1

Treatment of HIV-Associated

Facial Lipoatrophy

US FDA Pivotal Trial Results

FDA HIV Facial

LipoatrophyStudy Design

• 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 Months 6 Months 12 Months 18 Months

12 months after touchup30 Months0 Months

Initial TreatmentPhase

Follow-up Phase

Baseline

Follow-on Study

4.7 cc 1.8 cc 2.4 cc

Average Initial Volume6.5cc

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

Patient Demographics

Balanced distribution

of all skin types

Balanced distribution of

lipoatrophy severity

Fitzpatrick Skin Type Scores n=100

I

3% II

13%

III

33%

IV

21%

V

13%

VI

17%

Fitzpatrick Skin Type Scores n=100

I

3% II

13%

III

33%

IV

21%

V

13%

VI

17%

HIV-Associated Facial Lipoatrophy

Severity Ratings n=100

,

,

, I., 0%

II.,

48%

IV.,

13%

III.,

39%

HIV-Associated Facial Lipoatrophy

Severity Ratings n=100

,

,

, I., 0%

II.,

48%

IV.,

13%

III.,

39%

Type IV.13%

Type III.39%

Type II.48%

GAIS ResultsThrough 18 Months

3 Monthsn=100

6 Monthsn=98

(before touch up)

12 Monthsn=98

(6mo after touch up)

Improved

Much

Improved

Very Much

Improved

No Change

Worse

2%

72%

26%

--

--

7%

86%

7%

16%

53%

31%

--

--

18 Monthsn=94

(12mo after touch up)

38%

44%

10%

9%

--

100% of Patients Improved through 12 Months

91% of Patients

maintain

Improvement

Baseline Month 6

Month 12 Month 18

40 yo

Male

Total Volume

8.0 ml

Representative Study Images

(12 months after touch-up)

Baseline Month 6

Month 12 Month 18

41 yo

Male

Total Volume

15.9 mL

Representative Study Images

(12 months after touch-up)

Baseline Month 6

Month 18Month 12

50 year old

male

Total volume

17.2 ml

Representative Study Images

(12 months after refinement)

Mean Cheek Thickness Measurement

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

Baseline 3 Months 6 Months 12 Months 18 Months

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

Baseline 3 Months 6 Months 12Months

18Months

p < 0.001 p < 0.001

Left SideRight Side

Cheek Thickness Increase

99%

97%

98%

100%

99%

“Yes” at 12 months

98%

96%

98%

100%

99%

“Yes” at 6 months

99%98%

Do you have more confidence in your

appearance since receiving the Radiesse treatment?

95%91%Is your emotional wellbeing

better since receiving Radiesse treatment?

98%98%Do you feel more attractive

since receiving the Radiesse treatment?

99%100%Has the Radiesse treatment

been beneficial to you?

99%99%Would you recommend Radiesse treatment?

“Yes” at 18 months

“Yes” at 3 months

Patient SatisfactionThrough 18 Months

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

ADVERSE EVENTS

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Edem

aEch

ymos

is

Oth

ers

Eryth

ema

Pain

Prurit

isH

emat

oma

Gra

nulo

ma

Nod

ule

Infe

ctio

n

Nec

rosi

sN

eedl

e Ja

m%

of

Pati

en

ts w

ith

Even

tSafety – Adverse Events

HIV Lipoatrophy StudyConclusions

• 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

Radiographic Evaluation of

Radiesse

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

Short-Term Facial Lipoatrophy

Pre-Injection Immediately Post-Injection

Total Volume: 15.6 ml

Long-Term Facial LipoatrophyPost-12 Month

Injection

Volume Added: 9.1 ml

Pre-12 Month Injection

Initial Volume Injected: 25.0 ml

Short-Term Nasolabial FoldsPre-Injection Post-Injection

Total Volume: 2.6 ml

No Obstruction of Underlying

StructuresCommon dental work results in interference

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