Breakthrough Evidence on Vomaris Bioelectric Technology’s Impact on Wound Biofilm Infection

Vomaris Innovations, Inc. announced today breakthrough results of the first controlled, preclinical in vivo evidence on the anti-biofilm impact of the Company’s bioelectric antimicrobial technology. The study found that the technology can prevent and disrupt biofilm infection and restore functional wound healing. The manuscript, “Electric Field Based Dressing Disrupts Mixed-Species Bacterial Biofilm Infection and Restores Functional Wound Healing,” was published online in the Annals of Surgery. The research was led by Chandan Sen, Ph.D., Professor of Surgery and Director of the Comprehensive Wound Center at The Ohio State University’s Wexner Medical Center.

Bacteria use electrical interactions to communicate with each other in a process called quorum sensing (QS), signaling them to adhere to a wound, multiply, and encase themselves within a protective structural substance known as a biofilm. This protective biofilm barrier impedes the body’s immune defense system and renders the bacteria highly resistant to antibiotics, making biofilm infections extremely difficult to treat.

The impact of biofilm infection in both chronic and surgical wounds is substantial, leading to increased morbidity, mortality, and cost. Approximately 80% of these infections are believed to be caused by bacteria within biofilm.^1,2 Chronic wounds affect an estimated 6.5 million patients a year and over $25 billion is estimated to be spent annually on their treatment.³ Surgical site infections (SSIs) occur in 2% to 5% of all patients undergoing inpatient surgery and affect up to 300,000 patients a year in the U.S. alone. Annual costs of managing SSIs are believed to range from $3.5 billion to $10 billion.^4,5

The biofilm infection problem is further compounded by the growing concern over antibiotic resistance. According to a recent World Health Organization (WHO) report, antibiotic resistance is a significant global health threat causing an estimated 700,000 deaths a year—a figure that is expected to explode to 10 million a year by 2050 if no action is taken.⁶

In the fight against biofilms and antibiotic resistance, current wound care practices and infection control strategies are no longer adequate. New antibiotics are likely not the answer as they can take up to a decade to reach the market. The need for alternative non-antibiotic solutions has never been greater.

Because deliberate infection with highly pathogenic biofilm-forming bacteria may only be conducted in a preclinical wound setting, Dr. Sen and his research team used an established porcine model of chronic biofilm infection to understand the wireless electroceutical dressing’s (WED) (i.e. Vomaris’s bioelectric technology) mechanism of action in the presence of an intact immune system.

 Pseudomonas aeruginosa and Acinetobacter baumannii are two of the most commonly found bacteria in wounds. They are well known for producing biofilms and being resistant to antibiotics and are also on the WHO list of 12 bacteria that pose the greatest risk to human health.⁶

In Dr. Sen’s study, burn wounds were inoculated with P. aeruginosa and A. baumannii and then treated with either a placebo dressing or WED for up to two months. In one cohort, the “prevention group,” the WED was applied within 2 hours of inoculation to test its ability to prevent biofilm formation. In the other cohort, the “rescue group,” the WED was applied after 7 days of inoculation and biofilm infection establishment to study disruption of existing biofilm.

Sen and colleagues report:

• When used preventively, WED circumvented biofilm formation.
• Even after a pathogenic biofilm infection had formed, WED disrupted biofilm infection and related pathological complications.
• WED markedly blunted the biofilm-induced expression of QS genes (p<0.05 compared to placebo), a finding that was consistent with published in vitro This effectively disabled the biofilm’s structural integrity.

“Electric principles offer significant potential to fight biofilm infection and address antibiotic resistance,” said Dr. Sen. “The approach is safe for humans and relies on principles that are not subject to conventional drug-resistance mechanisms often employed by bacteria to overcome pharmacological interventions,” he added.

Sen also found that WED blunted the expression of genes responsible for biofilm-induced loss of skin barrier function. “This is significant because wounds can sometimes appear closed, yet functionally they are open because skin barrier function remains compromised. We found that in the biofilm prevention and rescue groups, both placebo and WED-treated wounds appeared to be healing as appreciated visually and yet, upon deeper examination, only the wounds treated with WED demonstrated significant restoration of skin barrier function – or true functional closure,” Dr. Sen explained.

“We are very excited to have this anti-biofilm data published in the most widely cited surgical journal in the world. No other wound care company to date has published in vivo anti-biofilm evidence,” said Vomaris President and CEO Michael Nagel. “Our technology is simple to use, extremely cost effective, and has the potential to disrupt the advanced wound care market. It may provide surgeons and wound care clinicians with a non-antibiotic solution to the growing wound biofilm infection and antimicrobial resistance problems.”

References

1. Edmiston CE, McBain AJ, Roberts C, et al. Clinical and Microbiological Aspect of Biofilm-Associated Surgical Site Infections. Adv Exp Med Biol. 2015;830:47-67.
2. Wolcott R, Dowd S. The Role of Biofilms: Are We Hitting the Right Target? Plast Reconstr Surg. 2011;172:28S-35S.
3. Sen CK, Gordillo GM, Roy S, et al. Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy. Wound Repair Regen. 2009;17:763-771.
4. Korol E, Johnston K, Waser N, et al. A Systematic Review of Risk Factors Associated with Surgical Site Infections Among Surgical Patients. PLoS One. 2013;8:e83743.
5. Loyola University Health System. Surgical Site Infections are the Most Common and Costly of Hospital Infections [ScienceDaily web site]. January 19, 2017. Available at: https://www.sciencedaily.com/releases/2017/01/170119161551.htm. Accessed September 12, 2017.
6. Senthilingam M. WHO: These 12 Bacteria Pose Greatest Risk to Human Health. February 27, 2017. Available at: http://www.cnn.com/2017/02/27/health/who-bacteria-antibiotics-list-amr/index.html. Accessed September 12, 2017.
7. Available at: https://vomaris.com/. Accessed September 12, 2017.