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Ceragenin-coated pedicle screws to tackle surgical-site infectionsAward last edited on: 2/9/2024
Sponsored Program
SBIRAwarding Agency
NIH : NIAIDTotal Award Amount
$258,455Award Phase
1Solicitation Topic Code
855Principal Investigator
Glenn BrunnerCompany Information
Phase I
Contract Number: 1R43AI174666-01Start Date: 12/2/2022 Completed: 11/30/2024
Phase I year
2023Phase I Amount
$258,455Public Health Relevance Statement:
PROJECT NARRATIVE Surgical Site Infection (SSI) is one of the major complications of spinal surgery, where SSI leads to unfavorable health and functional outcomes. Current strategies to generate antimicrobial coatings to prevent microbial colonization on the surface of implanted medical devices, such as pedicle screws, do not show broad-spectrum antimicrobial activity. N8 Medical proposes a novel coated pedicle screw based on ceragenins (CSAs) able to eradicate both bacterial and fungal populations (including resistant strains) and to prevent the formation of biofilms without engendering resistance.
Project Terms:
Anti-Infective Drugs; Anti-Infectives; Anti-infective Preparation; AntiInfective Drugs; AntiInfectives; Antiinfective Agents; communicable disease control agent; Anti-Infective Agents; Antiseptics; Local Antiinfective Agents; Topical Anti-Infective Agents; Topical Antiinfective Agents; Local Anti-Infective Agents; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Antibiotics; Biochemistry; Biological Chemistry; Body Weight; bone; Bone Screws; California; Candida albicans; C albicans; C. albicans; C.albicans; Cells; Cell Body; Chemistry; High Pressure Liquid Chromatography; HPLC; High Performance Liquid Chromatography; High Speed Liquid Chromatography; Communities; Complete Blood Count; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Extracellular Matrix; Cell-Extracellular Matrix; ECM; Face; faces; facial; fungus; Gram-Negative Bacteria; Health; Healthcare Systems; Health Care Systems; Implantation procedure; implant placement; implant procedure; In Vitro; Infection; Leadership; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; lumbar vertebra bone structure; Lumbar Vertebrae; Marketing; Medical Device; Medicine; Metals; Morbidity - disease rate; Morbidity; mortality; Patients; Polymers; polymer; polymeric; Postoperative Period; Post-Operative; Postoperative; Production; Pseudomonas aeruginosa; P aeruginosa; P. aeruginosa; Pseudomonas pyocyanea; Quality of life; QOL; Oryctolagus cuniculus; Domestic Rabbit; Rabbits; Rabbits Mammals; Risk; Safety; Sales; Vertebral column; Spinal Column; Spine; backbone; Genus staphylococcus; Staphylococcus; Staphylococcus aureus; S aureus; S. aureus; Staph aureus; Mechanical Stress; Surgical Wound Infection; surgical site infection; Medical Technology; Tissues; Body Tissues; Titanium; Ti element; Universities; Generations; Measures; Microbial Biofilms; biofilm; Businesses; polycaprolactone; Organ; improved; Surface; Clinical; Microscopic; Penetration; Phase; Medical; Failure; Licensing; Dysfunction; Physiopathology; pathophysiology; Functional disorder; Antibiotic Premedication; Antibiotic Prophylaxis; Frequencies; Immune; Immunes; microorganism; Spinal; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; spine bone structure; Vertebrae; Vertebral; Surgeon; amphiphilicity; biomaterial compatibility; biocompatibility; experience; success; microbial colonization; professor; novel; Reporting; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Deterioration; Modeling; Property; Intervention; Intervention Strategies; interventional strategy; Surgical Models; Second Look Surgery; Second Look; Surgical Revision; MRSA; Methicillin Resistant S Aureus; Methicillin Resistant S. Aureus; methicillin-resistant S. aureus; methicillin resistant Staphylococcus aureus; Effectiveness; Tissue Sample; preventing; prevent; Dose; Device or Instrument Development; device development; instrument development; Harvest; International; in vivo; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; validations; Monitor; Principal Investigator; Process; Modification; Development; developmental; pre-clinical; preclinical; antimicrobial peptide; anti-microbial peptide; medical implant; designing; design; functional outcomes; pathogen; Population; resistant; Resistance; anti-microbial; antimicrobial; Implant; implantation; resistance strain; resistant strain; full scale manufacturing; large scale manufacturing; mass production; large scale production; flexible; flexibility; Phase I Study; phase 1 study; metallicity; Formulation; Spinal surgery; Spine surgery; in vivo testing; in vivo evaluation; death risk; mortality risk; rate of infection; infection rate
Phase II
Contract Number: ----------Start Date: 00/00/00 Completed: 00/00/00