NAVEH PHARMA

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NAVEH PHARMA

• COMMON PROBLEMS
• SMART SOLUTIONS
• CleanEars
• JUNE 2009

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CLEANEARSEAR WAX REMOVAL SYSTEM

• All in One Ear irrigation ear wax removal
• CE approved

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Clean Ears The Market

• Impacted Cerumen is a common ear problem
  encountered in
• 26 of the general population,
• 57 of the elderly population (particularly
  among hearing aids users).
• Earwax accumulation can cause
• hearing impairment, irritation and pain.

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Ear Wax Removal Current Solutions Problems

• WASH-ONLY SOLUTIONS
• Ear Irrigation performed by physicians with
  water and syringe is time consuming, associated
  with as much as 38 complications (such as
  eardrum perforation or canal laceration).
• DISSOLVE-ONLY SOLUTIONS
• Cerumenolytic preparations Ear drop application,
  requires head tilting for 5-10 minutes, is
  uncomfortable, with occasional leak out of the
  ear, bad odor, soiling of bed sheets or cloths.

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CleanEars Ingredients Mechanism of Action

• CleanEars is based on physical - mechanical
  logic.
• The active ingredient is natural squalan
  extracted from olive oil.
• Squalan has similar composition, structure and
  character as of ear wax but is in liquid form.
• When applied into the ear canal as a spray,
  squalan particles slam into the slow moving wax
  particles. As in any collision, some of the
  kinetic energy is transferred to the wax solid
  particles, enabling their transformation into
  liquid wax material.
• The Vehicle Mineral oil provides inert
  irrigation, flushes the dissolved cerumen.
• Spearmint oil warms the ear canal and catalyzes
  the physical process while providing better
  feeling to the patient and fresh odor of the
  preparation.

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CleanEars Clinical Studies

• In a clinical trial at ENT Department of the
  Bikur Holim University Hospital, Jerusalem
• 74 patients
• Efficacy of over 82
• No side effects reported
• Another clinical trial at ENT Department of the
  Wolfson University Hospital, Holon
• 19 patients (38 ears)
• Complains related to earwax accumulation
• Treatment for one week (2 sprays per ear/x 2/day)
• Evaluation by ENT after 1 week
• Efficacy over 74
• No side effect reported

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CleanEars - Clinical Study
Number of Ears
Obstruction Degree
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Clean Ears vs. Competitors it is certainly not
another ME TOO product

• Superior efficacy of more than 75(1) In
  comparison, with Cerumenex, Murine and placebo
  that was respectively observed in 29.2, 15.4,
  and 41.7 (2)
• Innovative
• Double action - Wash Dissolve
• No need to tilt head for 5-10 minutes during
  application
• Optimal dispersion in ear canal
• User friendly
• High safety profile
• Well established cerumenolytic agents
• Fresh odor
• CE approved (BE/CA01/1-05766-00001)
• US Patent app. No. 60/987,431