Sanuwave Health (NASDAQ:SNWV) reported preliminary fourth-quarter revenue that reached an all-time high, as the medical device maker effectively navigated a volatile reimbursement landscape that has left many of its competitors in the wound-care sector reeling.
The Eden Prairie, Minnesota-based company expects Q4 2025 revenue to land between $13.3 million and $13.4 million, representing a 29% to 30% increase over the same period last year.
This record performance brought full-year 2025 revenue to approximately $44.4 million, up 36% year-over-year.
The results are particularly notable given the "intense transition" currently reshaping the advanced wound-care market.
The Centers for Medicare & Medicaid Services (CMS) recently finalized aggressive cuts to reimbursement rates for skin substitutes and allografts—products that many clinics have relied on for high-margin revenue.
These changes, aimed at curbing fraud and overspending, have caused a significant market contraction for biological tissue products.
However, Sanuwave’s flagship UltraMIST system—a non-contact, low-frequency ultrasound therapy—has emerged as a beneficiary of this disruption.
Because UltraMIST is billed under a distinct mechanical CPT code (97610), its reimbursement remained largely untouched by the new CMS rules.