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Landmark Study Reveals the Promise of Infection-Free Medical Implantation is Near: By Wayne Gattinella CEO DeBogy Molecular

Landmark Study Reveals the Promise of Infection-Free Medical Implantation is Near
Wayne Gattinella CEO DeBogy Molecular, Inc.

Infection-Free Medical Implantation Is Near

The demand for bacteria-free surfaces continues to increase—and there is no greater need for a sterile, antibacterial surface than with a biomedical device or implant.

Implant-related Infection (IRI) accounts for over half of the 2 million yearly healthcare-associated infections in the U.S. Treating these post-operative infections carries an enormous personal and financial burden. The full cost of medical device-related implant infections in the U.S. alone is estimated at $27 billion dollars annually.

For more than 50 years the common protocol to counter IRIs has been the prophylactic use of site-specific antibiotics or antiseptic solutions, applied internally to inhibit bacterial infection in the tissues that directly surround the physical implant. Unfortunately, these preventative measures do little to control the growth of bacterial biofilm on the surface of the implant itself.  It’s the biofilm on the surface that becomes the most challenging and dangerous source of postoperative infection. Once formed, an IRI will consume significant health resources to mitigate and in more than half of the cases will require a surgical revision to eliminate. For patients already burdened with comorbidities or age-related risks, a surgical revision yields dangerously high rates of morbidity and mortality.

Despite meaningful improvements in surgical hygiene and perioperative antibiotics, IRI remains the most frequently reported complication following surgery. Infections are the cause of 2 of every 5 total knee replacement revisions and nearly one-third of total hip arthroplasty revisions, with considerably lower survivorship when compared to aseptic causes.

The promise of a new, disruptive treatment technology that can permanently protect the surface of an implantable device, without the transient coating of toxic chemicals or metals and that does not alter the performance of the device itself, is transformational.

This is the promise of the new technology– a permanently grafted, biocompatible anti-microbial molecule, that confidently safeguards the newly implanted device from the harmful growth of bacterial biofilm.

This is the promise from our company at DeBogy Molecular.

Our company began as a family story in Paris more than two decades ago, where Dr. Othman Bouloussa, then Professor of Chemistry at the Curie Institute, perfected his research on antimicrobial surface modification. In 2019 DeBogy Molecular was founded, when orthopedic surgeon Dr. Houssam Bouloussa patented his uncle’s scientific discoveries here in the U.S. Today we are a diverse team of medical and scientific business professionals dedicated to surface modification innovation. Our proprietary IP can modify molecular surface structures to electrostatically destroy virus, bacteria, and fungus on contact.

Last month the results of an important landmark in vivo study were announced, that found DeBogy technology safely reduces the dangerous bacterial biofilm on medical implants by 99.97%, without the use of antibiotics or toxic chemicals. The preclinical research study was designed to evaluate the efficacy and safety of DeBogy-treated titanium implants against the formation of bacterial biofilm.  Vivexia, an independent CRO, implanted a total of 121 mice and studied them 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.

The research study found that:

  • 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. In the presence of infection, the data strongly demonstrates that DeBogy-treated titanium discs were able to effectively mitigate infection with a dramatic decrease in biofilm formation, and even eradicate infection completely in some of the animals, without the use of antibiotics.

In the surrounding tissue, there was significant bacterial log reductions reported at day 7 (2.7 median log10 reduction) and even more at day 14. Given that DeBogy technology is non-eluting and contact-killing, this time-dependent effect seems to reflect the combined impact of biofilm-inhibition at the surface of implants and the innate cellular immune response that clears the infection from the surrounding tissues. Indeed, biofilm plays a central role in the persistence of an IRI by allowing bacteria to shelter, use nutrients, and seed to further colonize the implant surface. This study affirms our view that preventing biofilm formation using covalently bound biocidal compounds will translate into lower rates of infection control failure, infection recurrence, surgical revisions, and overall morbidity and mortality.

Regarding the safety data, the pathology report, clinical tolerance data, and biochemical tests revealed no difference in local or systemic toxicity between the treated and control groups. Taken together, these findings strongly support an outstanding biocompatibility profile of DeBogy-treated titanium-alloy implants.

It should also be noted that these study results were delivered under a stringent model using a high MRSA inoculum 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.

What’s next….

With the efficacy and safety study results in hand, we are now turning our efforts to building a clear pathway for regulatory approval and new market applications. Indeed, the antimicrobial treatment of devices has been recognized by regulatory bodies as an integral factor towards combating healthcare-acquired infections. We are also focused on extending the innovation of DeBogy antimicrobial surface modifications across the entirety of surgical and medical applications. The versatility of our grafted antimicrobial technology is effective across a wide range of substrate materials, that include metals as well as plastics, fibers, and mixed composites.

The broader medical applications and benefits of antimicrobial surface modification are enormous. As practicing orthopedic surgeons, our DeBogy co-founders are keenly aware of the potential risks of contamination from all areas of the operating environment—surgical instruments, draperies, PPE, adhesives, and on the device itself. Despite the best efforts of laminar airflow and surgical aseptic techniques, once removed from the package, any of these “sterile” items can be contaminated by virulent bacteria that are increasingly resistant to even the most potent modern-day antibiotics.

Additionally, an often-overlooked area for health-acquired infections are the bloodstream infections that emanate from an IV line insertion—causing an estimated 500,000 central line-associated bloodstream infections each year. There are no market-stage vascular access devices that provide lasting protection against infection today. In addition, another 500,000 catheter-associated urinary tract infections are caused annually from bacterial contamination—which the CDC has declared an “unresolved issue”.

Conclusion

DeBogy technology that can protect the surface of an implantable device from the formation of bacterial biofilm, while maintaining a strong biocompatible safety profile, provides a promising breakthrough solution to reducing the enormous burden of postoperative infection and device-related healthcare-acquired infections. When viewed across the broader spectrum of health-acquired infections, I strongly believe that DeBogy’s transformative technology has the potential to save the lives and dramatically improve the quality of life for millions of people, young and old.

About the Author: Wayne was appointed CEO of DeBogy Molecular in June 2020. He leads the company’s initiatives to innovate and commercialize their proprietary IP, that can modify surface structures to destroy virus, bacteria and fungus on contact.  

An experienced CEO with a strong track record of scaling early-stage technology companies through high-performance growth cycles, Wayne has demonstrated strong leadership in driving product innovation, brand leadership, business development, and organizational transformation.

Wayne was CEO/President of WebMD from 2001-2012 where he built the company as the most recognized and trusted brand of health information for consumers and healthcare professionals. He led the company’s IPO in 2005 and grew the corp. over a to $600M revenues with a +$3B market cap over a 10-year period.

Most recently Wayne was CEO of DoubleVerify, an industry-leading digital data and analytics technology company. Wayne led the company’s explosive growth over an 8-year period from VC-backed start-up through a successful private equity transition, increasing revenues and net margins over 12x.

Wayne has held executive positions with Merck & Co, MCI Telecommunications, as well as board director positions with several public and private companies.  Wayne serves on the advisory board of the LeBow College of Business at Drexel University and holds an MBA from St Joseph’s University in Philadelphia.

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