The long-term solution for smile lines · The Origin of Acne Scars Acne scarring starts with aggressive acne inflammation. The inflammation can lead to irregular healing and loss

The long-term solution for smile linesIt’s possible with Bellafill®. Bellafill® is the only dermal filler that’s FDA approved to treat both smile lines and acne scars.

See Important Safety Information on page 19.

OVERVIEW

Actual Bellafill® patient

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Unlike hyaluronic acid fillers, which often dissolve within a few months, Bellafill® creates a lasting improvement in your skin. Its smooth collagen gel base houses tiny polymethyl methacrylate (PMMA) microspheres. These microspheres are about the same diameter as a human hair, so it’s almost impossible to see them.

Once injected, Bellafill® immediately reduces the look of lines, wrinkles, and scars. Over time, your body uses the PMMA microspheres as a “scaffold” onto which your own collagen can develop1,2.

Now there is a better choice in dermal fillers — Bellafill®, the only 5 year filler.

80%collagen

20%PMMA

80% INJECTED COLLAGEN

(polymethylmethacrylate) microspheres by volume

GEL COMPOSITION

Epidermis

Dermis

Subcutaneous Tissue

Bellafill® is placed below the depression using a fine needle.

The injectable gel immediately adds volume to the skin to lift and smooth out scars and wrinkles.4

Gel immediately after injection.

4 months after injection. Collagen tissue and blood

vessels have formed around PMMA1

Body produces collagen that integrates with Bellafill®

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Let’s talk safety.

Bellafill® is FDA approved and has been proven safe and effective in rigorously conducted clinical studies. In the largest and longest safety study ever conducted on dermal fillers (data on file), Bellafill® performed exceptionally well. At the study’s completion, 83% of patients were still satisfied with their results 5 years after treatment.3

Bellafill® is the only dermal filler on the market with 5 year safety and efficacy data. Its satisfaction data and safety profile is unmatched, making it one of the safest fillers on the market to date.

As with other injectable fillers, you may experience bruising, itching, pain, swelling, redness, discoloration, lumpiness, bumps, acne, or increased sensitivity at the treatment site. These side effects usually resolve themselves quickly.

Results that instill confidence:

87%

83%

NO

Retention Rate3

Satisfaction Rate3

Treatment-related serious adverse events3

5 YEAR STUDY DATA

ACNE STUDY

84%of subjects were satisfied1

90%of subjects were satisfied1

At 6 months At 12 months

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Your Questions: Nasolabial FoldsWhat is Bellafill® and how does it work?Bellafill® is a smooth, collagen gel-based dermal filler that contains tiny PMMA microspheres. The collagen gel in Bellafill® provides immediate volume and lift to correct lines and wrinkles, smoothing them away for instant results. Even as the collagen is absorbed by your body, the PMMA microspheres remain in place and create a “scaffold” that supports your own natural collagen production.

Is Bellafill® safe?Yes, Bellafill® is FDA approved and has been proven safe and effective in rigorously conducted clinical studies. Bellafill® performed very well in the largest and longest safety study ever conducted on dermal fillers (safety on file). At the study’s completion, 83% of patients were still satisfied with their results 5 years after treatment.

Who are the best candidates for Bellafill®?Candidates for Bellafill® must be 21 years of age or older. Bellafill® works on all skin types and in both men and women. Bellafill® is a great option for patients who want to avoid the time and expense associated with other, more temporary fillers. A quick skin test is required to ensure you’re not allergic to any of the ingredients in Bellafill®. Be sure to consult with a licensed provider to determine how Bellafill® may work for you.

What results can I expect with Bellafill®? How long does it take to see them?Bellafill® creates a lasting improvement in your skin. There’s no required downtime after your treatment with Bellafill®. You can get back to your normal routine immediately.

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Your Questions: Acne ScarsWhat treatment options currently exist for acne scars?Topical treatments, chemical peels, dermabrasion, microneedling, and laser resurfacing are among the current available treatment options for acne scars. However, these treatments may be associated with significant downtime. It can also take a significant amount of time before their results are visible -- and they often lack rigorous, controlled data to support their safety or efficacy.

Bellafill® is the only filler that’s approved by the FDA to treat acne scars. It offers a new hope and treatment choice to millions of Americans affected by this skin condition.

Is Bellafill® safe?Yes, Bellafill® is the only dermal filler that’s FDA approved for the correction of moderate to severe atrophic, distensible facial acne scars on the cheek in patients over 21 years of age. Bellafill® has been proven to provide both immediate and lasting results in rigorous clinical studies that demonstrated effectiveness, safety, and high rates of patient satisfaction.

How frequently do you have to get injected with Bellafill®? What is the upkeep?Bellafill® is a lasting solution. In a clinical study on acne scarring, safety and effectiveness was demonstrated through 12 months. In a separate clinical study on nasolabial folds (smile lines), its safety and effectiveness was established through 5 years. Your licensed provider can give you the best recommendations on how Bellafill® can be used to achieve optimal results.

Does Bellafill® only treat facial acne scars?In the U.S., Bellafill® is also approved for the correction of smile lines through 5 years. In a recent clinical study, 83% of Bellafill® patients were still satisfied with their results 5 years after treatment3,4.

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Rediscover Smoother SkinBellafill® is the only injectable that’s FDA-approved to treat moderate to severe atrophic, distensible acne scars on the cheeks.

ACNE SCARSACNE SCARS


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The Origin of Acne Scars

Acne scarring starts with aggressive acne inflammation.

The inflammation can lead to irregular healing and loss of collagen, which is a key structural component of skin. This can result in a sunken scar and an uneven skin surface.

Inflamed TissueSkin with an acne breakout

Epidermis

Dermis

Subcutaneous Tissue

Resulting scar formation

Pilosebaceous Unit

Rolling Scar

Thin Dermis

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Bellafill® Smooths Acne Scars

The collagen gel in Bellafill® provides immediate volume below acne scars to lift them to the level of the surrounding skin.1

Skin with a pitted acne scar

Over time, the collagen gel is absorbed by the body. The PMMA microspheres remain in place and create a scaffold that supports production of the body’s own collagen for lasting correction.1,2

Acne scar lifted to the level of the surrounding skin

Gel immediately after injection.

4 months after injection. Collagen tissue and blood

vessels have formed around PMMA1

Body’s natural integration with Bellafill®

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Know Your Scars

Acne scars come in several shapes and sizes, but Bellafill® is best for rolling scars.

Note: all acne scar types may be present in one patient.

Deep and narrow pitting of the skin.

Sharp vertical edges with a wide base.

3 TYPES OF ATROPHIC ACNE SCARS5

ICEPICK (Narrow)

ROLLING (Wide)

BOXCAR (Narrow to wide)

Soft shoulders and rounded saucer-like shape.

Bellafill® works best on distensible (which means they disappear when stretched), depressed scars with soft edges. Your licensed provider can help you determine if Bellafill® can offer you the results you want.

Distensible scars Smooths when stretched

Bellafill® is only for correction of distensible, rolling acne scars. To determine if a scar is appropriate for correction, pull the surrounding skin taut. If the skin appears normal when stretched, then it is a distensible scar, and may be optimal for treating with Bellafill® .

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Why Bellafill® for Acne Scars?

• Bellafill® works with your body to immediately reduce the look of acne scars.

• Your simple treatment is performed right in your doctor’s office.

• Results appear immediately, and you can get back to your day quickly.

• 90% of patients were still satisfied with their results after 1 year.

PATIENT 1 PATIENT 2 PATIENT 3

AFTER

BEFORE

AFTER

BEFORE

Actual Bellafill® patients. Individual results may vary.

AFTER

BEFORE

62% of patients concerned about noticeable acne scars have consulted a doctor or other healthcare professional at some time.4 Until recently, the treatment options for reducing scarring, such as microneedling, laser and light therapies, were limited. Now Bellafill® offers a solution for reducing the look of scars when resurfacing procedures are not favored, or simply do not provide the outcomes you desire. Results are both immediate and lasting, improving your sense of personal confidence.

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Real Patients, Real Results

Actual Bellafill® patients. Only circled scars were treated. Individual results may vary.

PATIENT 4 - BEFORE AT 1 YEAR

Befo

re & A

fter G

allery

“ I see a difference in my

complexion as far as

smoothness. It makes

me feel a whole lot

better about myself, and

my self-confidence has

boosted significantly.”6

AT 1 YEAR

PATIENT 5 - BEFORE (RIGHT SIDE)

PATIENT 5 - BEFORE (LEFT SIDE)

AT 1 YEAR

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Befo

re & A

fter G

allery

“ I felt very satisfied.

I felt there was a

noticeable improvement,

and no downside to

the treatment.”6

PATIENT 7 - BEFORE (LEFT SIDE)

PATIENT 7 - BEFORE (RIGHT SIDE) AT 6 MONTHS

AT 6 MONTHS

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Real Patients, Real ResultsPATIENT 8 - BEFORE AT 1 YEAR

Befo

re & A

fter G

allery

“ I would recommend

Bellafill® to anybody who

is trying to fill in acne

scars. You walk in with

a scar and you walk out

without a scar.”6


PATIENT 9 - BEFORE (MAGNIFIED) AT 1 YEAR (MAGNIFIED)


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Smile LinesSMILE LINES

Results in an instant that can last through 5 years


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Know Your Wrinkles

Bellafill® works best on nasolabial folds, also called smile lines.

Frown lines

Nasolabial folds

Crow’s feet

Forehead lines

We all know how to spot a wrinkle but how do you know if Bellafill® is a match for you?

Marionette lines

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Why Bellafill® for wrinkles?• Bellafill® is the only injectable filler

that creates instant results that can last through 5 years3.

• Your simple treatment is performed in your doctor’s office — and you can go back to your day immediately afterward.

• Bellafill® works with your body to reduce the look of lines and wrinkles.


PATIENT 1 - BEFORE AT 5 YEARS



Natural-looking results that last

Over time, Bellafill® helps your body develop its own collagen, making your long-lasting results look soft and natural.

Befo

re & A

fter G

allery

“ I am truly, truly happy with the results that I got from the Bellafill® treatments. It gave me exactly what I was looking for and the fact that you can’t see it or feel it is really the best part about it.”6

— Marissa

“ I’m at the age where I’m starting to feel the effects of aging. The fact that I feel young and still look good and I’m catching those wrinkles early on makes me feel better about myself and translates into other areas of my life.”6

— Linda

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PATIENT 4 - BEFORE AFTER




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Real Patients, Real ResultsB

efore &

After

Gallery

“ The results are what I had hoped for. I feel that Bellafill® really has changed my look, but not in a dramatic way. I feel as if it has enhanced me, it has made me feel younger and look younger and I’ve had positive results and a lot of compliments.”6

— Marina


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Bellafill® is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. Patients who have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill.® The safety of Bellafill® for use during pregnancy, breastfeeding, or in patients under 21 has not been established. You may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1–7 days. You may experience lumps/bumps/papules that may occur more than one month after injection and that may persist. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, lumps/bumps, acne, and increased sensitivity at treatment sites. Infrequently, granulomas may occur and may be treated by your licensed physician provider. Be sure to call your licensed provider immediately if you notice any unusual skin reactions around the treatment area. Based on the 5-year Post Approval Study on nasolabial folds with 1008 patients, long term safety of Bellafill® for up to 5 years has been established. For more safety information, please consult with your physician and the patient labeling that can be found by visiting our website www.bellafill.com.

Toll-free call (U.S. & Canada): 844-Bellafill (844-235-5234). Local calls: 858-550-9999. International calls: ++ 858-550-9999.

IMPORTANT SAFETY INFORMATION

www.SunevaMedical.com ©2017 SUNEVA MEDICAL, INC. SM1769REV03

References:

1. Gottfried Lemperle, et. al., ArteFill® Permanent Injectable for Soft Tissue Augmentation: I. Mechanism of Action and Injection Techniques., Aesthetic Plast Surg. 2010 Jun;34(3):264–72.

2. Proposed mechanism of action.

3. Based on the 5 year post approval study for the correction of nasolabial folds.

4. Data on file. Suneva Medical, Inc.

5. Jacob CI, Dover JS, Kaminer MS. Acne scarring: A classification system and review of treatment options. J Am Acad Dermatol; July 2001; 109-117. 1. Gottfried Lemperle, et. al., ArteFill® Permanent Injectable for Soft Tissue Augmentation: I. Mechanism of Action and Injection Techniques., Aesthetic Plast Surg. 2010 Jun;34(3):264–72.

6. RealSelf.com

Documents

The long-term solution for smile lines · The Origin of Acne Scars Acne scarring starts with aggressive acne inflammation. The inflammation can lead to irregular healing and loss