SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (NASDAQ: SNWV) operates as a medical device company focused on regenerative medicine through noninvasive ultrasound technology for wound care applications. The company's website is www.sanuwave.com.

The company's primary product is the UltraMIST system, an FDA-cleared device that delivers low-frequency, non-thermal ultrasound to target tissues using a fluid mist to transmit energy in a non-contact, pain-free manner. This technology penetrates deep into wound beds to promote healing while reducing inflammation, killing bacteria and biofilms, and increasing blood vessel growth. UltraMIST has received FDA clearance for treating various acute and chronic wounds, including diabetic foot ulcers, venous leg ulcers, split-thickness wounds and skin grafts, deep tissue pressure injuries, and surgical wounds. The device operates under CPT code 97610 with Category 1 reimbursement from the Centers for Medicare and Medicaid Services.

The company employs a "razor and razor blade" business model where customers purchase an UltraMIST system and then purchase sterile, single-use applicators sold in cases of twelve for each treatment. Consumables represent approximately fifty-eight percent of total revenues and constitute the largest revenue stream. As of December 31, 2025, there were 1,292 active systems in the field, defined as those owned by customers who ordered consumable applicators within the last six months.

UltraMIST systems and consumables represented approximately ninety-nine percent of revenues in 2025. The company maintains an intellectual property portfolio of over sixty issued or pending patents worldwide covering various aspects of its technology. Key trademarks include SANUWAVE, UltraMIST, Celleration, MIST Therapy, and Proven Healing.

The company operates through a combination of direct sales representatives, independent distributors, and resellers, with primary sales in the United States. Manufacturing is conducted through a network of suppliers and contract service providers, with final product testing performed internally at the company's FDA-registered, ISO 13485:2016 certified facility in Eden Prairie, Minnesota. As of December 31, 2025, the company employed fifty-five full-time employees in the United States, with fifteen engaged in research and development, clinical, regulatory, and quality functions.