Sentinel Studies Find New Microcurrent Generating Wound Dressing Effective in Disrupting Bacterial Biofilms

TEMPE, Arizona, April 6, 2015 /PRNewswire/ -- Procellera^® from Vomaris Innovations, Inc. (now available through Arthrex as JumpStart™) - the only wound dressing powered by Advanced Microcurrent Technology™, has been found to significantly disrupt bacterial biofilms, according to two new published research studies in PLoS ONE and the Journal of Wound Care^1-2.

Studies conducted at The Ohio State University (OSU) Wexner Medical Center, and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and its Diagnostics and Translational Research Center (DTRC) both confirmed significant anti-biofilm efficacy of Procellera Technology. Bacterial biofilms are complex networks of microorganisms bound together and covered with a slimy protective barrier. They can be found in living tissues, indwelling medical devices, and implants. Biofilm-associated bacteria are extremely resistant to antibiotics and have been implicated in wound infections, resulting in delayed healing, poor clinical outcomes and significant healthcare costs.

In the OSU study, researchers evaluated the effects of Procellera / JumpStart technology to better understand its antimicrobial properties, particularly related to the disruption of Pseudomonas aeruginosa. This bacterial species is often present in chronic wound infections and readily forms biofilm, making it extremely difficult to treat effectively with available antibiotics.

"This work presents clear evidence that this wireless electroceutical dressing disrupts bacterial biofilm," said Chandan K Sen, Ph.D., Professor of Surgery and Director of the Comprehensive Wound Center at OSU Wexner Medical Center. "Our findings introduce the option of a new affordable technology platform to fight chronic wound infection in which bacterial biofilms are abundant."

Several mechanisms behind the ability of this Advanced Microcurrent Technology to disrupt the formation of bacterial biofilms were identified:

• First, the microcurrent technology aided the generation of superoxide radicals, chemical compounds that are produced by white blood cells in the body with the goal to fight infection.
• Second, researchers discovered that the microcurrents significantly impaired the activity of glycerol-3-phosphate dehydrogenase (GPDH), an electrically sensitive enzyme that is required for bacterial respiration and metabolism.
• Finally, the research found that the microcurrents disrupted some key antimicrobial resistance genes, silenced some key redox-sensitive, quorum sensing genes and interfered with production of bacteria signaling molecules, thus preventing the bacteria from forming the complex networks that make up biofilms.

Because bacterial biofilms are known to compromise production of antimicrobial superoxide radicals by immune cells, weakening the ability of the body to fight infection, the study's observation that Procellera initiated spontaneous generation of superoxide radicals is particularly significant.

Research performed at DTRC and HJF studied the anti-biofilm properties of Procellera Technology against ten clinical wound pathogens in a poloxamer biofilm model customized to evaluate the bioelectric dressing. Investigators demonstrated Procellera / JumpStart's effectiveness against biofilms across multiple species of clinical wound pathogens, with up to a thousand-fold inhibition of microbial growth in several species when compared to controls. This observation is consistent with the observations reported independently from OSU.

"We are very encouraged by the implications of these results for wound care, which showed that this electroceutical dressing was effective in inhibiting growth of both mono- and multi-species biofilms, including multi-drug resistant strains," said Dr. Mina Izadjoo, principal investigator for the DTRC/HJF study.

"Bacterial biofilms can dramatically impede wound healing and penetrate deeper into a wound bed to further infect implanted devices," said Michael Nagel, President and Chief Executive Officer of Vomaris Innovations, Inc. "Because of their resistance to treatment, biofilms present a significant challenge in today's healthcare environment. We, at Vomaris, are extremely pleased by these latest findings by two independent laboratories about this Technology's ability to inhibit and disrupt biofilms and the significant implications this has for infection control and wound healing."

PLoS One study co-authors included Jaideep Banerjee, Piya Das Ghatak, Sashwati Roy, Ph.D., Savita Khanna, Ph.D., Craig Hemann, Jay L Zweier, M.D., and Daniel Wozniak, Ph.D. of The Ohio State University. The study was supported in part by the National Institutes of Health: Grant Numbers GM077185, GM069589 and DOD W81XWH-11-2-0142 to CKS; NIH NR013898 to CKS and DJW; and in part by NIH DK076566 to SR and NIH R01AI097511 to DJW.

Co-authors of the Journal of Wound Care article included Hosan Kim, Ph.D. The study was supported by Vomaris.

About Vomaris Innovations
Vomaris Innovations, Inc. is an electroceutical company specializing in microcurrent-generating solutions for the wound care market and beyond. Utilizing electricity to mimic the body's own physiologic electric currents, which are essential for skin repair and wound healing, Vomaris' core technology platform employs imbedded microcell batteries that generate microcurrents in the presence of a conductive medium to harness the power of electricity to support healing.

Vomaris' flagship product, Procellera^® Antimicrobial Wound Dressing is the only wound dressing in the world powered by Advanced Microcurrent Technology. It is a new generation solution for wound and incisional care with demonstrated broad-spectrum antimicrobial efficacy³ and the ability to promote wound healing⁴, and is available exclusively through Arthrex as JumpStart Technology with Advanced Microcurrent Healing.

Procellera / JumpStart is currently used in multiple acute and chronic wound care settings, including clinical, animal and consumer health. The company's ongoing mission is to develop and deliver evidence-based, patient-focused and cost-effective solutions, backed by a commitment to quality and innovation for the improvement of lives.

About Arthrex
Arthrex, Inc. is a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 8,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide. Arthrex remains dedicated to delivering uncompromising quality to the healthcare professionals who use its products, and ultimately, the millions of patients whose lives these products impact.

1. Kim H, Izadjoo MJ. Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. J Wound Care 2015; 24 Suppl 2:S10-4.
2. Banerjee J, Ghatak PD, Roy S, Khanna S, Hemann C, Deng B, et al. (2015) Silver-Zinc Redox-Coupled Electroceutical Wound Dressing Disrupts Bacterial Biofilm. PLoS ONE 10(3): e0119531. doi:10.1371/journal.pone.0119531
3. Kim H, Makin I, Skiba J, Ho A, Housler G, Stojadinovic A, Izadjoo M. Antibacterial Efficacy Testing of a Bioelectric Wound Dressing Against Clinical Wound Pathogens.  The Open Microbiology Journal 2014; 8:15-21.
4. Banerjee J, Ghatak P, Roy S, Khanna S, Sequin EK, Bellman K, Dickinson BC, Suri P, Subramaniam V, Chang CJ, Sen CK.  Improvement of human keratinocyte migration by a redox active bioelectric dressing. PLOS ONE. 2014; 9(3).