2
X X BlastX Antimicrobial Wound Gel Demonstrates Successful Management of the Wound % Wound Closure 100% 80% 60% 40% 20% 0% BlastX No Statistical Difference >1.5X Wound Closure SOC SOC + BlastX 53% 80% 93% A 4-week, prospective, randomized, clinical trial evaluating 45 patients with chronic wounds. All wounds received serial debridement and either BlastX Antimicrobial Wound Gel, custom topical antibiotics Standard of Care (SOC) or the combination of both. Wound Closure: 1.5X relative increase in wound treatment success over the SOC when using BlastX, (53% and 80% respectively, P<0.05), with no statistical difference over BlastX when BlastX and the SOC were combined. Wound Volume Reduction: 32% greater wound volume reduction when using BlastX compared to the SOC. * A successfully treated wound is defined as >50% reduction of wound volume in 4 weeks. BlastX Antimicrobial Wound Gel works by creating a moist wound healing environment that removes barriers to the body’s natural healing process. Please refer to indications for use of this product. BlastX Antimicrobial Wound Gel Demonstrates Successful Management of the Wound 10 The Challenge of Chronic Wounds and Biofilm Biofilm is prevalent in nearly 80% of all chronic wounds and it perpetuates the inflammatory phase of wound healing. 1 As biofilm matures, bacteria continue changing their phenotype, sharing their resistance to antibiotics with the community. 2 Compounding this challenge is the fact that current available biofilm treatments can stall healing. 12 The periodic release of planktonic bacteria from biofilms has been linked to chronic relapsing infections. 5 10% 90% OF BACTERIA ARE PLANKTONIC/ FREE-FLOATING OF BACTERIA EXISTS IN BIOFILMS 6 Bacteria protected by biofilm EPS can be more resistant to antibiotics than planktonic bacteria. 3,4 BlastX Antimicrobial Gel helps solve the problem of bacterial biofilm. Others only address the tip of the iceberg 1,000x BlastX Antimicrobial Wound Gel Reduces Biofilm Bacteria 4-6 Log in Laboratory Tests In in vitro studies, BlastX Antimicrobial Wound Gel was compared to antimicrobial containing therapies. 24 hours after application, measurements were taken for two different kinds of biofilm bacteria (S. aureus and P. aeruginosa). Compared to the other topical antimicrobials, BlastX Antimicrobial Wound Gel significantly reduced the number of biofilm bacteria present by 4 to 6 log. 8,9 Log Reduction from Control (CFU) 1.0 0.0 2.0 3.0 4.0 5.0 6.0 Microcyn ® Prontosan ® Thermazene ® Mepilex Ag ® SilvaSorb ® BlastX All product names are the property of their respective owners. P. aeruginosa S. aureus Optimize/personalize therapy according to healing status Assess inflammation and healing status ~ days 5-7 ~ weeks 1-4 Continue until healed Evaluate wound healing and decide Step up to advanced therapies Re-evaluate need for topical antiseptics and systemic antibiotics Advanced therapies: • Growth factors • Skin grafts • Combination products • Negative pressure wound therapy Optimize/personalize topical antiseptics and systemic antibiotics Continue management of host factors Continue management of host factors Standard care Standard care ~ days 1-4 Empiric topical antiseptics and systemic antibiotics Manage host factors (off-loading, compression, diabetes, nutrition) DNA identification of microorganisms and point-of-care diagnostics Appropriate debridement De-escalate treatment as wound improves Assess inflammation and healing status Maintenance debridement Initiate multiple therapies in combination Aggressive debridement Source: Schultz G, Bjarnsholt T, James GA, et al. Consensus guidelines for the identification and treatment of biofilms in chronic nonhealing wounds. Wound Repair Regen. 2017;25(5): 744-757. Early intervention with multiple therapies and effective antibiofilm antimicrobial is key Upgrade your standard of care with effective antibiofilm technology Follow this recommended step-down/step-up approach with the use of biofilm- disrupting technology for the management of wounds. 11

antibiofilm technology · Technology With the biofilm matrix dissolved, bacteria are exposed and more vulnerable to attack. The Xbio Technology creates a high osmolarity condition

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Page 1: antibiofilm technology · Technology With the biofilm matrix dissolved, bacteria are exposed and more vulnerable to attack. The Xbio Technology creates a high osmolarity condition

XX

BlastX Antimicrobial Wound Gel Demonstrates Successful Management of the Wound

% W

ound

Clo

sure

100%

80%

60%

40%

20%

0%BlastX

No Statistical Difference

>1.5X Wound Closure

SOC SOC + BlastX

53%

80%93%

A 4-week, prospective, randomized, clinical trial evaluating 45 patients with chronic wounds. All wounds received serial debridement and either BlastX Antimicrobial Wound Gel, custom topical antibiotics Standard of Care (SOC) or the combination of both.

‣ Wound Closure: 1.5X relative increase in wound treatment success over the SOC when using BlastX, (53% and 80% respectively, P<0.05), with no statistical difference over BlastX when BlastX and the SOC were combined.

‣ Wound Volume Reduction: 32% greater wound volume reduction when using BlastX compared to the SOC.

* A successfully treated wound is defined as >50% reduction of wound volume in 4 weeks. BlastX Antimicrobial Wound Gel works by creating a moist wound healing environment that removes barriers to the body’s natural healing process. Please refer to indications for use of this product.

BlastX Antimicrobial Wound Gel Demonstrates Successful Management of the Wound10

The Challenge of Chronic Wounds and BiofilmBiofilm is prevalent in nearly 80% of all chronic wounds and it perpetuates the inflammatory phase of wound healing.1

As biofilm matures, bacteria continue changing their phenotype, sharing their resistance to antibiotics with the community.2

Compounding this challenge is the fact that current available biofilm treatments can stall healing.12

The periodic release of planktonic bacteria from biofilms has been linked to chronic relapsing infections.5

10%

90%

OF BACTERIA ARE PLANKTONIC/FREE-FLOATING

OF BACTERIA EXISTS IN BIOFILMS6

Bacteria protected by biofilm EPS can be

more resistant to antibiotics than planktonic bacteria.3,4

BlastX Antimicrobial Gel helps solve the problem of bacterial biofilm.

Others only address the tip of the iceberg

1,000x

BlastX Antimicrobial Wound Gel Reduces Biofilm Bacteria 4-6 Log in Laboratory Tests

In in vitro studies, BlastX Antimicrobial Wound Gel was compared to antimicrobial containing therapies. 24 hours after application, measurements were taken for two different kinds of biofilm bacteria (S. aureus and P. aeruginosa). Compared to the other topical antimicrobials, BlastX Antimicrobial Wound Gel significantly reduced the number of biofilm bacteria present by 4 to 6 log.8,9

Log

Red

uctio

n fr

om C

ontr

ol (C

FU) 1.0

0.0

2.0

3.0

4.0

5.0

6.0

Microcyn®Prontosan® Thermazene®Mepilex Ag® SilvaSorb® BlastX™

All product names are the property of their respective owners. P. aeruginosa S. aureus

Optimize/personalize therapy according to healing status

Assess inflammation and healing status

~ days 5-7 ~ weeks 1-4 Continue until healed

Evaluate wound healing and decide

Step up to advanced therapies

Re-evaluate need for topical antiseptics and systemic antibiotics

Advanced therapies:

• Growth factors• Skin grafts• Combination products• Negative pressure wound therapy

Optimize/personalize topical antiseptics and systemic antibiotics

Continue management of host factors

Continue management of host factors

Standard care Standard care

~ days 1-4

Empiric topical antiseptics and systemic antibiotics

Manage host factors (off-loading, compression,diabetes, nutrition)

DNA identification of microorganisms and point-of-care diagnostics

Appropriate debridement

De-escalate treatment as wound improves

Assess inflammation and healing status

Maintenance debridement

Initiate multiple therapies in combination

Aggressive debridement

Source: Schultz G, Bjarnsholt T, James GA, et al. Consensus guidelines for the identification and treatment of biofilms in chronic nonhealing wounds. Wound Repair Regen. 2017;25(5): 744-757.

Early intervention with multiple therapies and effective antibiofilm antimicrobial is key

Upgrade your standard of care with effective antibiofilm technologyFollow this recommended step-down/step-up approach with the use of biofilm-disrupting technology for the management of wounds.11

Page 2: antibiofilm technology · Technology With the biofilm matrix dissolved, bacteria are exposed and more vulnerable to attack. The Xbio Technology creates a high osmolarity condition

CONTAINS: Benzalkonium Chloride 0.13%, Polyethylene Glycol 400, Polyethylene Glycol 3350, Sodium Citrate, Citric Acid, and Water. CONTRAINDICATIONS: BlastX Antimicrobial Wound Gel should not be used if there is a history of allergy to any of the ingredients.PRECAUTIONS: Do not cover with alginate dressings.

ORDERING INFORMATION

Document MPN-WG-003 Rev D | 70-2011-7187-6

10550 Deerwood Park Blvd #300Jacksonville, FL [email protected]

Phone 1-800-228-3957Web 3M.com/Medical

INDICATIONS BlastX Antimicrobial Wound Gel is indicated for the management of wounds such as: ‣ stage I-IV pressure ulcers ‣ partial- and full-thickness wounds ‣ diabetic foot and leg ulcers

‣ post-surgical wounds ‣ first and second degree burns ‣ grafted and donor sites DISCOVER THE

X FACTOR IN BIOFILM DISRUPTION

ANTIMICROBIAL WOUND GEL

1. James GA, Swogger E, Wolcott R, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008;16(1):37-44. 2. Omar A, Wright JB, Schultz G, Burrell R, Nadworny P. Microbial Biofilms and Chronic Wounds. Microorganisms. 2017;5(1):9. 3. Chadha T. Bacterial biofilms: survival mechanisms and antibiotic resistance. J Bacteriol Parasitol. 2014;5(3):190. 4. Gupta K, Marques CN, Petrova OE, Sauer K. Antimicrobial tolerance of Pseudomonas aeruginosa biofilms is activated during an early developmental stage and requires the two-component hybrid SagS. J Bacteriol. 2013;195(21):4975-87. 5. Omar, A. W. (2017 March 7). Microbial biofilms and chronic wounds. Microorganisms 5(1). 6. Petrova OE, Sauer K. Sticky situations: key components that control bacterial surface attachment. J Bacteriol. 2012;194(10):2413-25. 7. Data on file. 8. Miller KG, Tran PL, Haley CL, Kruzek C, Colmer-Hamood JA, Myntti M, Hamood AN. Next science wound gel technology, a novel agent that inhibits biofilm development by gram-positive and gram-negative wound pathogens. Antimicrob Agents Chemother. 2014;58(6):3060-72. 9. Laboratory testing data on file. 10. Wolcott, R. (2015). Disrupting the biofilm matrix improves wound healing outcomes. Journal of Wound Care 24(8), 366-71. doi: 10.12968/jowc.2015.24.8.366 11. Schultz G, Bjarnsholt T, James GA, Leaper DJ, McBain AJ, Malone M, Stoodley P, Swanson T, Tachi M, Wolcott RD. Consensus guidelines for the identification and treatment of biofilms in chronic nonhealing wounds. Wound Repair Regen. 2017;25(5): 744-757. 12. Snyder, R. B. (2017). Wound Biofilm: current perspectives and strategies on biofilm disruption and treatments. Wounds Supplement 29(6 suppl) , S1-S17.

BLASTX and XBIO are trademarks of Next Science IP Holdings Pty Ltd.3M is a registered trademark of 3M Company. © 2019 Next Science.

Biofilm EPS MatrixNegatively Affects HealingBiofilms are formed in wounds when bacteria attach to surface structures and produce a protective barrier called extracellular polymeric substance (EPS). This biofilm matrix surrounds and encapsulates the bacteria, shielding them from both mechanical and chemical attack. EPS protects bacteria—making it up to 1000x more difficult to eradicate—and delays the wound healing process.3,4

Wound biofilms are comprised of EPS matrix and may containpolymicrobial species of: ‣ gram-positive bacteria ‣ gram-negative bacteria ‣ fungi and spores

FDA CLASSIFICATION: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.

Discover the X Factor

BlastX is a breakthrough antimicrobial wound gel powered by Next Science’s patented, non-toxic, biofilm-disrupting Xbio™ Technology.

It deconstructs the bacterial biofilm EPS matrix, destroys bacteria within the gel, and defends from recolonization while maintaining a moist wound environment.

7

The 3 Dimensions of How BlastX Antimicrobial Wound Gel Works

DECONSTRUCTthe bacterial biofilm matrix

As opposed to free-floating bacteria, biofilms are powerful communities that function as a single entity with robust defense mechanisms. By targeting the biofilm structure and breaking it apart, Next Science’s Xbio Technology deconstructs the biofilm matrix without harming healthy human tissue.9

DESTROYbacteria within the Technology

With the biofilm matrix dissolved, bacteria are exposed and more vulnerable to attack. The Xbio Technology creates a high osmolarity condition. This environment coupled with a surfactant induces cell lysis for bacteria enveloped within the gel. Cell lysis is nondiscriminatory, therefore Xbio Technology destroys gram-positive and gram-negative bacteria, persister cells, and spores.9

DEFENDfrom recolonization

Disrupting and destroying the biofilm matrix can reduce the rate of recurrence more than 100x, effectively defending against recolonization. Other antimicrobial agents may claim to destroy biofilms; however their efficacy could be undermined by bacterial resistance. In contrast, the biofilm matrix cannot re-form in the presence of the BlastX Antimicrobial Wound Gel wound gel. There is no known evidence of bacterial resistance to the Xbio Technology.9