Clinical Research Data

vs. vs.

Medical Disclosure

• Dr. Patrick J. Treacy is a Cosmetic Dermatologist presently on the Specialist Register in Ireland

• I have purchased my own Radiesse product in Ailesbury Clinic.• I have no financial interest or stock in BioForm nor do I receive

any additional remuneration or other compensation for product bought by you as a result of your attendance at this IMAS lecture.

Multi-Centre Research Data

vs. vs.

•Multi Centre •Randomised•Blinded •Comparative Study

Results published in the Dec 2007 Journal of Dermatological Surgery

Comparative StudyRadiesse vs Perlane vs Juvederm 24/24HV

(N=205)

• Comparison of efficacy, durability, and patient satisfaction variables

• Treatment of Nasolabial Folds– Month 0 and 4.

• Results at 4, 8, and 12 month post 2nd injection

Head to Head Studies

1. Radiesse vs. Restylane Trial Design (2 sites)– Split face study, n=60– GAIS, WSRS, and Injection Volume– Live Blinded Evaluator and patient satisfaction questionnaires

2. Radiesse vs. Juvederm & Perlane Trial Design (5 sites)– Patients randomized to one of three treatments (both NL-folds), n=205– GAIS, WSRS, and Injection Volume– Live Blinded Evaluator and patient satisfaction questionnaires

6 Months 9 Months3 Months0 Months

12 Months8 Months4 Months0 Months

Results after 1st treatment

Less volume

vsRestylane

vs Restylane

% of Patients Improved or better (n=60 Split Face)% of Patients Improved or better (n=60 Split Face)% of Patients Improved or better (n=60 Split Face)% of Patients Improved or better (n=60 Split Face)

3 Months 6 Months 9 Months0%

20%

40%

60%

80%

100%

RadiesseRestylane

79%

44%

More Patients improved with Radiesse than with Restylane

Time post 2nd Injection

Comparative Study: Radiesse vs RestylaneGAIS

WSRS = Wrinkle Severity Rating Scale

5 Extreme Extremely deep and long folds, detrimental to facial appearance.

2-4mm Visible V-shaped fold when stretched

Unlikely to have satisfactory correction with injectable implant alone.

4 Severe Very long and deep folds; prominent facial feature.

Less than 2mm visible fold when stretched.

Significant improvement is expected from injectable implant.

3 Moderate Moderately deep folds.

Clear facial feature visible at normal appearance but not when stretched.

Excellent correction is expected from injectable implant.

2 Mild Shallow but visible fold with a slight indentation; minor facial feature.

Implant is expected to produce a slight improvement in appearance.

1 Absent No visible fold, continuous skin line.

1 5

4

3

2

GAIS = Global Aesthetic Improvement Scale

Very Much Improved Optimal cosmetic result for the implant in this patient.

Much Improved Marked improvement in appearance but not completely optimal for this patient. A touch-up would slightly improve the result.

Improved Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.

No Change The appearance is essentially the same as the original condition.

Worse The appearance is worse than the original condition.

Comparative StudyRadiesse vs Perlane vs Juvederm 24/24HV

(N=205)

• Comparison of efficacy, durability, and patient satisfaction variables

• Treatment of Nasolabial Folds– Month 0 and 4.

• Results at 4, 8, and 12 month post 2nd injection

% of Patients Improved or better (n=205)% of Patients Improved or better (n=205)% of Patients Improved or better (n=205)% of Patients Improved or better (n=205)

4 Months 8 Months 12 Months

0%

20%

40%

60%

80%

100%RadiessePerlaneJuvederm HV

More Patients improved with Radiesse than with Perlane & Juvederm

Time post 2nd Injection

62%

50%48%

88%

53%

64%

Comparative StudyRadiesse vs Perlane vs Juvederm 24/24HV

GAIS

One fold (split face)(touch up at 3 Months)

Both folds(touch up at 4 Months)

Radiesse 0.89

Restylane 1.26

Radiesse 2.21

Perlane

2.89

Juvederm HV

2.940 1 2 3Volume Required to Achieve Optimal Correction (cc)

cc - including touch up

Syringes needed for 2 Folds

Full Correction

1.4

2.5

1.7

2.9

3.7

% of OptimalCorrection w/One Syringe

70%

40%

60%

34%

27%

Volume Comparison

% of Patients That are Satisfied & Extremely Satisfied*% of Patients That are Satisfied & Extremely Satisfied*% of Patients That are Satisfied & Extremely Satisfied*% of Patients That are Satisfied & Extremely Satisfied*

89%

61% 58%

96%

6 Months 9 Months

More patients were Satisfied with Radiesse than with Restylane, even at 6 Months

Time post 2nd Injection

Radiesse

Restylane

Comparative Study: Radiesse vs RestylanePatient Satisfaction

% of Patients That are Satisfied & Extremely Satisfied% of Patients That are Satisfied & Extremely Satisfied% of Patients That are Satisfied & Extremely Satisfied% of Patients That are Satisfied & Extremely Satisfied

97%90%

95%

48%

58%

73%

4 Months 8 Months 12 Months

RadiessePerlaneJuvederm Juvederm HV

More patients were Satisfied with Radiesse than with Perlane or Juvederm

Time post 2nd Injection

Comparative StudyRadiesse vs Perlane vs Juvederm 24/24HV

Patient Satisfaction

% of Patients who say that they are Likely or % of Patients who say that they are Likely or Extremely Likely to return for future treatments Extremely Likely to return for future treatments

% of Patients who say that they are Likely or % of Patients who say that they are Likely or Extremely Likely to return for future treatments Extremely Likely to return for future treatments

Patients are 3 times more likely to return for re-treatments with Radiesse

24% 25%

75% 75%

6 Months 9 MonthsTime post 2nd Injection

RadiesseRestylane

Comparative Study: Radiesse vs RestylanePatients likely to return

98%

35%

43%38%

93%92%

4 Months 8 Months 12 Months

RadiessePerlaneJuvederm Juvederm HV

Patients are much more likely to come in for re-treatments with Radiesse

Time post 2nd Injection

% of Patients who say that they are Likely or % of Patients who say that they are Likely or Extremely Likely to return for future treatments Extremely Likely to return for future treatments

% of Patients who say that they are Likely or % of Patients who say that they are Likely or Extremely Likely to return for future treatments Extremely Likely to return for future treatments

Comparative StudyRadiesse vs Perlane vs Juvederm 24/24HV

Patients likely to return

• Radiesse treated patients are more satisfied compared to hyaluronic acid treated patients

• Radiesse delivers better correction at 3 months & beyond

• Radiesse delivers longer-lasting correction

• Radiesse requires less volume to achieve the same immediate correction

• Radiesse patients are more likely to return for future treatments

Comparative Studies with RadiesseSUMMAY FINDINGS

Acknowledgements and Participating Centers

Marion Moers-Carpi, Munich, Germany

Stephan Vogt, Hanover, Germany

Jaime Opi Tufet, Barcelona, Spain

Begonia Martinez Santos, Barcelona, Spain

Jorge Planas, Barcelona, Spain

Sonia Rovira Vallve, Barcelona, Spain

Calcium Hydroxylapatite

Gel carrier (~70%)

Sodium-CarboxyMethylCelluloseGlycerineH2O

Structural component (~30%)Ca2+ PO4

3- ions (Ca10(PO4)6(OH)2)

Natural mineral (identical to teeth & bone)

Calcium Hydroxylapatite

Macrophages dissolve gel carrier & fibroblasts form new collagen.

Natural mineral non-antigenic, non-irritant, non-toxic metabolizes via homeostatic mechanisms

Facial Augmentation

Nasolabial Fold

Mental creaseJaw Line

Chin

Post-rhinoplasty

Marionette Line

Cheek

Malar

Radial Lip Lines