Sanuwave Health, Inc. · NASDAQ:SNWV
Sanuwave Health — Technical Presentation (July 2011)
32 slides from Sanuwave Health's technical presentation, Jul 12, 2011
Slide 1: PACE Technology in the Treatment of Diabetic Foot Ulcers: 24-Week Top-Line Data
Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: ASham-controlled, Double-blinded, Randomized Clinical Trial 24-Week Top-Line Safety and Efficacy Data July 12, 2011
Slide 2: Pulsed Acoustic Cellular Expression (PACE)
SANUWAVE’ Hoang eee. Cura onarow, Pulsed Acoustic Cellular Expression (PACE*) PACE is a proprietary form of ESWT that utilizes high-energy acoustic pressure waves in the shock wave spectrum created through an electrohydraulic method. F dermaPACE PACE consists of a procedure console and applicator. S
Slide 3: PACE Procedures
PACE® Procedures SANUWAVS SANUWAVE’ Hoang eee. Cura onarow, Deliver Positive and Negative Pressure Shock Wave Pressure-Time Diagram Pressure in bar Tus 1 ——sasseeteeeal pulse width (-6db): < Positive Pressure (382,531 mmHg) p+: 510 bar 4 Shock Waves per Second P-: -90 bar r ao rise time: 33 ns ; a N
Slide 4: PACE Elicits a Biologic Response
SANUWAVE’ emia any Cara ooron. PACE*® Elicits a Biologic Response Immediate Cellular signaling Lastingnew Tissue microcirculatory initiates angiogenic microcirculation granulation and improvement, acute growth factor and andnew complete wound inflammatory and protein upregulation vascularization hea
Slide 5: dermaPACE Pivotal Phase III DFU Study
SANUWAVE’ Hoang eee. Cura tomorow dermaPACE® Pivotal Phase III DFU Study © 206-patient, randomized, double-blinded, parallel-group, sham-controlled, multicenter, 24-week pivotal clinical trial. Purpose: Compare safety and effectiveness of the dermaPACE deviceto sham application, when both are admini
Slide 6: Robert Galiano, M.D.
Robert Galiano, M.D. Assistant Professor, Division of Plastic Surgery, Department of Surgery at the Northwestern University Feinberg School of Medicine
Slide 7: Baseline Subject and Target Ulcer Characteristics
SANUWAVE’ Hoang eee. Cura onarow, Baseline Subject and Target Ulcer Characteristics © The average age for all subjects treated with dermaPACE’ was significantly higher than subjects treated with Sham-control, 60.4 +10.4 years versus 56.2 + 9.4 years (p=0.005) with a median age of 62 and 57, respecti
Slide 8: Subjects Randomized (ITT Population)
SANUWAVE’ Subjects Randomized (ITT Population)" 206 Remaining Subjects at 12-Week Visit (Visit 11) Remaining Subjects at 24-Week Visit (Visit 17) 49 ‘The Intent-to-Treat (ITT) population included any subject that was randomized and received at least one active: detmaPACE® or sham-control treatment E
Slide 9: dermaPACE Pivotal Phase III DFU Study (Rigorous Design)
SANUWAVE’ Hoang eee. Cura onarow, dermaPACE® Pivotal Phase III| DFU Study (Rigorous Design) ° Double-blinded (patient and physician), sham-controlled clinical trial that eliminated study bias regarding patient selection, evaluation and treatment assignment. ° No allowance for surgical closure by sec
Slide 10: dermaPACE Pivotal Phase III DFU Study (Rigorous Design)
SANUWAVE’ Hoang eee. Cura tomorow dermaPACE® Pivotal Phase III DFU Study (Rigorous Design) = dermaPACE was tested in a double-blinded (patient and physician), sham-controlled study that eliminated study bias regarding patient selection, evaluation and treatment assignment. * 83% ofall patients and 7
Slide 11: Effectiveness Analysis and Results
SANUWAVE’ Hoang eee. Cura onarow, dermaPACE® Pivotal Phase III DFU Study (Effectiveness Analysis and Results) In the 12-week analysis, the dermaPACE patients showed a strong positive trend in the primary endpoint of 100% wound closure, but this was not statistically significant. By 12 weeks, 22/107
Slide 12: Effectiveness Analysis and Results
SANUWAVE’ Hoang eee. Cura onarow, dermaPACE® Pivotal Phase III DFU Study (Effectiveness Analysis and Results) ° Based on the pure, controlled design of the study restricting investigators from closing the wound surgically, a = 90% wound closure endpoint was determined to be clinically meaningful and
Slide 13: SANUWAVE’
SANUWAVE’ 13
Slide 14: Effectiveness Analysis and Results
SANUWAVE’ Hoang eee. Cura onarow, dermaPACE® Pivotal Phase III DFU Study (Effectiveness Analysis and Results) ° dermaPACE patients were twice as likely to achieve 90% to 100% wound closure compared to Sham-conitrol patients within 12 weeks of the initial treatment. ° Of the patients who achieved com
Slide 15: Average Wound Area Reduction
SANUWAVE’ Hoang eee. Cura tomorow By 12 weeks, the average percent reduction in the size of the target ulcer in patients treated with dermaPACE® was £ compared to only 7% in the Sham-control group patients. ‘Average Wound Area (cm?) 15 Weeks H— Sham control (n=99) “l= dermaPACE (n=107) Change in wou
Slide 16: Change in Wound Perimeter from Baseline
SANUWAVE’ Hoang eee. Cura tomorow In Wour CHANGE IN WOUND PERIMETER MEASUREMENTS FROM BASELINE BY RANDOMIZED TREATMENT ASSIGNMENT. (MEAN NFIDENCE LIMITS) (OBSERVED DATA) Probability values are derived from a generalized linear model. At 12 weeks, p= Sham-control dermaPACE® Avg.wound perime' reductio
Slide 17: Percent Reduction in Wound Area — Secondary Efficacy Endpoint
SANUWAVE’ Percent Reduction in Wound Area — Secondary Efficacy Endpoint The change from baseline results in wound area first achieved statistical significance at 6 weeks (4 weeks from last treatment) with 60% or greater reduction in wound area in 56% of all dermaPAC! subjects (p=0.048). PERCENTAGE O
Slide 18: Percent Reduction in Wound Area — Secondary Efficacy Endpoint
SANUWAVE’ Percent Reduction in Wound Area — Secondary Efficacy Endpoint *® The separation in the wound area healing rates steadily increases from2 50% (week 6) to= 90% reduction by 12 weeks. By 12 weeks, 46% ofall dermaPACE® subjects experienceda> 90% closure as comparedto 28% of Sham-control subjec
Slide 19: Patients Experiencing Increase in Wound Area
SANUWAVE’ Hoang eee. Cura tomorow When comparing patients with an increase in wound area as comparedto baseline from the outset, afterthe first application, the Sham-control group showsa significant number of patients whose wounds gotworse as compared to the dermaPACE® group. PERCENTAGE OF PATIENTS
Slide 20: Median Time to Complete Wound Closure
SANUWAVE’ + The point estimates for the median time to complete wound closure were not estimable for both the dermaPACE® and Sham-control treatment groups, since less than 50% of the subjects achieved the endpoint + Kaplan-Meier estimates were not statistically significant for the ITT Population at
Slide 21: Examples of dermaPACE Study Patients Who Achieved 100% Wound Closure
SANUWAVE’ Hoang eee. Cura tomorow Examples of dermaPACE® Study Patients Who Achieved 100% Wound Closure a
Slide 22: dermaPACE Subject A
Hoang eee. Cura onarow, dermaPACE® Subject A Visit 11- Fully Closed at Week 8 Distant Close-Up Visit 1 Visit 11 ] Thispicture representsa patient reatedwith dermaPACE thathy the study design endnointwactully closed at week 12 as confirmed attwo consecutvevisits i wl 2
Slide 23: dermaPACE Subject B
SANUWAVE’ Hoang eee. Cura onarow, dermaPACE® Subject B Visit 11- Fully Closed at Week 6 Distant Visit 1 Visit 11 i" Thispicture representa patient treated with dermaPACE thatby the study design endpointwasfully closed atweek 12 as confirmed attwo consecutivevists, 1] \ 23
Slide 24: dermaPACE Subject C
SANUWAVE: Hoang eee. Cura onarow, dermaPACE® Subject C Visit 11- Fully Closed at Week 8 Distant Close- i Visit 1 Visit 11 faba y ‘This picture representsa patient treated with detmaPACE thatby the study design endpointwastully closed at week as confirmed attwo consecutive visits, ij i TN) 24
Slide 25: Examples of dermaPACE Study Patients Who Achieved 90%-99% Wound Closure
SANUWAVE’ Hoang eee. Cura tomorow Examples of dermaPACE® Study Patients Who Achieved 90% - 99% Wound Closure 25
Slide 26: dermaPACE Subject D
dermaPACE® Subject D Visit 11- 97% Improved Distant Visit 1 Visit 11 Bey ity Tripler ee esl dorarACEHn ob ay Sengneranwencdeat Oh eda olan ‘THAR NMR) 38
Slide 27: dermaPACE Subject E
dermaPACE® Subject E Visit 11- 96% Improved Distant Close-Up Visit 11 yy thy i Thispicture representsa patient treated with dermaPACE thatby the study design endpointwasnot considered fully closed atweek 12. A | I n |
Slide 28: dermaPACE Subject F
dermaPACE® Subject F Visit 11- 99% Improved Distant Visit 1 Visit 11
Slide 29: Lawrence Bass, M.D., Safety Monitor
SANUWAVE’ Hoang eee. Cura tomorow Lawrence Bass, M.D. Safety Monitor Clinical Assistant Professor of Plastic Surgery Department of Plastic Surgery NYU School of Medicine 29
Slide 30: dermaPACE Pivotal Phase III DFU Study (Safety Results)
SANUWAVE’ Hoang eee. Cura onarow, dermaPACE® Pivotal Phase III DFU Study (Safety Results) ° No statistical differences in the overall adverse event rates were seen between the two groups. ° Lower overall incidence of infection in the dermaPACE group. ° There were no issues regarding the tolerability
Slide 31: Conclusions Drawn From The Study
SANUWAVE’ ngs Cara taro Conclusions Drawn From The Study Efficacy of dermaPACE® * The overall results of this study revealed thata significant proportion ofdermaPACE subjects achieved complete wound closure beginning at 20 weeks following the initial application in the ITT population (p=0.047) and E
Slide 32: Overall Observation
SANUWAVE’ Hoang eee. Cura tomorow Overall Observation: The highly positive clinical results from this rigorous Phase ||| study validate the ability of dermaPACE to safely heal diabetic foot ulcers. The study showed a high degree of significance in the size reduction of ulcers treated with dermaPACE