GINER LIFE SCIENCES, INC. — Department of Health and Human Services SBIR Phase I: Y

Description

PROJECT SUMMARY ABSTRACT An estimatedmastoidectomies andtympanoplasties are performed each year throughout the U Swith published failure rates ranging fromtoOne cause of failure is initial mucosalization in place of epithelialization at the wound siteleading to mucosalization of the mastoid cavity and tympanic membranewith tympanic membrane perforationmastoiditisor otitis media as possible sequelaeAccording to Giner s otolaryngologist consultantsDrsElizabeth Toh and Peter Webersome form of the previous scenarios occurs in almostof patients post surgerytypically healing aftertoweeks under the current standard of post surgical carepacking the ear and using anti biotic drops to prevent infectionFor the approximateof patients whose inflammatory process does not resolvea surgical revision may be necessaryDrsToh and Weber believe that one possible way to decrease recovery timedry the middle ear sooner by encouraging epithelialization over mucosalizationand prevent a revision surgery is to provide concentrated oxygen to the wound siteGiner has developed a miniature Electrochemical Oxygen GeneratorEOGunder previous NIDDK funding for a bio artificial pancreasthis proven technology would be further reduced in size and integrated into a hearing aid shellGiner will also continue development of a self regulating EOG and dosage control electronics to operate the device in order to provide a constant flow rate to the wound siteAdditionally an ear piece will be developed that will provide a path for oxygen entry into the earThe objective of this Phase I SBIR is to createwearable Ear Oxygenation DevicesEODseach with their own electronics and ear pieceThese devices will be operated in vitro for a minimum ofweeks to demonstrate compatibility with the current recovery timeplus a safety margin PROJECT NARRATIVE Patients undergoing middle ear surgeries experience the wound site being covered with mucuspossibly leading to mucus in the mastoid cavityear drum perforationor infections of the middle ear or mastoid cavityany of which may necessitate to a repeat surgeryThis project seeks to improve wound healing by providing concentrated oxygen to the woundthereby encouraging normal healing over mucosalization and preventing a repeat surgeryThis project will build on Giner s proven miniature Electrochemical Oxygen GeneratorEOGtechnologydeveloped under Grant NoRDKand Self Regulating EOG and dosage control electronicsdeveloped under Grant NoRDKto develop a wearable Ear Oxygenation Device