Market accessCompany release

Sanuwave Q3 revenue falls 24% to $8.6M as CMS proposal hits Ultramist sales

🇺🇸 SANUWAVE Health, Inc. (SNWV) · Tue 10 Nov 2026

The wound-care device maker says a CMS proposed rule on skin substitute pricing and CPT code 97610 curbed Ultramist system sales, which fell to 40 units from 155.

Sanuwave Health reported revenue of $8.6 million for the quarter ended 30 September 2026, down from $11.3 million in the same period a year earlier, a decline of 24%. The company recorded an operating loss of $1.1 million and a net loss of $1.4 million.

The sharpest movement was in Ultramist system sales, which dropped to 40 units from 155 a year before. Management attributed the slowdown to a proposed rule from the US Centers for Medicare & Medicaid Services (CMS) covering skin substitute pricing and CPT code 97610.

The company also pointed to elements of the proposal it regards as more favourable. These include a proposed 14% increase in the hospital outpatient rate for the code and the removal of its Q1 packaging status. As general context, packaging in Medicare outpatient payment generally means a service is bundled into another payment rather than reimbursed separately.

The material available does not give further detail on the proposed rule's timetable, the full financial statements or company guidance, so the wider commercial effect remains unclear.

What it means for your team

  • Market-access teams in wound care should track how the CMS proposal on skin substitute pricing and CPT 97610 may affect purchasing decisions for related devices.
  • Sanuwave's drop from 155 to 40 Ultramist units shows how a proposed reimbursement change can depress sales before it is finalised.
  • The proposed 14% hospital outpatient rate increase and removal of Q1 packaging status for the code are the points to watch in the final rule.

Company's press release (SEC filing): SANUWAVE Health, Inc. ↗

Article written by VigiEye from the official source (SANUWAVE Health, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Market access All →