SANUWAVE Health, Inc.

Sanuwave is a medical device company that provides directed energy products for wound care. The company focuses on regenerative medicine, using noninvasive ultrasound to promote tissue, musculoskeletal, and vascular repair and regeneration. Sanuwave's primary product is the UltraMIST® system, which is patented and FDA cleared. This system treats various acute and chronic wounds. The company holds an intellectual property portfolio of over 60 patents. In the year ended December 31, 2025, Sanuwave reported total revenues of $44.1 million, a 35% increase from $32.6 million in the year ended December 31, 2024. UltraMIST systems and consumables accounted for approximately 99% of 2025 revenues, compared to 98% of revenues in 2024. The UltraMIST system is the only commercial product currently marketed by the company. It delivers low-frequency, non-thermal ultrasound to target tissues using a fluid mist, transmitting energy in a non-contact manner. This energy penetrates wound beds to promote healing, reduce inflammation, kill bacteria and biofilms, and increase blood vessel growth in and around the wound. The FDA has cleared UltraMIST for wound healing and debridement for various acute and chronic wounds, including diabetic foot ulcers, venous leg ulcers, split thickness wounds/skin grafts, deep tissue pressure injuries, and surgical wounds. The UltraMIST system is cleared for marketing in the U.S. by the FDA (K140782) and has Centers for Medicare and Medicaid Services (CMS) category one reimbursement under code 97610. A healthcare professional must administer the UltraMIST system treatment.