................................................. 98

6.2.4 Agency for Medical Innovation ............................................................................... 99

6.2.5 Bariatric Solutions................................................................................................. 100

6.2.6 Baronova .............................................................................................................. 101

6.2.7 BaroSense, Inc. .................................................................................................... 102

6.2.8 BFKW ................................................................................................................... 103

6.2.9 Cousin Biotech ..................................................................................................... 104

6.2.10 CR Bard ................................................................................................................ 105

6.2.11 Endalis Laboratory ............................................................................................... 106

6.2.12 EndoGastric Solutions .......................................................................................... 107

6.2.13 EndoSphere, Inc. .................................................................................................. 108

6.2.14 EnteroMedics, Inc. ................................................................................................ 109

6.2.15 Ethicon Endo-Surgery .......................................................................................... 110

6.2.16 GI Dynamics ......................................................................................................... 111

Page 7: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 7 GDME001M FR / Published MAY 2013

6.2.17 Helioscopie ........................................................................................................... 112

6.2.18 IntraPace, Inc. ...................................................................................................... 113

6.2.19 Medical Innovation Development ......................................................................... 114

6.2.20 MetaCure Inc. ....................................................................................................... 115

6.2.21 Obalon Therapeutics ............................................................................................ 116

6.2.22 ReShape Medical ................................................................................................. 117

6.2.23 Spatz Medical ....................................................................................................... 118

6.2.24 ValenTx, Inc. ......................................................................................................... 119

7 Appendix ............................................................................................................................. 120

7.1 Bibliography ................................................................................................................ 120

7.2 Abbreviations .............................................................................................................. 125

7.3 Definitions ................................................................................................................... 126

7.4 Methodology ............................................................................................................... 126

7.5 Coverage..................................................................................................................... 127

7.6 Primary Research ....................................................................................................... 127

7.7 Physicians and Specialists Included in this Study ...................................................... 128

7.8 Secondary Research .................................................................................................. 129

7.9 About the Authors ....................................................................................................... 130

7.9.1 Analysts ................................................................................................................ 130

7.9.2 Global Head of Healthcare ................................................................................... 131

7.10 About GlobalData ........................................................................................................ 132

7.11 Contact Us .................................................................................................................. 132

7.12 Disclaimer ................................................................................................................... 132

Page 8: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 8 GDME001M FR / Published MAY 2013

1.1 List of Tables

Table 1: Ideal Bariatric Treatment Attributes ........................................................................ 24

Table 2: Obesity Treatment Marketed Devices by Type ...................................................... 25

Table 3: Product Profile – End Ball ...................................................................................... 28

Table 4: End Ball SWOT Analysis ........................................................................................ 29

Table 5: Product Profile – Obalon ........................................................................................ 29

Table 6: Obalon SWOT Analysis .......................................................................................... 31

Table 7: Product Profile – Orbera ......................................................................................... 31

Table 8: Orbera SWOT Analysis .......................................................................................... 33

Table 9: Product Profile – Heliosphere ................................................................................. 34

Table 10: Heliosphere SWOT Analysis .................................................................................. 35

Table 11: Product Profile – ReShape Duo ............................................................................. 36

Table 12: ReShape Duo SWOT Analysis ............................................................................... 37

Table 13: Product Profile – SatiSphere .................................................................................. 37

Table 14: SatiSphere SWOT Analysis ................................................................................... 38

Table 15: Product Profile – Spatz ........................................................................................... 39

Table 16: Spatz SWOT Analysis ............................................................................................ 41

Table 17: Product Profile – Intraluminal Circular Stapler ....................................................... 42

Table 18: Intraluminal Stapler SWOT Analysis ...................................................................... 43

Table 19: Product Profile – OverStitch ................................................................................... 44

Table 20: Overstitch SWOT Analysis ..................................................................................... 45

Table 21: Product Profile – StomaphyX ................................................................................. 46

Table 22: StomaphyX SWOT Analysis ................................................................................... 48

Table 23: Product Profile – Abiliti ........................................................................................... 50

Table 24: Abiliti SWOT Analysis ............................................................................................. 51

Table 25: Product Profile – DIAMOND Tantalus .................................................................... 52

Table 26: DIAMOND Tantalus SWOT Analysis ..................................................................... 54

Table 27: Product Profile – AspireAssist ................................................................................ 55

Page 9: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 9 GDME001M FR / Published MAY 2013

Table 28: AspireAssist SWOT Analysis ................................................................................. 56

Table 29: Product Profile – EndoBarrier ................................................................................. 57

Table 30: EndoBarrier SWOT Analysis .................................................................................. 58

Table 31: Product Profile – Vbloc Maestro System ................................................................ 59

Table 32: Maestro System with Vbloc SWOT Analysis .......................................................... 60

Table 33: Product Profile – AMI Band .................................................................................... 62

Table 34: AMI Band SWOT Analysis ..................................................................................... 63

Table 35: Product Profile – Bioring ......................................................................................... 64

Table 36: Bioring SWOT Analysis .......................................................................................... 65

Table 37: Product Profile – Heliogast ..................................................................................... 66

Table 38: Heliogast SWOT Analysis ...................................................................................... 68

Table 39: Product Profile – Lap-Band .................................................................................... 68

Table 40: Lap-Band SWOT Analysis ...................................................................................... 71

Table 41: Product Profile – Midband ...................................................................................... 72

Table 42: Midband SWOT Analysis ....................................................................................... 73

Table 43: Product Profile – MiniMizer .................................................................................... 73

Table 44: MiniMizer SWOT Analysis ...................................................................................... 75

Table 45: Product Profile – Swedish/Realize Band ................................................................ 75

Table 46: Swedish/Realize Band SWOT Analysis ................................................................. 77

Table 47: Obesity Treatment Pipeline Devices by Type ........................................................ 78

Table 48: Product Profile – Full Sense Device ....................................................................... 79

Table 49: Full Sense Device SWOT Analysis ........................................................................ 80

Table 50: Product Profile – TransPyloric Shuttle ................................................................... 81

Table 51: TransPyloric Shuttle SWOT Analysis ..................................................................... 81

Table 52: Product Profile – Deep Brain Stimulation Device ................................................... 82

Table 53: Deep Brain Stimulation Device SWOT Analysis .................................................... 83

Table 54: Product Profile – ACE Stapler ................................................................................ 84

Table 55: ACE Stapler SWOT Analysis ................................................................................. 85

Page 10: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 10 GDME001M FR / Published MAY 2013

Table 56: Product Profile – RS2 Restore ............................................................................... 85

Table 57: RS2 Restore SWOT Analysis ................................................................................. 86

Table 58: Product Profile – ValenTx ....................................................................................... 87

Table 59: ValenTx SWOT Analysis ........................................................................................ 87

Table 60: Product Profile – AMI B-Band ................................................................................ 88

Table 61: AMI B-Band SWOT Analysis .................................................................................. 89

Table 62: Product Profile – AMI Basket ................................................................................. 89

Table 63: AMI Basket SWOT Analysis ................................................................................... 90

Table 64: Product Profile – TERIS ......................................................................................... 91

Table 65: TERIS SWOT Analysis ........................................................................................... 92

Table 66: Company Profile – Allergan .................................................................................... 95

Table 67: Allergan SWOT Analysis ........................................................................................ 96

Table 68: Company Profile – Apollo Endosurgery ................................................................. 97

Table 69: Apollo Endosurgery SWOT Analysis ...................................................................... 97

Table 70: Company Profile – Aspire Bariatrics, Inc. ............................................................... 98

Table 71: Aspire Bariatrics, Inc. SWOT Analysis ................................................................... 98

Table 72: Company Profile – Agency for Medical Innovation ................................................ 99

Table 73: Agency for Medical Innovation SWOT Analysis ..................................................... 99

Table 74: Company Profile – Bariatric Solutions .................................................................. 100

Table 75: Bariatric Solutions SWOT Analysis ...................................................................... 100

Table 76: Company Profile – Baronova ............................................................................... 101

Table 77: Baronova SWOT Analysis .................................................................................... 101

Table 78: Company Profile – BaroSense, Inc. ..................................................................... 102

Table 79: BaroSense, Inc. SWOT Analysis .......................................................................... 102

Table 80: Company Profile – BFKW .................................................................................... 103

Table 81: BFKW SWOT Analysis ......................................................................................... 103

Table 82: Company Profile – Cousin Biotech ....................................................................... 104

Table 83: Cousin Biotech SWOT Analysis ........................................................................... 104

Page 11: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 11 GDME001M FR / Published MAY 2013

Table 84: Company Profile – CR Bard ................................................................................. 105

Table 85: CR Bard SWOT Analysis ..................................................................................... 105

Table 86: Company Profile – Endalis Laboratory ................................................................. 106

Table 87: Endalis Laboratory SWOT Analysis ..................................................................... 106

Table 88: Company Profile – EndoGastric Solutions ........................................................... 107

Table 89: EndoGastric Solutions SWOT Analysis................................................................ 107

Table 90: Company Profile – EndoSphere, Inc. ................................................................... 108

Table 91: EndoSphere, Inc. SWOT Analysis ....................................................................... 108

Table 92: Company Profile – EnteroMedics, Inc. ................................................................. 109

Table 93: EnteroMedics, Inc. SWOT Analysis ..................................................................... 109

Table 94: Company Profile – Ethicon Endo-Surgery ........................................................... 110

Table 95: Ethicon Endo-Surgery SWOT Analysis ................................................................ 110

Table 96: Company Profile – GI Dynamics .......................................................................... 111

Table 97: GI Dynamics SWOT Analysis ............................................................................... 111

Table 98: Company Profile – Helioscopie ............................................................................ 112

Table 99: Helioscopie SWOT Analysis ................................................................................. 112

Table 100: Company Profile – IntraPace Inc. ......................................................................... 113

Table 101: IntraPace Inc. SWOT Analysis ............................................................................. 113

Table 102: Company Profile – Medical Innovation Development .......................................... 114

Table 103: Medical Innovation Development SWOT Analysis ............................................... 114

Table 104: Company Profile – MetaCure, Inc. ....................................................................... 115

Table 105: MetaCure, Inc. SWOT Analysis ............................................................................ 115

Table 106: Company Profile – Obalon Therapeutics ............................................................. 116

Table 107: Obalon Therapeutics SWOT Analysis .................................................................. 116

Table 108: Company Profile – ReShape Medical .................................................................. 117

Table 109: ReShape Medical SWOT Analysis ....................................................................... 117

Table 110: Company Profile – Spatz Medical ........................................................................ 118

Table 111: Spatz Medical SWOT Analysis ............................................................................. 118

Page 12: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Table of Contents

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 12 GDME001M FR / Published MAY 2013

Table 112: Company Profile – ValenTx, Inc. .......................................................................... 119

Table 113: ValenTx, Inc. SWOT Analysis .............................................................................. 119

Page 13: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Introduction

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 13 GDME001MFR / Published MAY 2013

2 Introduction

Obesity is on e of th e most prevalent health conditions impacting the worldwide healthcare market

today, yet tre atment is limi ted and the industry is largely underserved. Exercise and dieting have

generally proven ineffective, and while pharmaceuticals and bariatric surgery have improved over

the past few decades, the adoption of these treatments remains limited. Furthermore, only a small

percentage o f patients utilizing ph armacotherapy options eve r su ccessfully lose excess body

weight from taking these drugs, and many have undesirable side effects. As a result, the med-tech

industry is striving to take signifi cant market share from the failing pharmaceutical industry. All but

three marketed pharmaceuticals that were once available have b een discontinued due to lack of

efficacy. Whi le pipelin e p roducts have sho wn som e potential, particula rly for spe cific target

populations, doctors aren’t expecting an obesity blockbuster drug any time soon.

For many patients who have not had success with exercising, dieting, or pharmacotherapy, surgical

intervention offers a potential solution; however, patients are reluctant to opt for surgery because it

can be extremely invasive and is not easily reversible, if at all. Approximately 20 million Americans

qualify for insurance coverage for bariatric surgery, yet only 200,000 opt to have it done. In l ieu of

invasive b ariatric surgery and in effective pharma cotherapy, ma ny patients are now turn ing to

device impla ntation a s a safe and ef fective adj unct to a life style ch ange program to promote

healthy weight loss.

2.1 Catalyst

The troubling and ever-increasing prevalence of obesity is well kno wn, yet effect ive treatment has

been hi storically elusive, particula rly in rega rds to drug the rapy. As medical device safety and

efficacy has improved, along with reduced manufacturing costs, improved implantation methods,

and ever-am assing clinical experie nce, more and more patie nts are n ow turning to devi ce

implantation for weight-loss indications. When used in combination with lifestyle changes, bariatric

devices have exhibited notable weight-loss results and generated significant attention worldwide.

There are a number of d evices in the industry that take ve ry different approaches to weight loss;

some m arket segm ents a re mo re mat ure tha n ot hers. Altogeth er, thoug h, the obe sity medical

device i ndustry is exp ected to expe rience significant gro wth in th e co ming fe w yea rs, d riven by

physician adoption, patient awareness and increased device efficacy.

Page 14: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Introduction

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 14 GDME001MFR / Published MAY 2013

This re port covers six su bcategories of ba riatric devices: r estrictive dev ices, art ificial f ullness

devices, mal absorption d evices, deep brain stim ulation device s, gast ric e mptying aspi ration

devices, and appetite suppression devices. The report also covers transoral surgical tools that aid

in endo scopic procedu res to redu ce ef fective stoma ch si ze i n order to redu ce calo ric inta ke. A

number of compani es currently developing me dical device pro ducts for ob esity indicati ons a re

profiled, such as Allergan, Apollo E ndosurgery, Aspire Bariatrics, Agency fo r Medical Innovation,

Bariatric Solu tions, Baronova, BaroSense, BFKW, Cousin Biotech, CR Bard, Endali s Laboratory,

EndoGastric Solution s, EndoSph ere, EnteroM edics, Ethico n Endo -Surgery, GI Dynamics,

Helioscopie, IntraPace, Medical In novation De velopment, MetaCu re, Obalo n Therapeuti cs,

ReShape Medical, Spatz Medical, and ValenTx.

2.2 Related Reports

Bariatric Su rgery Devices – Glo bal Pi peline An alysis, Competitive Land scape, and M arket

Forecasts to 2018 (July 2012, GDME0152MAR)

Reshaping the Obesity Treatment Paradigm (April 2012, GDME0087VPT)

2.3 Upcoming Related Reports

MediFocus: Obesity Pharmaceutical Products (June 2013)

Page 15: GDME001MFR-Medical Devices for the Treatment of Obesity ...Allergan Sees Decline in Sales as New Devices Enter the Market Whereas th e obe sity treatment d evice in dustry has previously

Appendix

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 132 GDME001MFR / Published MAY 2013

7.10 About GlobalData

GlobalData i s a lea ding global p rovider of b usiness intellige nce in the Healthcare i ndustry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in medi cal d evice research, di sease analysis, an d clini cal re search an d developm ent. Ou r

integrated business intelligence solutions include a range of interactive online databases, analytical

tools, reports and forecast s. Our analysis is supported by a 24/7 client support and a nalyst team.

GlobalData has offices in New York, Boston, London, India and Singapore.

7.12 Disclaimer

All Rights Reserved.

No part of this pu blication may be re produced, stored in a ret rieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior

permission of the publisher, GlobalData.