Company: SNWV
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001628280-25-014141
Chunk: 1

Company: SANUWAVE Health, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
Chunk 1
---
 providers serving patient homes.  Treatment may be provided by a doctor, nurse, nurse practitioner, or physical therapist.  

Treating chronic wounds is a difficult and time-consuming process.  Current modalities for wound management typically involve the use of ointments and liquid solutions, specialized bandages, topical skin substitutes, negative pressure, or hyperbaric oxygen. Despite this, many patients are left with chronic wounds resistant to healing.

Sanuwave’s Energy First™ protocol is at the forefront of improving the standard of care for advanced and chronic wounds. Our solutions help expedite the healing process at a cellular level, a better and simpler alternative that can lead to improved patient outcomes and enhanced quality of life.

5

As the UltraMIST device never touches the wound, the treatment is painless and patients report a significant reduction in pain post treatment.  Significant clinical research demonstrates reductions in healing time, patient pain, and other indicators of patient healing (for more clinical information, please visit our website: https://sanuwave.com/clinical).  The UltraMIST system is in use with many top hospitals and wound care providers across the United States.  Typical treatment time is 6 minutes (and ranges from 3 to 20 minutes).

UltraMIST is sold using a simple “razor/razor blade” model.  Customers purchase an UltraMIST system and then each treatment utilizes a sterile, single use applicator sold in cases of 12.  UM consumables revenues constitute the majority of Sanuwave revenue amounting to approximately 61% of total revenues in 2024 and are expected to remain the largest revenue stream for the Company.  Over 1,000 UM systems were in the field as of December 31, 2024.

PACE

The PACE systems use acoustic pressure shockwaves generated by the Company’s Pulsed Acoustic Cellular Expression (PACE) technology to converge at precise selected targets to produce an extremely short duration compression burst and 

6

are used in both wound and orthopedic applications under the brand names dermaPACE, Profile, and orthoPACE.  The PACE systems are marketed in the U.S., and the European Union (CE Mark).

Market

The wound care market exceeds $45 billion per year in the United States and is spread among a number of key categories:

1) Rice et al. Diabetes Care 2014;37:651-658.

2) Rice et al. J Med Econ. 2014;17-(5): 347-