What changed in this filing

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Item 1. Business

2026-03-26 compared with 2025-03-20 · 52 added, 69 removed, 203 unchanged (37% of the section changed)

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Our mission is to improve patient lives and outcomes by developing and marketing effective, easy to use products to decrease wound burden, lessen healing times, and reduce patient pain.

Our focus is regenerative medicine utilizing noninvasive ultrasound or shockwaves to produce a biological response promoting the repair and regeneration of tissue, musculoskeletal, and vascular structures.

The Company’s patented and FDA cleared products include the UltraMIST ® system (UM) and the PACE ® family of products, both of which are used to treat a variety of acute and chronic wounds.

These products are backed by an intellectual property (“IP”) portfolio of over 165 patents.

Our focus is regenerative medicine utilizing noninvasive ultrasound to produce a biological response promoting the repair and regeneration of tissue, musculoskeletal, and vascular structures.

The Company’s patented and FDA cleared product is the UltraMIST ® system, which is used to treat a variety of acute and chronic wounds.

The Company is backed by an intellectual property (“IP”) portfolio of over 60 patents.

In the year ended December 31, 2025 , we had total revenues of $44.1 million , a 35% increase from revenues of $32.6 million in the year ended December 31, 2024 .

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Our Products and Services:

The Company currently markets directed energy products using both ultrasound and high energy acoustic shockwaves.

The UltraMIST system delivers low frequency, non-thermal ultrasound to target tissues using a fluid mist to transmit energy in a non-contact and pain free fashion.

The Company develops and markets directed energy products that utilize ultrasound technology.

UltraMIST is the only commercial product currently marketed by the Company.

The UltraMIST system delivers low frequency, non-thermal ultrasound to target tissues using a fluid mist to transmit energy in a non-contact, pain free fashion.

This energy penetrates deep into wound beds to promote healing while reducing inflammation, killing bacteria and biofilms, and increasing the growth of blood vessels in the wound and peri-wound.

This proprietary technology has been shown to speed healing and reduce reported pain, and it has been cleared by the FDA for wound healing and debridement for a variety of acute and chronic wounds including:

This proprietary technology has been shown to speed healing and reduce reported pain.

UltraMIST has been cleared by the FDA for wound healing and debridement for a variety of acute and chronic wounds including:

• diabetic foot ulcers,

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The UltraMIST system is cleared for marketing in the U.S.

by the FDA (K140782) and has CMS schedule one reimbursement under code 97610.

by the FDA (K140782) and has the Centers for Medicare and Medicaid Services ("CMS") category one reimbursement under code 97610.

The UltraMIST system treatment must be administered by a healthcare professional.

The UltraMIST system is highly portable and is used in hospitals, physician’s offices, wound centers, nursing homes, and skilled nursing facilities, and by mobile wound care providers serving patient homes.

The UltraMIST system is highly portable and is used in hospitals, physician’s offices, wound centers, nursing homes, skilled nursing facilities, and by mobile wound care providers serving patient homes.

Treatment may be provided by a doctor, nurse, nurse practitioner, or physical therapist.

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Despite this, many patients are left with chronic wounds resistant to healing.

Sanuwave’s Energy First™ protocol is at the forefront of improving the standard of care for advanced and chronic wounds.

Sanuwave’s UltraMIST protocol is at the forefront of improving the standard of care for advanced and chronic wounds.

Our solutions help expedite the healing process at a cellular level, a better and simpler alternative that can lead to improved patient outcomes and enhanced quality of life.

As the UltraMIST device never touches the wound, the treatment is painless and patients report a significant reduction in pain post treatment.

Significant clinical research demonstrates reductions in healing time, patient pain, and other indicators of patient healing (for more clinical information, please visit our website:

Significant clinical research demonstrates reductions in healing time, patient pain, and other indicators of patient healing (more clinical information can be found on our website:

https://sanuwave.com/clinical).

The UltraMIST system is in use with many top hospitals and wound care providers across the United States.

Typical treatment time is 6 minutes (and ranges from 3 to 20 minutes).

Typical treatment time is six minutes (and ranges from three to 20 minutes).

UltraMIST is sold using a simple “razor/razor blade” model.

Customers purchase an UltraMIST system and then each treatment utilizes a sterile, single use applicator sold in cases of 12.

UM consumables revenues constitute the majority of Sanuwave revenue amounting to approximately 61% of total revenues in 2024 and are expected to remain the largest revenue stream for the Company.

Over 1,000 UM systems were in the field as of December 31, 2024.

The PACE systems use acoustic pressure shockwaves generated by the Company’s Pulsed Acoustic Cellular Expression (PACE) technology to converge at precise selected targets to produce an extremely short duration compression burst and

are used in both wound and orthopedic applications under the brand names dermaPACE, Profile, and orthoPACE.

The PACE systems are marketed in the U.S., and the European Union (CE Mark).

The wound care market exceeds $45 billion per year in the United States and is spread among a number of key categories:

UltraMIST consumables revenues constitute the majority of Sanuwave revenue amounting to approximately 58% of total revenues in 2025 and are expected to remain the largest revenue stream for the Company.

As of December 31, 2025, there were 1,292 active systems in the field.

Act ive systems are defined as those owned by customers who have ordered consumable applicators within the last 6 months (or within their expected ordering timeframe for those who order infrequently).

In the event that customers are known to have discontinued use, their systems may be removed from this total earlier.

We estimate the wound care market exceeds $67 billion per year in the United States and is spread among a number of key categories

1) Rice et al.

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3) National Pressure Ulcer Advisory Panel (NPUAP).

The Centers for Medicare and Medicaid Services (the "CMS") have increasingly classified regenerative technology as medically necessary.

4) Nussbaum, Carter, Fife Value Health 2018.

With an aging population and high incidence of obesity, diabetes, cancers, and autoimmune disorders, the Company believes this market is likely to continue to expand.

The Company plans to focus on building a direct sales force and distribution network to market the UltraMIST product in the United States and to assess potential expansion abroad.

The Company sees two broad trends favoring UM adoption:

The Company is focused on building a direct sales force and distribution network to market the UltraMIST product in the United States and to assess potential expansion abroad.

The Company sees two broad trends favoring UltraMIST adoption:

transition to evidence-based medicine in wound care and “care to the edge”, as care is being directed away from hospital settings in an effort to treat patients where they are to increase ease of care and to reduce risks of nosocomial infection.

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To generate broad adoption, a technology needs to be more than just effective, it needs to be both user and patient friendly.

Our goal is to provide the technology that physicians need to provide the wound care that patients want.

Traditionally, many patients have been resistant to seek wound care because treatments are long in duration, difficult, involve cumbersome medical devices that must be worn long term, and are frequently painful.

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By lowering the bar of “willing to seek treatment,” Sanuwave seeks to engage with patients and wounds before they become severe.

By providing an effective, pain free system with short treatment times that practitioners can learn to use via video conference and for which nationwide CMS reimbursement is already available, the Company seeks to appeal to the “three P’s.”

By providing an effective, pain free system with short treatment times that practitioners can learn to use via video conference and for which nationwide category 1 CMS reimbursement is already available, the Company seeks to appeal to the “three P’s.”

• Patients want to get better sooner and to experience less pain.

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Sales, Marketing and Distribution

The Company sells systems through a combination of direct sales representatives and independent distributors.

The Company sells systems through a combination of direct sales representatives, independent distributors, and resellers.

The systems are used in hospitals, clinics, and alternate care facilities.

Our primary sales are in the Unites States.

Our primary sales are in the United States.

Manufacturing

The Company has developed a network of suppliers, manufacturers, and contract service providers to provide sufficient quantities of our products.

The Company is party to a manufacturing supply agreement with Nortech in Wayzata, MN and Biomerics in Salt Lake City UT, covering the generator and treatment wand components of our products.

The Company sources the generator and treatment wand components of its products from Nortech Systems, Inc in Maple Grove, MN.

Our generators and treatment wands are manufactured in accordance with applicable quality standards and applicable industry and regulatory standards.

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The Company also has not conducted a competitive analysis or valuation with respect to our issued and pending patent portfolio in relation to our current products and/or competitor products.

In August 2005, we entered into a license agreement with HealthTronics Inc.

(“HealthTronics”) in connection with our acquisition of certain assets and intellectual property relating to orthopedic, tendinopathy, skin wounds, cardiac, dental, neural medical conditions and to all conditions in animals (the “Ortho Field”) from HealthTronics.

The majority of the intellectual property licensed from HealthTronics was associated with the construction of shockwave devices, indications for orthopedic treatments, and wound care.

These patents and patent applications have either expired or were not pursued in our portfolio.

Under our license to HealthTronics, Inc., we reserved exclusive rights in our purchased portfolio as to the Ortho Field.

HealthTronics received field-exclusive and sublicensable rights under the purchased portfolio as to (1) certain HealthTronics lithotripsy devices in all fields other than the Ortho Field, and (2) all products in the treatment of renal,

ureteral, gall stones and other urological conditions (the “Litho Field”).

HealthTronics also received non-exclusive and non-sublicensable rights in the purchased portfolio as to any products in all fields other than the Ortho Field and Litho Field.

Pursuant to mutual amendment and other assignment-back rights under the patent license agreement with HealthTronics, we are also a licensee of certain patents and patent applications that have been assigned to HealthTronics.

We received a perpetual, non-exclusive and royalty-free license to nine issued foreign patents.

Our non-exclusive license is subject to HealthTronics’ sole discretion to further maintain any of the patents and pending applications assigned back to HealthTronics.

In August 2020, we entered into an asset purchase agreement with Celularity Inc.

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These assets are for use in low frequency and non-contact ultrasound to treat wounds.

In August 2020, we also entered into a License and Marketing Agreement with Celularity, pursuant to which we were granted an exclusive, royalty-bearing license to commercialize Biovance, a minimally processed human amniotic membrane, and Interfyl, a human connective tissue matrix, for the care and treatment of acute and chronic wounds performed in an operating room setting for worldwide commercialization, excluding the Asia Pacific region.

Under the terms of the agreement, Celularity was to provide Biovance and Interfyl product to us for commercialization in exchange for a quarterly license fee payment.

In May 2021, we received notification of non-compliance with the terms of the agreement due to alleged non-payment of the quarterly license fee.

Pursuant to the notification, we ceased commercialization of the licensed products and have not resumed commercialization.

Since other products on the market compete with our products, the Company believes that our product brand names are an important factor in establishing and maintaining brand recognition.

The Company has the following trademark registrations:

SANUWAVE ® (United States, European Community, Canada, Japan, Switzerland, United Kingdom, Taiwan and under the Madrid Protocol), dermaPACE ® (United States, European Community, Japan, South Korea, Switzerland, Taiwan, Canada, China, Brazil, and under the Madrid Protocol), angioPACE ® (European Community and United Kingdom), PACE ® - Pulsed Acoustic Cellular Expression (United States, European Community, China, Hong Kong, Singapore, Switzerland, United Kingdom Taiwan, and Canada), orthoPACE ® (United States, United Kingdom, and European Community), DAP ® - Diffused Acoustic Pressure (United States, United Kingdom, and European Community), Profile ® (United States, European Community, and United Kingdom), Energy First ® (United States), Healing Today, Curing Tomorrow ® (United States), and UltraMIST ® (United States).

SANUWAVE ® (United States, European Community, Canada, Japan, Switzerland, United Kingdom, Taiwan and under the Madrid Protocol), Energy First ® (United States), Healing Today, Curing Tomorrow ® (United States), and UltraMIST ® (United States).

Through the acquisition of UltraMIST®/MIST assets from Celularity Inc., the Company is the owner of the Celleration ® (United States, Australia, Europe Community, and Japan), Proven Healing ® (Madrid Protocol, European Community, and United Kingdom), MIST Ultrasound Healing Therapy & Design ® (United States), MIST ® (United States), MIST Therapy ® (United States), and MIST & Design ® (United States) registered trademarks.

The Company also maintains trademark registrations for:

OssaTron ® (United States), evoPACE ® (United Kingdom), Evotron ® (Switzerland), and Orthotripsy ® (United States).

The Company phased out the OssaTrode ® (United States, Germany and Switzerland), Equitron ® (United States and Switzerland), Reflectron ® (Germany and Switzerland), Reflectrode ® (Germany and Switzerland), OSWT ® (Switzerland), Evotrode ® (United States, Germany and Switzerland), and evoPACE ® (Canada, Australia, European Community and Switzerland) trademarks, due to the fact that OssaTrode ® , Equitron ® , Reflectron ® , Reflectrode ® , OSWT ® , Evotrode ® , products are no longer available for sale in any market and evoPACE ® is a product that is not commercialized.

The Company believes the advanced wound care market can benefit from our technology which up-regulates the biological factors that promote wound healing.

Current medical technologies developed by Acelity L.P.

Inc, (formerly Kinetic Concepts, Inc., now owned by 3M), Organogenesis, Inc., Smith & Nephew plc, Derma Sciences, Inc., MiMedx Group, Inc., Osiris Therapeutics, Inc.

(now owned by Smith & Nephew), Molnlycke Health Care, Systagenix Wound Management (US), Inc.

(now owned by Scapa Group Ltd) and SoftWave Tissue Regeneration Technologies manage wounds, but, in our opinion, do not provide the value proposition to the patients and care givers like our PACE technology has the potential to do.

The leading medical device serving this market is the Vacuum Assisted Closure (“V.A.C.”) System marketed by Kinetic Concepts Inc.

is a negative pressure wound therapy device that applies suction to debride and manage wounds.

There are also several companies that market extracorporeal shockwave device products targeting lithotripsy and orthopedic markets, including Dornier MedTech, Storz Medical AG, Electro Medical Systems (EMS) S.A., SoftWave Tissue Regeneration Technologies, and CellSonic Medical, which could ultimately pursue the wound care market.

Nevertheless, the Company believes that the PACE systems have a competitive advantage over all of these existing technologies by achieving wound closure by means of a minimally invasive process through innate biological response to PACE technology.

Regarding the companies that use low frequency ultrasound that creates a pressure wave producing micro-strains due to mechanical forces that deform cell membrane and therefore promote healing, there are technologies developed by Arobella Medical LLC, NanoVibronix, Chattanooga, and EDAP TMS to manage wound care.

However, these treatment devices or medical systems are different in design and mode of application of the ultrasound when compared to Sanuwave’s UltraMIST.

The Company believes that UltraMIST has a competitive advantage over all of these existing technologies, due to broad medical indications, simplicity of use, wound healing results and the tolerability of the treatment by the patients, especially for painful wounds.

The Company also maintains other trademark registrations.

The advanced wound care market is highly competitive and includes a broad range of technologies used to promote wound healing, manage exudate, control infection, and support tissue regeneration.

The Company competes with manufacturers of advanced wound dressings, negative pressure wound therapy systems, cellular and tissue-based products, biologic grafts, and energy-based wound treatment technologies.

Many of these companies have significantly greater financial, marketing, sales, and research resources than the Company.

Major participants in the wound care market include multinational medical device and wound care companies such as Solventum, Smith & Nephew, Molnlycke Health Care, Essity, Coloplast, and Convatec, which offer portfolios of advanced wound dressings, wound management products, and negative pressure wound therapy systems.

The Company also competes with manufacturers of cellular and tissue-based products and biologic wound therapies, including Organogenesis, MiMedx Group, Integra LifeSciences, Vericel, and Kerecis.

In addition, the Company competes with energy-based wound treatment technologies, including ultrasound systems developed by Arobella Medical and NanoVibronix, and acoustic wave technologies developed by SoftWave Tissue Regeneration Technologies.

Wound imaging and diagnostic technologies from companies such as MolecuLight and MIMOSA Diagnostics may also influence treatment decisions in wound care.

The UltraMIST therapy system, delivers non-contact low-frequency ultrasound therapy intended to promote wound healing through mechanical stimulation of tissue.

The Company believes UltraMIST may offer advantages in certain settings due to its non-contact application, ease of use, and patient tolerability.

Healthcare providers, however, may choose among many treatment alternatives depending on clinical protocols, reimbursement considerations, and physician or facility preference.

The Company’s products also compete with conventional wound care approaches, including surgical or sharp debridement, standard wound dressings, compression therapy, and other established wound management practices.

Competitive factors include clinical outcomes, ease of use, patient comfort, reimbursement coverage, cost, and the availability of supporting clinical evidence.

Regulatory Matters

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The certificate does not represent marketing authorization, nor does it require any regulatory authority to issue a marketing authorization or endorsement to the device manufacturer.

The Company has been certified to the MDSAP requirements for the U.S., most recently successfully completing a MDSAP surveillance audit in September 2024.

The Company has been certified to the MDSAP requirements for the U.S., most recently successfully completing a MDSAP recertification audit in June 2025.

Audit to additional countries will be conducted if expansion to those markets is considered.

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Annual surveillance audits are required to maintain this certification.

A full recertification will be conducted in 2025.

A surveillance will be conducted in 2026.

Manufacturing cGMP Requirements

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Failure to comply with statutory and regulatory requirements subjects a manufacturer to possible legal or regulatory action, including the seizure or recall of products, injunctions, consent decrees placing significant restrictions on or suspending manufacturing operations, and civil and criminal penalties.

Adverse experiences with the product must be reported to the FDA and could result in the imposition of marketing restrictions through labeling changes or in product withdrawal.

Adverse experiences with the product must be reported to the FDA and could result in the

imposition of marketing restrictions through labeling changes or in product withdrawal.

Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following the approval.

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This Category 1 code describes a system used in wound care that uses low frequency ultrasonic energy to atomize a liquid and deliver continuous low frequency ultrasound to the wound bed.

The CPT codes for the dermaPACE System using extracorporeal shock wave technology to treat diabetic foot ulcers are 0512T and 0513T.

The codes 0512T and 0513T are for extracorporeal shock wave for integumentary wound healing, including topical application and dressing and high energy extracorporeal shockwave therapy for integumentary wound healing.

While these are Category 3 codes because the dermaPACE System is considered experimental by the CMS, this designation does not preclude billing and obtaining payment.

Instead, claims are reviewed on an individual basis.

In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific product lines and procedures.

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The Office for Civil Rights of the U.S.

Department of Health and Human Services ("HHS"), the agency responsible for enforcing HIPAA, has published regulations to address the privacy (the “Privacy Rule”) and security (the “Security Rule”) of protected health information ("PHI").

Department of Health and Human Services

("HHS"), the agency responsible for enforcing HIPAA, has published regulations to address the privacy (the “Privacy Rule”) and security (the “Security Rule”) of protected health information ("PHI").

HIPAA also requires that all providers who transmit claims for health care goods or services electronically utilize standard transaction and data sets and to standardize national provider identification codes.

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We have adopted policies and procedures to comply with the Privacy Rule, the Security Rule and the HIPAA statute as such regulations become applicable to our business.

We currently don’t capture patient data through our PACE system.

In addition to HIPAA, many states have laws that govern the processing, collection, use, disclosure, transfer, storage, disposal and protection of health-related and other sensitive and personal information.

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These additional rights and the establishment of an agency with independent enforcement powers are expected to increase data breach litigation and government enforcement activity in California.

Comprehensive privacy legislation similar to the CCPA has been adopted in other U.S.

states including Colorado, Connecticut, Kentucky, Maryland, Minnesota, Montana, New Jersey, New Hampshire, Nevada, Oregon, Rhode Island, Tennessee, Texas, Utah, and Virginia.

Comprehensive privacy legislation similar to the CCPA has been adopted in many other U.S.

In the event that we are subject to or affected by HIPAA, the CCPA, or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.

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Our operations are subject to extensive Federal, state, provincial and municipal environmental statutes, regulations and policies, including those promulgated by the Occupational Safety and Health Administration, the United States Environmental Protection Agency, Environment and Climate Change Canada, Alberta Environment and Protected Areas, the Department of Health Services, and the Air Quality Management District, that govern activities and operations that may have adverse environmental effects such as discharges into air and water, as well as handling and disposal practices for solid and hazardous wastes.

Some of these statutes and regulations impose strict liability for the costs of cleaning up, and for damages resulting from, sites of spills, disposals, or other releases of contaminants, hazardous substances and other materials and for the investigation and remediation of environmental contamination at properties leased or operated by us and at off-site locations where we have arranged for the disposal of hazardous substances.

materials and for the investigation and remediation of environmental contamination at properties leased or operated by us and at off-site locations where we have arranged for the disposal of hazardous substances.

In addition, we may be subject to claims and lawsuits brought by private parties seeking damages and other remedies with respect to similar matters.

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As of December 31, 2025, we had a total of 55 full time employees in the United States.

Of these, seven were engaged in research and development which also includes clinical, regulatory, and quality.

Of these, 15 were engaged in research and development which also includes clinical, regulatory, and quality.

None of our employees are represented by a labor union or covered by a collective bargaining agreement.

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We were formed as a Nevada corporation in 2004.

Our corporate headquarters address is 11495 Valley View Road, Eden Prairie, MN 55344, and our main telephone number is (800) 545-8810 or (952) 656-1029.

Our corporate headquarters address is 9600 W.

76th Street, Suite 118, Eden Prairie, MN, 55344, and our main telephone number is (800) 545-8810 or (952) 656-1029.

Available Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business