Introducing. Wound Dressing. Incorporated with

Transcription

1 q Introducing Wound Dressing Incorporated with

2 Exciton s exsalt SD7 Wound Dressing utilizes the Company s patented silver oxysalts technology: Broad spectrum antimicrobial action Excellent biocompatibility slow ph shift silver in the +1, +2 and +3 valence states

3 Higher Valence State Silver Silver oxysalts on substrate More silver to the site in an active form Potency Minimal risk of bacteria resistance Resistance Less impairment to wound healing Ag +1 Ag +2 Ag +3 Toxicity

4 Coating Technology Ultra-thin silver film layer deposited on substrate Ag 2 SO 4 Ag 7 O 8 NO 3 Ag 3 O 4 AgO Ag 2 O 3 Efficient dip-rinse-dry process is ideal for coating a variety of wound care materials in high volumes Multiple species and oxidation/valence states enhance antimicrobial properties

5 Product Description: Consists of 2 outer layers of High Density Polyethylene (HDPE) With an inner layer of absorbent polyester All layers are coated with silver oxysalts

6 Indications: Partial and full thickness wounds Decubitus ulcers Venous stasis ulcers Diabetic ulcers First and second degree burns Grafts and donor sites May be used over debrided and grafted wounds

7 Optimal Silver Concentration Silver Content of Dressings* Proprietary Name Ag content (mg/100cm 2 ) Silverlon 546 Acticoat Calgitrol Ag 141 Contreet Foam 85 exsalt TM SD7 40 Contreet Hydrocolloid 32 Aquacel Ag 8.3 SilvaSorb 5.3 Actisorb Silver * data available

8 Not all Silvers are the same XRD Diffraction Analysis Exsalt SD7 Acticoat Mepilex Ag Aquacel Ag Silver oxysalt Ag 7 O 8 NO 3 ( ) Silver oxide Ag 2 O ( ) Metallic silver, Ag 0 ( ) Silver chloride ( ) Silver Sulfate ( ) Silverlon

9 Antibacterial action of competitive silver dressings 8 7 Staphylococcus aureus (ATCC #6538) exsalt TM SD7 (Exciton) Log Reduction (10 X ) Pass Fail Acticoat 7 (Smith & Nephew) Silverlon (Argentum Medical) Allevyn Ag (Smith & Nephew) Medifoam S (Biopol Korea) Mepilex Ag (Mölnlycke) Aquacel Ag (Convatec) Silver Dressings (4 hr. exposure; 10 6 starting inoculum)

10 7 Consecutive Day Challenge with 10 6 CFU/mL of Inoculum Inoculation, Neutralization, Dilution and Plating Scheme of 7 Day Challenge of exsalt TM SD7 Wound Dressings Time Test Set ** Day 1 Test Set Day 3 Test Set Day 5 Test Set Day 7 Time 0* 1 ml FCS:MRD 1 ml FCS:MRD 1 ml FCS:MRD 1 ml FCS:MRD 0.7 ml FCS:MRD 0.5 ml FCS:MRD 0.3 ml FCS:MRD Time 0 Inoculation 1 ml inoculum 0.1 ml inoculum 0.1 ml inoculum 0.1 ml inoculum Day 1 (24 hrs) NDP 0.1 ml inoculum 0.1 ml inoculum 0.1 ml inoculum Day 2 (48 hrs) X 0.1 ml inoculum 0.1 ml inoculum 0.1 ml inoculum Day 3 (72 hrs) X NDP 0.1 ml inoculum 0.1 ml inoculum Day 4 (96 hrs) X X 0.1 ml inoculum 0.1 ml inoculum Day 5 (120 hrs) X X NDP 0.1 ml inoculum Day 6 (144 hrs) X X X 0.1 ml inoculum Day 7 (168 hrs) X X X NDP FCS = fetal calf serum; MRD = Maximum Recovery Diluent; NDP = neutralize, dilute, and plate; X = not applicable for that Day Test Set * Time 0 is the preparation of reaction test tubes ** Each Test Set consists of three replicates each plated in triplicate

11 Four Log Reduction Achieved over 7 days Dressings challenged daily with 10 6 CFU/mL; samples taken Day 1, 3, 5 & 7 Pseudomonas aeruginosa (ATCC #9027) Log Value (X10) Uncoated Control Day exsalt TM SD7 Dressing

12 Four Log Reduction Achieved over 7 days Dressings challenged daily with 10 6 CFU/mL; samples taken Day 1, 3, 5 & 7 Staphylococcus aureus (ATCC #6538) Log Value (X10) Uncoated Control Day exsalt TM SD7 Dressing

13 Feedback from Clinical Evaluations Dressing is appropriate for a variety of wound indications No pain caused by dressing (vs. Acticoat causes pain) Significant reduction of wound odour reported Effective moisture management No staining Decision to switch to exsalt SD7 influenced by lower price 13

14 Equivalent performance using 75% less silver Log Bacterial Count (10 X ) Enterococcus faecalis 4 Log Reduction exsalt TM SD7 Acticoat 7 0 hours 1 hr 3 days 7 days Broad spectrum antimicrobial efficacy (organisms tested to date): Gram Negative Acinetobacter baumannii Escherichia coli Pseudomonas aeruginosa Klebsiella pneumoniae Gram Positive Corynebacterium striatum Enterococcus faecalis Enterococcus faecalis VRE Staphylococcus epidermidis Staphylococcus aureus Yeast/fungi Candida albicans Aspergillus niger

15 Slower ph shift and potentially less pain ph level Time in minutes Equivalent to Acticoat compatibility & efficacy Acticoat 7 (1.6 mg Ag/cm 2 ) exsalt TM SD7 (0.4mg Ag/cm 2 )

16 Porcine Healing Model No negative impact on wound healing Data sufficient to warrant a human clinical trial now in progress at University of Alberta Hospital in Canada Day 0 Day 9

17 Directions for Use: Remove exsalt SD7 wound dressing from package. Apply the dressing dry or moist and cut to shape as necessary. Apply the dressing to the wound surface and cover with a secondary dressing as appropriate for the degree of exudate. Secure with surgical tape or a bandage as appropriate. Examine the dressing daily and change depending on the amount of exudate and the condition of the wound ensuring that a moist environment is maintained. If the dressing adheres to the wound, moisten or soak the dressing prior to removal. Avoid forceful removal and disruption of the healing wound.

18 Available Sizes: The dressing can be cut to size Product code PN PN PN PN PN Size 2 x 2 (5cm x 5cm) 4 x 5 (10cm x 12.5cm) 6 x 6 (15cm x 15cm) 8 x16 (20cm x 40cm) 16 x 16 (40cm x 40cm) Dressing per Carton Carton per Case HCPCS Code 5 20 A A A A A6253

19 For more information: Rod Szarka VP, Marketing Suite 4000, Jasper Avenue Edmonton, Alberta, T5J 4P6 (780)