SBIR-STTR Award

Photodynamic therapy (PDT) is a modality that uses a photosensitizing agent and laser light to create oxygen radicals resulting in the destruction of cancer cells and bacteria. As this modality destroys bacteria via a different mechanism than antibiotics, its effectiveness is not altered by bacteria that have antibiotic resistance. Recently, there has been a rapid increase in the strains of antibiotic resistant bacteria with over 90% of Staphylococcus aureus strains being methicillin resistant. These bacteria have resulted in an inability to adequately treat common wound infections with antibiotics causing morbidity and death. PDT destruction of antibiotic resistant Staphylococcus aureus in vivo and antibiotic resistant Streptococcus pyogenes and Pseudomonas aeruginosa in vitro has been demonstrated using methylene blue. The proposed research will evaluate the use of methylene blue with 664 nm laser light as an improved device and dye combination for the efficacious treatment of infected surface wounds. This treatment may ultimately be used to sterilize acutely and chronically infected wounds unresponsive to antibiotics. PROPOSED COMMERCIAL APPLICATIONS: The commercial applications of this research is the use of PDT antimicrobial treatment with methylene blue and 664 nm laser light for the sterilization of antibiotic resistant acutely and chronically infected wounds found in debilitated and diabetic patients.

Under two Phase I SBIR grants, Advanced Photodynamic Technologies successfully developed and patented a proprietary PDT technology that has been proven to be effective in the photoablation of antibiotic resistant microorganisms and biofilm that commonly infect chronic wounds. The primary objective of this Phase II SBIR research proposal is to develop a commercializable Antimicrobial Wound Bandage using the developed photodynamic therapy (PDT) technology. Chronic wounds afflict 18 million people in the United States annually and are a tremendous financial drain to our healthcare system, accounting for tens of billions of dollars annually. Wounds become chronic as a result of delayed or impaired healing usually caused by an underlying medical condition and/or most commonly by an infection. In addition to the problem, the prevalence of antibiotic resistant bacteria has diminished the effectiveness of standard antibiotic therapy for infections and has become a significant worldwide health problem that is causing the medical community to search for alternatives to antibiotic treatment. An alternative anti-infective modality for the treatment of wound/ulcer infections would be a significant medical advancement. The specific aim of this proposal is to develop and fabricate a commercializable PDT Antimicrobial Wound Bandage design based on the specifications established in previous studies. The PDT Bandage fabricated design will then be tested in vitro on antibiotic resistant bacteria and biofilm to optimize the definitive photosensitizer concentrations and light dosage. The PDT Bandage will then be tested in vivo on an infected wound model to demonstrate efficacy. The data generated by this proposal will be used to apply for regulatory 510k approval from the FDA.

Thesaurus Terms:
antibacterial agent, photosensitizing agent, phototherapy, technology /technique development, wound healing, wound infection biofilm, biomedical device power system, chronic disease /disorder, drug resistance, surgery material /equipment histology, swine