ARMINGTON, Conn.– 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.”
