NAVEH PHARMA

COMMON PROBLEMS SMART SOLUTIONS

CleanEars

JUNE 2009

CLEANEARS E

AR 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

canal laceration).

(such as eardrum perforation or

DISSOLVE-ONLY SOLUTIONS

Cerumenolytic preparations Ear drop application, requires

head tilting for 5-10

sheets or cloths.

minutes, is

uncomfortable

, with occasional leak out of the ear, bad odor, soiling of bed

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 cerumen.

– Mineral oil – provides inert irrigation, flushes the dissolved  Spearmint oil while providing better feeling to the patient and fresh odor of the preparation.

– warms the ear canal and catalyzes the physical process

CleanEars: Clinical Studies

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In a clinical trial at ENT Department of the Bikur Holim University Hospital, Jerusalem

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74 patients

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Efficacy of over 82%

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Another clinical trial at ENT Department of the Wolfson University Hospital, Holon

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No side effects reported 19 patients (38 ears)

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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% No side effect reported

60 50 40 30 20 10 0

CleanEars - Clinical Study

Prior to Treatment After Treatment with CleanEars Obstruction Degree

Clean Ears vs. Competitors

it is certainly not another “ME TOO” product

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Superior efficacy of more than 75%

with Cerumenex, Murine and placebo that was respectively observed in 29.2%, 15.4%, and 41.7%

(1) (2)

In comparison,

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