Company: SNWV
Filing Date: 2025-03-20
Form Type: 10-K
Source: 0001628280-25-014141
Chunk: 0

Company: SANUWAVE Health, Inc.
Filing Date: 2025-03-20
Form: 10-K
Item: Item 1
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Table of Contents

Item 1.    BUSINESS

Overview

Sanuwave is a medical device company providing directed energy products into the wound care space.  Our mission is to improve patient lives and outcomes by developing and marketing effective, easy to use products to decrease wound burden, lessen healing times, and reduce patient pain.

Our focus is regenerative medicine utilizing noninvasive ultrasound or shockwaves to produce a biological response promoting the repair and regeneration of tissue, musculoskeletal, and vascular structures.  The Company’s patented and FDA cleared products include the UltraMIST® system (UM) and the PACE® family of products, both of which are used to treat a variety of acute and chronic wounds.  These products are backed by an intellectual property (“IP”) portfolio of over 165 patents.

In the year ended December 31, 2024, we had total revenues of $32.6 million, a 60% increase from revenues of $20.4 million in the year ended December 31, 2023.  UltraMIST systems and consumables represented approximately 98% of 2024 revenues versus 90% of revenues in 2023.

Our Products and Services:

The Company currently markets directed energy products using both ultrasound and high energy acoustic shockwaves.

UltraMIST

The UltraMIST system delivers low frequency, non-thermal ultrasound to target tissues using a fluid mist to transmit energy in a non-contact and pain free fashion.  This energy penetrates deep into wound beds to promote healing while reducing inflammation, killing bacteria and biofilms, and increasing the growth of blood vessels in the wound and peri-wound.  

This proprietary technology has been shown to speed healing and reduce reported pain, and it has been cleared by the FDA for wound healing and debridement for a variety of acute and chronic wounds including: 

•diabetic foot ulcers, 

•venous leg ulcers, 

•split thickness wounds/skin grafts, 

•deep tissue pressure injuries, 

•surgical wounds, and

•many more wound types.

The UltraMIST System is cleared for marketing in the U.S. by the FDA (K140782) and has CMS schedule one reimbursement under code 97610.  The UltraMIST system treatment must be administered by a healthcare professional.

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The UltraMIST system is highly portable and is used in hospitals, physician’s offices, wound centers, nursing homes, and skilled nursing facilities, and by mobile wound care