Sanuwave Health, Inc. · NASDAQ:SNWV
Sanuwave Health — Investor Presentation (June 2017)
40 slides from Sanuwave Health's investor presentation, Jun 16, 2017
Slide 1: SANUWAVE: Healing today. Curing tomorrow.
SANUVWAVE Healing today. Curing tomorrow. Applying shockwave technology to repair and regenerate skin, musculoskeletal tissue, and vascular structures OTcaB: SNWV June 2017
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 emerging shockwave technology company
SANUWAVE Health (SNWV), Inc. is an emerging shockwave technology company focused on the development and commercialization of patented noninvasive, high-energy, acoustic shockwaves for the repair and regeneration of tissue, musculoskeletal and vascular structures. The Diabetic Foot Ulcer Wound Market
Slide 4: Investment Highlights & Recent Developments
Investment Highlights & Recent Developments = Accomplishments in 2016 + 50% revenue growth and 3 fold increase in devices placed during the year + Denovo application submitted to FOA + Patent portfolio over 66issued or pending + Partnerships with 7 colleges and institutions + Product approvedin Sout
Slide 5: Investment Highlights & Recent Developments
Investment Highlights & Recent Developments PACE® (Pulsed Acoustic Cellular Expression) is a proprietary technology that uses focused shockwaves ~ Lead product, dermaPACE® has completed Phase II! and Supplemental clinical trials in U.S. for diabetic footulcers dermaPACE offers alower cost and non-in
Slide 6: Investment Highlights & Recent Developments
Investment Highlights & Recent Developments = Expanded distribution Canada, Taiwan, Romania, and Columbia = Partnership with eKare, innovator in Al, one of first to enter wound market = Added Science & Medical Advisor, Dr. Patrick Sesto = Added Board of Director, Maj-Britt Kaltoft ® Significant futu
Slide 7: A Leader in Shockwave Technology
A Leader in Shockwave Technology Development and Commercialization + Patented, non-invasive devices for the repair and regeneration of: = Skin = Musculoskeletal tissue = Vascular structures + Devices activate biologic signaling and angiogenic responses, producing: = New vascularization = Microcircul
Slide 8: PACE - Total Addressable U.S. Market - $12B
PACE - Total Addressable U.S. Market - $12B ‘advanced Wound Care Big dollar epportunity, ven at 5 ‘marist ‘hare + Diabetic Foot Ulee Sports Medicine + Stem Cell *SearModulation + Blood Stelization * Chronic Mixed Wounds | + Tendon /Pain Proliferation * Reconstructive + Peripheral Artery + Pressure S
Slide 9: dermaPACE — Market Opportunity
dermaPACE — Market Opportunity U.S. Market Diabetic Foot Ulcers - $3B+ market size. 29 million people living with diabetes and 86 million pre-diabetics. 25% of diabetics will acquire a non- healing ulcer in their lifetime; "3 million diabetic ulcers annually. Diabetic foot ulcers lead to over 73,000
Slide 10: dermaPACE - Treating Diabetic Foot Ulcers
dermaPACE - Treating Diabetic Foot Ulcers Treatment Advantages + Robust closure with extremely low recurrence rates + Non-invasive, convenient, and safe + Mechanism of action (MOA) allows : * Increased blood flow (perfusion) and improved vascularization (angiogenesis) = Restored oxygenation to ische
Slide 11: dermaPACE DFU Trial Design
dermaPACE DFU Trial Design Design + The dermaPACE® system was evaluated using two studies under IDE GO70103. The studies were designed as prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers. + Atotal of 336 subjects were enrolled and tre
Slide 12: dermaPACE DFU Trial Results
dermaPACE DFU Trial Results Primary Endpoint — Complete Closure by 20 Weeks post initial application + Statistical significance in favor of dermaPACE was observed by the 20 week endpoint and was maintained through the end of the study. + At the 24 week endpoint, the rate of wound closure in the derm
Slide 13: dermaPACE DFU Trial Results
dermaPACE DFU Trial Results Primary Endpoint — Proportion of Patients with Wound Closure ‘The proportion of patients with wound closure can be seen inthis graph. The results of this Kaplan-Meier curveindicate a statistically significant difference between the dermaPACE. and the control groupin the p
Slide 14: dermaPACE DFU Trial Results
dermaPACE DFU Trial Results Additional Efficacy Analyses + -At24 weeks, several sub- Results Stratified by Demographic Characteristics by 24 Weeks populations demonstrated a (Wound Closure) statistically higher percentage ‘of wound closurein dermaPACE subjects compared Age 65 | 120] a5 | 975 | 129 |
Slide 15: dermaPACE DFU Trial Results
dermaPACE DFU Trial Results Additional Efficacy Analyses - Mean Wound Area Reduction + Themean wound reduction for Mean Wound Area Reduction dermaPACE® subjects at 24 weeks was 2.10cm? compared t0.0.83cm?in the control oun + There wasastascally significant difference between Week2 | 160] 1.04 100 |
Slide 16: dermaPACE DFU Trial Results
dermaPACE DFU Trial Results Additional Efficacy Analyses - Wound Area Increase/Worsening of Wound A significantly greater proportion (of sham control subjects had an increase of at least 10% in their woundarea. This indicates that not only does dermaPACE aid in wound healing (decrease in wound size)
Slide 17: dermaPACE DFU Trial Results
dermaPACE DFU Trial Results Safety Analy The adverse event rates between the dermaPACE and control subjects were similar with no statistical significance between the two cohorts in treatment-emergent adverse events (55.8% vs. 51.2%), device-related treatment ‘emergent adverse events (7.6% vs. 3.7%),
Slide 18: dermaPACE Commercial Plan for US
dermaPACE Commercial Plan for US + SANUWAVE’s business model is a per procedure pricing model + Treatment parameters inserted by physician into the console « In most cases patients receive up to eight noninvasive procedures of 500 impulses, which take approximately 10 minutes each, including patient
Slide 19: dermaPACE Commercial Plan for Other Markets
dermaPACE Commercial Plan for Other Markets + SANUWAVE’s business model is a per procedure pricing model + RFID card readers are built into each generator box. Sell individual procedure kits which contain procedure specific protocol RFID cards that activate the device for treatment + In most cases p
Slide 20: dermaPACE — Compelling Cost and Convenience
dermaPACE — Compelling Cost and Convenience Potentially less than half the cost of existing therapies dermaPACE offers: ¥ Non-invasive ‘Advanced Modality Cost Comparison for DFU Treatment treatment ais _ ¥ Lowest total treatment b soced $1800 cost Lana Y Convenient and ne on efficient treatments for
Slide 21: Growth Strategy
Growth Strategy Seek relationships with qualified partners and JV/licensing agreements * Address advanced wound care market - large and growing 7 * Serve other medical markets; Industral orthopedics, plastic/cosmetic, Other Applications vascular/cardiac Medical e Markets = Expand to non-medical indu
Slide 22: Intellectual Property (IP) Organic Growth
Intellectual Property (IP) Organic Growth Number of Patents in 2006, 2012, and 2017
Slide 23: Device Sales — Historical and 2017 Projection
Device Sales — Historical and 2017 Projection 2
Slide 24: Established SANUWAVE Products
Established SANUWAVE Products + Other Indications and Devices + While SANUWAVE's main focus is on wound care, the company’s technology is predicated on a mature and well proven line of orthopedic devices. + orthoPACE® is the next-generation device that has replaced OssaTron® outside of the US as the
Slide 25: Established SANUWAVE Products
Established SANUWAVE Products + orthoPACE + Plantar Fasciitis: Introduction of orthoPACE into the US market + This indication will be the most expeditious method for the US market + Submit a PMA supplement to the OssaTron PMA + Have conducted pre-submission discussion with FDA; even though equivalen
Slide 26: Established SANUWAVE Products
Established SANUWAVE Products * orthoPACE + Other indications with proven results (OUS): For Soft-Tissue: Insertion tendinopathies ‘Tendinosis calcarea (calcific shoulder conditions) Achillodynia (Achilles tendon) Patellar tendinosis, For Bone Stimulation: Delayed Fracture Healing Pseudoarthrosis Os
Slide 27: Established SANUWAVE Products
Established SANUWAVE Products + orthoPACE Currently planningto initiate series of studies with Dr. C.J. Wang in Taiwan to continue gaining clinical evidence for orthoPACE in various orthopedic indications. orthoPACE has tremendous potentialin the sports medicine arena + Proven results in management
Slide 28: Clinical Plans and Opportunities
Clinical Plans and Opportunities s in International Markets + dermaPACE stu Belgium: + Continuing clinical investigations on diabetic foot ulcers. This tril is to be conducted by the \VUB (Free University of Brussels) and UZ Brussel (University Hospital) This ral will take the home-care procedures,
Slide 29: Clinical Plans and Opportunities
Clinical Plans and Opportunities dermaPACE: Other Indications + dermaPACE is intended to treat conditions of the skin and subcutaneous soft tissue + SANUWAVE has identified several disease states that dermaPACE may be able to treat with positive outcomes: Arterial Leg Ulcers (ALU) and Venous Leg Ulc
Slide 30: Clinical Plans and Opportunities
Clinical Plans and Opportunities Arterial Leg Ulcers (ALU) and Venous Leg Ulcers (VLU) + Both of these conditions are caused by poor or obstructed blood flow within the veins or arteries, typically in the lower extremities + Current treatments, either on the market or in trial, ae topical in nature
Slide 31: Clinical Plans and Opportunities
Clinical Plans and Opportunities + Pre-operative conditioning or Post-operative induction of perfusion *+ In support of accelerated healing and quality of healing (cosmesis/scar prevention) * Utilize proven results of increased perfusion to treated areas ‘+ SANUWAVE has relationships with KOLs who c
Slide 32: Clinical Plans and Opportunities
Clinical Plans and Opportunities + Scar Reduction Current treatment includes topical ointments, surgical removal, radiotherapy, steroidal treatment Small pilot studies using dermaPACE show promise in the reduction of keloid scars dermaPACE treatment would be in-office and would avoid more radical tr
Slide 33: Clinical Plans and Opportunities
Clinical Plans and Opportunities + Other opportunities not related to skin + Infection and Biofilm + Have limited evidence that dermaPACE can inhibit or treat bacterial infections and biofilms + Study the effects with and without adjunctive antibiotics + Onychomycosis (toenail fungus) + Nerve regene
Slide 34: Clinical Plans and Opportunities
Clinical Plans and Opportunities + Other opportunities not related to skin + Sexual dysfunction + Shockwave treatment has been shown to be effective in treating male erectile dysfunction + SANUWAVE plans to work international partners in developingthis indication using our products + In addition, SA
Slide 35: Pipe-Line
Pipe-Line + Dubai distributor will look after United Arab Emirates, Kuwait, Kingdom of Saudi Arabia, Qatar and Egypt + Dubai distributor has First right of refusal on: Oman, Bahrain,traq, Lebanon Yemen, Maghreb countries (Tunisia, Morocco). All performance and outcomes achieved based + Indonesia- Co
Slide 36: Non-Medical Markets
Non-Medical Markets Addressable Opportunities Covered by Patents Energy Production Water = Advanced Fracking = Fracking Water Cleaning "Improved /EnhancedOil _* Industrial Water Cleaning Extraction Recovery = Drinking Water Cleaning Food Industry Industrial Biofilms = Preservation = Biofilm Destruct
Slide 37: Industry Valuations and Comparison
Industry Valuations and Comparison Company Name Ticker Symbol — Market Cap (as of 06/14/17) Integra Life Sciences Holdings Corp. NASDAQ: IART $3,998,074,710 Allscripts Healthcare Solutions, Inc. NASDAQ: MDRX $2,242,902,493 Osiris Therapeutics Inc. OTCMKTS: OSIR $20,161,104 Alliqua BioMedical, Inc. N
Slide 38: Select Financial Information
Select Financial Information Cash and Cash Equivalents - March 31, 2017 $0.1M Common Shares Outstanding 138.8M Warrants 76.1M Options 16.2M Notes Payable - Due January31, 2018 $5.4M «1 (1) Due to HealthTronics, Inc. as part of original 2005 purchase price
Slide 39: Management Team
Management Team Kevin Richardson Il, Chairman of the Board — Joined August 2005 * Joined the Company as chairman of the board of directors in August of 2005. Brings a broad array of financial knowledge for healthcare information technology, financial services, business services and other industries.
Slide 40: SANUWAVE: Healing today. Curing tomorrow.
SANUVAVE Healing today. Curing tomorrow. OTCOB: SNWV SANUWAVE Health, Inc. 3360 Martin Farm Road, Suite 100 ‘Suwanee, GA 30024 info@sanuwave.com +1(770) 419-7525