DeBogy Molecular, Inc, a biotech startup that specializes in antimicrobial surface modification, today announced the findings of a landmark in vivo research study that affirms the effectiveness and safety of their new technology to kill the dangerous bacteria that proliferates on the surface of a medical implant following surgery.
Infection resulting from bacterial biofilm that forms on the surface of a medical implant represents one of the most serious complications that can follow orthopedic surgery or the implantation of a medical device. Implant related infections account for over half of the 2 million yearly healthcare-associated infections in the U.S., at a cost of over $27 billion dollars annually.
A preclinical research study was conducted by Vivexia, an independent Clinical Research Organization, to evaluate the efficacy and safety of DeBogy-treated titanium implants against the formation of bacterial biofilm. A total of 121 mice were implanted and studied for bacterial attachment on the implant and the level of infection in the surrounding tissue vs untreated control. The study was overseen by a group of medical research scientists and all lab protocols were validated by a veterinary ethics committee.
Study Results Summary
Bacterial biofilm on the DeBogy-treated implants was reduced by 99.97% vs untreated control, 7 days following surgery
Bacterial load in the surrounding tissue in animals with DeBogy-treated implants was reduced by 99.8% vs untreated control, 7 days following surgery
The surrounding tissue in animals with DeBogy-treated implants was healthier overall, with decreases in inflammation, fibrosis, vascularization, and necrosis
Excellent clinical health and biocompatibility were recorded in animals with DeBogy-treated implants
“The promise of a new, disruptive technology that can permanently protect the surface of an implantable device from the formation of dangerous bacterial biofilm, without the use of toxic chemicals, coatings or even antibiotics, is truly transformational,” said Wayne Gattinella, CEO of DeBogy Molecular. “The study results affirm that DeBogy technology has the potential to save lives and dramatically improve the quality of life for millions of people, young and old.”
It should be noted that these study results were delivered under a stringent model using a high inoculum of methicillin-resistant Staphylococcus aureus (MRSA) with direct injection into the operative site after skin closure and without the use of antibiotics. This far surpasses most real-world situations for clinical surgical contamination.
“The bacterial reductions reported on the DeBogy-treated implants and in the surrounding tissues vastly outperformed existing scientific literature on similar animal models using conventional treatment,” said Dr Houssam Bouloussa, spine surgeon and cofounder, DeBogy Molecular. “This technology has the potential to revolutionize the way we prevent and treat surgical-site infections.”
Initial feedback was collected from key opinion leaders in orthopaedic surgery and infectious disease on the significance of these study findings:
“Implant-related infections are difficult to treat and are often devastating to patients and healthcare payers alike. The results of the DeBogy antimicrobial study bring hope to clinicians like me that an effective preventative measure for implant-related infections is finally on the horizon.”
Dr Matthew Grant, Assistant Professor of Infectious Disease, Yale School of Medicine
“DeBogy technology has the potential to deliver the most important antimicrobial solution to the medical marketplace that I have seen in my 30 years of practice. The efficacy and safety of this new technology can dramatically reduce the patient burden associated with implant related infections.”
Dr James J. Yue, Orthopedic Spine Surgeon, CT Orthopaedic Specialists,
Associate Professor, Frank H Netter School of Medicine,
former Co-Chief of Orthopedic Spine Surgery, Yale School of Medicine
“Periprosthetic joint infections are recognized as a leading cause of morbidity and mortality in orthopaedic surgery. The results of the DeBogy in vivo study show unique promise to introduce a new solution to this recognized postoperative complication.”
Dr Antonia Chen, Orthopedic Surgeon
The complete DeBogy research study will be presented at the North American Spine Society Annual Meeting in Chicago in October 2022. For a copy of the research White Paper send your request to contact@debogy.com.
About DeBogy Molecular
DeBogy Molecular Inc is a biotechnology company dedicated to surface modification innovation. Founded in 2019 after more than 15 years of research and development, our proprietary IP can modify molecular surface structures to electrostatically destroy virus, bacteria, and fungus on contact. The DeBogy platform is effective across a wide range of materials for industries that include medical, consumer health, textiles and industrial manufacturing. Our goal is to ensure a safe, secure, germ-free environment.