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Radiesse.pdf
1.
2. US Filler Market Evolution
2004 2006
FDA Approved December 2006
Lines and Wrinkles
HIV Facial Lipoatrophy
1980’s
Collagen
Established Fillers
2-3 mos. durability
(ZyplastTM
, ZydermTM
, etc.)
Approximate
Timeline
Hyaluronic Acid
Revolutionized Fillers
6 mos. durability
(Restylane®, Hylaform®, etc.)
Next Generation
Longer-lasting: 12-18 mos.
Without being permanent
First One-year filler
2007
3. United States Europe Canada
Latin America
& Other
Facial Soft Tissue
Approved
December 2006
Vocal Fold
Oral / Maxillofacial
Craniofacial Augmentation
US Regulatory Approvals
4. • 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
US Regulatory Approvals
5. Radiesse is a safe, next generation cosmetic dermal filler that’s setting a new
standard for the correction of facial lines and wrinkles such as nasolabial folds.
Clinical studies prove that Radiesse lasts longer than the leading filler to deliver a
natural look that lasts.
Synthetic Calcium Hydroxylapatite (CaHA)
microspheres [30%] suspended in a carboxy-
methylcellulose resorbable aqueous gel carrier
[70%]
Promotes natural collagen in-growth because
spheres act as “scaffold”
Pre-filled 1.3 cc & 0.3 cc syringes
No skin or allergy testing
No special handling requirements
6. Decalcified 25µm to 45 µm particles
• When placed into soft tissue,
Radiesse provides immediate
correction
– Gel + CaHA Particles
• Over time the gel is resorbed
and the CaHA particles support
in-growth of new collagen
– Collagen + CaHA Particles
Radiesse Supports Natural
Collagen Integration
7. New Collagen Infiltration Around Radiesse Particles
(16-week histology, Canine Dermis)
Gel + CaHA Particles
Collagen + CaHA
Particles
Radiesse Supports Natural
Collagen Integration
8. 6-Month Human 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”
Radiesse Supports Natural
Collagen Integration
9. CaHA particles are slowly dissolved into
calcium and phosphate ions through
normal metabolic processes
CaHA particles post-implantation
Radiesse Particles Break
Down Naturally
11. • Radiesse cannot form bone in soft tissue
– Radiesse microspheres support in-growth of resident soft tissue (skin, vocal fold and bladder neck)
– There are no bone morphogenic proteins or osteoblast progenitor cells in soft tissues
– No reports of calcification or ossification in facial soft tissues
• Radiesse particles do not migrate
– Exhaustive pre-clinical studies have demonstrated no migration
– Particles are 25-45µm & thus too large (>15 microns) to be encapsulated by macrophage and migrate via
lymphatic system
– Collagen infiltration around particles hold them into place
• Radiesse will not obscure x-rays
– If visible, it is only faint & whispy and won’t interfere
– Barely visible on diagnostic x-ray, clearly evident bilaterally on CT scan with no masking of other structures,
distinct from teeth and bone
• Lip nodules are not granulomas
– No granulomas reported in multicenter clinical trials (>1,000 patients)
– CaHA molecular and chemical composition is identical to that in the human body and does not generate a
foreign body Rx
– Not seen as a foreign body so no delayed inflammatory response
– Not for use in lips due to muscle motion & cohesive properties of the gel carrier
– Nodules are not granulomas – nodules are early onset, accumulations of product, which are distinct from late
onset granulomatous foreign body reactions
Some Misperceptions…
12. BioForm’s Commitment to
Clinical Data
Indication Location # of Sites Number of Patients
Nasolabial Fold US 4 117
Facial Lipoatrophy US 3 100
Facial Lipoatrophy Canada 1 30
Radiesse vs. Restylane Europe 2 60
Radiesse vs. Juvederm/Perlane Europe 5 205
Stress Urinary Incontinence US 14 296
Vesicoureteral Reflux US 10 98
Vocal Fold Insufficiency Worldwide 12 103
1,009 patients
13. 6 Months 12 Months
Baseline*
Continued safety follow-up & optional
touch-up injection
(Optional)
2 week*
(Optional)
4 week*
* Safety: 72 hour follow-up calls
& 1-month safety visit after each
injection
Canfield Scientific Core
Lab
3 Blinded Evaluators
Investigational
Site
Prospective, randomized, controlled, split-face trial compared Radiesse to CosmoPlast®
Optimal Correction
3 Months
3 Months
FDA Nasolabial Fold Study
14. Live GAIS Rating at 6 Months
Assessment by Treating Investigator
Radiesse
0% 20% 40% 60% 80% 100%
Worse
No Change
Improved
Much
Improved
Very Much
Improved
CosmoPlast
0% 20% 40% 60% 80% 100%
Worse
No Change
Improved
Much
Improved
Very Much
Improved
94.6%
Improved
2.7%
Improved
15. Volume vs. Cost Comparison
Average volume needed to
reach Optimal Correction
(p<0.0001)
List price Estimated cost of Tx
Radiesse 1.2 cc $ 295 $ 295
CosmoPlast 2.4 cc $ 175 $ 411
16. Baseline Optimal 3 Month 6 Month
Radiesse
Total
Volume
1.5 mL
CosmoPlast
Total
Volume
3.6 mL
Representative Study Images
18. • Radiesse is safe
– The safety profile of Radiesse was comparable to the
collagen control
• Radiesse is effective
– Met all primary and secondary effectiveness endpoints
– >80% of Radiesse folds were improved at 3 and 6
months
– Radiesse found superior to collagen at 3 & 6 months
– Patients and Physicians preferred Radiesse (>96%)
NLF Study Conclusions
19. Radiesse vs. Restylane
Split-face head-to-head study
• 60 patients
• Evaluations by Global Aesthetic Improvement Scale (GAIS) and Wrinkle
Severity Rating Scale (WSRS)
• Live blinded evaluator
• Inclusion criteria: 3 or 4 on the WSRS
– Dr. Moers-Carpi Germany
– Dr. Tufet Spain
6 Months 9 Months
3 Months
Feb-06 May-06 Aug-06
0 Months
20. % Patients
Improved at 9 months:
Radiesse = 79%
Restylane = 44%
Radiesse Delivers Longer
Lasting Improvement
More Patients are Improved at Every Time Point
Radiesse vs. Restylane
Improvement over Time (GAIS)
0
10
20
30
40
50
60
70
80
90
100
3 mo's 6 mo's 9 mo's
Time post 2nd injection
%
of
Patients
with
Improvement
Radiesse
Restylane
21. Radiesse Delivers Greater
Improvement than Restylane
Radiesse vs. Restylane
How much improvement on average over time?
0
0.2
0.4
0.6
0.8
1
1.2
3 mo's 6 mo's 9 mo's
Time post 2nd injection
Mean
Improvement
from
Baseline
(WSRS)
Radiesse Improvement
Restylane Improvement
RADIESSE
RESTYLANE
22. Radiesse Provides Superior
Improvement at 6 and 9 Months
Radiesse vs. Restylane (GAIS)
What % of Patients had Superior improvement?
56.9
48.3
6.9
3.4
0
10
20
30
40
50
60
6 mo's 9 mo's
Time post 2nd injection
%
of
Patients
Radiesse Superior Restylane Superior Same
Radiesse
Same
Restylane
23. Patients Prefer Radiesse 2:1
Which fold looks better (patient preference)?
0
10
20
30
40
50
60
70
3 mo's 6 mo's 9 mo's
Time post 2nd Injection
%
of
Patients
Radiesse
Restylane
Radiesse
Restylane
24. Radiesse vs. Restylane
Baseline Month 3
Month 9
Month 6
Restylane- Left
Fold
Total Volume:
1.4 mL
Radiesse-
Right Fold
Total Volume:
0.8 mL
25. Volume vs. Cost Comparison
Radiesse is more cost effective to the doctor per NLF treatment
– It’s cheaper cc for cc
– It requires less product overall
Even better if you buy 30 or more at $235@
Restylane
List
Radiesse
List
Radiesse at
30+
Price to Doctor per syringe: $240 $295 $235
cc per syringe: 1.0 1.3 1.3
Price/cc $240 $227 $181
Avg. cc/single NLF in study: 1.23 0.89 0.89
Folds per treatment: 2 2 2
cc/treatment: 2.46 1.78 1.78
Avg. Price/NLF treatment: $590 $404 $322
26. Radiesse vs. Restylane
Summary
Radiesse provides:
Not just longer lasting results, but better results
throughout the course of treatment
– Longer lasting improvement overall
– Superior improvement at 6 and 9 months
– Greater average improvement at every time point
Happier and more satisfied patients:
27. Facial Lipoatrophy Clinical 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
3 Months 6 Months 12 Months 18 Months 30 Months
0 Months
Initial Treatment
Phase
Follow-up Phase
Baseline
4.7 cc 1.8 cc
Average Initial
Volume
6.5cc
2.4 cc
28. GAIS Results Through 18 Months
3 Months
n=100
6 Months
n=98
(before touch up)
12 Months
n=98
(6mo after touch up)
Improved
Much Improved
Very Much
Improved
No Change
Worse
2%
72%
26%
--
--
7%
86%
7%
16%
53%
31%
--
--
18 Months
n=94
(12mo after touch up)
38%
44%
10%
9%
--
100% of Patients Improved through 12 Months
91% of Patients
maintain
Improvement
29. • 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
Facial Lipoatrophy Clinical Trial
Safety Summary
30. Baseline Month 6
Month 12 Month 18
40 yo
Male
Total Volume
8.0 mL
Representative Patient Photos
31. “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%
Patient Satisfaction Through
18 Months
32. Radiesse 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
– All primary and secondary endpoints were met
33. Placement of Radiesse
into the Skin
Subdermal Plane
• 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
34. Mark areas to be treated (if necessary) with
patient in upright position
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
Make the patient comfortable by providing some
level of anesthesia
Pearls of Wisdom for Injecting
Radiesse
35. Nasolabial Folds with Radiesse
Linear Threading and Fanning
Using 1.25” or 1.5” Needle Using 0.5” Needle
41. Miles Graivier, MD
Roswell, GA.
Pre Injection
1.4 cc
22 Months
0.6 cc touch
up
24 Months 36 Months
Nasolabial Folds with Radiesse
42. Marionette Lines with Radiesse
Linear 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
Progressively bring to full correction
Massage with thumb and forefinger as
needed
44. Marionette Lines with Radiesse
Samuel Lam, MD
Dallas, TX
Before After 6 months
0.4 cc per side
45. R. Allan Bexton, MD
Bakersfield, CA
Before After 3 Months
(1.3 cc total)
Marionette Lines and
Mental Crease with Radiesse
46. Before After 10 months
1.6 cc total
Peter Karlsberg, MD
Ventura, CA
Marionette Lines and
Peri-Oral with Radiesse
47. Pre-Jowl Sulcus with Radiesse
Use 1.25” or 1.5” (recommended) 27g
needle
Make the patient comfortable- “mini-
block” and field infiltration
Insert needle at insertion point #1 and
inject material in retrograde manner
Use fanning technique to help lift and
support the area
Opposite the original insertion point, lay
down additional threads to cross hatch
material
Be conservative in placement of volume
and progressively bring patient to full
correction
Use thumb and forefinger to massage
and mold to desired effect
50. Nasolabial Folds, Marionette Lines
and Pre-Jowl Sulcus with Radiesse
Steven Dayan, MD
Chicago, IL
Before After 3 Months
(3.9 cc total)
51. Nasolabial Folds
Mental Crease
Nasal Defects
Marionette Lines
Submalar
Jaw Line Contouring
Infra-Orbital
Malar Enhancement
Acne or trauma
scarring Nasal Tip
Oral Commissure
Chin
Glabellar Line
Expanded Uses of Radiesse
52. • Aging causes a loss of midfacial volume as a
result of descent and loss of midfacial fat
• This causes deepening of nasolabial folds,
lengthening of the lower eyelids, infraorbital
hollows, and loss malar prominence
• Injection of Radiesse into the malar and
infraorbital areas restores volume and
accentuates the underlying bone structure
• It helps recreate the “Triangle of Beauty”
Why Cheek Augmentation?
53. • In the younger patient treatment of the
malar eminence may be sufficient
• In these cases, placement of material
along the zygomatic arch is sufficient for
the desired effects
• Thus, you are creating cheeks in patients
that never had them
Cheek Augmentation
Malar eminence only
54. Outline area to be treated with patient
upright (make-up pencils work well)
Make the patient comfortable- infraorbital
block and field infiltration into areas to be
injected
Use conservative amounts for field
infiltration so as not to distort tissue
1.25” or 1.5” 27g needle
Place material in dermal/subcutaneous
junction (subdermal plane)
Inject multiple threads of material in a
retrograde manner (0.05 cc/thread)
Layer additional threads in deeper plane
(Sub-Q) to provide volumizing effect
Massage and mold as needed
Cheek Augmentation
Malar eminence only
56. • When treating for mid-face volume
enhancement, the entire zone must be
addressed to provide volume and create
a natural appearance
• You are adding material to an area that
never had volume
• Areas- Inferior lateral orbital rim
Malar eminence
Infraorbital hollow
• Try to achieve a blending between the
lower eyelid, nasolabial fold, and the
cheek
Cheek Augmentation
Mid-Face Volume Enhancement
57. Outline area to be treated with patient upright
(make-up pencils work well)
Make the patient comfortable- infraorbital block
and field infiltration into areas to be injected
Use conservative amounts for field infiltration so as
not to distort tissue
1.25” or 1.5” 27g needle
Place material in dermal/subcutaneous junction
(subdermal plane)
Inject multiple threads of material in a retrograde
manner (0.05 cc/thread) by fanning from multiple
injection points
Feather material medially and laterally to blend in
with surrounding tissue
Layer additional threads in deeper plane (Sub-Q) to
provide volumizing effect
Massage and mold as needed
Cheek Augmentation
Mid-Face Volume Enhancement
