© COPYRIGHT 2013 BELLUS MEDICAL LLC. ALL RIGHTS RESERVED. SkinPen: The Next Step in Microtherapy

What is Microneedling? Microneedling is the procedure by which multiple tiny, sterile needles are used to create microscopic, closely spaced holes in the skin in order to induce the body’s natural healing response to produce fresh, new dermal tissues. Also referred to as Collagen Induction Therapy (CIT) or Percutaneous Collagen Induction (PCI) Depth of needle used can vary based on patient need Can help with general cosmesis (e.g., anti-aging) or for medical applications (e.g., scar tissue revision or to increased penetration of topical medications)

History of Microneedling Important milestones in the development of microneedling  „1950s: First described by Dr. Michel Pistor 1  1995: Subcision is introduced. 2  1997: Needle dermabrasion using a “tattoo pistol” to treat scars. 3  1998: Dr. Des Fernandes of South Africa presented his findings on needling at a conference in San Francisco 4  2000: Horst Liebl designs his first microneedling medical device  2004: Clinical Resolution Laboratory, a California company, redesigned the device, called MTS Roller 1. Pistor, M. Presse Med Jun 4;66(44): Orentreich DS, Orentreich N. Dermatol Surg. 1995;21:6543–9 3.Camirand A, Doucet J. Needle dermabrasion. Aesthet Plast Surg. 1997;21:48–51. 4.Fernandes D., Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2006;17:51–63

Introducing SkinPen 2013: The next step in microtherapy SkinPen is a medical-grade, state-of-the-art precision tool available only through skincare professionals. SkinPen works by creating a series of hundreds of microscopic channels into the dermis to stimulate the skin’s natural production of new collagen and elastin, helping skin to look and feel healthier.  Fine lines or moderate wrinkles  Diminished skin texture, tone and color 1.8  Atrophic acne scars  Stretch marks  Traumatic scars  Photo aging

How Does Microneedling Work? Microinjuries allow for release of serum containing cytokines and growth factors, important for cell renewal Promotes deposition of fresh new collagen without scar formation Creation of microchannels in the skin with minimal damage to epidermis Microchannels allow topicals to penetrate deeper than typically possible, but only temporarily (<1 hr)

Creation of microchannels in the skin with minimal damage to epidermis*  Microchannels are open for a short time, which allows for more efficient penetration of topicals  Minimal damage to tissue equals minimal downtime 1.14 Microchannel Formation *Fernandes, D. OralL Maxillofacial Surg Clin 2005;17:51-63.

1.17 These channels remain open long enough to allow for topical penetration, and then close to begin the natural healing process that leads to new, fresh dermal tissue deposition. Microchannel Characteristics Figure from: The AAPS Journal, Vol. 13, No. 3, September 2011

1.1 1 Collagen Induction Therapy *Abd El-Aal NH, et al. J Dermatol 2012;57:181-6 What does old vs. young skin look like?* Biopsy of young skin showing thick bundles of collagen bundles. Biopsy of aged skin showing thin and loose collagen fibers (Masson- Trichrome ×100).

Comparison with Other Treatments 1.20

Lasers vs. Microneedling Advantages of CIT over laser treatments ► The biggest differences are cost and treatment recovery time. ► Either will take several sessions to treat your acne scars. ► Lasers run risk of post-inflammatory hyperpigmentation; CIT does not. ► The recovery time is longer between laser treatments than it is with CIT. ► Microneedling helps your body to create more collagen naturally. ► CIT does not burn your skin. ► CIT tightens what is already there. 1.21

SkinPen Advantage Microneedling offers a simple and safe modality to improve the appearance of acne scars without risk of dyspigmentation in patient of all skin types  60 patients of skin types phototype I to VI were treated with microneedling for treatment of acne scars  Three treatments at monthly intervals.  Evaluated by using a Global Aesthetic Improvement Scale (GAIS), and analyzed statistically by computerized image analysis of the patients’ photographs.  Average reduction of 31% of scarring.  No short- or long-term dyschromia was observed. Fabbrocini G, et al.. J Dermatolog Treat Dec 8. [Epub ahead of print].

1.13 Increased Dermal Thickness BeforeAfter Patient had an increase in dermal thickness after 5 months. Dermal thickness increased from 1.91 mm to 2.41 mm. Moon, HS et. al; Department of Dermatology, Eulji University School of Medicine

Recommended Needle Depth Needle depth is contingent on:  Thickness of dermis in area to be treated:  The dermis of the face is variable, typically no deeper than 1.5 mm  Dermis in other areas of the body may be thicker or thinner, with the dermis of the back typically the thickest (~3 mm)  Reason for Treatment:  Facial rejuvenation for improvement of skin texture of fine lines will require less penetration  Improvement of scar tissue will require a more aggressive treatment and therefore deeper penetration Fabbrocini G, et al.. J Dermatolog Treat Dec 8. [Epub ahead of print]. 3.4

Contraindications SkinPen is contraindicated for patients with: A history of keloid scars, scleroderma, collagen vascular diseases or cardiac abnormalitities A hemorrhagic disorder or hemostatic dysfunction An active bacterial or fungal infection

Precautions and warnings SkinPen has not been evaluated in the following patient populations, and as such, precautions should be taken when determining whether to treat: Scars and stretch marks less than 1 year old Women who are pregnant or nursing Keloid scars Patients with history of eczema, psoriasis and other chronic conditions Patients with history of actinic (solar) keratosis Patients with history of herpes simplex infections Diabetics or patients with wound-healing deficiencies Patients on immunosuppressive therapy Skin with presence of raised moles or warts on targeted area

Easy Maintenance For optimal results, it is essential to feed your cells the nutriens they need to produce fresh, strong extracellular matrix proteins or ECM: Daily Skin Care Regimen: 1.Gentle cleanse 2.Restore: Topical vitamins A, C, E, hyaluronic acid 3.Protect: Apply antioxidant SPF 30 sunscreen. Note: Patient should avoid sweaty exercise and sun exposure between days 1 and 3 following microneedling

Little-to-No Downtime! Post-treatment Expectations  Day 1: Patients should expect mild to moderate swelling and redness, similar to a mild sunburn. There may be some mild bruising in some patients as well.  Day 2: Some persisting redness may be present, but all redness, bruising and swelling should be diminishing. Nothing some clean, mineral based makeup wouldn’t cover.  Day 3: Most redness, bruising and swelling should be nearly gone. Normal appearance with makeup may be achieved.  Day 4: Patient should appear mostly normal at this point with some minor swelling.

Instructions for Use Possible Side Effects Side effects are rare with microneedling, especially when using disposable needles. However, some possible, rare side effects may be:  Allergic reaction to steel or serums used  Robust inflammation of treated area  Persisting itching  Cutaneous eruption  Reactivation of pre-existing HSV If any of the above effects or any other effects of concern are noted after treatment, make sure the supervising physician is notified immediately to avoid further complication.

Improvement in Atrophic Scars  34 of 36 patients achieved a reduction in scar severity by one or two grades. *  More than 80% of patients assessed their treatment as “excellent” on a 10-point scale. * *J Cutan Aesthet Surg Jan; 2(1):26–30 BEFOREAFTER 3–4 TRE A TMENTS ACN E SCA R PO X SCA R 3.34

Plast Surg Int. ID Epub 2011 Apr 7 MICRONEEDLING + DEPIGMENTING SERUM DEPIGMENTING SERUM ALONE BEFOREAFTER 2 MONTHS Microneedling has been shown to enhance pen- etration of a depigmenting serum in a 20-subject study for treatment of melasma. Microneedling + depigmenting serum:  Mean MASI score of 19.1 at baseline  Mean MASI score of 14.4 (P <.001) at 1 month  Mean MASI score 9.2 (P <.001) at 2 months Depigmenting serum alone:  Mean MASI score of 20.4 at baseline  Mean MASI score of 17.4 (P <.05) at 1 month  Mean MASI score of 13.3 (P <.05) at 2 months Enhancement of Topical Penetration 3.36

Photos courtesy of Dr. Christie Matter, BeforeAfter Six weeks after one treatment. North Texas Dermatology

Four weeks after one treatment. Three passes at 1.0 mm. Photos courtesy of Dr. Christie Matter, North Texas Dermatology BeforeAfter

BeforeAfter After one treatment. Photos courtesy of Spectacular Skin

BeforeAfter After one treatment. Photos courtesy of Spectacular Skin

Before Photos courtesy of Spectacular Skin After After one treatment.

After one treatment. First pass at 0.5 mm; second pass at 1.0 mm. Before Photos courtesy of Dr. Ken Oleszek, LaFontaine Aesthetics After

After one treatment. First pass at 0.5 mm; second pass at 1.0 mm. Before Photos courtesy of Dr. Ken Oleszek, LaFontaine Aesthetics After

After three weeks. One localized area treatment using a 2.0mm needle. Photos courtesy of the Women’s Centre for Excellence BeforeAfter

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