Physician%20Reference%20Slides%202007

1
Physician Reference Slides 2007
2
US Filler Market Evolution
Next GenerationLong-lasting 12-18 mos.
without being permanentMay last a year or more
in many patients
Hyaluronic Acid Revolutionized Fillers 6
mos. durability (Restylane, Juvederm,
Hylaform, etc. )
Collagen Established Fillers 2-3 mos.
durability (ZyplastTM, ZydermTM, etc.)
FDA Approved December 2006 Wrinkles and Folds HIV
Facial Lipoatrophy
Approximate Timeline
2004
2006
1980s
2007
3
US Regulatory Approvals

• Radiesse received approval from the FDA December
  26, 2006 for facial soft tissue augmentation
• Treatment of facial wrinkles and folds, such as
  nasolabial folds, marionette lines, etc.
• Correction of facial wasting as a result of
  HIV-associated Lipoatrophy
• Radiesse is the first dermal filler to receive
  FDA approval for two facial aesthetic applications

4
Radiesse is a safe, next generation cosmetic
dermal filler aiming to become the new standard
for long lasting correction of facial lines and
wrinkles. Clinical studies prove that in many
patients Radiesse lasts a year or longer and
delivers a natural look that results in very high
patient satisfaction.

• Synthetic Calcium Hydroxylapatite (CaHA)
  microspheres 30 suspended in a
  carboxy-methylcellulose resorbable aqueous gel
  carrier 70
• Stimulates the body to produce new collagen
• Pre-filled 1.3 cc 0.3 cc syringes
• No skin or allergy testing
• No special handling requirements

5
Radiesse Not Only Fills, but Volumizes

• When placed into soft tissue, Radiesse provides
  immediate correction
• Gel CaHA Particles
• Over time the gel is resorbed and the CaHA
  particles stimulate the body to produce collagen
• Collagen CaHA Particles

Decalcified 25µm to 45 µm particles
6
Radiesse Stimulates NewCollagen Production
16 Weeks
4 Weeks
32 Weeks
78 Weeks
Histology studies demonstrate increased collagen
deposition around CaHA micro-spheres over a time
course. Collagen fibers stain red using
picrosirius red (60x mag).
7
Radiesse Supports Natural Collagen Integration
6-Month Human Skin Histology Tissue infiltration
(Light Blue Stain)
J. Cosmetic Laser Therapy 2004 6 223-226 by
Ellen S Marmur MD, Robert Phelps MD and David J
Goldberg MD, Clinical, histologic and electron
microscopic findings after injection of a calcium
hydroxylapatite filler
8
Radiesse Particles Break Down Naturally
CaHA particles are slowly dissolved into calcium
and phosphate ions through normal metabolic
processes
CaHA particles post-implantation
9
Radiesse Provides Both Immediate Correction and
Long Lasting Results
Dermal Filler (Immediate Correction) Tissue Regeneration (Extended Correction)
Collagen ?
Hyaluronic Acid ?
Poly-L-lactic Acid ?
? ?
10
Radiesse is Safe- AE ProfileSimilar to Other
Fillers

• Hundreds of thousands of patients have been
  successfully injected with Radiesse worldwide
• In the pivotal Nasolabial Fold clinical trial
  compared to collagen, Radiesse had fewer nodules
  and a similar safety profile
• In another head-to-head clinical study comparing
  Radiesse to Restylane, the adverse event
  profiles were similar for both products

Multiple Documented Studies Demonstrate the
Efficacy and Safety of CaHA




Urological applications used Radiesses sister
product, Coaptite in clinical studies (75-125
microns)
11
Radiesse is Safe- No Reported Granulomas

• In two separate 100 patient FDA Clinical Trials,
  Radiesse had zero granulomas

12
Radiesse is Safe- It will notForm Bone in Soft
Tissue

• Bone cannot be formed because
• No osteo-progenitor cells or bone morphogenic
  proteins are present in the dermis
• The CaHA present in Radiesse is not bone- it is a
  mineral component found in bones and teeth
• Radiesse stimulates the patients own collagen to
  be produced, resulting in a soft and natural
  appearance and feel
• The CaHA microspheres are synthetically derived
  and break down naturally over time by the bodys
  own metabolic processes into Ca2 and PO32 ions.
• No ossification or calcification of CaHA has been
  reported in over 6 years of clinical use and
  gt400,000 syringes injected

13
Radiesse is Safe- It will notObscure X-rays

• The volume/density placed in facial injections
  will not interfere with x-rays
• If visible, it is only faint and whispy and will
  not interfere
• Barely visible on diagnostic x-ray
• Clearly evident bilaterally on CT scan, distinct
  from bone, and no masking of underlying structures

CT Scan Immediately-post injection
X-ray after 2.4 cc Radiesse injection in lower
face
14
FDA Nasolabial Fold Study
Prospective, randomized, controlled, split-face
trial compared Radiesse to CosmoPlast
Canfield Scientific Core Lab 3 Blinded
Evaluators
Continued safety follow-up optional touch-up
injection
(Optional)
(Optional)
6 Months
12 Months
Baseline
2 week
4 week
3 Months
Optimal Correction
Safety 72 hour follow-up calls 1-month
safety visit after each injection
3 Months
15
Live GAIS Rating at 6 MonthsAssessment by
Treating Investigator
94.6 Improved
2.7 Improved
16
Volume vs. Cost Comparison

Average volume needed to reach Optimal Correction (plt0.0001) List price Estimated cost of Tx
Radiesse 1.2 cc 295 295
CosmoPlast 2.4 cc 175 411
17
Representative Study Images

Baseline
Optimal
3 Month
6 Month
Total Volume 1.5 mL
Radiesse
Total Volume 3.6 mL
CosmoPlast
18
Adverse Event Analysis
19
NLF Study Conclusions

• Radiesse is safe
• The safety profile of Radiesse was comparable to
  the collagen control
• Radiesse is effective
• Met all primary and secondary effectiveness
  endpoints
• gt80 of Radiesse folds were improved at 3 and 6
  months
• Radiesse found superior to collagen at 3 6
  months
• Patients and Physicians preferred Radiesse (gt96)

20
Facial Lipoatrophy Trial

• Purpose
• Safety and effectiveness of Radiesse
• Sites
• Stacey Silvers MD, New York (60 patients)
• Joseph Eviatar MD, New York (34 patients)
• Michael Echavez MD, San Francisco (6 patients)
• Parallel Study with 30 patients in Canada by Dr.
  Alastair Carruthers

Initial Treatment Phase
Follow-up Phase
4.7 cc
1.8 cc
2.4 cc
Baseline
3 Months
6 Months
12 Months
18 Months
30 Months
0 Months
Average Initial Volume 6.5cc
21
GAIS Results up to 18 Months
91 of Patients maintain Improvement
100 of Patients Improved through 12 Months
Very Much Improved
26
7
31
10
Much Improved
72
86
53
44
38
Improved
2
7
16
9
No Change
--
--
--
Worse
--
--
3 Months n100
6 Months n98 (before touch up)
12 Months n98 (6mo after touch up)
18 Months n94 (12mo after touch up)
22
Facial Lipoatrophy TrialSafety Summary

• No nodules or granulomas at large injection
  volumes
• No product related serious adverse events in the
  study
• Post-treatment expectations
• Pain on injection, resolves quickly
• Transient conditions resolving in a few days
• Redness
• Swelling
• Itching
• Bruising

23
Representative Patient Photos
40 yo Male Total Volume 8.0 mL
Baseline
Month 6
Month 12
Month 18
24
Patient Satisfaction Through18 Months
Yes at 3 months Yes at 6 months Yes at 12 months Yes at 18 months
Would you recommend Radiesse treatment? 99 99 99 99
Has the Radiesse treatment been beneficial to you? 100 100 100 99
Do you feel more attractive since receiving the Radiesse treatment? 98 98 98 98
Is your emotional wellbeing better since receiving Radiesse treatment? 91 96 97 95
Do you have more confidence in your appearance since receiving the Radiesse treatment? 98 98 99 99
25
Radiesse HIV StudyConclusions

• Radiesse is safe
• No reports of serious adverse events
• Minor AEs resolved within 7 days
• Radiesse is effective
• 100 of patients were improved through 12 months
• gt 90 of patients were improved through 18 months
• All primary and secondary endpoints were met
• gt 90 patient satisfaction through 18 months

26
Facial Beauty
27
Facial Aging
28
Placement of Radiesse into the Skin

• Objective is to fill the depression and
  structurally support the line and provide volume
• Inject Radiesse into the deep dermis and
  subdermal plane
• Use non-dominant index finger to guide needle
• Deeper threads can be placed to bolster
  depression
• Use thumb and forefinger to massage and mold
  Radiesse

29
Pearls of Wisdom for Injecting Radiesse

• Mark areas to be treated (if necessary) with
  patient in upright position
• Make the patient comfortable by providing some
  level of anesthesia
• 27-gauge needle
• 1.25, 1.5 or 0.5 needle can be used (area
  dependent)
• Inject small amounts (0.05 cc) in multiple passes
• Limit puncture sites and stop injecting prior to
  withdraw of the needle
• Massage and mold area for desired look
• Progressively bring the patient to full
  correction -no overcorrection necessary

30
Nasolabial Folds with RadiesseLinear Threading
and Fanning
Using 1.25 or 1.5 Needle
Using 0.5 Needle
31
Nasolabial Folds with RadiesseLinear Threading
and Fanning
32
Nasolabial Folds with RadiesseLinear Threading
and Fanning
33
Nasolabial Folds with Radiesse
Before
Immediately After (1.3 cc total)
Susan Weinkle, MD Tampa, FL
34
Nasolabial Folds with Radiesse
6 Months (No Touch-up)
Before
Immediately After (1.3 cc total)
Henri Gaboriau, MD Seattle, WA
35
Nasolabial Folds with Radiesse
Before
12 months 1.3 cc
Steven Bloch, MD Highland Park, IL
36
Nasolabial Folds with Radiesse
Pre Injection 1.4 cc
22 Months 0.6 cc touch up
24 Months
36 Months
Miles Graivier, MD Roswell, GA.
37
Marionette Lines with RadiesseLinear Threading
and Fanning

• Use 0.5 or 1.25 27g needle
• Lidocaine infiltration may be suitable
• Use fanning technique with retrograde threading
  to lift and fill marionette line
• Be conservative with volume and do not place
  material too deep
• Treat the entire zone- may include lateral chin
  area, not just the line
• Progressively bring to full correction
• Massage with thumb and forefinger as needed

38
Marionette Lines with RadiesseLinear Threading
and Fanning
39
Marionette Lines with RadiesseLinear Threading
and Fanning
40
Marionette Lines with Radiesse
Before
After 6 months 0.4 cc per side
Samuel Lam, MD Dallas, TX
41
Marionette Lines andMental Crease with Radiesse
Before
After 3 Months (1.3 cc total)
R. Allan Bexton, MD Bakersfield, CA
42
Marionette Lines with Radiesse
Before
After 10 months 1.6 cc total
Peter Karlsberg, MD Ventura, CA
43
Pre-jowl Sulcus TechniqueLinear Threading
44
Pre-jowl Sulcus TechniqueLinear Threading
45
Pre-Jowl Sulcus
Before
After
Robert Glasgold, MD Highland Park, NJ
46
Nasolabial Folds, Marionette Linesand Pre-Jowl
Sulcus
After 3 Months (3.9 cc total)
Before
Steven Dayan, MD Chicago, IL
47
HIV Facial Lipoatrophy

• Progressive loss of fat within the face as a
  result of HAART therapy (Graded on a severity
  scale of 1-4 with 4 most severe)
• Central facial hollows lateral to nasolabial
  folds
• May involve volume loss in submalar, malar,
  infraorbital and temporal areas
• Very psychologically and emotionally distressing
• Immediately obvious in public as HIV sufferer
• All social interactions are threatened
• Radiesse can be used to re-volumize areas of
  deficiency to restore normal contours

48
HIV Facial LipoatrophySubmalar volume correction

• Use 1.25 27g or 25g needle
• Provide adequate anesthesia- infraorbital,
  mini-block and field infiltration as needed
• Insert needle into dermal/subcutaneous junction
  or subcutaneous space
• Inject multiple threads of material using fanning
  technique to augment area
• Layer additional threads of Radiesse into a
  deeper plane. Massage and mold with thumb and
  forefinger as needed.
• Expect major improvement with 1-2 cc per side of
  face
• Patients may require touch-ups and augmentation
  of additional areas as lipoatrophy progresses

49
HIV Facial LipoatrophySubmalar volume correction
50
HIV Facial LipoatrophyMalar and infraorbital
volume correction

• In some cases, the malar area must also be
  augmented in lipoatrophy patients to restore
  normal volume
• The entire zone must be addressed to provide
  volume and create a natural appearance
• You are adding material to an area that has lost
  volume
• Areas- Inferior lateral orbital rim
• Malar eminence
• Infraorbital hollow
• Try to achieve a blending between the lower
  eyelid, nasolabial fold, and the cheek

For demonstration purposes, patient is not HIV
51
HIV Facial LipoatrophyMalar and infraorbital
volume correction
52
HIV Facial LipoatrophyMalar, submalar and
infraorbital volume correction
53
HIV Facial Lipoatrophy
Courtesy of, Todd Owsley, MD Greensboro, NC
After
Before
Todd Owsley, MD Greensboro, NC
54
HIV Facial Lipoatrophy
40 y/o Male Total Volume 8.0 mL
Baseline
Month 6
Month 12
Month 18
55
HIV Facial Lipoatrophy

• Immediate outcome improvement immediate
• Provides augmentation lasting a year or more in
  most patients
• Swelling is to be expected, but resolves within
  hours
• Adverse event profile is minor and similar to
  other injectables
• The firmness of the injected material will soften
  by 2 wks and it will become like the resident
  soft tissue
• The patients are ecstatic with the immediate
  result and this contributes to a positive quality
  of life

56
Summary

• Radiesse is clinically proven to be safe.
• It has been used on hundreds of thousands of
  patients worldwide
• Zero granulomas in two separate 100 patient FDA
  trials
• Radiesse provides long lasting correction- about
  a year or more in most patients
• Radiesse both fills and stimulates the body to
  produce new collagen with Calcium-based
  microspheres
• Radiesse will grow your aesthetics practice with
  a wider range of applications
• Radiesse is a better patient value
• Greater patient satisfaction means more patients
  for you