SANUWAVE Health, Inc.

Except as set forth below, there have been no material changes from the risk factors previously disclosed in Part I, Item 1A, “Risk Factors,” in our 2025 Annual Report. The risk factors below supplement, and should be read together with, the risk factors in our 2025 Annual Report.

Changes in Medicare reimbursement for skin substitutes and other wound care products and procedures have adversely affected, and may continue to adversely affect, our customers and demand for our products.

The wound care market is highly dependent on reimbursement from governmental and private third-party payors, including the Centers for Medicare & Medicaid Services (“CMS”) and Medicare Administrative Contractors (“MACs”). CMS and other payors periodically revise coverage policies, payment levels, coding guidance, and utilization rules for wound care products and procedures, including cellular and tissue-based products for skin wounds (“skin substitutes” or allografts) and other advanced wound care therapies.

Effective January 1, 2026, under the Calendar Year 2026 Medicare Physician Fee Schedule final rule, CMS stopped paying for most skin substitutes as biologicals under the average sales price methodology. It now pays for them as incident-to supplies at a single national rate of approximately $127 per square centimeter in both the physician office and hospital outpatient settings. CMS estimated this change would reduce Medicare spending on these products by nearly 90%. On November 4, 2026, CMS released the Calendar Year 2027 Physician Fee Schedule final rule, which maintains this payment methodology for 2027 and extends national pricing to non-sheet form skin substitutes.

Our Ultramist® system is not a skin substitute or allograft product and is not paid under the skin substitute payment methodology. However, Ultramist® treatment is billed under CPT code 97610, which is paid under the Physician Fee Schedule in the physician office setting. The 2027 final rule reduces the relative value units for CPT code 97610 and reduces the conversion factor applicable to all services paid under the Physician Fee Schedule. As a result, the national Medicare payment for CPT code 97610 in the physician office and mobile clinic setting will be $314.54 per treatment in 2027, compared with $397.81 in 2026, a reduction of approximately 21%. The reduction in relative value units is being phased in, and CMS’s final rule reflects a further decline at full phase-in in 2028. Although the 2028 conversion factor has not been established, absent further rulemaking, we expect a further significant reduction in the 2028 payment rate for CPT code 97610. Lower reimbursement for Ultramist® treatment could reduce demand for our systems and applicators, lengthen sales cycles, and put pressure on our pricing.

In addition, many of our customers operate in care settings where skin substitutes have historically been a significant part of wound care treatment protocols and provider revenue. These changes have reduced revenue at certain wound care practices, hospitals, and other providers. We believe they have contributed to longer sales cycles, deferred or reduced capital purchases, and practice consolidations or closures among our customers and prospective customers during 2026. Continued pressure on provider economics could further alter treatment protocols, limit capital expenditures, reduce demand for our systems and consumables, and impair some customers’ ability to pay amounts they owe us.

CMS has indicated it may continue to revise payment rates and product categories for skin substitutes. MACs and other payors may also adopt new coverage policies, prior authorization requirements, or utilization limits affecting wound care products and procedures. Reimbursement policies are determined by governmental and private payors and are outside our control, and we cannot predict the timing, scope, or effect of future changes. Changes in the wound care reimbursement environment, including those already in effect, could adversely affect our customers’ financial condition and have a material adverse effect on our business, financial condition, and results of operations.

We did not comply with a financial covenant under our JPM Credit Agreement as of September 30, 2026, and any future failure to comply with our covenants could result in an event of default and the acceleration of our indebtedness.

Our JPM Credit Agreement requires us to maintain a minimum fixed charge coverage ratio and to comply with other financial and operating covenants. As of September 30, 2026, we did not meet the fixed charge coverage ratio for the twelve months then ended. On October 28, 2026, we entered into the Amendment pursuant to which the lenders waived the resulting event of default. The Amendment also imposes additional restrictions, including lender consent requirements for acquisitions and repurchases of our equity securities and reduced limits on certain other indebtedness and investments.

As of September 30, 2026, $17.3 million was outstanding under the Term Loan and $0.7 million was outstanding under the Revolver, which matures in September 2027. We cannot assure you that we will comply with our covenants in future periods, or that the lenders would grant future waivers or amendments on acceptable terms, or at all. If we fail to comply and do not obtain a waiver, the lenders could declare all amounts outstanding immediately due and payable, terminate their commitments under the Revolver, and foreclose on the collateral securing the JPM Credit Agreement, which includes substantially all of our assets. Any of these events would have a material adverse effect on our business, financial condition, and results of operations.

We have received a notice from Nasdaq that we do not satisfy a continued listing requirement, and if we are unable to regain compliance, our common stock could be delisted from The Nasdaq Global Market.

On September 23, 2026, we received a notice from Nasdaq that, for the prior 30 consecutive business days, the market value of our listed securities(“MVLS”)was below the $50.0 million minimum required for continued listing on The Nasdaq Global Market. We have until March 22, 2027 to regain compliance, which requires the MVLS to close at $50.0 million or more for at least 10 consecutive business days. If we do not regain compliance by Nasdaq's deadline and are unable to transfer our common stock to The Nasdaq Capital Market, our common stock would be subject to delisting.