Sanuwave Health, Inc. · NASDAQ:SNWV
Sanuwave Health — Investor Presentation (March 2013)
36 slides from Sanuwave Health's investor presentation, Mar 26, 2013
Slide 1: SANUWAVE: Healing today. Curing tomorrow.
SANLUVVAVE Healing today. Curing tomorrow. Ticker: SNWV March 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)
—————— SANUWAVE Health, Inc. (SNWV) Repositioned and refocused as a shock wave technology company with potential applications across multiple industries. KEY POINTS = Improved Strategy, Focus, and Execution = Senior management changes — added experience and focus in critical areas. = Improved Financ
Slide 4: Management Focus
Management Focus We are rapidly driving forward the product approval, marketing, and partnering process. EMPHASIS ON RESULTS = Expected initial enrollment of dermaPACE trial —-2Q 2013. = Discussions with partners/licensees in non-medical industries — already commenced. = Discussions with partners/li
Slide 5: dermaPACE Clinical Trial Supplement
dermaPACE Clinical Trial Supplement Focus is additional treatments and new CRO/Clinical Manager to improve trial management. KEY ELEMENTS OF SUPPLEMENTAL TRIAL = A doubling of active dermaPACE treatments. = New CRO specializing in wound trials and new Trial Manager to conduct and manage trial and it
Slide 6: Substantial Technology and History
8 SSS... 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 pro
Slide 7: Regenerative Medicine Markets
8 SSS... 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
Slide 8: 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 9: Execution of Corporate Goals Underway
8 SSS... Execution of Corporate Goals Underway With sequencing of products, marketing, and relationship development to meet corporate goals. PARALLEL PROCESSES Initiated dermaPACE Supplemental trial to enroll as quickly as possible. Initiated discussions with partners outside the U.S. to improve sal
Slide 10: 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 Seay” eavatey and significant changes in pressure. SNWV has significant intellectual property surrounding the use of = Non-invasive usi
Slide 11: 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 micr
Slide 12: Competitive Landscape
Competitive Landscape Scientific research demonstrates clear differentiation and significant advantages of our technology when compared with other technologies. Uiieerecsl|| CECI | eric. |atcenemat| ‘ie Lond pais dis cules re aatitecaunel| Geanec || seas || peak eae ere Ee Ultrasound] '**** | Freque
Slide 13: Patent Portfolio
Patent Portfolio Includes 33 holdings in the form of issued patents or patent applications pending approval. INTELLECTUAL PROPERTY PORTFOLIO = Portfolio covers various methods and devices for treating a range of conditions using acoustic pressure waves in the high-energy “shock wave” spectrum. = 17
Slide 14: Pulsed Acoustic Cellular Expression (PACE)
Pulsed Acoustic Cellular Expression (PACE*) Proprietary shock wave technology for the regenerative medicine market. PACE TREATMENTS = Increase blood flow: as PACE shock waves penetrate the microcirculatory system there is an immediate increase in local blood flow (perfusion) in the treated area. = C
Slide 15: PACE Product Portfolio: dermaPACE
PACE Product Portfolio: dermaPACE 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. SANUWAVE 15
Slide 16: dermaPACE
dermaPACE CE Marked — for patients suffering from acute and chronic wounds. TREATMENT OVERVIEW = During the noninvasive treatment, the dermaPACE applicator gently glides over the wound surface as the acoustic pressure impulse is applied into the tissue by direct contact through sterile conductive ge
Slide 17: dermaPACE - Diabetic Foot Ulcers (DFU)
8 SSS... dermaPACE - Diabetic Foot Ulcers (DFU) $5+ billion U.S. market U.S. MARKET OVERVIEW = 27 million persons 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
Slide 18: dermaPACE — Diabetic Foot Ulcers
dermaPACE — Diabetic Foot Ulcers Offers a significant advance in the treatment of diabetic foot ulcers. ADVANTAGES Advanced Modality Cost Comparison for Diabetic Foot Ulcer v Lowest total treatment $16,000 aa costs. $14,000 $11,600 $12,000 Lg $10,000 Vv Significantly lower $8,000 ea recurrence rates
Slide 19: No Direct Competitor for dermaPACE
8 SSS... No Direct Competitor for dermaPACE Significant unmet need for a superior chronic wound care treatment modality. COMPETITIVE SNAPSHOT = Kinetic Concepts Inc. (KCI) an FDA-cleared Negative Pressure Wound Therapy (NPWT) VAC System; device is attached for extended period. = Organogenesis' FDA a
Slide 20: dermaPACE — Phase III Trial
LS... dermaPACE — Phase III Trial FDA has approved Investigational Device Exemption (IDE) to conduct additional dermaPACE clinical trial. PHASE III TRIAL SUPPLEMENT = We estimate trial supplement will be completed and submitted in support of a PMA application for dermaPACE in 4Q 2014. = We have iden
Slide 21: dermaPACE — Phase III Trial
LS... dermaPACE — Phase III Trial We believe that the additional dermaPACE study will generate outcomes that meet the FDA’s requirement for approval. SUPPLEMENTAL PHASE III TRIAL DESIGN = Doubles the number of treatments - four (4) additional dermaPACE procedures administered bi-weekly, between week
Slide 22: dermaPACE - Trial Treatments
LS... dermaPACE - Trial Treatments Four (4) additional treatments should improve the Healing Curve. 100 \ 90 70 g complete Closure by12 Weeks Ls Ar | —290% Wound Area Reduction by 12 30 \ L Weeks Base Rand 3d Gd Sd wk Awk ©«Gwk Swk 10wk I2wk idwk 16wk 18wk 20wk 22wk 26wk Time SANUWAVE 2
Slide 23: dermaPACE — Phase III Improvements
dermaPACE — Phase III Improvements We believe that the new dermaPACE study design will generate outcomes that meet the FDA’s requirement for approval. SUPPLEMENTAL PHASE III TRIAL MANAGEMENT = New CRO specializing in wound trials and new Trial Manager enhances trial conduct and detail management. =
Slide 24: dermaPACE - International Market
dermaPACE - International Market The international global wound care market of $22 billion offers significant expansion opportunity for dermaPACE. INTERNATIONAL MARKET = Globally there are 366 million people living with diabetes and it is expected to reach 552 million by 2030, an increase of 50.7%.
Slide 25: PACE Product Portfolio: orthoPACE
LS... PACE Product Portfolio: orthoPACE 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. SANUWAVE 2
Slide 26: orthoPACE — Uses Approved in Europe
orthoPACE — Uses Approved in Europe 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 tis
Slide 27: orthoPACE - International Strategy
orthoPACE - International Strategy Available in Europe, Canada, and Asia/Pacific through select distributors. INTERNATIONAL GROWTH STRATEGY = Seek out relationships with qualified partners. = Use the outside US markets for proof of concept, protocol development, and pilot studies. = Build momentum w
Slide 28: orthoPACE — U.S. Strategy
8 SSS... orthoPACE — U.S. Strategy We will explore bone and tendon opportunities building on our legacy OssaTron’s FDA approval. U.S. MARKET = 2 million patients are treated for plantar fasciitis (heel pain) every year. = It is estimated there are over 2 million fractures costing $17 billion per yea
Slide 29: PACE Product Portfolio: OssaTron
LS... PACE Product Portfolio: OssaTron OSSATRON Our legacy OssaTron device is approved by the FDA for multiple orthopedic conditions, which have failed to respond to conservative treatment. SANUWAVE 23
Slide 30: Management Team
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 Management
Slide 31: 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 32: SANUWAVE Health, Inc.
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 33: dermaPACE (Original Trial)
8 SSS... 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, sham- controlled, 24 week trial. = Compared safety and
Slide 34: dermaPACE (Original Trial)
8 SSS... dermaPACE (Original Trial) Original dermaPACE trial, begun in 2007, achieved Primary Endpoint — but not in FDA’s required timeframe. PHASE III TRIAL: 2007- 2010 Efficacy Endpoints Primary Endpoint: ies Sham Contre Efficacy —ITT 1%) p-value Complete Wound Closure at 12 Weeks 22 (20.6%) 15 (1
Slide 35: dermaPACE (Original Trial)
8 SSS... 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 s
Slide 36: dermaPACE (Original Trial)
8 SSS... 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 effec