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.
This stability has allowed Sanuwave to position its technology as a financially viable alternative for clinics looking to replace lost allograft income.
The company’s growth in 2025 was further bolstered by the expansion of its UltraMIST line into Healogics’ iSupply platform, giving it direct access to a massive network of wound care centers and skilled nursing facilities.
With gross margins historically hovering near 78%, the revenue surge suggests a significant improvement in the company's path toward sustained profitability.
Investors are now looking toward the final audited March earnings report for details on operating income and 2026 guidance.