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Bone targeted antimicrobials for biofilm-mediated osteolytic infection treatment

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42DE025789-02
Agency Tracking Number: R42DE025789
Amount: $1,500,000.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDCR
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Santa Barbara, CA 93101-2507
United States
DUNS: 078871379
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (513) 532-4084
Business Contact
Phone: (310) 730-5609
Research Institution
LOS ANGELES, CA 90089-0701
United States

 Nonprofit College or University

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

* Information listed above is at the time of submission. *

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