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Lexington International, LLC


... hair loss. FDA Clearance Jan 2007 for the Promotion of Hair Growth' ... US FDA clearance for only medical device to promote hair growth and treat AGA in males. ... – PowerPoint PPT presentation

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Title: Lexington International, LLC

Lexington International, LLC The HairMax LaserCo

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

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

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
  • Introduced original HairMax LaserComb (March
  • 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
  • FDA Submission Feb 2008 for female hair loss

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
  • Seborrheic dermatitis clinical study underway
  • Continued clinical research into mechanisms of
    action and LLLT biostimulation.

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

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

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

Macro Images
New York Study
Multi-Centered Study
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
  • 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.
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