NAVEH PHARMA COMMON PROBLEMS SMART SOLUTIONS CleanEars JUNE 2009.

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Presentation transcript:

NAVEH PHARMA COMMON PROBLEMS SMART SOLUTIONS CleanEars JUNE 2009

CLEANEARS E AR WAX REMOVAL SYSTEM All in One Ear irrigation & ear wax removal All in One Ear irrigation & ear wax removal CE approved

Clean Ears: The Market Impacted Cerumen is a common ear problem encountered in: Impacted Cerumen is a common ear problem encountered in: 26% of the general population, 26% of the general population, 57% of the elderly population (particularly among hearing aids users). 57% of the elderly population (particularly among hearing aids users). Earwax accumulation can cause Earwax accumulation can cause hearing impairment, irritation and pain. 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). 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 CleanEars is based on physical - mechanical logic. CleanEars is based on physical - mechanical logic. The active ingredient is natural squalan extracted from olive oil. 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. 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. 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. 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. 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 In a clinical trial at ENT Department of the Bikur Holim University Hospital, Jerusalem In a clinical trial at ENT Department of the Bikur Holim University Hospital, Jerusalem 74 patients 74 patients Efficacy of over 82% No side effects reported No side effects reported Another clinical trial at ENT Department of the Wolfson University Hospital, Holon Another clinical trial at ENT Department of the Wolfson University Hospital, Holon 19 patients (38 ears) 19 patients (38 ears) Complains related to earwax accumulation Complains 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 week Evaluation by ENT after 1 week Efficacy over 74% No side effect reported No side effect reported

Number of Ears Obstruction Degree CleanEars - Clinical Study

Clean Ears vs. Competitors it is certainly not another “ME TOO” product Superior efficacy of more than 75% (1) (2) 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 Innovative Double action - Wash & Dissolve Double action - Wash & Dissolve No need to tilt head for 5-10 minutes during application No need to tilt head for 5-10 minutes during application Optimal dispersion in ear canal Optimal dispersion in ear canal User friendly User friendly High safety profile High safety profile Well established cerumenolytic agents Well established cerumenolytic agents Fresh odor Fresh odor CE approved (BE/CA01/ ) CE approved (BE/CA01/ ) US Patent app. No. 60/987,431 US Patent app. No. 60/987,431