1. I
SkinPen®
© 2014 BELLUS MEDICAL LLC. ALL RIGHTS RESERVED. SKINPEN® IS A REGISTERED TRADEMARK OF BELLUS MEDICAL. 1

2. History of Microneedling
1.2
History of Microneedling
Important milestones in the development of microneedling
► First described by the founder of mesotherapy, Dr. Michel Pistor, who didn’t employ the method himself but came up with the concept that pricking skin would promote collagen formation.*
*Pistor, M. Presse Med Jun 4;66(44): 2

3. History of Microneedling
1.3
History of Microneedling
Important milestones in the development of microneedling
► 1995: Subcision, a new method of subcuticular undermining for the treatment of depressed cutaneous scars and wrinkles is introduced.*
► Mechanism of action is two-fold:
Releasing action of the procedure
2. New connective tissue via the wound-healing response
*Orentreich DS, Orentreich N. Dermatol Surg. 1995;21:6543–9 3

4. History of Microneedling
1.4
History of Microneedling
1997: Needle dermabrasion using a “tattoo pistol” to treat scars.*
► Intended to remove the tension and tightness in the skin caused by scarring
► Patients receiving skin-colored tattoos over facial scars saw evidence of pigmentation after 1–2 years even though
the tattoo pigment was long gone
► Scars were immensely improved in texture, appearance and color
► Not feasible, due to time and labor intensive nature of using just one needle to treat scars
*Camirand A, Doucet J. Needle dermabrasion. Aesthet Plast Surg. 1997;21:48–51. 4

5. History of Microneedling
1.5
History of Microneedling
1998: Dr. Des Fernandes of South Africa presented his findings on needling at a conference in San Francisco*
► Introduced needling device, a small needle stamp, to induce collagen and used as a regular treatment in his surgical practice.
*Fernandes D., Minimally invasive percutaneous collagen induction. Oral Maxillofac Surg Clin North Am. 2006;17:51–63 5

6. History of Microneedling
1.6
History of Microneedling
2000: Horst Liebl, inventor of the original German Dermaroller, designed the very first microneedling medical device
► Revolutionized a formerly time-consuming and labor-intensive technique
► Consisted of many fine needles on a drum-shaped roller device
► Ability to treat larger areas of the skin easily and quickly. 6

7. History of Microneedling
1.7
History of Microneedling
2004: Clinical Resolution Laboratory, a California company, redesigned the device, called MTS Roller 7

8. Introducing SkinPen II
1.8
Introducing SkinPen II
2014: The next step in Microtherapy
SkinPen II is a medical-grade, state-of-the-art precision tool available only through medical professionals. SkinPen II 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.
SkinPen II is designed to address various dermatologic conditions, such as:
► Fine lines or moderate wrinkles
► Diminished skin texture, tone and color
► Atrophic acne scars
► Stretch marks
► Traumatic scars
► Photo aging 8

9. SkinPen Modernizes Microneedling
1.9
SkinPen Modernizes Microneedling
SkinPen provides the safety and efficiency expected by today’s busy medical practice:
► Versatility and efficiency
Cordless
Disposable needle tips
Adjustable needle depth
Suitable for Fitz I-VI
Treats small facial areas to large body surfaces
Powerful motor reaches endpoint faster
► Safety
Sterile needle tips
Bio-Sleeve
Bio-Sheath 9

10. Advanced Microneedle Cartridge
Exhaust port prevents suction and reduces risk of broken capillaries
Bio-Sleeve prevents fluids from leaking beyond the microneedle cartridge
12 medical-grade
32-gauge needles minimize
epidermal destruction 10

11. Additional Layer of Protection.
Custom, disposable SkinPen Bio-Sheath, combined with the Advanced Microneedle Cartridge, virtually eliminates the risk of cross-contamination. 11

12. Efficiency For dermal rollers, the number of microchannels
1.15
Efficiency
For dermal rollers, the number of microchannels
increases as a function of the number of passes made.
1 pass
3 passes
5 passes
10 passes
15 passes
*Figure from: The AAPS Journal, Vol. 13, No. 3, September 2011 12

13. 1.16
Efficiency
For SkinPen, the number of microchannels depends on how quickly you move the SkinPen across the surface of the skin.
► Needles cycle at 142 Hz or 142 “stamps”/second, potentially creating microchannels/second when moving the skin pen
► Slower movement at a rate of 1 cm/second, you can create roughly microchannels/ cm2 of skin*
► Faster movement at a rate of 3 cm/second, you can create roughly microchannels/ cm2 of skin*
► The SkinPen produces significantly more microchannels with one pass than created by a dermal rollers after many passes!
*Needles are ~1 mm apart (1000 microns) and the cartridge head has a diameter of 3.5 mm 13

14. How Does Medical Needling Work?
1.15
How Does Medical Needling Work?
0.5mm – 3.0mm
Uses very fine, surgical stainless steel needles to create microscopic channels into the epidermis and dermis to release growth factors
Promotes scarless healing and deposition of normal woven collagen rather than scar collagen
Similar to Fraxel, without the negative loss of dermal papillae, potential destruction of melanocytes, abnormal collagen, coagulated growth factors
Allows 80% more product into the skin (compared to 7-10% normally) 14

15. Collagen Induction Therapy
1.10
Collagen Induction Therapy
Microinjuries allow for release of serum containing cytokines and growth factors*
*Fernandes, D. OralL Maxillofacial Surg Clin 2005; 17:51-63 15

16. 1.19
Phases of Wound Repair
After the injury, growth factors start the wound repair process. Macrophages start cleaning up dead cells . Cell infiltration, blood profusion to the site, granulation occurs immediately. Swelling redness and tenderness.
Then proliferation phase begins. Temporary collagen with tightness. Contraction phase of wound repair.
Then Phase 3, where long term benefit occurs. Happens 3 weeks to 1 year 1 depending on age and skin. Most remodeling completed at 6 months. Type 3 is temporary collagen then replaced with Type 1.
Wait at least 4 weeks between medical needling treatments for this process to occur. Under 0.5mm can be done more often can do more often. 16

17. Collagen: Young vs. Old What does young vs. old skin look like?
1.1 1
Collagen: Young vs. Old
What does young vs. old 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).
*Abd El-Aal NH, et al. J Dermatol 2012;57:181-6 17

18. Thickness: Young vs. Old Skin
1.1 1
Thickness: Young vs. Old Skin
What does young vs. old skin look like?*
Ultrasound study. Dermal thickness increased 0.5mm after 5 months. We have shown multiple studies proving that microneedling thickens the dermis and epidermis which leads to a more youthful appearance with no fine lines and wrinkles.
Young skin showing normal epidermis and dermis with mean epidermal measurement of 37.4±µm.
Ages skin showing thinning of the epidermis and flattening of the dermal epidermal junction (DEJ) with the mean epidermal measurement of 17.6±8µm.
*Abd El-Aal NH, et al. J Dermatol 2012;57:181-6 18

19. Collagen Induction Therapy
1.12
Collagen Induction Therapy
CIT Promotes deposition of fresh new collagen without scar formation*
Left, before CIT. Right, six months after CIT, more collagen (pink) and elastin (brown) can be detected. Estimated > 400% more collagen and improved epidermal/dermal thickness
*Fernandes, D. OralLMaxillofacial Surg Clin 2005; 17:51-63 19

20. Increased Dermal Thickness
1.13
Increased Dermal Thickness
Before After
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 20

21. 1.14
SkinPen Advantage
Creation of microchannels in the skin with minimal damage to epidermis*
► Minimal damage to tissue equals minimal downtime
Vertical insertion microneedling minimizes destruction to the epidermis. Receive all of the benefits of skin rejuvenation, yet minimize the risk of scarring, hyperpigmentation and infection. No disruption of the skin barrier function. Minimizes downtime.
*Fernandes, D. OralL Maxillofacial Surg Clin 2005;17:51-63. 21

22. SkinPen Advantage
Microneedling offers a simple and safe modality to improve the appearance of acne scars without risk of dyspigmentation in patients 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 GlobalAesthetic 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]. 22

23. Microchannel Characteristics
1.17
Microchannel Characteristics
Recovery of skin barrier function following microneedling treatment as measured by transepidermal water loss (TEWL)
Figure from: The AAPS Journal, Vol. 13, No. 3, September 2011 23

24. Microchannel Characteristics
1.18
Microchannel Characteristics
Calcein imaging to study closure of microchannels formed by 0.7 mm microneedles.
Channels closed by 18 hours post treatment, showing the
reversible nature of the channels.
I N T A C T S K I N
0 H O U R S
4 H O U R S
6 H O U R S
8 H O U R S
H O U R S
H O U R S
H O U R S
H O U R S
Figure from: The AAPS Journal, Vol. 13, No. 3, September 2011 24

25. Comparison with Other Treatments
1.20
Comparison with Other Treatments 25

26. Lasers vs. CIT Advantages of CIT over laser treatments
1.21
Lasers vs. CIT
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 is does not burn your skin.
► CIT tightens what is already there. 26

27. 1.22
Comparison with IPL
Collagen Induction Therapy in 54 mice (IPL vs. microneedling)
► 18 control mice ► 18 microneedling mice
► 18 IPL mice
This slide set up the study (poster presentation) that is outlined in the next three slides. Mice were evaluated 3 times, at weeks. Mice lived to 8 weeks then portions of their skin were evaluated.
Moon, HS et. al; Department of Dermatology, Eulji University School of Medicine 27

28. Comparison with IPL Skin Thickness
1.23
Comparison with IPL
Skin Thickness
After eight weeks, when skin thickness was measured in all three groups:
Control (no treatment)
IPL
MN (microneedling)
Results were greater an increase in skin thickness in the IPL group, yet an even greater increase in the microneedling group. These results were statistically significant as represented by the P-Values.
Moon, HS et. al; Department of Dermatology, Eulji University School of Medicine 28

29. Comparison with IPL Histology (MT stain x100) Control IPL
1.24
Comparison with IPL
Histology (MT stain x100)
Control
IPL
Microneedling
The results were duplicated in the MT stain.
Moon, HS et. al; Department of Dermatology, Eulji University School of Medicine 29

30. Comparison with IPL Collagen Quantitation (Western Blot)
1.26
Comparison with IPL
Collagen Quantitation (Western Blot)
► β-actin serves as a “loading control” to show the same amount of sample was loaded for each experimental group
► As can be seen here, the Western Blot confirms the elisa assay results showing significantly more production of collagen protein in the micro-needling group of mice (3-M and 4-M) as opposed to the control (C) or IPL (I)
And when you compare collagen content among the three treatment groups through Western Blot, you see the microneedling group (3-M and 4-M) show greater collagen increase.
BACKGROUND: Western Blot measures protein; gel separates protein by size and molecular weight; take an antibody to that protein and determine if that protein is in your sample and how much. B-actin is in every cell so used as a sample group. We know from the B-actin group that the collagen increase is true b/c the same amount of protein is loaded in each well. These slides represent 2 of the 18 mice (3 and 4). This proves the results were duplicateable.
Collagen
ß-actin
3-C
3-I
3-M
4-C
4-I
4-M
Moon, HS et. al; Department of Dermatology, Eulji University School of Medicine 30

31. Comparison with IPL Conclusion: Skin thickness:
1.27
Comparison with IPL
Conclusion:
Skin thickness:
Control < IPL < Microneedling
MT Stain (collagen fiber): Control < IPL < Microneedling
Collagen quantative anaysis (ELISA,WB): Control < IPL < Microneedling
Looking across all three forms of evaluation, results were consistently in favor of microneedling in increasing skin thickness through building collagen. 31

32. Questions? 32

33. Before After five treatments
Photos courtesy of Dr. Christie Matter, North Texas Dermatology. 33

34. Before After four treatments
Photos courtesy of Cathy Presnick, A Perfect Complexion LLC 34

35. Before After five treatments
Photos courtesy of Cathy Presnick, A Perfect Complexion LLC 35

36. After one treatment
Before
Photos courtesy of Spectacular Skin 36

37. After one treatment Before
First pass at 0.5 mm; second pass at 1.0 mm.
Photos courtesy of Dr. Ken Oleszek, LaFontaine Aesthetics 37

38. After one treatment Before
First pass at 0.5 mm; second pass at 1.0 mm.
Photos courtesy of Dr. Ken Oleszek, LaFontaine Aesthetics 38

39. After one treatment Before Six weeks after one treatment
Photos courtesy of Dr. Christie Matter, North Texas Dermatology 39

40. After two treatments
Before
Photos courtesy of Spectacular Skin 40

41. After three treatments
Before
Photos courtesy of Christy Bunyan, Licensed Aesthetician, North Texas Dermatology 41

42. After one treatment
Before
Photos courtesy of Spectacular Skin 42

43. Positioning SkinPen in your practice
Stand alone treatment or in combination with other treatment modalities
Patients at high risk of post-inflammatory hyperpigmentation
Patients with no time for downtime
Patients who desire a more “natural” or approach to skin rejuvenation
A cost effective alternative to laser therapy
To rebuild epidermal health in ablative therapy patients 43

44. Partnering with Bellus Medical
► On-site training and certification
► Proven implementation strategy: SkinPen Bootcamp
► Advanced education
► Customer-centric website: skinpen.com
► Digital marketing and social media
► SkinPen.com physician finder
► Premier Partner program 44

45. SkinPen Boot Camp Designed to: ► Introduce your patients to SkinPen
► Train your staff to educate patients, optimize results, and sell packages
► Teach your practice how to turn satisfied patients into practice advocates to increase patient referrals
► Generate revenue. We’ll help you pay for your SkinPen in one day! 45

46. Social Media
Bellus Medical provides a digital marketing team dedicated to promoting your practice.
SkinPen:
► “Likes” you on Facebook
► “Follows” you on Twitter
► “Adds you to our circle” on Google+
► “Follows” you on Pinterest
► “Shares” your YouTube videos 46

47. Premier Partner Program
► Preferred placement on skinpen.com Physician Finder
► Lifetime warranty of SkinPen device
► Upgrade SkinPen device to the next generation at no charge
► $1000 off on additional devices
► 25% discount on marketing materials
► Preferred pricing on Advanced Training Courses 47

48. The Revenue
SkinPen can add profitability to your practice while offering a cost-effective and efficacious treatment to your client
► Packaging options
► Pay for your SkinPen in one day during SkinPen Bootcamp.
Example: 5 patients purchase a package of 3 “training” package for $700 each = $3,500
► Earn $140,000 annually for your practice with just three new patients per week at $300/treatment
Each patient represents $900 revenue (3 procedures x $300)
56 weeks x 3 patients = 168 patients
168 patients X $900 = $151,200 48

49. Questions? 49

50. Operating Your SkinPen II50

51. Using SkinPen Bio-Sheaths51

52. Operating Your SkinPen
Installing the Microneedle Cartridge
Turn the dial to zero. Install the microneedle cartridge by pressing down and rotating clockwise until the cartridge will turn no further. To remove, turn dial to zero, then rotate cartridge counterclockwise until it releases. 52

53. Operating Your SkinPen
Adjusting Needle Depth
The needle depth ranges from 0.0 to 2.0 mm by turning the needle dial clockwise (deeper) or counterclockwise (shallower). The arrow points to the current depth. 53

54. Operating Your SkinPen
Charging
1. Screw the battery unit into the charging unit. 54

55. Operating Your SkinPen
Charging
2. Insert the charger adapter into the charging unit and insert the plug into a power outlet. The red light on the charging unit will come on. Charge
until the light turns green (approximately 3 hours). 55

56. Operating Your SkinPen
Charging
3. After charging, unscrew the battery and screw in the SkinPen II. 56

57. Operating Your SkinPen
Changing Speed
SkinPen II provides three speed selections. The pen will start on the speed on which it was previously powered off.
Most often, you will operate the pen at the highest speed.
Press on/off button one time to move through each of the three speed settings. The flash speed of the indicator light will change accordingly as you move from slow, medium, and high speeds. 57

58. Questions? 58

59. SkinPen II Instructions for Use
► Overview
SkinPen is a microneedling technology designed for use by skincare professionals. Sterile Microneedle cartridges are provided sterile for single use.
► Intended Use
SkinPen II is an FDA Registered Class I Medical Device intended for the treatment of the symptoms of aging skin and scars, including acne, surgical and trauma. 59

60. Contraindications SkinPen is contraindicated for patients with:
► A history of keloid scars, scleroderma, collagen vascular diseases or cardiac abnormalities
► A hemorrhagic disorder or hemostatic dysfunction
► An active bacterial or fungal infection
It is important to distinguish between keloid scars and hypertrophic scars as they are often confused.
Keloid scars are thick, rounded, irregular clusters of scar tissue that extend beyond the original wound. Keloids may occur at any age, but tend to develop more readily in younger individuals darker-skinned people. They often appear red or darker in color when compared with the surrounding skin. Keloids may not develop for many months after injury, and can worsen during pregnancy. 60

61. 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 one 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 61

62. Pre-treatment Considerations
► Avoid sun exposure/burns 24 hours prior to treatment.
► Discontinue use of retinoids 12 hours prior to treatment.
► Avoid treatment on patients with active breakouts or open lesions.
► Allow at least 12 hours after autoimmune therapies before using SkinPen II.
► Wait six months following isotretinoin use.
► Fitz IV-VI, pigment may darken prior to lightening. 62

63. Treatment Instructions
Have patient complete consent form.
Explain the SkinPen II procedure to the patient and set expectations.
Cleanse patient’s face with a gentle cleanser to effectively remove makeup, sunscreen and surface oils.
Take “before” pictures of the treatment area.
Apply numbing cream to the patient’s face and leave on for 15–50 minutes, based on product instructions.
Remove numbing cream and thoroughly cleanse again with a gentle cleanser.
continued on next slide 63

64. Treatment Instructions continued
Wipe Skin with alcohol to ensure all numbing agent is removed. Important: Anything remaining on the skin or placed on the skin pre-procedure may increase complications post procedure.
At this time, Bellus Medical only recommends use of HydraMax Replenishing Serum.
Apply a disposable Bio-Sheath to SkinPen II to ensure no blood or fluid comes in contact with the pen.
Install the Advanced Microneedle Cartridge based on the instructions provided under “Installing the Microneedle Cartridge.”
continued on next slide 64

65. Treatment Instructions continued
Apply a thin layer of HydraMax Replenishing Serum or sterile saline to assist the glide of SkinPen II. If the layer is too thick or if the numbing agent was not adequately removed from the skin, the microneedle cartridge may become clogged.
Start at a depth setting of 0.25mm. If you do not see even erythema (redness), gradually increase the depth to a maximum of 1.0mm on the face or 2.0mm on the body. Lower to 0.25mm to perform treatment on the forehead or around the orbital rim.
continued on next slide 65

66. Treatment Instructions continued
Divide the face into four quadrants. Start with the right cheek, move to chin/lip/nose, and finish with forehead.
As you work each area, hold the skin taut and glide the pen in controlled horizontal motions. Repeat with vertical motions in the same area. Repeat the pattern if the
erythema endpoint has not been reached.
Depth may be increased within the
guidelines if necessary. You may use
gentle, one-directional circular motions in
small targeted area if needed. 66

67. Proper Technique for SkinPen II
As you work each area, hold the skin taut and glide the pen in controlled horizontal motions.
Repeat with similar controlled vertical motions in the same area.
Repeat the pattern if the erythema endpoint is not reached. Depth may be increased within guidelines if necessary.
May use gentle, one-directional, circular motions in small targeted areas. 67

68. Recommended Needle Depth
3.5
Recommended Needle Depth
Average Skin Thickness Measurements
Site AVG ABC
Upper lip
Lower lip
Philtrum
Chin
Upper eyelid
Lower eyelid
Forehead
Right cheek
Site AVG ABC
0.83 ± 0.17
0.82 ± 0.15
0.83 ± 0.10
1.15 ± 0.11
0.38 ± 0.09
0.82 ± 0.21
1.03 ± 0.15
1.07 ± 0.09
Left cheek Malar eminence Submental Nasal tip
Nasal dorsum Right neck Left neck
1.17 ± 0.08
1.05 ± 0.45
0.89 ± 0.19
1.22 ± 0.15
1.15 ± 0.11
0.52 ± 0.23
0.54 ± 0.20
Dermis on the face is 1.5mm. At 2.0 mm, hitting fat, hypodermis.
Not going to be building collagen beyond 1.5mm on the face. May go to 2.0mm on other parts of body. Beyond 1.5mm on the face, causing more injury than necessary and doing more harm than good.
Plast Reconstr Surg May;115(6): 68

69. Post-Treatment Instructions
Immediately
Gently use sterile gauze dampened with sterile saline to pat down the treated area.
Reapply a thin layer of HydraMax Replenishing Serum.
IMPORTANT: Some of the microchannels created may remain open up to 4 hours. Caution should be exercised when placing additional products on the skin during this time. Unexpected complications may occur when products not proven safe for use with microneedling are applied post-procedure.
Review after-care instructions with patient.
Schedule next appointment at 4 weeks.
NOTE: Avoid sweaty exercise and sun exposure between days 1 and 3.
continued on next slide 69

70. Post-Treatment Instructions
Days 2 and 3
Cleanse: Use a gentle cleanser.
Restore: Apply HydraMax Replenishing Serum over entire treatment area to reduce inflammation and hydrate the skin.
Protect: Apply antioxidant SPF 30 sunscreen of your choice.
Day 4
Resume normal skin care routine. 70

71. Post-Treatment Expectations
► Day 1: Patients should expect mild to moderate edema and erythema, 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.
► 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. 71

72. Possible Side Effects ► Allergic reaction to steel or serums used
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. 72

73. Treatment Protocols ► Series of 1–3 Tx at 4-week intervals
Texture
Uneven skin tone
Large pore size
Fine lines
► Series of 3–6+ Tx at 4-week intervals
Moderate to deep wrinkles
Striae/stretch marks
Atrophic acne scars
Traumatic scars 73

74. Combination with Other Therapies
► Neurotoxins. It is recommended that needling not be performed within hours of injection with any toxin, as increased perfusion and edema may diminish the effect and distribution of the toxin.
► Fillers. Medical discretion should be used in determining when needling is performed following injection of dermal fillers, as performing needling too soon may possibly lead to adverse inflammatory reactions. Additionally, care should be taken when treating over fillers known to produce an inflammatory response (e.g., foreign body granuloma) following trauma to the tissues adjacent to the filler.
► IPL, Laser, etc. To ensure optimal efficacy of these treatments, when combining with microneedling, the order of the treatment should be considered. 74

75. Questions? 75

76. Thank You! 76