PHARMINGTON, Connecticut – June 27, 2022 – DeBogy Molecular, Inc., a biotech startup that specializes in antimicrobial surface modification, today announced the findings of a remarkable in vivo study that confirms the effectiveness and safety of their new technology to kill dangerous bacteria. which multiply on the surface of a medical implant after surgery.
Infection resulting from a bacterial biofilm that forms on the surface of a medical implant is one of the most serious complications that can follow orthopedic surgery or implantation of a medical device. Implant-related infections account for more than half of the 2 million annual health-related infections in the United States, at a cost of more than $ 27 billion a year.
A preclinical study was performed by Vivexia, an independent clinical research organization, to evaluate the efficacy and safety of DeBogy-treated titanium implants against bacterial biofilm formation. A total of 121 mice were implanted and tested for bacterial attachment to the implant and the level of infection in the surrounding tissues relative to the untreated control. The study was monitored by a team of medical scientists and all laboratory protocols were validated by a veterinary ethics committee.
Summary of study results
- Bacterial biofilm on implants treated with DeBogy was reduced by 99.97% compared to the untreated control, 7 days after surgery
- The bacterial load in the surrounding tissues in animals with implants treated with DeBogy was reduced by 99.8% compared to the untreated control, 7 days after surgery
- Surrounding tissues in animals with DeBogy-treated implants are generally healthier, with reduced inflammation, fibrosis, vascularization, and necrosis.
- Excellent clinical health and biocompatibility have been reported in animals with implants treated with DeBogy
“The promise of new, destructive technology that can permanently protect the surface of an implantable device from the formation of a dangerous bacterial biofilm, without the use of toxic chemicals, coatings or even antibiotics, is truly transformative,” said Wayne Gatinella, CEO of Molecular DeBogy. . “The results of the study confirm that DeBogy technology has the potential to save lives and dramatically improve the quality of life of millions of people, young and old.
It should be noted that these test results were delivered in a rigorous model using a high inoculum of methicillin-resistant Staphylococcus aureus (MRSA) with direct injection at the surgical site after skin closure and without the use of antibiotics. This goes far beyond most real situations of clinical surgical contamination.
“The reduction in bacteria reported on DeBogy-treated implants and in surrounding tissues is far superior to the existing scientific literature on such animal models using conventional treatments,” said Dr. Houssam Bouloussa, a spinal surgeon and co-founder of DeBogy Molecular. “This technology has the potential to revolutionize the way we prevent and treat surgical infections.
Initial feedback was gathered from key opinion leaders in orthopedic surgery and infectious diseases about the importance of these study results:
“Implant-related infections are difficult to treat and often devastating for both patients and paying healthcare providers. The results of DeBogy’s antimicrobial study inspire clinicians like me to hope that an effective preventative measure for implant-related infections is finally on the horizon. – Dr. Matthew Grant, Infectious Diseases Assistant, Yale School of Medicine
“DeBogy technology has the potential to deliver the most important antimicrobial solution on the medical market that I have seen in my 30 years of practice. The efficacy and safety of this new technology can drastically reduce the severity of patients associated with implant-related infections. “-Dr. H Netter, former co-director of Orthopedic Spine Surgery, Yale School of Medicine
“Periprosthetic joint infections are recognized as a leading cause of morbidity and mortality in orthopedic surgery. The results of the DeBogy in vivo study show a unique promise to introduce a new solution to this recognized postoperative complication. – Dr. Antonia Chen, orthopedic surgeon
The full DeBogy research study will be presented at the annual meeting of the North American Spine Society in Chicago in October 2022. For a copy of the study’s White Paper, send your request to [email protected]
Published: June 29, 2022
Source: DeBogy Molecular, Inc.