BIOVINC, LLC — Department of Health and Human Services STTR Phase II: NIDCR

Description

ABSTRACT Dental implants are a central part of modern dental practice with the overall market for replacement and reconstruction of teeth expected to reach over $billion in the next several yearsIt is estimated that overmillion people in the United States are missing all of the teeth in one or both of their jaws leading to lower quality of lifeMost of these implants will be successful for long term reconstructionhoweversome fail early after implantations and someup toeventually succumb to peri implantitis which is usually caused by a bacterial biofilm infectionTo counter peri implantitiscurrent practice includes local and or systemic antibiotic treatment and surgical removal of the infected bone area around the implantFollowing surgical debridement of the infected bonebone grafting with natural or substitute bone graft material is often performedHoweverclinical experience has demonstrated that the current treatments including systemic and or local antibiotic therapysurgeryand combinations of these do not universally result in cureBioVinc is a company founded to be a leader in bone related diseases and has recently demonstrated in the Phase I projectthe feasibility of treating peri implantitis with systemic delivery of a bisphosphonate antibioticciprofloxacinconjugateIn this Phase II STTR proposal we will move the BioVinc peri implantitis solution toward commercial use by combining the conjugate compound with a bone graft substitute material for use in this indicationThe BioVinc solution will allow sustained local release of the antibiotic directly into the bone specifically at the area where surgical cleaning and graft placement was carried outthus allowing high therapeutic concentrations of antibiotic to be achieved at the disease sites without the potential for systemic toxicities associated with these agentsOur plan is to seek approval of this combination as a class III device and thus have a streamlined regulatory pathwaySuccessful completion of the proposed work will allow us to commercialize our innovative conjugate bone graft materialmarking a significant advance in the treatment of peri implantitis disease