Sanuwave Health, Inc. · NASDAQ:SNWV
Sanuwave Health — Investor Presentation (May 2013)
40 slides from Sanuwave Health's investor presentation, May 30, 2013
Slide 1: SANUWAVE: Healing today. Curing tomorrow.
SANUVVAVE' Healing today. Curing tomorrow. Ticker: SNWV May 2013
Slide 2: Forward-Looking Statement Disclaimer
Forward-Looking Statement Disclaimer This presentation may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective.
Slide 3: SANUWAVE Health, Inc. (SNWV) Investment Highlights
ee SANUWAVE Health, Inc. (SNWV) Shock wave technology company with potential applications across multiple industries. INVESTMENT HIGHLIGHTS Lead Product, dermaPACE? in U.S. Phase III Clinical Trial Supplement = For closure of diabetic foot ulcers - commences in 2Q 2013 = Anticipated approval in earl
Slide 4: Technology Platform
— Technology Platform SNWYV - THE leader in the development and commercialization of acoustic shock wave technology. SHOCK WAVES = Carry energy and create sudden Sree sean eavate) mi 1) ( i) and significant changes in pressure. SNWV has 34 patents (issued or pending) surrounding the use of = Non-inv
Slide 5: Technology Platform - Advantages
— Technology Platform - Advantages Scientific research demonstrates clear differentiation and significant advantages of our technology when compared with other technologies. TECHNOLOGY FOCUSED | Uiieerecsl|| CECI | eric. |atcenemat| inecey Low bene ‘ dis cules re aatitecaunel| Geanec || seas || peak
Slide 6: PACE Product Portfolio: dermaPACE
EEE PACE Product Portfolio: dermaPACE A 7 ers. DERMAPACE CE Marked for advanced wound care indications and available in international markets. In U.S. available only to physicians and patients involved in a U.S. IDE clinical trial. SANUVWAVE
Slide 7: dermaPACE - International Market
dermaPACE - International Market The international global wound care market of $22 billion offers significant expansion opportunity for CE marked dermaPACE. INTERNATIONAL MARKET = Globally there are 366 million people living with diabetes and it is expected to reach 552 million by 2030, an increase
Slide 8: dermaPACE - $10B U.S. Market Potential
dermaPACE - $10B U.S. Market Potential "4 Diabetic Foot Ulcer *Chronic Mixed Wounds «Pressure Sores -Burns SANUVWAVE / Trauma / Fracture Osteoarthritis *Tendon/ Pain *Spine *Body Contouring *Scar Modulation +Reconstructive and Grafting «Myocardial Ischemia Peripheral Artery Disease -Artherosclerosis
Slide 9: dermaPACE - Diabetic Foot Ulcers
EEE dermaPACE — Diabetic Foot Ulcers Diabetic Foot Ulcers - $2B+ = 27 million people living with diabetes and 79 million pre-diabetics. = 25% of diabetics will acquire a non-healing ulcer in their lifetime; ~1.5+ million diabetic ulcers annually. dermaPACE being used to treat a diabetic foot ulcer.
Slide 10: dermaPACE - Competitive Landscape
dermaPACE — Competitive Landscape No direct competitor to dermaPACE. FDA CLEARED/APPROVED PRODUCTS = Negative Pressure Wound Therapy (NPWT) VAC System; device is attached for extended period - Kinetic Concepts Inc. (KCI). = Apligraf, a living cell-based product used to treat venous leg ulcers and di
Slide 11: dermaPACE - Treatment Advantages
dermaPACE — Treatment Advantages Offers a significant advance in the treatment of diabetic foot ulcers. ADVANTAGES Advanced Modality Cost Comparison for Diabetic Foot Ulcer v Non-invasive. $16,000 aise Staio00 $11,600 v Lowest total treatment $12,000 $10,000 costs. $8,000 $6,000 Vv Significantly low
Slide 12: dermaPACE - Original Phase III Trial
— dermaPACE -— Original Phase III Trial Results demonstrate dermaPACE safely heals diabetic foot ulcers. DESIGN = Enrolled 206 patients to quantify safety and efficacy of 4 dermaPACE treatments delivered over a 2-week period. = Primary Endpoint: complete wound closure at 12 weeks. EFFICACY = Achieve
Slide 13: dermaPACE - Original Phase III Trial
— dermaPACE -— Original Phase III Trial Achieved primary endpoint at time point later than required by FDA. PHASE III TRIAL — Efficacy Endpoints Complete (100%) Wound Closure dermaPACE | Sham-Control eyalie ITT (MITT)! (n=107) (n=99) P 22 (20.6%) 15 (15.2%) 0.363 39 (36.4%) 23 (23.2%) 0.047 42 (39.3
Slide 14: dermaPACE - Original Phase III Trial
dermaPACE -— Original Phase III Trial dermaPACE generated significant statistical improvement in wound closure versus control. PHASE III TRIAL — Efficacy Endpoints Number of Wounds Achieving2 90 % dermaPACE Sham-Control p-value Reduction (n=107) (n=99) at Various Weeks s2(@9on) —18(i82%) 092 fone FS
Slide 15: dermaPACE - Original Phase III Trial
dermaPACE -— Original Phase III Trial Results demonstrate dermaPACE safely heals diabetic foot ulcers significantly better than control. PHASE III TRIAL — Review Period Number of Wounds Achievi 90% Reduction by 12 Weeks Closing after 12 weeks and before 24 Weeks Number of Wounds Number of Patients E
Slide 16: dermaPACE - Supplemental Trial
— dermaPACE — Supplemental Trial The company shared with the FDA the positive but slower than required outcomes of the original trial, which provide a statistical foundation for supplemental trial. RATIONALE FOR SUPPLEMENTAL TRIAL = FDA approval of Bayesian Statistics to incorporate positive results
Slide 17: dermaPACE - Current Phase III Design
— dermaPACE — Current Phase III Design We believe that the supplemental dermaPACE study will generate outcomes that meet the FDA’s requirement for approval. SUPPLEMENTAL PHASE III TRIAL DESIGN = Ninety (90) patients at 20 U.S. sites required to achieve significance. Up to 150 patients can be enrolle
Slide 18: dermaPACE - Regulatory Timeline
dermaPACE — Regulatory Timeline FDA has approved Investigational Device Exemption (IDE) to conduct supplemental dermaPACE clinical trial. PHASE III TRIAL TIMELINES = 20 clinical study sites identified; 18 have IRB approval. = Patient enrollment is expected to begin in 2Q 2013. = Estimate completing
Slide 19: PACE Product Portfolio: orthoPACE
PACE Product Portfolio: orthoPACE SANUVWAVE — » ORTHOPACE orthoPACE is CE Marked for international markets for orthopedic and musculoskeletal indications, but is not approved for sale or distribution in the U.S. 19
Slide 20: orthoPACE
EEE orthoPACE orthoPACE applies PACE shock wave treatment for orthopedic and musculoskeletal indications. PRODUCT OVERVIEW orthoPACE is CE Marked for the application of pulsed acoustic waves for the stimulation of osteogenesis and for the treatment of painful bone near soft tissue, including: = Plan
Slide 21: orthoPACE - U.S. Market Potential
EEE orthoPACE — U.S. Market Potential In the U.S., we are exploring bone and tendon opportunities building on our legacy OssaTron’s FDA approval. U.S. MARKET = In the U.S., 2 million patients are treated for plantar fasciitis (heel pain) every year. = It is estimated there are over 2 million fractur
Slide 22: SANUWAVE: Opportunity and Focus
ee SANUWAVE Our team is driven to develop relationships that take advantage of the global demand for cost efficient healthcare. OPPORTUNITY & FOCUS SANUWAVE: =
Slide 23: Market Penetration
Market Penetration Sufficiently large markets to support entry and provide excellent growth opportunity. GLOBAL MARKET = Healthcare market in excess of $2.6T. = Relevant global market size in excess of $112B. = Current sales level ~S1M — new efforts to increase penetration (estimated at 2% in 5 year
Slide 24: Current International Placement
Current International Placement More than 150 Sanuwave devices are currently available in Europe, Canada, and Asia/Pacific through users and select distributors. DEVICES IN USE INTERNATIONALLY German 41 Ital 2 Belgium 2 ‘Spain Fr Portugal 3 * ‘Austria 8 Czech Republic 8 ‘Switzerland z Korea 6 Singap
Slide 25: Growth Strategy
— Growth Strategy Expand distribution of devices through additional relationships. INTERNATIONAL GROWTH STRATEGY = Seek out relationships with qualified partners, joint ventures, and licensing agreements. = Use the outside U.S. markets for proof of concept, protocol development, and pilot studies. =
Slide 26: Milestones
Milestones Management — execution of corporate objectives underway with sequencing of products, marketing, and relationship development to meet corporate goals. ANTICIPATED OVER NEXT 12 MONTHS = Initiate dermaPACE Supplemental trial and begin enrollment in Q2 713. Complete enrollment in dermaPACE Su
Slide 27: SANUWAVE Health, Inc. (SNWV) Investment Highlights
ee SANUWAVE Health, Inc. (SNWV) Shock wave technology company with potential applications across multiple industries. INVESTMENT HIGHLIGHTS Lead Product, dermaPACE? in U.S. Phase III Clinical Trial Supplement = For closure of diabetic foot ulcers - commences in 2Q 2013 = Anticipated approval in earl
Slide 28: SANUWAVE: Healing today. Curing tomorrow.
SANUVVAVE' Healing today. Curing tomorrow. Ticker: SNWV SANUWAVE Health, Inc. 11475 Great Oaks Way, Suite 150 Alpharetta, GA 30022 info@sanuwave.com +1(770) 419-7525
Slide 29: SANUWAVE: Technology & Expansion
ee SANUWAVE Our licensed, patented shock-wave technology offers extensive expansion opportunities for medical and non-medical uses. TECHNOLOGY & EXPANSION SANUWAVE: 29
Slide 30: Substantial Technology and History
Substantial Technology and History Over $54 million invested in shock wave technology platform since 2005. BACKGROUND = Technology platform acquired in 2005 from HealthTronics, a leader in urology and lithotripsy. = Acquired significant intellectual property and legacy global orthopedic product line
Slide 31: Expansion Opportunities
— Expansion Opportunities Science behind the technology is extensive and offers extensive opportunities. PACE® causes an inflammatory response and proliferation of growth factors leading to angiogenesis (development of new blood vessels). to ulceration. Positive inflammatory response and improved mi
Slide 32: Regenerative Medicine Markets
Regenerative Medicine Markets Multiple markets exist with significant opportunities to monetize technology platform, know-how, and IP. MEDICAL MARKET OPPORTUNITIES Advanced Wound Care Cleaning and Sterilization Tissue Regeneration = Diabetic Foot Ulcer = Blood = Nerve Regeneration = Chronic Mixed Wo
Slide 33: Non-Medical Markets
Non-Medical Markets SNWYV - well positioned to use acoustic shockwave technology in many industrial applications. NON-MEDICAL MARKET OPPORTUNITIES Energy Production Water = Advanced Fracking = Fracking Water Cleaning = Improved / Enhanced Oil = Industrial Water Cleaning Extraction Recovery = Drinkin
Slide 34: Intellectual Property
Intellectual Property Patent portfolio includes 34 holdings in the form of issued patents or patent applications pending approval. TECHNOLOGY IP PORTFOLIO = Covers various methods and devices for treating a range of conditions using acoustic pressure waves in the high-energy “shock wave” spectrum. =
Slide 35: Appendix: Management Team & Research
ee SANUWAVE Appendix MANAGEMENT TEAM & RESEARCH SANUVWAVE
Slide 36: Management Team
SS Management Team Joseph Chiarelli Joined SANUWAVE as Chief Executive Officer and a Director in 2013. Mr. Chiarelli has been responsible for financial advisory, business development, and a healthcare hedge fund at Auriga Capital Management. Mr. Chiarelli was the Chairman of Clarent Hospital Managem
Slide 37: Management Team
Management Team lulian Cioanta, Ph.D. Joined SANUWAVE in June 2007 as Vice President of Research and Development. Prior to joining SANUWAVE, Dr. Cioanta served as Business Unit Manager with Cordis Endovascular, a Johnson & Johnson company, Director of Development Engineering with Kensey Nash Corpora
Slide 38: dermaPACE (Original Trial)
~~ dermaPACE (Original Trial) Original dermaPACE trial, begun in 2007, achieved Primary Endpoint — but not in FDA’s required timeframe. PHASE III TRIAL: 2007- 2010 = Enrolled 206 patients in double-blinded (patient & physician), parallel, placebo- controlled, 24 week trial. = Compared safety and eff
Slide 39: dermaPACE (Original Trial)
~~ dermaPACE (Original Trial) Dr. Maria Siemionow’s research at the Cleveland Clinic supports the benefit of additional shock wave treatments. PHASE III TRIAL: 2007- 2010 = Up to 24 hours after dermaPACE application on tissue strong inflammatory modulation and proangiogenic acute effects are seen as
Slide 40: dermaPACE (Original Trial)
~~ dermaPACE (Original Trial) Wound reduction results suggested complete closure could be achieved in 12 weeks if additional treatments were administered. PHASE III TRIAL: 2007- 2010 * Siemionow, et al! found that in order to preserve dermaPACE therapy proangiogenic and anti-inflammatory effects ove