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• Medtronic for regenerative wound healing.
• Boston Scientific for non-invasive wound healing.

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• The dermaPACE System: A medical device that utilizes high-energy acoustic waves for the non-invasive treatment of chronic wounds.

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For the public company SANUWAVE Health (symbol: SNWV), it primarily sells its medical technology products to other companies. Based on available public filings (such as 10-K reports), SANUWAVE Health does not disclose specific major customer companies that individually account for a significant portion (typically 10% or more) of its revenue. This indicates a diversified customer base within the healthcare sector rather than reliance on a few named large customers.

While specific named customer companies are not publicly identified, SANUWAVE Health's customer base generally consists of the following categories of businesses:

• Healthcare Providers: This broad category includes hospitals, specialized wound care clinics, other medical facilities, and private practices (such as podiatry or orthopedic clinics) that directly purchase and utilize SANUWAVE's shockwave devices, like the dermaPACE® system, for patient treatment.
• Third-Party Distributors: These are companies that acquire SANUWAVE's products for resale to end-user healthcare providers within specific geographic territories. Distributors act as channel partners to expand SANUWAVE's market reach.

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Morgan Frank, CEO/Chairman of the Board

Morgan Frank joined SANUWAVE as Chairman of the Board in August 2022 and became CEO in May 2023. He has been a principal at the life sciences-focused investment fund Manchester Management since 2003 and a director of Manchester Explorer Cayman Ltd since 2013. Previously, he was a founder and managing director at First Principles Group, a boutique consultancy specializing in corporate restructuring, restarts, and spin-outs. Mr. Frank also served as CEO, CFO, Company Secretary, and Treasurer of Modular Medical, Inc. from April to July 2017. He brings 29 years of experience in U.S. public equity and capital markets, with a focus on life sciences and technology.

Peter Sorensen, CFO

Peter Sorensen joined SANUWAVE as Chief Financial Officer in April 2024. He brings over a decade of finance experience, including in the medical device industry since 2017. Prior to SANUWAVE, he was the Vice President of Finance and Human Resources at Endogenex, Inc., a venture-backed medical device company. He also held roles at LivaNova PLC and provided consulting services for financial planning and analysis (FP&A) solutions to public and private companies at eCapital Advisors.

Daniel Coyle, Chief Operating Officer

Daniel Coyle became Chief Operating Officer in 2025, after joining SANUWAVE as EVP Engineering in 2024. He has approximately 15 years of experience in medical device product development, manufacturing, and operations, leading cross-functional teams through all phases of the product lifecycle. Prior to joining Sanuwave Health, he was a program director at Nextern, a medical device manufacturer, from September 2019 through September 2024.

Dustin Libby, Executive Vice President of Commercial Operations

Dustin Libby joined Sanuwave in June 2025. He brings 20 years of medical device experience, focusing on commercial growth, sales operations, and launch execution. His career includes leadership roles at Abiomed, where he contributed to scaling a surgical business from $15 million to over $500 million in revenue. He also has experience at Smith & Nephew, Arthrex, and Hill-ROM.

Timothy Wern, Executive Vice President of Sales – U.S. Wound

Timothy Wern joined SANUWAVE as Executive Vice President of Sales for the U.S. Wound business, bringing over 20 years of sales leadership experience in the medical device industry. He has held progressive leadership roles at pioneering healthcare companies such as HeartWare (acquired by Medtronic), Abiomed (acquired by Johnson & Johnson), and Ceevra Inc.

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The key risks to SANUWAVE Health (SNWV) include its precarious financial health, the impact of reimbursement policy changes, and the volatility of its stock.

1. Financial Health and Debt Burden: SANUWAVE Health faces significant financial challenges, as indicated by its poor financial strength, negative working capital, and a low Altman Z-Score, which suggests a possibility of bankruptcy within the next two years. The company has incurred recurring operating losses in prior years and has a substantial amount of debt, including a $26 million Senior Secured Note due in September 2025. While the company has shown recent improvements in operating income and aims to recapitalize and pay down this debt, its ability to successfully refinance or manage this debt is a critical risk to its continued operation.
2. Reimbursement Policy Changes and Regulatory Risks: The company's revenue streams are vulnerable to changes in healthcare regulations and reimbursement policies, particularly those from the Centers for Medicare & Medicaid Services (CMS). Although the reimbursement for its UltraMIST product (CPT code 97610) has seen a slight increase and is not directly affected by recent uncertainties regarding skin substitutes and grafts, broader market hesitation in the wound care sector due to potential policy changes has led to delayed purchasing decisions by providers and revised revenue guidance for SANUWAVE.
3. Stock Volatility and Limited Market Liquidity: SANUWAVE Health's common stock is characterized by high volatility, with a beta suggesting greater sensitivity to overall market movements, leading to potential significant price fluctuations. Historically, the trading market for its common stock has been limited, and while the company recently uplisted to the NASDAQ Global Exchange in March 2025, market visibility and liquidity remain ongoing concerns for investors.

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SANUWAVE Health (SNWV) focuses on regenerative medicine through its patented ultrasound and shock wave technology systems. Their main products address wound healing and musculoskeletal conditions.

• dermaPACE System: This system is FDA cleared for the treatment of Diabetic Foot Ulcers (DFUs).
  • Global Addressable Market: The global diabetic foot ulcer treatment market was valued at approximately USD 4.3 billion in 2023 and is projected to reach over USD 7.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of around 6.5% from 2024 to 2031. Other estimates for the global market include USD 7 billion in 2024, expected to reach USD 12.8 billion by 2034 (CAGR of 6.3%), and USD 8.83 billion in 2024, projected to reach USD 14.37 billion by 2032 (CAGR of 6.3%).
  • U.S. Addressable Market: North America held a dominant position in the global DFU treatment market, with a market size valued at USD 3.45 billion in 2024. An earlier estimate from 2014 suggested a $3 billion market opportunity in the United States for dermaPACE in DFU treatment.
• UltraMIST System: This non-contact ultrasound system is used for treating complex and non-healing wounds.
  • Addressable Market: The UltraMIST system operates in an estimated $1.6 billion annual market. It is an FDA-cleared product with established CMS reimbursement. While this is a more specific market segment, the larger global and U.S. diabetic foot ulcer treatment markets mentioned above are also relevant, as UltraMIST treats non-healing wounds, including DFUs.
• orthoPACE System: This system uses PACE technology for treating chronic pain from musculoskeletal disorders. This product falls under the broader Extracorporeal Shock Wave Therapy (ESWT) device market.
  • Global Addressable Market: The global extracorporeal shock wave therapy device market was valued at USD 98.31 million in 2024 and is projected to reach USD 147.11 million by 2031, with a CAGR of 5.70%. Another report valued the global ESWT device market at USD 108.7 million in 2024, expecting it to reach USD 166.7 million by 2031 at a CAGR of 6.3%.
  • North America Addressable Market: North America is expected to witness the highest CAGR in the ESWT device market and accounted for a majority of the shockwave therapy market share in 2021.

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SANUWAVE Health (NASDAQ: SNWV) is expected to drive future revenue growth over the next 2-3 years through several key factors, primarily centered on the continued adoption and expansion of its UltraMIST system and strategic operational improvements.

1. Increased Sales of UltraMIST Systems and Consumables: The company has demonstrated consistent growth in the sales of its UltraMIST systems and associated applicators. In Q3 2025, SANUWAVE sold a record 155 UltraMIST systems, contributing to a 22% year-over-year revenue increase. Applicator sales also reached an all-time high, comprising 59% of the quarterly revenue. This trend of increasing system placements in the field (1,416 units by Q3 2025) and subsequent growth in recurring consumable sales is a primary driver of future revenue.
2. Alleviating Reimbursement Uncertainty and Market Clarity: Uncertainty regarding proposed reimbursement changes for certain wound care modalities had previously "frozen the market a bit." However, with the Centers for Medicare & Medicaid Services (CMS) releasing its final rule for 2026, and the reimbursement for the 97610 code (relevant to UltraMIST) showing a slight increase, management is optimistic about market clarity. This reduction in uncertainty is expected to unfreeze the market and accelerate purchasing decisions by customers and distribution partners, thereby boosting revenue.
3. Expansion of Sales Force and Distribution Channels: SANUWAVE has been focusing on expanding its direct sales force and scaling its commercial team to achieve national coverage. This strategic initiative aims to reach a broader customer base and enhance market penetration, directly contributing to increased sales of their wound care products. The company continues to attract interest from new customers and distribution partners.
4. Improved Manufacturing Processes for Applicators: The company is making ongoing progress with new manufacturing processes for its UltraMIST applicators, with commercial production expected to begin in January. These improvements are likely to enhance efficiency, potentially reduce costs, and ensure a more robust supply chain to meet growing demand, supporting revenue growth from consumable sales.
5. Leveraging Innovative Technology in Regenerative Medicine: SANUWAVE is positioned as a pioneer in ultrasound and shockwave technology for the repair and regeneration of tissue. The company's end-to-end wound care portfolio of regenerative medicine products, with UltraMIST being a key component, addresses chronic wounds. Continued innovation and market acceptance of their patented, non-invasive technologies will likely support sustained revenue growth.

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Share Issuance

• As of November 3, 2025, SANUWAVE Health had 8,576,164 shares of common stock outstanding.
• A one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding common stock was put into effect on October 18, 2024.
• The company plans to increase its authorized common stock to allow for the exercise of outstanding warrants and the conversion of future advance convertible promissory notes.

Inbound Investments

• Institutional investors collectively purchased approximately $53.43 million in SANUWAVE Health shares over the last 24 months, with Opaleye Management Inc. being a significant investor.
• In the third quarter of 2025, net income was positively impacted by a $6.1 million favorable change in warrant fair value and a $5.0 million payment from a patent sale.
• On September 25, 2025, SANUWAVE secured a new credit facility, including a $23.0 million secured term loan and a $5.0 million revolving credit facility, which was used to repay previous senior secured debt.

Capital Expenditures

• Capital investments totaled $1.3 million in the first half of 2025.
• Capital expenditures for the quarter ending June 30, 2025, were $1.2 million.
• SANUWAVE Health expects to allocate significant resources toward the commercialization of its UltraMIST product.