NAVEH PHARMANAVEH PHARMACOMMON PROBLEMSCOMMON PROBLEMSSMART SOLUTIONSSMART SOLUTIONS

CleanEarsCleanEars

JUNE 2009JUNE 2009

CLEANEARSCLEANEARSEEAR WAXAR WAX REMOVALREMOVAL SYSTEM SYSTEM

All in One Ear irrigation & ear wax removalAll in One Ear irrigation & ear wax removal

CE approvedCE approved

Clean EarsClean Ears: : The MarketThe Market

Impacted Impacted CerumenCerumen is a common ear problem is a common ear problem encountered in:encountered in:

26% of the general population, 26% of the general population,

57% of the elderly population 57% of the elderly population (particularly among (particularly among hearing aids users). hearing aids users).

Earwax accumulation can cause Earwax accumulation can cause hearing impairment, irritation and painhearing impairment, irritation and pain..

Ear Wax Removal:Ear Wax Removal: Current Solutions Current Solutions &&

ProblemsProblems WASH-ONLY SOLUTIONS Ear Irrigation Ear Irrigation peperrformed by physicians with water formed by physicians with water

and syringe is and syringe is time consumingtime consuming, associated with , associated with as much as 38% as much as 38% complicationscomplications (such as eardrum (such as eardrum perforation or canal laceration).perforation or canal laceration).

DISSOLVE-ONLY SOLUTIONSCerumenolytic preparations Ear drop application, Cerumenolytic preparations Ear drop application, requires requires head tilting for 5-10head tilting for 5-10 minutes, is minutes, is uncomfortableuncomfortable, with occasional leak out of the , with occasional leak out of the ear, bad odor, soiling of bed sheets or cloths.ear, bad odor, soiling of bed sheets or cloths.

CleanEars CleanEars Ingredients Ingredients && Mechanism of Action Mechanism of Action

CleanEars is based on CleanEars is based on physical - mechanical logic.physical - mechanical logic.

The active ingredient is natural squalanThe active ingredient is natural squalan extracted from olive oil. extracted from olive oil.

Squalan has similar composition, structure and character as of ear Squalan has similar composition, structure and character as of ear wax but is in liquid form. wax but is in liquid form.

When applied into the ear canal as a spray, When applied into the ear canal as a spray, squalan particles slam squalan particles slam into the slow moving wax particlesinto the slow moving wax particles. As in any. As in any collision, some of the collision, some of the kinetic energy is transferred to the wax solid particles, kinetic energy is transferred to the wax solid particles, enabling enabling their transformation into liquid wax material. their transformation into liquid wax material.

The VehicleThe Vehicle – Mineral oil – provides inert irrigation, flushes the – Mineral oil – provides inert irrigation, flushes the dissolved cerumen.dissolved cerumen.

Spearmint oilSpearmint oil – warms the ear canal and catalyzes the physical – warms the ear canal and catalyzes the physical process while providing better feeling to the patient and fresh odor process while providing better feeling to the patient and fresh odor of the preparation.of the preparation.

CleanEarsCleanEars:: Clinical Studies Clinical Studies

In a clinical trial at ENT Department of the In a clinical trial at ENT Department of the Bikur Bikur Holim University Hospital, JerusalemHolim University Hospital, Jerusalem 74 patients74 patients Efficacy of over 82% No side effects reportedNo side effects reported

Another clinical trial at ENT Department of the Another clinical trial at ENT Department of the Wolfson University Hospital, HolonWolfson University Hospital, Holon 19 patients (38 ears)19 patients (38 ears) Complains related to earwax accumulationComplains related to earwax accumulation Treatment for one week (2 sprays per ear/x 2/day)Treatment for one week (2 sprays per ear/x 2/day) Evaluation by ENT after 1 weekEvaluation by ENT after 1 week Efficacy over 74% No side effect reportedNo side effect reported

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CleanEars - Clinical Study

Clean Ears vs. Competitors Clean Ears vs. Competitors

it is certainly not another “ME TOO” productit is certainly not another “ME TOO” product

Superior efficacy of more than 75%Superior efficacy of more than 75%(1)(1) In comparison, with Cerumenex, Murine and placebo that was respectively observed in 29.2%, 15.4%, and 41.7% (2)(2)

Innovative Innovative Double action - Wash & DissolveDouble action - Wash & Dissolve No need to tilt head for 5-10 minutes during No need to tilt head for 5-10 minutes during

applicationapplication Optimal dispersion in ear canalOptimal dispersion in ear canal User friendlyUser friendly High safety profileHigh safety profile Well established cerumWell established cerumeenolytic agentsnolytic agents Fresh odorFresh odor CE approved (BE/CA01/1-05766-00001)CE approved (BE/CA01/1-05766-00001) US Patent app. No. 60/987,431US Patent app. No. 60/987,431