LYNNTECH INC. — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant Ulcerative keratitis caused by infectious microbes bacteria fungi amoebae and viruses represents a major area of medical concern It is one of the most important causes of corneal opacifications which is the second common cause of legal blindness world wide after cataracts In in the USA alone of the approximately doctorandapos s office and outpatient clinic and emergency department visits related to ocular distress and emergencies resulted in antibiotic prescriptions for microbil keratitis The total annual financial burden on our healthcare system for keratitis cases was estimated to be $ million in direct health care expenditures in and was also estimated to consume over annual hours of clinician time Bacterial keratitis manifests as corneal ulcer corneal edema and or hypopyon and can cause significant complications including corneal perforation corneal thinning elevated intraocular pressure and progression to endophthalmitis This could lead to severe clinical outcomes including partial or complete vision loss necessity for penetrating keratoplasty corneal grafts enucleation and evisceration Although topical and systemic antibiotics are effective in reducing microbial loads in keratitis cases unless the microbe is resistant to the antibiotic utilized the time required to resolve th infection is generally quite lengthy Furthermore antibiotics are typically ineffective in reducin inflammation and evoking regenerative repair of corneal and or scleral defects and scarring which may be induced by the infection Lynntech Inc in collaboration with the University of Mississippi Medical Center proposes to develop an innovative inexpensive and compact device termed iCAP to effectively treat microbial keratitis at the point of diagnosis This device will be engineered to rapidly and reagentlessly significantly reduce or totally eliminate bacterial loads regardless of antimicrobial susceptibility status of the infecting microbial species Furthermore iCAP has the potential to simultaneously trigger certain cellular signaling pathways which could result in improved regeneration of corneal and scleral defects induced by the infection During this Phase I SBIR effort our specific aims are to design and fabricate prototype iCAP devices utilize in vitro microbial and mammalian cell culture techniques to obtain pilot ranges of iCAP device operating parameters likely to be effective in vivo and demonstrate that iCAP can significantly reduce or eliminate bacterial loads and orchestrate healing of infection induced corneal scleral defects in a relevant in vivo rabbit eye model of bacterial keratitis The successful completion of these specific aims should demonstrate ample feasibility of this innovative new microbial keratitis treatment approach and will enable us to execute more comprehensive technology development and commercialization thrusts in a future follow on Phase II effort The eventual commercial availability of iCAP devices is likely to sustai high positive impact for the patient populace suffering from microbial keratitis PUBLIC HEALTH RELEVANCE The potential long term impact of this SBIR effort is an effective new paradigm in the treatment of microbial keratitis right at the point of diagnosis Our envisioned automated iCAP devices have the potential to not only resolve the infection in a faster timeframe than with the use of antibiotics but also heal eye defects induced as a consequence of the infection iCAP could thus provide significant clinical benefit for microbial keratitis patients worldwide and enable faster healing coupled with lowered costs of treatment