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NAVEH PHARMA
COMMON PROBLEMS
SMART SOLUTIONS
CleanEars
JUNE 2009
CLEANEARS
EAR WAX REMOVAL SYSTEM
All in One Ear irrigation & ear wax removal
CE approved
Clean Ears: The Market
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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.
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.
CleanEars
Ingredients & Mechanism of Action
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CleanEars is based on physical - mechanical logic.
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The active ingredient is natural squalan extracted from olive oil.
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Squalan has similar composition, structure and character as of ear wax
but is in liquid form.
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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.
CleanEars: Clinical Studies
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In a clinical trial at ENT Department of the Bikur Holim
University Hospital, Jerusalem
 74 patients
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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
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Efficacy over 74%
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No side effect reported
CleanEars - Clinical Study
50
Prior to Treatment
40
After Treatment
with CleanEars
30
20
10
Obstruction Degree
No
Minimal
Partial
0
Complete
Number of Ears
60
Clean Ears vs. Competitors
it is certainly not another “ME TOO” product
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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