HIV Lipoatrophy FDA Study with conclusions • Radiesse is safe – No reports of serious adverse events • Radiesse is effective – 100% of patients were improved through 12 months – > 90% of patients were improved through 18 months demonstrating 1 year longevity – All primary and secondary endpoints were met – > 90% patient satisfaction through 18 months

1. Treatment of HIV-Associated
Facial Lipoatrophy
US FDA Pivotal Trial Results
1

2. FDA HIV Facial
Lipoatrophy
Study Design
Initial Treatment Follow-up Phase
Phase
4.7 cc 1.8 cc 2.4 cc
Baseline 0 Months 3 Months 6 Months 12 Months 18 Months 30 Months
12 months after touchup
Follow-on Study
Average Initial
Volume
6.5cc
• Multi-center, prospective, open-label trial of 100 subjects at 3 sites:
– Stacey Silvers, MD New York, NY
– Joseph Eviatar, MD New York, NY
– Michael Echavez, MD San Francisco, CA
• Grade 3 or 4 facial lipoatrophy

3. Efficacy Criteria
• Primary Endpoint:
– Global Aesthetic Improvement Scale (GAIS)
assessment at 3 months
• Secondary Endpoints:
– GAIS assessment at 6 months
– Cheek skin thickness at 3 and 6 months

4. Patient Demographics
HIV-Associated Facial Lipoatrophy Fitzpatrick Skin Type Scores n=100
HIV-Associated Facial Lipoatrophy Fitzpatrick Skin Type Scores n=100
Severity Ratings n=100
Severity Ratings n=100 I
I
VI II
, I.,I., 0%
0% 3%
VI II
IV.,
3%
IV., , 17% 13%
13% 17% 13%
13%
,
Type IV.
,
13%
V
II., V
II.,
Type II. 13%
48%
13%
48%
48%
Type III.
39%
III
III.,
III
III.,
39% 33%
39% 33%
IV
IV
,
21%
,
21%
Balanced distribution of Balanced distribution
lipoatrophy severity of all skin types

5. GAIS Results
Through 18 Months 91% of Patients
maintain
100% of Patients Improved through 12 Months Improvement
Very Much
26% 7% 31% 10%
Improved
Much
72% 86% 53% 44%
Improved
38%
Improved 2% 7% 16%
9%
No Change
-- --
Worse
-- --
--
3 Months 6 Months 12 Months 18 Months
n=100 n=98 n=98 n=94
(before touch up) (6mo after touch up) (12mo after touch up)

6. Representative Study Images
40 yo
Male
Baseline Month 6
Total Volume
8.0 ml
Month 12 Month 18
(12 months after touch-up)

7. Representative Study Images
41 yo
Male
Baseline Month 6
Total Volume
15.9 mL
Month 12 Month 18 (12 months after touch-up)

8. Representative Study Images
50 year old
male
Baseline Month 6
Total volume
17.2 ml
Month 12 Month 18 (12 months after refinement)

9. Cheek Thickness Increase
Mean Cheek Thickness Measurement
10.0
Right Side Left Side
10.0
9.0
9.0
8.0
8.0
7.0
7.0
6.0
6.0
5.0
5.0
4.0
4.0
3.0
3.0
2.0 2.0
1.0 1.0
0.0 0.0
Baseline 3 Months 6 Months 12 18 Baseline 3 Months 6 Months 12 Months 18 Months
Months Months
p < 0.001 p < 0.001

10. Patient Satisfaction
Through 18 Months
“Yes” at 3 “Yes” at 6 “Yes” at 12 “Yes” at
months months months 18 months
Would you recommend
99% 99% 99% 99%
Radiesse treatment?
Has the Radiesse treatment
100% 100% 100% 99%
been beneficial to you?
Do you feel more attractive
98% 98% 98% 98%
since receiving the
Radiesse treatment?
Is your emotional wellbeing
91% 96% 97% 95%
better since receiving
Radiesse treatment?
Do you have more
confidence in your
98% 98% 99% 99%
appearance since receiving
the Radiesse treatment?

11. Safety – Adverse Events
• Typical Adverse Events Reported:
• Edema
• Ecchymosis
• Erythema
• Pruritis
• Pain
• No product related serious adverse events
• No Granulomas
• Most AE’s resolved within 1-2 weeks

12. % of Patients with Event
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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H
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ADVERSE EVENTS
G
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a
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In
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ct
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N
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N
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Safety – Adverse Events
Ja
m

13. HIV Lipoatrophy Study
Conclusions
• Radiesse is safe
– No reports of serious adverse events
– Minor AE’s resolved within 7 days
• Radiesse is effective
– 100% of patients were improved through 12 months
– > 90% of patients were improved through 18 months
demonstrating 1 year longevity
– All primary and secondary endpoints were met
– > 90% patient satisfaction through 18 months

14. Radiographic Evaluation of
Radiesse

15. Study Overview
• Objective: To assess the radiographic
appearance of Radiesse when injected into the
soft tissues of the face
• 58 patients treated in Vancouver, Canada by Dr.
Alastair Carruthers
– 28 patients: Long-term facial lipoatrophy (>12 Months)
– 15 patients: Short-term facial lipoatrophy (<1 Month)
– 15 patients: Short-term nasolabial fold (<1 Month)
• Images sent to blinded independent evaluators
in New York, directed by Dr. Marc Liebeskind

16. Short-Term Facial Lipoatrophy
Pre-Injection Immediately Post-Injection
Total Volume: 15.6 ml

17. Long-Term Facial Lipoatrophy
Post-12 Month
Pre-12 Month
Injection
Injection
Initial Volume Injected: 25.0 ml Volume Added: 9.1 ml

18. Short-Term Nasolabial Folds
Pre-Injection Post-Injection
Total Volume: 2.6 ml

19. No Obstruction of Underlying
Structures
Common dental work results in interference

20. Radiographic Findings
Summary
• Radiesse is not consistently evident on X-ray
• Radiesse is clearly visible on CT Scan
– Distinctly separate from bone
– For facial soft tissue applications, Radiesse is visible
bi-laterally (not typical of an adverse clinical finding)
– Radiesse volume dissipates over time
• No evidence that Radiesse migrates
• Radiesse as a radiographic material does not
pose a safety concern