Treatment of HIV-Associated
     Facial Lipoatrophy

US FDA Pivotal Trial Results


                               1
FDA HIV Facial
                                           Lipoatrophy
                                                Stud...
Efficacy Criteria
• Primary Endpoint:
  – Global Aesthetic Improvement Scale (GAIS)
    assessment at 3 months
• Secondary...
Patient Demographics
   HIV-Associated Facial Lipoatrophy                                        Fitzpatrick Skin Type Sco...
GAIS Results
                                  Through 18 Months                                   91% of Patients
       ...
Representative Study Images



                                                 40 yo
                                    ...
Representative Study Images



                                                41 yo
                                     ...
Representative Study Images



                                            50 year old
                                   ...
Cheek Thickness Increase
                        Mean Cheek Thickness Measurement
                                        ...
Patient Satisfaction
                                 Through 18 Months
                              “Yes” at 3   “Yes” a...
Safety – Adverse Events

• Typical Adverse Events Reported:
      •   Edema
      •   Ecchymosis
      •   Erythema
      ...
% of Patients with Event




                    0%
                         10%
                               20%
      ...
HIV Lipoatrophy Study
                          Conclusions
• Radiesse is safe
  – No reports of serious adverse events
  ...
Radiographic Evaluation of
        Radiesse
Study Overview

• Objective: To assess the radiographic
  appearance of Radiesse when injected into the
  soft tissues of ...
Short-Term Facial Lipoatrophy
Pre-Injection     Immediately Post-Injection
                    Total Volume: 15.6 ml
Long-Term Facial Lipoatrophy
                                      Post-12 Month
        Pre-12 Month
                    ...
Short-Term Nasolabial Folds
Pre-Injection            Post-Injection
                      Total Volume: 2.6 ml
No Obstruction of Underlying
              Structures
Common dental work results in interference
Radiographic Findings
                        Summary
• Radiesse is not consistently evident on X-ray
• Radiesse is clearl...
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FDA HIV Lipoatrophy Trials with Radiesse in the United States

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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

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FDA HIV Lipoatrophy Trials with Radiesse in the United States

  1. 1. Treatment of HIV-Associated Facial Lipoatrophy US FDA Pivotal Trial Results 1
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 12. % of Patients with Event 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Ed em a Ec hy m os is O th er s Er yt he m a Pa in Pr ur it is H em at om a ADVERSE EVENTS G ra nu lo m a N od ul e In fe ct io n N ec ro si s N ee dl e Safety – Adverse Events Ja m
  13. 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. 14. Radiographic Evaluation of Radiesse
  15. 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. 16. Short-Term Facial Lipoatrophy Pre-Injection Immediately Post-Injection Total Volume: 15.6 ml
  17. 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. 18. Short-Term Nasolabial Folds Pre-Injection Post-Injection Total Volume: 2.6 ml
  19. 19. No Obstruction of Underlying Structures Common dental work results in interference
  20. 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

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