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A novel therapeutic for the treatment of biofilms in periprosthetic joint infections

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI179543-01
Agency Tracking Number: R41AI179543
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-07
Award End Date (Contract End Date): 2025-08-31
Small Business Information
Blacksburg, VA 24060-8200
United States
DUNS: 062571548
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (540) 231-6904
Business Contact
Phone: (540) 231-6904
Research Institution
4200 5TH AVE
PITTSBURGH, PA 15260-0001
United States

 Nonprofit College or University

Total joint arthroplasty (TJA) procedures are estimated to rise by over 300% by the year 2030. Periprosthetic
joint infection (PJI) is the most significant complication following TJA with healthcare costs exceeding $1.6 billion
annually. Treatment of PJI generally requires surgical intervention combined with a prolonged course of
antibiotics costing $50,000 per patient. Despite this aggressive treatment, treatment is only successful in half of
patients. The leading cause of treatment failure in PJI is the formation of protective bacterial biofilms or
communities of bacteria encased within an extracellular matrix which are tolerant to commercially available
antibiotics. We have discovered that platelet-rich plasma (PRP) displays both antibacterial and antibiofilm
properties. Nevertheless, there is tremendous variability in the literature on the clinical efficacy of PRP. To
overcome this variability, we have developed a PRP-derived biologic that is specifically formulated with high
antimicrobial and anti-inflammatory activity with little to no lot-to-lot variability, termed BIO-PLY™. In an equine
model of native joint infection, BIO-PLY™ not only decreased intraarticular bacterial load but also dampened
inflammation and protected venerable cartilage from damage. In this proposal, we will capitalize on the equine
model of native joint infection to manufacture a human equivalent and evaluate the safety and efficacy of human
BIO-PLY™ using established in vitro and in vivo models of PJI. The goal of this proposal is to generate the key
data necessary for a go/no-go decision to advance BIO-PLY™ toward a Phase II pre-clinical animal model and
an Investigational New Drug (IND) application with the Federal Drug Administration.

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

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