Sanuwave (NASDAQ: SNWV) trims Q2 2026 outlook as Ultramist market softens
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Sanuwave Health updated its outlook for the quarter ending June 30, 2026, now expecting second-quarter revenue between $8.5 million and $9.5 million, which is below the guidance discussed on its prior quarterly call.
The company cites worsening conditions in the capital equipment market for its Ultramist system, driven by widespread clawbacks of CMS reimbursement for skin substitutes and allografts. These clawbacks are pressuring wound care practices, leading to closures and a growing secondary market for used Ultramist systems that is weighing on new system sales.
Despite weaker capital equipment demand, Sanuwave reports that applicator and other consumable volumes remain strong and that it is on pace for a record quarterly unit volume of consumables in the second quarter. Management emphasizes a focus on supporting new users, especially those acquiring systems via the secondary market, and remains optimistic about its product pipeline and longer-term potential while acknowledging near-term challenges for capital sales.
Positive
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Negative
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Insights
Sanuwave trims Q2 revenue outlook as Ultramist capital sales soften, while consumables remain strong.
Sanuwave Health now expects Q2 2026 revenue between $8.5M and $9.5M, explicitly below the guidance discussed on its Q1 earnings call. The key pressure point is the capital equipment market for the Ultramist system, where demand has weakened.
Management links this to widespread clawbacks of CMS reimbursement for skin substitutes and allografts, which are pushing some wound care practices into financial distress or closure. That dynamic appears to be fueling a secondary market for used Ultramist systems, which in turn reduces demand for new units.
At the same time, applicator and consumable shipments are described as robust, with the company on pace for record quarterly unit volume in Q2 2026. Longer term, the company’s outlook hinges on its ability to convert system placements—new and secondary-market—into recurring consumable revenue and to navigate reimbursement and regulatory risks highlighted in its forward-looking statements.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Q2 2026 revenue guidance (low end): $8.5 million
Q2 2026 revenue guidance (high end): $9.5 million
Quarter referenced: Q2 2026
3 metrics
Q2 2026 revenue guidance (low end)
$8.5 million
Expected revenue range for second quarter 2026
Q2 2026 revenue guidance (high end)
$9.5 million
Expected revenue range for second quarter 2026
Quarter referenced
Q2 2026
Guidance update and record consumable unit volume reference
Key Terms
guidance, CMS reimbursement, clawbacks, secondary market, +1 more
5 terms
guidance financial
"revenues for the second quarter of 2026 are expected to be in the range of $8.5 to $9.5 million, below the guidance provided"
Guidance is the information that a company provides about its expected future performance or plans. It helps investors understand what the company aims to achieve and whether it anticipates growth or challenges ahead, much like a weather forecast helps people prepare for upcoming conditions. This information influences investment decisions by giving a clearer picture of the company's outlook.
CMS reimbursement regulatory
"Widespread clawbacks of CMS reimbursement for skin sub and allograft usage have been coming in far worse"
CMS reimbursement is the payment and coverage rules set by the U.S. Centers for Medicare & Medicaid Services for medical services, devices, tests and drugs when billed to Medicare or Medicaid. For investors, these rules act like a price list and demand signal from a very large buyer: they determine how much providers and manufacturers can get paid and how widely a product or service will be used, which directly affects revenue and market growth.
clawbacks financial
"Widespread clawbacks of CMS reimbursement for skin sub and allograft usage have been coming in far worse"
secondary market financial
"closures/liquidations appear to be resulting in used Ultramist systems for sale in the marketplace and this has had a significant cannibalization effect"
The secondary market is where investors buy and sell financial assets, such as stocks or bonds, after they have been initially issued. It functions like a marketplace where ownership changes hands, allowing investors to cash out or acquire investments more easily. This market provides liquidity, making it easier for people to turn their investments into cash or find new opportunities.
forward-looking statements regulatory
"This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of earliest event reported) | |||||
| (Exact name of registrant as specified in its charter) | ||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
| Common stock, par value $0.001 per share | SNWV | The Nasdaq Stock Market LLC | ||||||
Indicate by check mark whether the registration is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
1
Item 7.01 Regulation FD Disclosure.
On June 16, 2026, Sanuwave Health, Inc., a Nevada corporation (the “Company”), issued a press release announcing updated guidance for the quarter ended June 30, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
Exhibit No. | Description | |||||||
99.1 | Press Release dated June 16, 2026 | |||||||
| 104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. | |||||||
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SANUWAVE HEALTH, INC. | ||||||||
| Dated: June 16, 2026 | By: | /s/ Morgan C. Frank | ||||||
| Name: | Morgan C. Frank | |||||||
| Title: | Chief Executive Officer | |||||||
3
Exhibit 99.1
Sanuwave Health Updates Second Quarter 2026 Guidance
Sanuwave updates guidance for Q2 2026 to $8.5 - $9.5 million
Company on pace for record unit sales of applicators in Q2
Market disruption impacting Ultramist system sales
EDEN PRAIRIE, MN, June 16, 2026 (GLOBE NEWSWIRE) Sanuwave Health, Inc. (the "Company" or "Sanuwave”) (NASDAQ: SNWV), a leading provider of FDA-cleared directed energy systems used in advanced wound care, today announced that revenues for the second quarter of 2026 are expected to be in the range of $8.5 to $9.5 million, below the guidance provided on the Q1 earnings call on May 13 of this year.
“In the time since we had our Q1 call, we have seen material changes in the conditions in the capital equipment market for the Ultramist system,” said CEO Morgan Frank. “While March and April had shown signs of market improvement, May and the first part of June saw a reversal of these trends.”
“Widespread clawbacks of CMS reimbursement for skin sub and allograft usage have been coming in far worse than many seem to have expected and this has been driving a number of wound care practices out of business. Some of these closures/liquidations appear to be resulting in used Ultramist systems for sale in the marketplace and this has had a significant cannibalization effect on the market for new systems.”
“Sanuwave will always seek to do what’s best for the patients. As such, we will seek to lean in to qualify, train, and support new users in order to help ensure that they are able to provide the highest possible standard of care. We also believe that this is the best choice for the company: in the end, we’re in the applicator business, and patients, providers, and Sanuwave all win from increased levels of treatment.”
“On a positive note, applicator volumes remain robust and the company is on pace for a record quarterly unit volume of consumables shipments in Q2. We remain optimistic about our pipeline and about our forward potential, but from a capital sales standpoint, this is going to be some near-term wood to chop.”
About Sanuwave
Sanuwave Health is focused on the research, development, and commercialization of its patented, non-invasive directed energy systems used in the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.
Sanuwave's end-to-end wound care portfolio of regenerative medicine products and product candidates help restore the body’s normal healing processes. Sanuwave applies and researches its patented and FDA approved/cleared energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, production expectations, and plans for future business development activities. Forward-looking statements include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are: reductions, clawbacks, or recoupments of CMS reimbursement for skin substitutes, allografts, or other advanced wound care products, and their effect on customer behavior and capital budgets; the financial distress, closure, or liquidation of wound care practices and the resulting impact on demand for the Company's systems; the emergence and growth of a secondary market for used Ultramist systems and the cannibalizing effect of such resales on sales of new systems; the Company's ability to qualify, train, and support new users acquiring systems through the secondary market, and the related regulatory, quality, and product-liability considerations; the Company's ability to sustain applicator and consumable volumes and convert system placements into recurring consumable revenue; any differences between updated guidance and final reported results following completion of the quarter; risks associated with regulatory oversight; the Company's ability to manage its capital resources; competition; and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
Contact: investors@sanuwave.com
FAQ
What new Q2 2026 revenue guidance did Sanuwave Health (SNWV) provide?
Sanuwave now expects Q2 2026 revenue between $8.5 million and $9.5 million. This range is stated as being below the guidance discussed on the company’s Q1 2026 earnings call, reflecting softer demand for Ultramist capital equipment.
Why did Sanuwave Health (SNWV) lower its Q2 2026 outlook?
The company attributes the reduced outlook to a weaker capital equipment market for its Ultramist system. It cites widespread clawbacks of CMS reimbursement for skin substitutes and allografts, which are hurting wound care practices and increasing resale of used Ultramist systems.
How are Sanuwave’s Ultramist capital equipment sales being affected in Q2 2026?
Ultramist capital equipment sales are being pressured by market disruption and a growing secondary market for used systems. Practice closures and reimbursement clawbacks are leading to more used devices for sale, which Sanuwave says is significantly cannibalizing demand for new systems.
What positives did Sanuwave Health (SNWV) highlight alongside its Q2 2026 guidance cut?
Sanuwave reports that applicator volumes remain robust and that it is on pace for a record quarterly unit volume of consumables in Q2 2026. Management remains optimistic about its pipeline and long-term potential despite near-term capital sales challenges.
How is Sanuwave responding to the secondary market for used Ultramist systems?
The company plans to qualify, train, and support new users acquiring Ultramist systems through the secondary market. Management believes this approach supports patient care and helps drive recurring applicator and consumable usage across the installed base.
What risks does Sanuwave mention in relation to its updated Q2 2026 guidance?
The company notes risks around CMS reimbursement clawbacks, wound care practice closures, secondary-market cannibalization of new Ultramist sales, sustaining applicator volumes, regulatory oversight, competition, and potential differences between this updated guidance and final reported results for Q2 2026.