Company: SNWV
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001628280-25-014141
Chunk: 2

Company: SANUWAVE Health, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 2
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356.

3) National Pressure Ulcer Advisory Panel (NPUAP).

The Centers for Medicare and Medicaid Services (the "CMS") have increasingly classified regenerative technology as medically necessary.  With an aging population and high incidence of obesity, diabetes, cancers, and autoimmune disorders, the Company believes this market is likely to continue to expand.

Strategy

The Company plans to focus on building a direct sales force and distribution network to market the UltraMIST product in the United States and to assess potential expansion abroad.  The Company sees two broad trends favoring UM adoption: 

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transition to evidence-based medicine in wound care and “care to the edge”, as care is being directed away from hospital settings in an effort to treat patients where they are to increase ease of care and to reduce risks of nosocomial infection. 

Reimbursement is being restructured around efficacy and cost effectiveness as payors, physicians, and patients seek better outcomes for less money.  

The Company believes that both trends are favorable to Sanuwave.

We aim to change the wound care space by bringing cost effective, easy to use technology to market, and putting it into the hands of providers who can easily adopt it as well as integrate it into their workflow and patient treatment plans.  To generate broad adoption, a technology needs to be more than just effective, it needs to be both user and patient friendly.  

Traditionally, many patients have been resistant to seek wound care because treatments are long in duration, difficult, involve cumbersome medical devices that must be worn long term, and are frequently painful.  The Company seeks to overcome such patient and provider objections in order to expand access to high quality, modern wound care and to get more patients seen and seen earlier.  By lowering the bar of “willing to seek treatment”, Sanuwave seeks to engage with patients and wounds before they become severe.  

By providing an effective, pain free system with short treatment times that practitioners can learn to use via video conference and for which nationwide CMS reimbursement is already available, the Company seeks to appeal to the “three P’s.”

•Patients want to get better sooner and to experience less pain.

•Physicians want patients to get better but also need to be able to integrate care into their practice flow and economic models.

•Payors want to see patients get better faster and to receive early treatment often outside of hospital settings as such treatments save money.

When the needs of Patients, Physicians, and Payors are aligned, markets are ready adopters of products and markets are ready for