Lexington International, LLC

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Lexington International, LLC The HairMax LaserCo
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Overview

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Lexington International

• Developer and manufacturer of quality laser
  phototherapy devices
  
• Expertise in laser design
• Focused on medical and consumer markets
• The HairMax LaserComb
• Device has extensive User Experiences
• Efficacy from well-controlled clinical trials

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Hair Loss Market

• Over 85 million hair loss individuals in US
• Over 162 million in Primary Global Markets US,
  Europe, Japan and Korea
  
• Over 149 million in Secondary Global Markets of
  China, India and South America.
  
• Less than 4 have attempted treatment
• Lack of sufficient results
• Fear of medicinal side effects
• Ongoing treatment costs

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Hair Loss/Growth Market

• Prescription drugs approximately 300,000 users
  per year
  
• Male only
• Perception of negative side effects
• OTC Rogaine Generic Minoxidil over 6 million
  have tried or are current users
  
• Surgical hair transplants approximately
  125,000/year (US alone)
  

Data represents only 4 of the population that
has sought treatment
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Milestones

• Introduced original HairMax LaserComb (March
  2001)
  
• 1ST USA patent approved Dec 24 2002
• Published in a Peer Reviewed Medical Journal
  (October 2003)
  
• Dateline NBC (November 2004, July 2005). An
  independent TV journalist evaluation comparing to
  other accepted treatments
  
• Two European sales offices established Jan 2005
• Completed multi-centered, placebo-controlled,
  double-blind, clinical study (Sept 2005)
  
• FDA Submission Feb 2006 for male hair loss
• FDA Clearance Jan 2007 for the Promotion of Hair
  Growth
  
• FDA Submission Feb 2008 for female hair loss

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FDA Clearance forPromotion of Hair Growth

• US FDA clearance for only medical device to
  promote hair growth and treat AGA in males.
  
• Female study has been completed with equally
  significant results. 510(K) submitted on Feb
  2008.
  
• Seborrheic dermatitis clinical study underway
• Continued clinical research into mechanisms of
  action and LLLT biostimulation.

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HairMax LaserComb Advantages

• In addition to hair growth, the HairMax
  LaserComb provides noticeable, additional
  benefits including
  
• Hair Grows Faster, Thicker, Stronger (Tensile
  Strength)
  
• Scalp Conditions mostly normalized (Dandruff,
  Seborrhea Dermatitis, Itch)
  
• Reverse Miniaturization
• Regrowth of Dormant Follicles
• Decrease in shedding
• More manageable

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Hypotheses of Mechanism of Action

• Increased ATP- Leads to increased production of
  ATP within the mitochondria of the cell. ATP is
  the carrier of cellular energy. The increase in
  ATP promotes increases in cell proliferation
  inside the hair matrix. Increased levels of ATP
  may provide the necessary cellular energy for the
  hair follicle to produce healthier hair and
  overcome the negative effects of DHT.
• Cellular Apoptosis Other studies indicate that
  LLLT may have a positive effect on cell
  regeneration.
  

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Phases of Hair Growth
A. Growth Phase or Anagen Phase, each hair
grows approximately one centimeter (1/2 inch) a
month for a period of 2 to 8 years. The LaserComb
provides energy and increases blood circulation
to the hair growth process thus producing
healthier, fuller hair.
B. Resting Phase or Telogen Phase, the hair
stops growing, disconnects from the follicle and
rests for 2 to 4 months waiting to be shed. The
LaserComb helps stimulate re-growth of new
healthy hair replacement
C. Weakened root with a miniaturized Vellus
Hair (light colored, short, fine "peach fuzz
hairs). The HairMax LaserComb stimulates
cellular metabolism and increase blood flow to
promote thicker, more mature Anagen hair.
D. Dead Root. The follicle is no longer receiving
nutrients from the blood supply. The follicle is
completely inactive.
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Clinical Studies

• Clearwater Pilot study - published in peer
  reviewed medical journal
  
• New York study (males and females, vertex and
  temporal)
  
• Multi-center Study (males)
• Multi-center Study (females)

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Macro Images
New York Study
Multi-Centered Study
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Typical User Experience

• 8 to 16 Weeks New Hair Growth and General
  Appearance Improvements Shinier, Thicker Hair.
  Users report that hair grows faster and is more
  manageable.
• 6 to 12 Months - Hair becomes fuller, stronger
  and denser appearance of hair gradually regresses
  back to its original state.
  
• Regular LaserComb usage is recommended. As few as
  three times a week for 10 to 15 minutes a session
  is sufficient to see results over time.