Sanuwave withdraws FY2026 guidance after CMS reimbursement proposal, reports Q2 results
Sanuwave pulled its full-year outlook citing Medicare payment uncertainty as Q2 revenue fell 3% to $9.7 million and system sales dropped on reimbursement pressure and a used-equipment market.
Sanuwave Health reported financial results for the quarter ended June 30, 2026 in a release dated August 6, 2026. Citing market conditions including recent Medicare reimbursement developments, the company withdrew its previously issued fiscal year 2026 guidance, saying it should no longer be relied upon.1 Sanuwave said it will hold off on quarterly or annual guidance until there is more clarity, and plans to revisit the topic after CMS issues its final rule, expected in the fourth quarter of 2026.1
The guidance pause follows a CMS proposed rule on 2027 reimbursement for procedure code 97610. CEO Morgan Frank said the proposed rule was not what the company had hoped for or expected, particularly after a 14% increase in the proposed HOPD reimbursement rate had come out just weeks earlier.1 Frank said Sanuwave supports CMS's stated goal of accurate, data-driven payment but disagrees with aspects of the methodology and assumptions in the proposal, and the company intends to participate actively in the comment period to seek changes before a final rule is issued.1
On operating results, Q2 2026 revenue was $9.7 million, down 3% from $10.1 million in Q2 2025.1 The company sold 82 Ultramist systems in the quarter, down from 116 in Q2 2025 and from 97 in Q1 2026.1 Applicator revenue for the Ultramist system rose 13% to $7.3 million from $6.4 million a year earlier.1 Frank attributed weaker system sales to ongoing stress on customers from CMS reimbursement changes and recoupments tied to allografts, along with growth in a secondary market for used Ultramist systems that pressured new unit sales.1
GAAP operating loss was $0.3 million in Q2 2026 versus operating income of $1.4 million in Q2 2025.1
Fact check notes
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On the balance sheet, cash and cash equivalents were $9,376,000 at June 30, 2026, compared with $11,959,000 at December 31, 2025, according to the company's condensed balance sheet.
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