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Physician Reference Slides 2007. US Filler Market Evolution 2004 2006 FDA Approved December 2006 Wrinkles and Folds HIV Facial Lipoatrophy 1980’s Collagen.

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Presentation on theme: "Physician Reference Slides 2007. US Filler Market Evolution 2004 2006 FDA Approved December 2006 Wrinkles and Folds HIV Facial Lipoatrophy 1980’s Collagen."— Presentation transcript:

1 Physician Reference Slides 2007

2 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 (Zyplast TM, Zyderm TM, etc.) Approximate Timeline Hyaluronic Acid Revolutionized Fillers 6 mos. durability (Restylane®, Juvederm®, Hylaform®, etc. ) Next Generation Long-lasting: 12-18 mos. without being permanent May last a year or more in many patients 2007

3 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

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 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

6 Radiesse Stimulates New Collagen Production 32 Weeks78 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).

7 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” Radiesse Supports Natural Collagen Integration

8 CaHA particles are slowly dissolved into calcium and phosphate ions through normal metabolic processes CaHA particles post-implantation Radiesse Particles Break Down Naturally

9 Dermal Filler (Immediate Correction) Tissue Regeneration (Extended Correction) Collagen  Hyaluronic Acid  Poly-L-lactic Acid   Radiesse Provides Both Immediate Correction and Long Lasting Results

10 Radiesse is Safe- AE Profile Similar 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 ™ ®

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 not Form 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 Ca 2+ 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

13 Radiesse is Safe- It will not Obscure 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 X-ray after 2.4 cc Radiesse injection in lower face CT Scan Immediately-post injection

14 6 Months12 MonthsBaseline* 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 FDA Nasolabial Fold Study

15 Live GAIS Rating at 6 Months Assessment by Treating Investigator 94.6% Improved 2.7% Improved

16 Volume vs. Cost Comparison Average volume needed to reach Optimal Correction (p<0.0001) List priceEstimated cost of Tx Radiesse1.2 cc$ 295 CosmoPlast2.4 cc$ 175$ 411

17 BaselineOptimal3 Month6 Month Radiesse Total Volume 1.5 mL CosmoPlast Total Volume 3.6 mL Representative Study Images

18 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% Edema Erythema Ecchymosis Other Pain Pruritis Needle Jamming Nodule Allergic Reaction Embolization Erosion Extrusion Granuloma Hematoma Infection Necrosis RadiesseControl

19 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

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 3 Months6 Months12 Months18 Months30 Months0 Months Initial Treatment Phase Follow-up Phase Baseline 4.7 cc1.8 cc Average Initial Volume 6.5cc 2.4 cc

21 GAIS Results up to 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

22 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 Trial Safety Summary

23 Baseline Month 6 Month 12 Month 18 40 yo Male Total Volume 8.0 mL Representative Patient Photos

24 “Yes” at 3 months “Yes” at 6 months “Yes” at 12 months “Yes” at 18 months Would you recommend Radiesse treatment? 99% Has the Radiesse treatment been beneficial to you? 100% 99% Do you feel more attractive since receiving the Radiesse treatment? 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% 99% Patient Satisfaction Through 18 Months

25 Radiesse HIV 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 –> 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 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

30 Nasolabial Folds with Radiesse Linear Threading and Fanning Using 1.25” or 1.5” NeedleUsing 0.5” Needle

31 Nasolabial Folds with Radiesse Linear Threading and Fanning


33 Susan Weinkle, MD Tampa, FL BeforeImmediately After (1.3 cc total) Nasolabial Folds with Radiesse

34 BeforeImmediately After (1.3 cc total) Nasolabial Folds with Radiesse Henri Gaboriau, MD Seattle, WA 6 Months (No Touch-up)

35 Steven Bloch, MD Highland Park, IL Before 12 months 1.3 cc Nasolabial Folds with Radiesse

36 Miles Graivier, MD Roswell, GA. Pre Injection 1.4 cc 22 Months 0.6 cc touch up 24 Months36 Months Nasolabial Folds with Radiesse

37 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 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 Radiesse Linear Threading and Fanning


40 Marionette Lines with Radiesse Samuel Lam, MD Dallas, TX BeforeAfter 6 months 0.4 cc per side

41 R. Allan Bexton, MD Bakersfield, CA BeforeAfter 3 Months (1.3 cc total) Marionette Lines and Mental Crease with Radiesse

42 BeforeAfter 10 months 1.6 cc total Peter Karlsberg, MD Ventura, CA Marionette Lines with Radiesse

43 Pre-jowl Sulcus Technique Linear Threading


45 Robert Glasgold, MD Highland Park, NJ Pre-Jowl Sulcus BeforeAfter

46 Nasolabial Folds, Marionette Lines and Pre-Jowl Sulcus Steven Dayan, MD Chicago, IL Before After 3 Months (3.9 cc total)

47 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

48 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 Lipoatrophy Submalar volume correction


50 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 Lipoatrophy Malar and infraorbital volume correction


52 HIV Facial Lipoatrophy Malar, submalar and infraorbital volume correction

53 Courtesy of, Todd Owsley, MD Greensboro, NC Todd Owsley, MD Greensboro, NC Before After HIV Facial Lipoatrophy

54 Baseline Month 6 Month 12 Month 18 40 y/o Male Total Volume 8.0 mL HIV Facial Lipoatrophy

55 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

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

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