Key Highlights

  • Third-quarter Revenue fell 24% to USD 8.579 million from USD 11.270 million, as management said UltraMIST system revenue dropped about 73% to USD 1.2 million from USD 4.4 million on a 74% decline in unit volume.
  • Net loss was USD 1.416 million, or USD 0.16 per share, against restated Net Income of USD 9.688 million a year earlier, which included a USD 6.1 million derivative gain and a USD 5 million Patent sale gain.
  • UltraMIST applicator revenue grew about 2% on 15% higher unit volume, while management said adjusted EBITDA, a non-GAAP measure, was positive USD 0.7 million against USD 3.2 million.
  • The company breached its fixed charge coverage covenant at September 30, 2026 and received a Waiver on October 28, with cash and cash equivalents of USD 6.569 million.

Capital Sales Slump as Wound Care Customers Retreat

SANUWAVE Health (NASDAQ:SNWV) filed its Quarterly Report on November 10, 2026, and held its call on November 11, 2026. The company sells noninvasive ultrasound and shockwave devices for tissue repair, led by the UltraMIST wound care system. On the call, management said the quarter was shaped by a proposed Medicare rule published July 14, which left skin substitute reimbursement unchanged and proposed a lower rate for code 97610. Some customers closed or shrank, used systems entered the market, and others waited to buy. Systems sold fell to 40 from 82 in the second quarter, though the company still added 60 new customers.

Recurring Applicators Hold While the Quarterly Result Swings

Consumables, parts and accessories rose about 5% to USD 7.2 million from USD 6.8 million. Gross Margin was USD 6.629 million, or 77.3% of revenue, versus 77.6% a year earlier, as the mix shifted toward lower-margin consumables. Operating expenses eased to USD 7.701 million from USD 7.841 million, but the operating result moved to a loss of USD 1.072 million from income of USD 0.903 million. Interest expense dropped to USD 0.276 million from USD 1.795 million after a refinancing in September 2025. Nine-month revenue was USD 27.937 million against USD 30.657 million, with a net loss of USD 3.537 million.

Reimbursement Cut, Covenant Waiver and a Thin Cash Cushion

Management said it estimates the 2027 physician fee schedule payment for code 97610 at USD 314.54, down from USD 397.81 in 2026, a cut of about 20.9% (calculated). Offsetting factors, it said, include a roughly 14% increase in the hospital outpatient rate to USD 235.04 and a status change that allows the code to be billed alongside others. Cash fell to USD 6.569 million from USD 11.959 million at year end after USD 4.3 million of Loan repayments and about USD 2.7 million of Sales Tax settlements. The company was not in compliance with its fixed charge coverage ratio at September 30, and lenders waived the default on October 28.

Where Things Stand

System sales fell because customers pulled back after the proposed reimbursement rule, while applicators kept growing. SANUWAVE Health (NASDAQ:SNWV) swung from restated net income of USD 9.688 million to a USD 1.416 million loss as higher-margin Capital sales dropped. The recurring applicator line grew about 2% and operating expenses edged lower. Against that, cash is down, the covenant needed a waiver, and 2027 payment for code 97610 is lower. Next markers are customer recovery, Demand for systems, further talks with the federal payer on the code structure and covenant compliance in coming quarters.