2007 radiesse physician_reference_slides
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US Filler Market Evolution
2004 2006
FDA Approved December 2006
Wrinkles and Folds
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®, Juvederm®, Hylaform®, etc. )
Next GenerationLong-lasting: 12-18 mos. without being permanentMay last a year or more in many patients
2007
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
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
Decalcified 25µm to 45 µm particles
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
Radiesse Stimulates NewCollagen Production
32 Weeks 78 Weeks
16 Weeks4 Weeks
Histology studies demonstrate increased collagen deposition around CaHA micro-spheres over a time course. Collagen fibers stain red using picrosirius red (60x mag).
6-Month Human Skin HistologyTissue 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
CaHA particles are slowly dissolved into calcium and
phosphate ions through normal metabolic processes
CaHA particles post-implantation
Radiesse Particles Break Down Naturally
Tissue Regeneration(Extended Correction)
Poly-L-lactic Acid
Hyaluronic Acid
Collagen
Dermal Filler(Immediate Correction)
Radiesse Provides Both Immediate Correction and Long Lasting Results
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
**
* Urological applications used Radiesse’s sister product, Coaptite in clinical studies (75-125 microns)
Multiple Documented Studies Demonstrate the Efficacy and Safety of CaHA
™ ®
Radiesse is Safe- No Reported Granulomas
In two separate 100+ patient FDA Clinical Trials, Radiesse had zero granulomas
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 patient’s 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 body’s own metabolic processes into Ca2+ and PO
3
2+ ions.
No ossification or calcification of CaHA has been reported in over 6 years of clinical use and >400,000 syringes injected
Radiesse is Safe- It will notObscure X-raysThe 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
X-ray after 2.4 cc Radiesse injection in lower face CT Scan Immediately-post injection
6 Months 12 MonthsBaseline*
Continued safety follow-up & optionaltouch-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 EvaluatorsInvestigationalSite
Prospective, randomized, controlled, split-face trial compared Radiesse to CosmoPlast®
Optimal Correction
3 Months
3 Months
FDA Nasolabial Fold Study
Live GAIS Rating at 6 MonthsAssessment by Treating Investigator
Radiesse
0% 20% 40% 60% 80% 100%
Worse
No Change
Improved
MuchImproved
Very MuchImproved
CosmoPlast
0% 20% 40% 60% 80% 100%
Worse
No Change
Improved
MuchImproved
Very MuchImproved
94.6% Improved
2.7% Improved
Volume vs. Cost Comparison
$ 411$ 1752.4 ccCosmoPlast
$ 295$ 2951.2 ccRadiesse
Estimated cost of TxList price
Average volume needed to reach Optimal Correction
(p<0.0001)
Baseline Optimal 3 Month 6 Month
Rad
iess
e
Total Volume
1.5 mL
Co
smo
Pla
st
TotalVolume
3.6 mL
Representative Study Images
Adverse Event Analysis
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Edem
a
Eryth
ema
Ecchy
mos
is
Other
Pain
Prurit
is
Needle
Jam
ming
Nodule
Allerg
ic Rea
ction
Embo
lizat
ion
Erosio
n
Extru
sion
Granu
loma
Hemat
oma
Infe
ction
Necro
sis
Radiesse Control
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
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
3 Months 6 Months 12 Months 18 Months 30 Months0 Months
Initial TreatmentPhase
Follow-up Phase
Baseline
4.7 cc 1.8 cc
Average Initial Volume6.5cc
2.4 cc
GAIS Results up to 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
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 TrialSafety Summary
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 Satisfaction Through18 Months
Radiesse HIV 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
– All primary and secondary endpoints were met
– > 90% patient satisfaction through 18 months
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
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
Pearls of Wisdom for Injecting Radiesse
Nasolabial Folds with RadiesseLinear Threading and Fanning
Using 1.25” or 1.5” Needle Using 0.5” Needle
Before Immediately After(1.3 cc total)
Nasolabial Folds with Radiesse
Henri Gaboriau, MD Seattle, WA
6 Months(No Touch-up)
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
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
R. Allan Bexton, MDBakersfield, CA
Before After 3 Months(1.3 cc total)
Marionette Lines andMental Crease with Radiesse
Nasolabial Folds, Marionette Linesand Pre-Jowl Sulcus
Steven Dayan, MDChicago, IL
Before After 3 Months(3.9 cc total)
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
HIV Facial Lipoatrophy
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
HIV Facial LipoatrophySubmalar 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+
HIV Facial LipoatrophyMalar and infraorbital volume correction
Courtesy of,Todd Owsley, MDGreensboro, NC
Todd Owsley, MDGreensboro, NC
Before After
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
HIV Facial Lipoatrophy
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