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Item 1. Business

2023-03-31 compared with 2022-05-13 · 338 added, 666 removed, 84 unchanged (92% of the section changed)

We are a shock wave technology company using a patented system of noninvasive, high-energy, acoustic shock waves for regenerative medicine and other applications.

Our initial focus is regenerative medicine

utilizing noninvasive, acoustic shock waves to produce a biological response resulting in the body healing itself through the repair and regeneration of tissue, musculoskeletal, and vascular structures.

Our lead regenerative product in the United States is the dermaPACE ® device, used for treating diabetic foot ulcers, which was

subject to two double-blinded, randomized Phase III clinical studies.

On December 28, 2017, the U.S.

Food and Drug Administration (the “FDA”) granted the Company’s request to classify the dermaPACE ® System as a Class II device via the de novo process.

As a result of this decision, the Company was able to immediately market the product for the treatment

of diabetic foot ulcers as described in the de novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

Our portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal

healing processes and regeneration.

We intend to apply our Pulsed Acoustic Cellular Expression (PACE ® ) technology in wound healing, orthopedic, plastic/cosmetic and

cardiac conditions.

The Company is marketing its dermaPACE ® System for treatment usage

in the United States and will continue to generate revenue from sales of the European Conformity Marking (CE Mark) devices and accessories in Europe, Canada, Asia, Brazil, Mexico, and Asia/Pacific.

The Company generates revenue streams

from dermaPACE ® treatments, product sales, licensing transactions and other activities, and with its recent acquisition

of the UltraMIST® assets, SANUWAVE now combines two highly complementary and market-cleared energy transfer technologies used in the dermaPACE® and UltraMIST® Systems and two human tissue biologic products (Biovance® and Interfyl®), creating a

platform of scale with an end-to-end product offering in the advanced wound care market.

Our lead product candidate for the global wound care market, dermaPACE ® , has received FDA clearance for commercial use to treat

diabetic foot ulcers in the United States and the CE Mark allowing for commercial use on acute and chronic defects of the skin and subcutaneous soft tissue.

We believe we have demonstrated that our patented technology is safe and effective in

stimulating healing in chronic conditions of the foot and the elbow through our United States FDA Class III Premarket Approvals (“PMAs”) approved OssaTron® device, and in the stimulation of bone and chronic tendonitis regeneration in the

musculoskeletal environment through the utilization of our OssaTron, Evotron®, and orthoPACE® devices in Europe and Asia.

We are focused on developing our PACE technology to activate healing in:

wound conditions, including diabetic foot ulcers, venous and arterial ulcers, pressure sores, burns and other skin eruption conditions;

orthopedic applications, such as eliminating chronic pain in joints from trauma, arthritis or tendons/ligaments inflammation, speeding the healing of fractures (including nonunion or delayed-union

conditions), improving bone density in osteoporosis, fusing bones in the extremities and spine, and other potential sports injury applications;

The Company is an ultrasound and shock wave technology company using patented systems of noninvasive, high-energy, acoustic shock waves or low intensity and non-contact ultrasound for regenerative medicine and other

applications.

Our focus is regenerative medicine utilizing noninvasive, acoustic shock waves or ultrasound to produce a biological response resulting in the body healing itself through the repair and regeneration of tissue, musculoskeletal, and

vascular structures.

Our two primary systems are UltraMIST ® and PACE ® .

UltraMIST and PACE are the only two Food and Drug Administration (FDA) approved directed energy systems for wound healing.

The UltraMIST system provides, through a fluid mist, low-frequency, non-contact, and pain free ultrasound energy deep inside the wound bed that promotes healing from within.

The ultrasound acoustic

waves promote healing by reducing inflammation and bacteria in the wound bed, while also increasing the growth of new blood vessels to the area.

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

This proprietary

technology has been cleared by the FDA for the promotion of wound healing through wound cleansing and maintenance debridement combined with ultrasound energy deposited inside the wound that stimulated tissue regeneration.

The PACE systems, use acoustic waves 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.

The precise targeting of tissue with PACE ® technology provides healthcare

professionals with a tool to positively influence cellular form and function, which can result in pain relief, improved circulation, and tissue regeneration.

The PACE ® system treatment must be administered by a healthcare professional.

The Company sells three PACE systems including:

dermaPACE ® :

Used to treat Diabetic Foot Ulcers and other chronic wounds

orthoPACE ® :

Used to treat acute musculoskeletal conditions

Used to provide therapeutic treatment of musculoskeletal conditions

Our portfolio of wound treatment solutions provides patients with a noninvasive technology that boosts the body’s normal healing and tissue regeneration processes.

The Company is

marketing its UltraMIST and PACE systems for usage primarily in the United States .

Regarding the non-contact and non-thermal low frequency ultrasound UltraMIST system, the Company is focused on the following:

Growth and expansion of sales across the United States

Improvement of the functionality and ease-of-use for both medical personnel and patients

Find antibacterial and anti-biofilm solutions to replace the saline solution used to produce the mist used by this system to conduct the ultrasound toward its target, which, the Company

believes would make the system more effective in treating bacterial infections associated with skin conditions

Design new applicators capable of treating large skin conditions, for improved efficiency in such cases.

The Company is focused on further developing our PACE proprietary technology to activate healing in:

Acute and chronic wound conditions, including diabetic foot ulcers, venous and arterial ulcers, pressure sores, burns and other skin eruption conditions ;

Orthopedic applications, such as eliminating chronic pain in joints from trauma, arthritis or tendons/ligaments inflammation or tendinopathies, speeding the healing of fractures (including nonunion or

delayed-union conditions), improving bone density in osteoporosis, fusing bones in the extremities and spine, and other potential sports injury applications;

Plastic/cosmetic applications such as cellulite smoothing, graft and transplant acceptance, skin tightening, scarring and other potential aesthetic uses;

cardiac applications for removing plaque due to atherosclerosis improving heart muscle performance.

In addition to healthcare uses, our high-energy, acoustic pressure shock waves, due to their powerful pressure gradients and localized cavitational effects, may have applications in secondary

and tertiary oil exploitation, for cleaning industrial waters and food liquids and finally for maintenance of industrial installations by disrupting biofilms formation.

Our business approach will be through licensing and/or partnership

opportunities.

The worldwide spread of the COVID-19 virus resulted in a global slowdown of economic activity which is likely to decrease demand for a broad variety of products, including from our customers.

We have experienced a disruption of our supply channels which will continue for an unknown period of time until the global supply chain can return to the pre- disease status.

Also, the pandemic may cause continued or additional actions by

hospitals and clinics such as limiting elective procedures and treatments and limiting clinical trial activities and data monitoring.

These factors have had and we expect that they will continue to have a negative impact on our sales and our

results of operations, the size and duration of which we are currently unable to predict.

Pulsed Acoustic Cellular Expression (PACE) Technology for Regenerative Medicine

Our PACE product candidates, including our lead product candidate, dermaPACE ® , deliver high-energy acoustic pressure waves in the

shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures.

These mechanical stresses at the cellular level have been shown in pre-clinical work to promote angiogenic and positive inflammatory responses, and

quickly initiate the healing cascade.

This has been shown in pre-clinical work to result in microcirculatory improvement, including increased perfusion and blood vessel widening (arteriogenesis), the production of angiogenic growth factors,

enhanced new blood vessel formation (angiogenesis) and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures.

PACE procedures trigger the initiation of an accelerated inflammatory response that speeds wounds

into proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help reinitiate the body’s own healing response.

We believe that our PACE technology is well suited for various applications due to its

activation of a broad spectrum of cellular events critical for the initiation and progression of healing.

High-energy, acoustic pressure shock waves are the primary component of our previously developed product, OssaTron, which was approved by the FDA and marketed in the United States for use in

chronic plantar fasciitis of the foot in 2000 and for elbow tendonitis in 2003.

Previously, acoustic pressure shock waves have been used safely at much higher energy and pulse levels in the lithotripsy procedure (breaking up kidney stones) by

urologists for over 25 years and has reached the care status of “golden standard” for the treatment of kidney stones.

We research, design, manufacture, market and service our products worldwide and believe we have already demonstrated that our technology is safe and effective in stimulating healing in chronic

musculoskeletal conditions of the foot and the elbow through our United States FDA Class III PMA approved OssaTron device, and in the stimulation of bone and chronic tendonitis regeneration in the musculoskeletal environment through the

utilization of our orthoPACE, Evotron and OssaTron devices in Europe, Asia and Asia/Pacific.

We believe our experience from our preclinical research and the clinical use of our predecessor legacy devices in Europe and Asia, as well as our OssaTron device in the United States,

demonstrates the safety, clinical utility and efficacy of these products.

In addition, we have preclinical programs focused on the development and better understanding of treatments specific to our target applications.

Cardiovascular applications for removing plaque due to atherosclerosis, eliminating occlusions and blood clots, and improving heart muscle and cardiac valves performance.

In addition to healthcare uses, our high-energy, acoustic pressure shock waves, due to their powerful pressure gradients and localized cavitational effects, may have applications in secondary and

tertiary oil exploitation, for cleaning industrial waters and food liquids, unclogging pipes and filtration systems, and finally for maintenance of industrial installations and underwater structures by disrupting biofilms formation and eliminating

The Company intends to pursue these opportunities through licensing and/or partnership opportunities.

The worldwide spread of the COVID-19 virus resulted in a global slowdown of economic activity, which has been further impacted by the war in Ukraine and related sanctions.

Due to the combination of the

COVID-19 slowdown and the war in the Ukraine, the Company has experienced a disruption of our supply channels during the years ended December 31, 2022, and 2021.

Also, the pandemic caused continued or additional actions by hospitals and clinics such

as limiting elective procedures and treatments and limiting clinical trial activities and data monitoring.

These factors have had a negative impact on our sales and our results of operations.

UltraMIST - Ultrasound Healing Therapy

UltraMIST is an FDA approved powerful, non-contact, non-thermal ultrasound therapy system used to promote healing in a wide range of wound types.

The system never touches the wound surface making it pain free.

UltraMIST promotes wound healing below the surface by modulating cell membranes to drive increased blood flow and capillary formation.

It also reduces and removes a wide range of bacteria, including biofilms, while preserving healthy structures.

UltraMIST is FDA approved to treat malaises such as diabetic foot ulcers, pressure ulcers, venous leg ulcers, deep tissue pressure injuries, and surgical wounds.

PACE Technology for Regenerative Medicine

Our PACE system candidates, including our dermaPACE System, deliver high-energy acoustic pressure shock waves to produce compressive and

tensile stresses on cells and tissue structures.

These mechanical stresses at the cellular level have been shown in pre-clinical work to promote angiogenic and positive modulated inflammatory responses, and quickly initiate the healing cascade.

has been shown in pre-clinical work to result in microcirculatory improvement, including increased perfusion and blood vessel widening, the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis) and the subsequent

regeneration of tissue such as skin, musculoskeletal and vascular structures.

PACE procedures trigger the initiation of an accelerated and modulated inflammatory response that speeds wounds into proliferation phases of healing and subsequently

returns a chronic condition to an acute condition to help reinitiate the body’s own healing response.

The Company believes our PACE technology is well suited for various applications due to its activation of a broad spectrum of cellular events

critical for the initiation and progression of healing.

Currently, there are limited biological or mechanical therapies available to activate the healing and regeneration of skin, musculoskeletal tissue, and vascular structures.

As baby boomers age,

the incidence of their targeted diseases and musculoskeletal injuries and ailments will be far more prevalent.

We believe that our pre-clinical and clinical studies suggest that our PACE technology will be effective in targeted applications.

anticipate that future clinical studies should lead to regulatory approval of our regenerative product candidates in the Americas, Middle East and Africa.

If approved by the appropriate regulatory authorities, we believe that our product

candidates will offer new, effective and noninvasive (extracorporeal) treatment options in wound healing, orthopedic injuries, plastic/cosmetic uses and cardiovascular procedures, improving the quality of life for millions of patients suffering

from injuries or deterioration of tissue, bones and vascular structures.

dermaPACE ® – Our

Lead Product Candidate

The FDA granted approval of our Investigational Device Exemption (IDE) to conduct two double-blinded, randomized clinical trials utilizing our lead device product for the global wound care market, the dermaPACE ® device, in the treatment of diabetic foot ulcers.

The dermaPACE ® system was evaluated using two studies under IDE G070103.

The studies were designed as prospective, randomized,

double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers.

A total of 336 subjects were enrolled and treated with either dermaPACE ®

plus conventional therapy or conventional therapy (a.k.a.

standard of care) alone.

Conventional therapy included, but was not limited to, debridement, saline-moistened gauze, and pressure reducing footwear.

The objective of the studies was to

compare the safety and efficacy of the dermaPACE ® device to sham-control application.

The prospectively defined primary efficacy endpoint for the dermaPACE ® studies was the incidence of complete wound closure at 12 weeks post-initial application of the dermaPACE ® system (active or sham).

Complete wound closure was defined as skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks.

If the wound was considered

closed for the first time at the 12-week visit, then the next visit was used to confirm closure.

Investigators continued to follow subjects and evaluate wound closure through 24 weeks.

Between the two studies there were over 336 patients evaluated, with 172 patients treated with dermaPACE ® and 164 control group

subjects with use of a non-functional device (sham).

Both treatment groups received wound care consistent with the standard of care in addition to device application.

Study subjects were enrolled using pre-determined inclusion/exclusion criteria

in order to obtain a homogenous study population with chronic diabetes and a diabetic foot ulcer that has persisted a minimum of 30 days and its area is between 1cm 2

and 16cm 2 , inclusive.

Subjects were enrolled at Visit 1 and followed for a run-in period of two weeks.

At two weeks (Visit 2 – Day 0), the first treatment was

applied (either dermaPACE ® or Sham Control application).

Applications with either dermaPACE ®

or Sham Control were then made at Day 3 (Visit 3), Day 6 (Visit 4), and Day 9 (Visit 5) with the potential for 4 additional treatments in Study 2.

Subject progress including wound size was then observed on a bi-weekly basis for up to 24 weeks at

a total of 12 visits (Weeks 2-24;

Visits 6-17).

We retained Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) in January 2015 to lead the Company’s interactions and correspondence with the FDA for the dermaPACE ® , which have already commenced.

MCRA has successfully worked with the FDA on numerous Premarket Approvals (PMAs) for various musculoskeletal, restorative and general surgical devices since 2006.

Working with MCRA, we submitted to FDA a de novo petition on July 23, 2016.

Due to the strong safety profile of our device and the efficacy of the data showing statistical

significance for wound closure for dermaPACE ® subjects at 20 weeks, we believe that the dermaPACE ® device should be considered for classification into Class II as there is no legally marketed predicate device and there is not an existing Class III classification regulation or one or more approved PMAs (which would have

required a reclassification under Section 513(e) or (f)(3) of the FD&C Act).

On December 28, 2017, the FDA determined that the criteria at section 513(a)(1)(A) of (B) of the FD&C Act were met and granted the de novo clearance classifying dermaPACE ® as Class II and available to be marketed immediately.

Finally, our dermaPACE ® device has received the European CE Mark approval to treat acute and chronic defects of the skin and

subcutaneous soft tissue, such as in the treatment of pressure ulcers, diabetic foot ulcers, burns, and traumatic and surgical wounds.

The dermaPACE ® is also

licensed for sale in Canada, Australia, New Zealand and South Korea.

Additionally, our joint venture partner in Brazil, Diversa SA, received approval from the Brazilian Agência Nacional de Vigilância

Sanitária (“National Health Surveillance Agency” or “ANVISA”) to market dermaPACE ® to treat diabetic foot ulcers in Brazil.

We are actively marketing the dermaPACE ® to the European Community, Canada, Brazil, Mexico, and Asia/Pacific, utilizing distributors in select countries.

Clinical Studies

A post-market pilot study to evaluate the effects of high energy focused, acoustic shock wave therapy on local skin perfusion and healing of diabetic foot ulcers was changed to a 15-patient case study with the same

primary objective of determining the effects of high-energy focused, acoustic shock wave therapy on oxygen saturation levels was completed.

A near-infrared spectroscopy device was used to measure the oxygen saturation levels prior to treatment

and after the full treatment regimen.

Treatment with the dermaPACE ® System resulted in all patients demonstrating a statistically significant increase in tissue

oxygen saturation within the wound bed, a key component of wound healing.

Additionally, the results showed all 15 wounds demonstrated a decrease in wound area and seven of the wounds healed.

The results of this case study are another indication

that treatment of Diabetic Foot Ulcers with the dermaPACE ® System prepares the wound bed via oxygenation and neo-vascularization, facilitating accelerated wound

resolution via the body’s natural healing process or preparing the wound to more readily respond to other advanced healing modalities.

UltraMIST® - Ultra sound healing Therapy

UltraMIST® is an FDA approved powerful, non-contact and non-thermal ultrasound therapy device used to promote wound healing.

UltraMIST® is FDA approved to treat malaises such as diabetic foot ulcers, pressure

ulcers, venous leg ulcers, deep tissue pressure injuries, and surgical wounds.

Currently, the Company’s dermaPACE ® is only approved to treat diabetic foot ulcer.

UltraMIST® currently has over 900 customers in 46 states providing the Company with a robust product offering in the advanced wound care market and an end-to-end advanced wound care product portfolio that addresses

the entire care pathway.

Biologic Products

BIOVANCE is a graft skin substitute product that provides a natural foundation for wound healing.

The product is an allograft that is prepared from the

amnion, the part of the amniotic sac closest to the developing embryo.

Key cells and proteins move into the BIOVANCE material so that tissues can regenerate, and wounds can continue to heal.

The product is adaptable and flexible, it can conform

to irregular surfaces.

It is also adaptable in that it can be sutured or glued if determined by the clinician to be a better option.

The product also has a 5-year shelf life at room temperature conditions and is available in multiple sizes for

application flexibility.

Interfyl is a liquid product that replaces damaged integumental soft tissue and augments / supplements inadequate connective tissues.

comprised of allogenic decellularized particulate human placental connective tissue matrix that is placed on a wound.

The product repairs small surgical defects resulting from either medical or surgical conditions, including patients with exposed

vital structures such as bone, tendon, ligament, or nerves.

Interfyl has the ability to fill irregular spaces or soft tissue deficits resulting from trauma or surgery.

The filler also allows for cell adherence and growth during tissue repair and

affords structural support and elasticity in the tissue.

The product is offered in a 1.5mL flowable format in a 3-mL syringe.

50mg and 100mg particulates are in each vial.

Growth Opportunity in Wound Care Treatment

We are focused on the development of products that treat unmet medical needs in large market opportunities.

Our FDA approval in the United States for our lead product candidate,

dermaPACE ® , is the first step in providing an option to a currently unmet need in the treatment of diabetic foot ulcers.

Diabetes is common, disabling and deadly.

As baby boomers age, the

incidence of their targeted diseases and musculoskeletal injuries and ailments will be far more prevalent.

The Company believes that our pre-clinical and clinical studies suggest that our PACE technology will be effective in targeted applications.

The Company anticipates that future clinical studies should lead to regulatory approval of our regenerative product candidates in the Americas, Middle East and Africa.

If approved by the appropriate regulatory authorities, the Company believes that

our product candidates will offer new, effective, and noninvasive (extracorporeal) treatment options in wound healing, orthopedic injuries, plastic/cosmetic uses and cardiovascular procedures, improving the quality of life for millions of patients

suffering from injuries or deterioration of tissue, bones and vascular structures.

dermaPACE – Our Wound Care Shockwave Product

The Company is focused on the development of products that treat unmet medical needs in large market opportunities.

Our FDA approval in the United States for our, dermaPACE system is the first step in providing an option to a currently unmet need in the treatment of diabetic foot ulcers.

common, disabling, and deadly.

In the United States, diabetes has reached epidemic proportions.

Based on our research, foot ulcerations are one of the leading causes of hospitalization in diabetic patients and lead to billions

of dollars in health care expenditures annually.

According to a 2020 report by the Centers for Disease Control and Prevention based on estimated 2018 data, approximately 34.1 million people aged 18 years or

older (diagnosed and undiagnosed), roughly 13.0% of the United States population, have diabetes and 1.5

million new cases of diabetes were diagnosed in people aged 18 years or older.

In 2016, there were 7.8 million hospital discharges with diabetes as a listed diagnosis.

The estimated total direct and indirect costs of diagnosed diabetes in the

United States in 2017 was $327 billion.

Between 2012 and 2017, medical costs per person associated with diabetes increased from $8,417 to $9,601.

Approximately 2 - 7% of diabetics will develop a diabetic foot ulcer each year.

ulcers are a significant complication of diabetes mellitus and often precede lower-extremity amputation.

The most frequent underlying etiologies are neuropathy, trauma, deformity, high plantar pressures, and peripheral arterial disease.

of Diabetic foot ulcers will become infected, resulting in high rates of hospitalization, increased morbidity and potential lower extremity amputation and up to 80% of Diabetic foot ulcers that have healed will re-ulcerate within 12 months.

According to the International Diabetes Federation 2019 Global Fact Sheet, approximately 463 million people has diabetes and 10% of global health expenditure is spent on diabetes (approximately $760 billion).

A majority of challenging wounds are non-healing chronic wounds and in addition, chronic diabetic foot ulcers and pressure ulcers are often slow-to-heal wounds, which often fail to heal for

many months, and sometimes, for several years.

These wounds often involve physiologic, complex and multiple complications such as reduced blood supply, compromised lymphatic systems or immune deficiencies that interfere with the body’s normal

wound healing processes.

These wounds often develop due to a patient’s impaired vascular and tissue repair capabilities.

Wounds that are difficult to treat do not always respond to traditional therapies, which include hydrocolloids, hydrogels and

alginates, among other treatments.

We believe that physicians and hospitals need a therapy that addresses the special needs of these chronic wounds with high levels of both clinical and cost effectiveness.

We believe we are developing a safe and advanced technology in the wound healing and tissue regeneration market with PACE.

Based on our research, foot ulcerations are one of the leading causes of hospitalization in diabetic patients and lead to billions of dollars in health

care expenditures annually.

dermaPACE is noninvasive and does not require anesthesia, making it a cost-effective, time-efficient, and painless approach to wound care.

Physicians and nurses look for

therapies that can accelerate the healing process and overcome the obstacles of patients’ compromised conditions and prefer therapies that are easy to administer.

In addition, since many of these patients are not confined to bed, healthcare

providers want therapies that are minimally disruptive to the patient’s or the caregiver’s daily routines.

dermaPACE’s noninvasive treatments are designed to elicit the body’s own healing response and, followed by simple standard of care

dressing changes, are designed to allow for limited disruption to the patients’ normal lives and have no effect on mobility while their wounds heal.

dermaPACE’s noninvasive treatments are designed to

elicit the body’s own healing response and followed by simple standard of care dressing changes, are designed to allow for limited disruption to the patients’ normal lives and have no effect on mobility while their wounds heal.

DermaPACE has received the European CE Mark approval to treat acute and chronic defects of the skin and subcutaneous soft tissue, such as in the treatment of pressure ulcers, diabetic foot ulcers, burns, and traumatic

and surgical wounds.

The dermaPACE is also licensed for sale in Canada, Australia, New Zealand and South Korea.

Additionally, our joint venture partner in Brazil, Diversa SA, received approval from the Brazilian

Agência Nacional de Vigilância Sanitária (“National Health Surveillance Agency” or “ANVISA”) to market dermaPACE to treat diabetic foot ulcers in Brazil.

Developing Product Opportunities - Orthopedic

The orthoPACE system, which is intended for use in orthopedic, trauma and sports medicine indications, continues to be a viable and effective treatment solution in Europe and South Korea.

device features four types of applicators including a unique applicator that is less painful for some indications and may reduce or completely eliminate anesthesia for some patients.

In the orthopedic setting, the orthoPACE System is being used

to treat tendinopathies and acute and nonunion fractures, including the soft tissue surrounding the fracture to accelerate healing and prevent secondary complications and their associated treatment costs

We believe there are significant opportunities in the worldwide orthopedic market, driven by aging baby boomers and their desire for active lifestyles well into retirement and the growth in the

incidence of osteoporosis, osteoarthritis, obesity, diabetes and other diseases that cause injury to musculoskeletal tissues and/or impair the ability of the body to heal injuries.

We have experience in the sports medicine field (which generally refers to the non-surgical and surgical management of cartilage, ligament and tendon injuries) through our legacy devices,

OssaTron and Evotron.

Common examples of these injuries include extremity joint pain, torn rotator cuffs (shoulder), tennis elbow, Achilles’ tendon tears and torn meniscus cartilage in the knee.

Injuries to these structures are very difficult to

treat because the body has a limited natural ability to regenerate these kinds of tissues.

Cartilage, ligament and tendons seldom return to a pre-injury state of function.

Due to a lack of therapies that can activate healing and regenerate these

tissues, many of these injuries will result in a degree of permanent impairment and chronic pain.

Prior investigations and pre-clinical work indicate that PACE can positively affect the body’s inflammatory process and activate various cell types

and may be an important adjunct to the management of sports medicine injuries.

We plan to submit to U.S.

FDA a 510(k) seeking clearance for general indications to address this growing field.

Additionally, we have developed and introduced Profile by SANUWAVE as an immediately available solution for pain management in sports medicine and physical therapy in the U.S.

by SANUWAVE is a therapeutic massager intended for the relief of minor muscle aches and pains via SANUWAVE’s Diffused Acoustic Pressure (DAP®) technology.

DAP® delivers the beneficial, therapeutic field of the acoustic pressure waves without the

impact and potential pain of a focused pulse.

There is a significant need in the U.S.

for pain management products and the non-invasive delivery of therapeutic shockwaves for its treatment can help to serve this market.

features four types of applicators including a unique applicator that is less painful for some indications and may reduce or eliminate anesthesia for some patients.

In the orthopedic setting, the orthoPACE system is being used to treat tendinopathies

and acute and nonunion fractures, including the soft tissue surrounding the fracture to accelerate healing and prevent secondary complications and their associated treatment costs.

Common examples of these injuries include extremity joint pain, torn

rotator cuffs (shoulder), tennis elbow, Achilles’ tendon tears and torn meniscus cartilage in the knee.

Injuries to these structures are very difficult to treat because the body has a limited natural ability to regenerate these kinds of tissues.

Prior investigations and pre-clinical work indicate that PACE can positively affect the body’s inflammatory process and activate various cell types and may be an important adjunct to the management of sports medicine injuries.

The Company plans to

submit to the FDA a 510(k) seeking clearance for general indications to address this growing field.

Additionally, the Company has developed and introduced Profile by SANUWAVE as an immediately available solution for pain management in sports medicine and physical therapy in the U.S.

SANUWAVE is a therapeutic massager intended for the relief of minor muscle aches and pains via SANUWAVE’s Diffused Acoustic Pressure (DAP ® ) technology.

DAP ® delivers the beneficial, therapeutic field of the acoustic pressure waves without the impact and potential pain of a focused pulse.

There is a significant need in the

for pain management products and the Company believes the non-invasive delivery of therapeutic shockwaves for its treatment can help to serve this market.

Non-Medical Uses for Our Shockwave Technology

We believe there are significant license/partnership opportunities for our acoustic pressure shockwave technology in non-medical uses, including in the energy, water, food, and industrial

Due to their powerful pressure gradients and localized cavitational effects, we believe that high-energy, acoustic pressure shockwaves can be used to clean, in an energy efficient manner,

contaminated fluids from impurities, bacteria, viruses, and other harmful micro-organisms, which provides opportunities for our technology in cleaning industrial and domestic/municipal waters.

Based on the same principles of action of the

acoustic pressure shockwaves against bacteria, viruses, and harmful micro-organisms, we believe our technology can be applied for cleaning or sterilization of various foods such as milk, natural juices, and meats.

In the energy sector, we believe that the acoustic pressure shockwaves can be used to improve oil recovery (IOR), as a supplement to or in conjunction with existing fracking technology, which

utilizes high pressurized water/gases to crack the rocks that trapped oil in the underground reservoir.

Through the use of our high-energy, acoustic pressure shockwaves the efficiency can be improved and at the same time the environmental impact

of the fracking process can be reduced.

Furthermore, we believe our technology can be used for enhanced oil recovery (EOR) based on the changes in oil flow characteristics resulting from acoustic pressure shockwave stimulation, as a tertiary

method of oil recovery from older oil fields.

Additionally, we demonstrated through three studies performed at Montana State University that high-energy, acoustic pressure shockwaves are disrupting biofilms and thus can be used for surface

cleaning monuments, ship hulls, and underwater structure cleaning, or to unclog pipes in the energy industry (shore or off-shore installations), food industry, and water management industry, which will reduce or eliminate down times with

significant financial benefits for maintenance of existing infrastructure.

Also, our technology should have a significant environmental impact by eliminating or reducing the use of harmful chemicals, which are the preferred biofilm cleaning

method at this time.

The Company believes there are also significant opportunities for our acoustic pressure shockwave technology in non-medical uses, including in the energy, water, food, and industrial markets.

Market Trends

We are focused on the development of regenerative medicine products that have the potential to address substantial unmet clinical needs across broad market indications.

We believe there are

limited therapeutic treatments currently available that directly and reproducibly activate healing processes in the areas in which we are focusing, particularly for wound care and repair of certain types of musculoskeletal conditions.

According to AdvaMed and Centers for Medicare & Medicaid Services data from 2006 and our internal projections, the United States advanced wound healing market for the

dermaPACE ® is estimated at $20 billion, which includes diabetic foot ulcers, pressure sores, burns and traumatic wounds,

and chronic mixed leg ulcers.

We also believe there are significant opportunities in the worldwide orthopedic and spine markets, driven by aging baby boomers and their desire for active lifestyles well into retirement and the growth in the

incidence of osteoporosis, osteoarthritis, obesity, diabetes and other diseases that cause injury to orthopedic tissues and/or impair the ability of the body to heal injuries.

With the success of negative pressure wound therapy devices in the wound care market over the last decade and the recognition of the global epidemic associated with certain types of wounds, as

well as deteriorating musculoskeletal conditions attributed to obesity, diabetes, vascular and heart disease, as well as sports injuries, we believe that Medicare and private insurers have become aware of the high costs and expenditures

associated with the adjunctive therapies being utilized for wound healing and orthopedic conditions that have limited efficacies in full skin closure, or bone and tissue regeneration.

We believe the wound healing and orthopedic markets are

undergoing a transition, and market participants are interested in biological response activating devices that are applied noninvasively and seek to activate the body’s own capabilities for regeneration of tissue at injury sites in a

cost-effective manner.

Our strategy is focused on the research, development, and commercialization of our patented, non-invasive and biological response-activating medical systems for the repair and regeneration of

skin, musculoskeletal tissue, and vascular structures.

Our 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

energy transfer technologies in wound healing, orthopedic, plastic/cosmetic, and cardiac/endovascular conditions.

Through our August 2020 acquisition of the UltraMIST® System, we now combine two highly complementary and market-cleared energy transfer technologies used in the dermaPACE ® and UltraMIST® medical device Systems, which creates a platform of scale in the advanced wound care market.

Our the dermaPACE ® device for treating diabetic foot

ulcers, which was subject to two double-blinded, randomized Phase III clinical studies.

On December 28, 2017, the U.S.

FDA granted the Company’s request to classify the dermaPACE ® System as a Class II device via the de novo process.

As a result of this decision, the Company was able to immediately market the product for the treatment of diabetic foot

ulcers as described in the de novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

Our portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to

restore the body’s normal healing processes and regeneration.

We intend to apply our Pulsed Acoustic Cellular Expression (PACE) technology in wound healing, orthopedic, plastic/cosmetic and cardiac conditions.

Our immediate goal for our regenerative medicine technology involves leveraging the knowledge we gained from our existing human heel and elbow indications to enter the advanced wound care market with innovative

The Company is focused on the development of regenerative medicine products that have the potential to address substantial unmet clinical needs across broad market indications.

The Company believes

there are limited therapeutic treatments currently available that directly and reproducibly activate healing processes in the areas in which the Company is focusing, particularly for wound care and repair of certain types of musculoskeletal

With the success of negative pressure wound therapy devices in the wound care market over the last decade and the recognition of the global epidemic associated with certain types of wounds, as well as

deteriorating musculoskeletal conditions attributed to obesity, diabetes, vascular and heart disease, as well as sports injuries, the Company believes that Medicare and private insurers have become aware of the high costs and expenditures associated

with the adjunctive therapies being utilized for wound healing and orthopedic conditions that have limited efficacies in full skin closure, or bone and tissue regeneration.

The Company believes the wound healing and orthopedic markets are undergoing

a transition, and market participants are interested in biological response activating devices that are applied noninvasively and seek to activate the body’s own capabilities for regeneration of tissue at injury sites in a cost-effective manner.

Our strategy is focused on the commercialization of our patented, non-invasive, and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular

Our wound care portfolio of regenerative medicine products and product candidates help restore the body’s normal healing processes, by activating biologic signaling and angiogenic responses.

The key elements of our strategy include the following:

Commercialize and support the domestic distribution of our dermaPACE ® device to treat diabetic foot ulcers.

We initially focused on obtaining FDA approval in the United States for our lead product candidate, dermaPACE ® , for the treatment of diabetic foot ulcers, which we believe represents a large, unmet need.

On December 28, 2017, the FDA granted the Company’s request to classify the dermaPACE ® System as a Class II device

via the de novo process.

As a result of this decision, the Company was able to immediately market the product for the treatment of diabetic foot ulcers as described in the de novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

We began the commercialization of dermaPACE® in the United States in 2018 through strategic partnership and have continued commercialization in 2019 through placement of devices in doctors’

offices, wound care centers and hospitals by our internal sales team.

For example, in February 2018, we entered into an agreement with Premier Shockwave Wound Care, Inc.

(“PSWC”) and Premier Shockwave, Inc.

(“PS”) for the purchase by PSWC and PS

of dermaPACE® Systems and related equipment sold by us and granting PSWC and PS limited but exclusive distribution rights to provide dermaPACE® Systems to certain government healthcare facilities in exchange for the payment of certain royalties

PSWC is a related party since it is owned by A.

Michael Stolarski, a member of the Company’s board of directors and an existing shareholder of the Company.

Develop and commercialize our noninvasive biological response activating devices in the regenerative medicine area for the treatment of skin, musculoskeletal tissue and vascular

We intend to use our proprietary technologies and know-how in the use of high-energy, acoustic pressure shock waves to address unmet medical needs in wound care, orthopedic,

plastic/cosmetic and cardiac indications, possibly through potential license and/or partnership arrangements.

License and seek partnership opportunities for our non-medical acoustic pressure shock wave technology platform, know-how and extensive patent portfolio .

We intend to use our acoustic pressure shock wave technology and know-how for non-medical uses, including energy, food, water cleaning and other industrial markets, through

license/partnership opportunities.

Commercialize and support the domestic distribution of our UltraMIST and PACE systems to treat wounds;

Reduce and normalize operating costs to support growth;

Develop and commercialize our noninvasive biological response activating devices in the regenerative medicine area for the treatment of skin, musculoskeletal tissue, and vascular structures;

Support the global distribution of our products.

Our portfolio of products, the dermaPACE ® and orthoPACE, are CE Marked and sold through select distributors in certain countries in Europe, Canada, Asia and Asia/Pacific.

Our revenues will continue from sales of the devices and related applicators in these markets.

continue to add additional distribution partners in the Americas, Middle East, Africa, Europe and Asia/Pacific.

Scientific Advisors

We have established a network of scientific advisors that brings expertise in wound healing, orthopedics, cosmetics, clinical and scientific research, and FDA experience.

We consult our

scientific advisors on an as-needed basis on clinical and pre-clinical study design, product development, and clinical indications.

We pay consulting fees to certain members of our scientific advisory board for the services they provide to us, in addition to reimbursing them for incurred expenses.

The amounts vary depending

on the nature of the services.

The Company has established a network of scientific advisors that brings expertise in wound healing, orthopedics, cosmetics, clinical and scientific research, and FDA experience.

The Company consults

our scientific advisors on an as-needed basis on clinical and pre-clinical study design, product development, and clinical indications.

The Company pays consulting fees to certain members of our scientific advisory board for the services they provide to us, in addition to reimbursing them for incurred expenses.

The amounts vary

depending on the nature of the services.

Sales, Marketing and Distribution

Following FDA approval in December 2017, we sought a development and/or commercialization partnership, or to commercialize the product ourselves domestically, including the commercialization of the assets obtained

in the Asset Purchase Agreement with our internal sales force.

Outside the United States, we retain distributors to represent our products in selective international markets.

These distributors have been selected based on their existing business

relationships and the ability of their sales force and distribution capabilities to effectively penetrate the market with our PACE product line.

We rely on these distributors to manage physical distribution, customer service and billing services

for our international customers.

For a period of approximately three months following the August 6, 2020 Asset Purchase Agreement, we utilized the seller to fulfill certain customer orders and to collect related accounts

receivable payments from customer orders that originated from the acquired business after August 6, 2020.

For the year ended December 31, 2020, orders fulfilled by the seller comprised approximately 41% of the Company’s 2020 full year revenues.

As of December 31, 2020, accounts receivable balances that originated from these seller-fulfilled orders constituted approximately 46% of accounts receivable balances, all of which were either reserved as of December 31, 2020 or subsequently

collected during 2021.

For the year ended December 31, 2021, orders fulfilled by the seller comprised approximately 16% of the accounts receivable balances, and one other vendor comprised approximately 24% of the accounts receivable balances.

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

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

Our primary sales are in the

Unites States.

Manufacturing

We have developed a network of suppliers, manufacturers and contract service providers to provide sufficient quantities of our products.

We are party to a manufacturing supply agreement with Swisstronics Contract Manufacturing AG in Switzerland, a division of Cicor Technologies Ltd., covering the generator box component of our

Our generator boxes are manufactured in accordance with applicable quality standards (EN ISO 13485) and applicable industry and regulatory standards.

We produce the applicators and applicator kits for our products.

In addition, we

program and load software for both the generator boxes and applicators and perform the final product testing and certifications internally.

Our facility in Suwanee, Georgia consists of 10,177 square feet and provides office, research and development, quality control, production and warehouse space.

It is a FDA registered facility

and is ISO 13485:2016 and Medical Device Single Audit Program (“MDSAP”) certified (for meeting the requirements for a comprehensive management system for the design and manufacture of medical devices).

We are party to a manufacturing supply agreement with Minnetronix Medical in St.

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 Swisstronics Contract Manufacturing AG in Switzerland, a division of Cicor Technologies Ltd., covering the generator box component of our

Our generator boxes are manufactured in accordance with applicable quality standards and applicable industry and regulatory standards.

The Company produces the applicators and applicator kits for our products.

In addition, the Company

programs and loads software for both the generator boxes and applicators and perform the final product testing and certifications internally.

The Company is party to a manufacturing supply agreement with Minnetronix Medical in St.

Paul, MN, covering the generator and treatment wand components of our products.

Our generators and treatment

wands are manufactured in accordance with applicable quality standards (EN ISO 13485) and applicable industry and regulatory standards.

In addition, we perform the final product testing for generators and treatment wands internally.

further information regarding a dispute with this supplier in Note 25, Subsequent Events.

We are party to a manufacturing supply agreement with Dynamic Group in Ramsey, MN, covering the applicator component of our products.

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

In addition, the Company performs the final product testing for generators and treatment wands internally.

The Company is party to a manufacturing supply agreement with Dynamic Group in Ramsey, MN, covering the applicator component of our products.

Our applicators are manufactured in accordance with

applicable quality standards (EN ISO 13485) and applicable industry and regulatory standards.

We produce the applicators and applicator kits for our products.

applicable quality standards and applicable industry and regulatory standards.

The Company produces the applicators and applicator kits for our products.

Our facility in Eden Prairie, MN consists of 8,199 square feet and provides office, product development, quality control, and warehouse space.

It is an FDA registered facility and is ISO

It is an FDA registered facility and is International

Organization for Standardization (ISO) 13485:2016 certified.

Intellectual Property

Our success depends in part on our ability to obtain and maintain proprietary protection for our products, product candidates, technology, and know-how, to operate without infringing on the

proprietary rights of others and to prevent others from infringing upon our proprietary rights.

We seek to protect our proprietary position by, among other methods, filing United States and selected foreign patent applications and United States

and selected foreign trademark applications related to our proprietary technology, inventions, products, and improvements that are important to the development of our business.

Effective trademark, service mark, copyright, patent, and trade

secret protection may not be available in every country in which our products are made available.

Our success depends in part on our ability to obtain and maintain proprietary protection for our products, product candidates, technology, and know-how, to operate without infringing on the proprietary

rights of others and to prevent others from infringing upon our proprietary rights.

The Company seeks to protect our proprietary position by, among other methods, filing United States and selected foreign patent applications and United States and

selected foreign trademark applications related to our proprietary technology, inventions, products, and improvements that are important to the development of our business.

Effective trademark, service mark, copyright, patent, and trade secret

protection may not be available in every country in which our products are made available.

The protection of our intellectual property may require the expenditure of significant financial and managerial resources.

We consider the protection afforded by patents important to our business.

We intend to seek and maintain patent protection in the United States and select foreign countries, where deemed

appropriate for products that we develop.

There are no assurances that any patents will result from our patent applications, or that any patents that may be issued will protect our intellectual property, or that any issued patents or pending

applications will not be successfully challenged, including as to ownership and/or validity, by third parties.

In addition, if we do not avoid infringement of the intellectual property rights of others, we may have to seek a license to sell our

products, defend an infringement action or challenge the validity of intellectual property in court.

Any current or future challenges to our patent rights, or challenges by us to the patent rights of others, could be expensive and time consuming.

We derive our patent rights, including as to both issued patents and “patent pending” applications, from three sources:

(1) assignee of patent rights in technology we developed;

(2) assignee of

patent rights purchased from HealthTronics, Inc.

(“HealthTronics”);

and (3) as licensee of certain patent rights assigned to HealthTronics.

In August 2005, we purchased a significant number of patents and patent applications from HealthTronics,

to whom we granted back perpetual and royalty-free field-of-use license rights in the purchased patent portfolio primarily for urological uses.

We believe that our owned and licensed patent rights provide a competitive advantage with respect to

others that might seek to utilize certain of our apparatuses and methods incorporating extracorporeal acoustic pressure shockwave technologies that we have patented.

However, we do not hold patent rights that cover all of our products, product

components, or methods that utilize our products.

We also have 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.

On the shockwave technology, we are the assignee of thirty-four (34) issued United States patents and forty-seven (47) issued foreign patents that are not expired, which on

average have remaining useful lives of ten years with the longest useful life extending to 2039.

On the ultrasound technology, we are the assignee of seventeen (17) issued United States patents and twenty-three (23) issued foreign patents that

are not expired, which on average have remaining useful life extending to 2028.

Our current issued United States and foreign patents include patent claims directed to particular electrode configurations for shockwave devices, piezoelectric

fiber shockwave devices, chemical components for shockwave generation, reflector geometries for focused shockwaves, general medical systems general construction, non-contact and low-frequency ultrasound device construction, disposable

applicator for ultrasound devices, ultrasonic catheter for drug delivery, ultrasonic method for wound treatment, combination of ultrasound and laser in wound care, and software architecture for licensing processes.

Our United States patents

also include patent claims directed to methods and devices such as our products for using acoustic pressure shockwaves or non-contact and low frequency ultrasound to treat ischemic conditions, spinal cord scar tissue and spinal injuries, bone

fractures and osteoporosis, blood sterilization, stem cell stimulation, tissue cleaning, and within particular treatment parameters using personalized medical treatments for diabetic foot ulcers or

pressure sores or venous ulcers or arterial ulcers or acute skin conditions.

Also, we have a significant number of US and international patents related to the extracorporeal or intracorporeal use of shockwaves or pressure waves for

cardiovascular field (plaque removal, elimination of occlusions, treatment of heart tissue ischemia, to name a few).

While such patented method and device claims may provide patent protection against certain indirect infringing promotion and

sales activities of competing manufacturers and distributors, certain medical methods performed by medical practitioners or related health care entities or methods executed by industrial operators may be subject to exemption from potential

infringement claims under 35 U.S.C.

§ 287(c) and, therefore, may limit enforcement of claims of our medical and non-medical method patents as compared to device construction patents.

We also currently maintain for shockwave technology twelve (12) United States patent applications and nineteen (19) foreign patent applications.

Our patent-pending rights include

inventions directed to certain shockwave devices and systems, ancillary products, and components for acoustic pressure shockwave treatment devices, and various methods of using acoustic pressure shockwaves in both medical and non-medical

applications.

The medical patent-pending methods include, for example, using acoustic pressure shockwaves to treat soft tissue disorders, bones, joints, wounds, skin, blood vessels, lymphatic disorders, cardiac tissue, fat and cellulite, lung

tissue, or to facilitate vaccination, or to disinfect reusable devices as ventilators and endoscopes, and for the use of shockwaves in combination with other energy medical technologies.

In the non-medical field, the use of acoustic pressure

shockwaves for blood and fluids sterilization, to facilitate oil extraction and processing, to destroy different pathogens from installation and different devices, to process fluids, meat and dairy products, to achieve desalination and

decontamination of radio-active waters, and to clean transport pipes.

For the ultrasound technology, we currently maintain two (2) United States patent applications and eight (8) foreign patent applications.

Our patent-pending rights include

inventions directed to non-contact and low-frequency ultrasound systems and methods for delivering cellular and biological materials to tissues and new designs used to deliver ultrasonic therapies to wound care.

All our United States and foreign pending applications either have yet to be examined or require response to an examiner’s office action rejections and, therefore, remain subject to further

prosecution, the possibility of further rejections and appeals, and/or the possibility we may elect to abandon prosecution, without assurance that a patent may issue from any pending application.

Under our license to HealthTronics, we reserve exclusive rights in our purchased portfolio as to orthopedic, tendonopathy, skin wounds, cardiac, dental, neural medical conditions and to all

conditions in animals (Ortho Field).

HealthTronics receives 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 (Litho Field).

HealthTronics also receives 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.

Refer to section “Contractual Obligations” for information on the default of our loan with HealthTronics.

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

The Company considers the protection afforded by patents important to our business.

The Company intends to seek and maintain patent protection in the United States and select foreign countries, where

deemed appropriate for products that the Company develops.

In general, our patents are effective ranging from 6 months to 16 years.

There are no assurances that any patents will result from our patent applications, or that any patents that may be

issued will protect our intellectual property, or that any issued patents or pending applications will not be successfully challenged, including as to ownership and/or validity, by third parties.

In addition, if the Company does not avoid

infringement of the intellectual property rights of others, the Company may have to seek a license to sell our products, defend an infringement action or challenge the validity of intellectual property in court.

Any current or future challenges to

our patent rights, or challenges by us to the patent rights of others, could be expensive and time consuming.

The Company believes that our owned and licensed patent rights provide a competitive advantage with respect to others that might seek to utilize certain of our apparatuses and methods incorporating

extracorporeal acoustic pressure shockwave technologies that the Company has patented.

However, the Company does not hold patent rights that cover all of our products, product components, or methods that utilize our products.

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.

Under our license to HealthTronics, Inc., the Company reserves exclusive rights in our purchased portfolio as to orthopedic, tendinopathy, skin wounds, cardiac, dental, neural medical conditions and to

all conditions in animals (the “Ortho Field”).

HealthTronics receives 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 receives 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, the Company 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.

The Company 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.

As part of the sale of the veterinary business in June 2009, we have also granted certain exclusive and non-exclusive patent license rights to Pulse Veterinary Technologies, LLC for most of our

medical patent portfolio issued before 2009 to utilize acoustic pressure shockwave technologies in the field of non-human mammals.

Given our international patent portfolio, there are growing risks of challenges to our existing and future patent rights.

Such challenges may result in invalidation or modification of some or

all of our patent rights in a particular patent territory and reduce our competitive advantage with respect to third party products and services.

Such challenges may also require the expenditure of significant financial and managerial resources.

If we become involved in future litigation or any other adverse intellectual property proceeding, for example, as a result of an alleged infringement, or a third party alleging an earlier date

of invention, we may have to spend significant amounts of money and time and, in the event of an adverse ruling, we could be subject to liability for damages, including treble damages, invalidation of our intellectual property and injunctive

relief that could prevent us from using technologies or developing products, any of which could have a significant adverse effect on our business, financial condition and results of operation.

In addition, any claims relating to the infringement

of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation or lengthy governmental proceedings and could divert management’s attention and resources and require us to enter into

royalty or license agreements which are not advantageous, if available at all.

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

We have the following trademark registrations:

The Company operates in an industry characterized by extensive patent litigation.

If the Company becomes involved in future litigation or any other adverse intellectual property proceeding, for example,

as a result of an alleged infringement, or a third party alleging an earlier date of invention, the Company may have to spend significant amounts of money and time and, in the event of an adverse ruling, the Company could be subject to liability for

damages, including treble damages, invalidation of our intellectual property and injunctive relief that could prevent us from using technologies or developing products, any of which could have a significant adverse effect on our business, financial

condition and results of operation.

In addition, any claims relating to the infringement of third-party proprietary rights, or earlier date of invention, even if not meritorious, could result in costly litigation or lengthy governmental proceedings

and could divert management’s attention and resources and require us to enter into royalty or license agreements which are not advantageous, if available at all.

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,

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China, Brazil, Mexico, 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, Taiwan, and Canada), orthoPACE ® (United States, United Kingdom, and European Community), DAP ® - Diffused Acoustic Pressure (United States and European Community), and Profile ® (United States, European Community, and United Kingdom).

Our newest trademark is Energy First ® (United States), Healing Today, Curing Tomorrow ® (United States), and UltraMIST ® (United States).

Through the acquisition of UltraMIST®/MIST assets from Celularity, now SANUWAVE is the owner of the Celleration ®

Our newest trademark is Energy First ®

(United States), Healing Today, Curing Tomorrow ® (United States), and UltraMIST ® (United

Through the acquisition of UltraMIST®/MIST assets from Celularity Inc., the Company is now 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.

We also maintain trademark registrations for:

The Company also maintains trademark registrations for:

OssaTron ® (United States), OSWT ® (Switzerland) Evotron ® (United States, Germany and Switzerland), Evotrode ® (United States, Germany and Switzerland), Orthotripsy ® (United States).

We phased out the OssaTrode ® (United States, Germany and Switzerland), Equitron ® (United States and Switzerland).

The Company phased out the OssaTrode ® (United States, Germany and Switzerland), Equitron ® (United States and Switzerland).

Reflectron ® (Germany and Switzerland) and Reflectrode ® (Germany and Switzerland),

evoPACE ® (Canada, Australia, European Community and Switzerland) trademarks, due to the fact that OssaTrode ® , Equitron ® , Reflectron ® and Reflectrode ® products are no longer available for sale in any market and evoPACE ® is a product

that was never commercialized.

Potential Intellectual Property Issues

Although we believe that the patents and patent applications, including those that we license, provide a competitive advantage, the patent positions of biotechnology and medical device

companies are highly complex and uncertain.

The medical device industry is characterized by the existence of a large number of patents and frequent litigation based on allegations of patent infringement.

Our success will depend in part on us not

infringing on patents issued to others, including our competitors and potential competitors, as well as our ability to enforce our patent rights.

We also rely on trade secrets, know-how, continuing technological innovation and in-licensing

opportunities to develop and maintain our proprietary position.

Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products and product candidates, or to obtain and use information that

we regard as proprietary.

In enforcement proceedings in Switzerland, we assisted HealthTronics as an informer of misappropriation by a Swiss company called SwiTech and related third parties of intellectual property rights in legacy proprietary

software and devices relating to assets we purchased from HealthTronics in August 2005.

As a result of this action, SwiTech was forced into bankruptcy.

We also pursued the alleged misappropriation by another Swiss company called SwiTalis and

related third parties of intellectual property rights in legacy proprietary software and devices relating to assets we purchased from HealthTronics in August 2005.

In 2016, SwiTalis claimed copyright rights on the High Voltage Modules that were

used in our devices and the old line of Pulse Vet devices during the manufacturing process at Swisstronics in Switzerland.

At this time, however, no such court action against Swisstronics is pending in Switzerland and we believe that it is

unlikely that SwiTalis will pursue their earlier allegations against Swisstronics and, indirectly, us.

In 2017, we abandoned our action against SwiTalis.

There can be no assurance, however, that future claims or lawsuits against us may not be

brought, and such present or future actions against violations of our intellectual property rights may result in us incurring material expense and divert the attention of management.

Third parties that license our proprietary rights, such as trademarks, patented technology or copyrighted material, may also take actions that diminish the value of our proprietary rights or

In addition, the steps we take to protect our proprietary rights may not be adequate and third parties may infringe or misappropriate our copyrights, trademarks, trade dress, patents, and similar proprietary rights.

We collaborate with other persons and entities on research, development, and commercialization activities and expect to do so in the future.

Disputes may arise about inventorship and

corresponding rights in know-how and inventions resulting from the joint creation or use of intellectual property by us and our collaborators, researchers, licensors, licensees and consultants.

In addition, other parties may circumvent any

proprietary protection that we do have.

As a result, we may not be able to maintain our proprietary position.

We believe 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

(formerly Kinetic Concepts, Inc.), Organogenesis, Inc., Smith & Nephew plc, Derma Sciences, Inc., MiMedx Group, Inc., Osiris Therapeutics, Inc., Molnlycke Health Care, and Systagenix Wound Management (US), Inc.

(now owned by Acelity) 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 KCI.

was never 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

Inc, (formerly Kinetic Concepts, Inc.) now owned by 3M, Organogenesis, Inc., Smith & Nephew plc, Derma Sciences, Inc., MiMedx Group, Inc., Osiris Therapeutics, Inc., Molnlycke Health Care, and Systagenix Wound Management (US), Inc.

(now owned by Acelity) 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 KCI.

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., and CellSonic Medical which could ultimately pursue the wound care market.

Nevertheless, we believe that the dermaPACE ® System has 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.

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 Regneration 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.

Developing and commercializing new products is highly competitive.

The market is characterized by extensive research and clinical efforts and rapid technological change.

We face intense

The Company faces intense

competition worldwide from medical device, biomedical technology and medical products and combination products companies, including major pharmaceutical companies.

We may be unable to respond to technological advances through the development and

introduction of new products.

The Company may be unable to respond to technological advances through the development

and introduction of new products.

Most of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources.

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Our competitors may commercialize new products in advance of our products.

Our products also face competition from numerous existing products and procedures, which

currently are considered part of the standard of care.

In order to compete effectively, our products will have to achieve widespread market acceptance.

Our products also face competition from numerous existing products and procedures, which currently

are considered part of the standard of care.

To compete effectively, our products will have to achieve widespread market acceptance.

Regulatory Matters

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Each of our products must be approved or cleared by the FDA before it is marketed in the United States.

Before and after approval or clearance in the United States, our product candidates are

subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act and/or the Public Health Service Act, as well as by other regulatory bodies.

FDA regulations govern, among other things, the development, testing,

manufacturing, labeling, safety, storage, record-keeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, and distribution of medical devices and pharmaceutical products.

Before and after approval or clearance in the United States, our product candidates are subject to

extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act and/or the Public Health Service Act, as well as by other regulatory bodies.

FDA regulations govern, among other things, the development, testing, manufacturing, labeling,

safety, storage, record-keeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, and distribution of medical devices and pharmaceutical products.

In the United States, the FDA subjects medical products to rigorous review.

If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing

applications or to allow us to manufacture or market our products, and we may be criminally prosecuted.

Failure to comply with the law could result in, among other things, warning letters, civil penalties, delays in approving or refusal to

approve a product candidate, product recall, product seizure, interruption of production, operating restrictions, suspension or withdrawal of product approval, injunctions, or criminal prosecution.

The FDA has determined that our technology and product candidates constitute “medical devices.” The FDA determines what center or centers within the FDA will review the product and its

indication for use, and also determines under what legal authority the product will be reviewed.

If the Company does not comply with applicable requirements, the Company may be fined, the government may refuse to approve

our marketing applications or to allow us to manufacture or market our products, and the Company may be criminally prosecuted.

Failure to comply with the law could result in, among other things, warning letters, civil penalties, delays in approving

or refusal to approve a product candidate, product recall, product seizure, interruption of production, operating restrictions, suspension or withdrawal of product approval, injunctions, or criminal prosecution.

The FDA has determined that our technology and product candidates constitute “medical devices.” The FDA determines what center or centers within the FDA will review the product and its indication for

use, and determines under what legal authority the product will be reviewed.

For the current indications, our products are being reviewed by the Center for Devices and Radiological Health.

However, we cannot be sure that the

FDA will not select a different center and/or legal authority for one or more of our other product candidates, in which case the governmental review requirements could vary in some respects.

However, the Company cannot be sure that the FDA will not

select a different center and/or legal authority for one or more of our other product candidates, in which case the governmental review requirements could vary in some respects.

FDA Approval or Clearance of Medical Devices

In the United States, medical devices are subject to varying degrees of regulatory control and are classified in one of three classes depending on the extent of controls the FDA determines are

necessary to reasonably ensure their safety and efficacy:

In the United States, medical devices are subject to varying degrees of regulatory control and are classified in one of three classes depending on the extent of controls the FDA determines are necessary

to reasonably ensure their safety and efficacy:

general controls, such as labeling and adherence to quality system regulations;

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Each of our product candidates require FDA authorization prior to marketing, by means of either a 510(k) clearance or a PMA approval.

To request marketing authorization by means of a 510(k) clearance, we must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to another legally

marketed medical device, has the same intended use, and is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than does a legally marketed device.

510(k) submissions generally

include, among other things, a description of the device and its manufacturing, device labeling, medical devices to which the device is substantially equivalent, safety and biocompatibility information, and the results of performance testing.

some cases, a 510(k) submission must include data from human clinical studies.

Marketing may commence only when the FDA issues a clearance letter finding substantial equivalence.

After a device receives 510(k) clearance, any product modification

that could significantly affect the safety or effectiveness of the product, or that would constitute a significant change in intended use, requires a new 510(k) clearance or, if the device would no longer be substantially equivalent, would

require a PMA.

If the FDA determines that the product does not qualify for 510(k) clearance, then a company must submit, and the FDA must approve, a PMA before marketing can begin.

In the past, the 510(k) pathway for product marketing required only the proof of significant equivalence in technology for a given indication with a previously cleared device.

Currently, there

has been a trend of the FDA requiring additional clinical work to prove efficacy in addition to technological equivalence.

Thus, no matter which regulatory pathway we may take in the future towards marketing products in the United States, we will

be required to provide clinical proof of device effectiveness.

Within the past few years, the FDA has released guidelines for the FDA’s reviewers to use during a product’s submission review process.

This guidance provides the FDA reviewers with a uniform

method of evaluating the benefits verses the risks of a device when used for a proposed specific indication.

Such a benefit/risk evaluation is very useful when applied to a novel device or to a novel indication and provides the FDA with a

consistent tool to document their decision process.

While intended as a guide for internal FDA use, the public availability of this guidance allows medical device manufacturers to use the review matrix to develop sound scientific and clinical

backup to support proposed clinical claims and to help guide the FDA, through the decision process, to look at the relevant data.

We intend to use this benefit/risk tool in our FDA submissions.

To request marketing authorization by means of a 510(k) clearance,

the Company must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to another legally marketed medical device, has the same intended use, and is as safe and effective as a legally marketed device and

does not raise different questions of safety and effectiveness than does a legally marketed device.

510(k) submissions generally include, among other things, a description of the device and its manufacturing, device labeling, medical devices to which

the device is substantially equivalent, safety and biocompatibility information, and the results of performance testing.

In some cases, a 510(k) submission must include data from human clinical studies.

Marketing may commence only when the FDA issues

a clearance letter finding substantial equivalence.

After a device receives 510(k) clearance, any product modification that could significantly affect the safety or effectiveness of the product, or that would constitute a significant change in

intended use, requires a new 510(k) clearance or, if the device would no longer be substantially equivalent, would require a PMA.

If the FDA determines that the product does not qualify for 510(k) clearance, then a company must submit, and the FDA

must approve, a PMA before marketing can begin.

A PMA application must provide a demonstration of safety and effectiveness, which generally requires extensive pre-clinical and clinical trial data.

Information about the device and its

components, device design, manufacturing and labeling, among other information, must also be included in the PMA.

As part of the PMA review, the FDA will inspect the manufacturer’s facilities for compliance with Quality System Regulation

requirements, which govern testing, control, documentation and other aspects of quality assurance with respect to manufacturing.

If the FDA determines the application or manufacturing facilities are not acceptable, the FDA may outline the

deficiencies in the submission and often will request additional testing or information.

Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory

criteria for approval.

During the review period, an FDA advisory committee, typically a panel of clinicians and statisticians, is likely to be convened to review the application and recommend to the FDA whether, or upon what conditions, the

device should be approved.

The FDA is not bound by the advisory panel decision.

While the FDA often follows the panel’s recommendation, there have been instances where the FDA has not.

If the FDA finds the information satisfactory, it will

approve the PMA.

The PMA approval can include post-approval conditions, including, among other things, restrictions on labeling, promotion, sale and distribution, or requirements to do additional clinical studies post-approval.

approval of a PMA, a new PMA or PMA supplement is required to authorize certain modifications to the device, its labeling or its manufacturing process.

Supplements to a PMA often require the submission of the same type of information required for

an original PMA, except that the supplement is generally limited to that information needed to support the proposed change from the product covered by the original PMA.

During the review of either a PMA application or 510(k) submission, the FDA may request more information or additional studies and may decide that the indications for which we seek approval or

clearance should be limited.

We cannot be sure that our product candidates will be approved or cleared in a timely fashion or at all.

In addition, laws and regulations and the interpretation of those laws and regulations by the FDA may change in

We cannot foresee what effect, if any, such changes may have on us.

Information about the device and its components,

device design, manufacturing, and labeling, among other information, must also be included in the PMA.

As part of the PMA review, the FDA will inspect the manufacturer’s facilities for compliance with quality system regulation requirements, which

govern testing, control, documentation, and other aspects of quality assurance with respect to manufacturing.

The PMA approval can include post-approval conditions, including, among other things, restrictions on labeling, promotion, sale and

distribution, or requirements to do additional clinical studies post-approval.

Even after approval of a PMA, a new PMA or PMA supplement is required to authorize certain modifications to the device, its labeling, or its manufacturing process.

Supplements to a PMA often require the submission of the same type of information required for an original PMA, except that the supplement is generally limited to that information needed to support the proposed change from the product covered by the

original PMA.

Obtaining medical device clearance, approval, or licensing in the United States or abroad can be an expensive process.

The fees for submitting an original PMA to the FDA for consideration of

device approval are substantial.

Fees for supplement PMA’s are less costly but still can be substantial.

International fee structures vary from minimal to substantial, depending on the country.

In addition, we are subject to annual establishment

registration fees in the United States and abroad.

International fee structures vary from minimal to substantial, depending on the

In addition, the Company is subject to annual establishment registration fees in the United States and abroad.

Device licenses require periodic renewal with associated fees as well.

In the United States, there is an annual requirement for submitting device reports for Class III/PMA devices, along with an

associated fee.

Currently, we are registered as a Small Business Manufacturer with the FDA and as such are subject to reduced fees.

If, in the future, our revenues exceed a certain annual threshold limit, we may not qualify for the Small Business

Manufacturer reduced fee amounts and will be required to pay full fee amounts.

Clinical Trials of Medical Devices

One or more clinical trials are almost always required to support a PMA application and more recently are becoming necessary to support a 510(k) submission.

Clinical studies of unapproved or

un-cleared medical devices or devices being studied for uses for which they are not approved or cleared (investigational devices) must be conducted in compliance with FDA requirements.

If an investigational device could pose a significant risk to

patients, the sponsor company must submit an IDE application to the FDA prior to initiation of the clinical study.

An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to

test the device on humans and that the testing protocol is scientifically sound.

The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin.

studies of investigational devices may not begin until an institutional review board (IRB) has approved the study.

During the study, the sponsor must comply with the FDA’s IDE requirements.

These requirements include investigator selection, trial monitoring, adverse event reporting, and record keeping.

investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of investigational devices, and comply with reporting and record keeping requirements.

We, the FDA, or the

IRB at each institution at which a clinical trial is being conducted, may suspend a clinical trial at any time for various reasons, including a belief that the subjects are being exposed to an unacceptable risk.

During the approval or clearance

process, the FDA typically inspects the records relating to the conduct of one or more investigational sites participating in the study supporting the application.

However, the COVID-19 pandemic has impacted our ability to enroll and treat patients in clinical trials and to monitor data at our clinical trial sites.

In the United States, there is an annual requirement for

submitting device reports for Class III/PMA devices, along with an associated fee.

Currently, the Company is registered as a Small Business Manufacturer with the FDA and as such are subject to reduced fees.

If, in the future, our revenues exceed a

certain annual threshold limit, the Company may not qualify for the Small Business Manufacturer reduced fee amounts and will be required to pay full fee amounts.

Post-Approval Regulation of Medical Devices

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These include:

the FDA Quality Systems Regulation (QSR), which governs, among other things, how manufacturers design, test, manufacture, exercise quality control over, and document manufacturing of their products;

the FDA quality systems regulation, which governs, among other things, how manufacturers design, test, manufacture, exercise quality control over, and document manufacturing of their products;

labeling and claims regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

the Medical Device Reporting regulation, which requires reporting to the FDA of certain adverse experiences associated with use of the product;

post market surveillance, including documentation of clinical experience and also follow-on, confirmatory studies.

We continue to be subject to inspection by the FDA to determine our compliance with regulatory requirements, as are our suppliers, contract manufacturers, and contract testing laboratories.

post market surveillance, including documentation of clinical experience and follow-on, confirmatory studies.

The Company continues to be subject to inspection by the FDA to determine our compliance with regulatory requirements, as are our suppliers, contract manufacturers, and contract testing laboratories.

International sales of medical devices manufactured in the United States that are not approved or cleared by the FDA are subject to FDA export requirements.

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regulatory requirements of each country to which the device is exported.

Exported devices may also fall under the jurisdiction of the United States Department of Commerce/Bureau of Industry and Security and compliance with export regulations may

be required for certain countries.

Exported devices may also fall under the jurisdiction of the United States Department of Commerce/Bureau of Industry and Security and compliance with export regulations may be

required for certain countries.

Manufacturing Certifications

The Medical Device Single Audit Program (MDSAP) – allows a single regulatory audit of a medical device manufacturer’s quality

management system to satisfy the requirements of multiple regulatory authorities (RAs).

The Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan),

and the FDA participated in a three-year MDSAP Pilot which concluded in December 2016.

These RAs will continue to participate in MDSAP as the program moved into its operational phase starting January 2017, with Health Canada making a full

transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP.

MDSAP uses recognized third-party auditors – auditing organizations (AOs) – to conduct a single quality management system audit that satisfies the requirements of multiple regulatory authorities.

Manufacturers only

needed to comply with the regulations from the jurisdictions where they sell their products.

The MDSAP certificate indicates that a manufacturer complies with the regulatory requirements for the markets defined in the certificate.

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 all five participating countries, most recently successfully completing a MDSAP recertification audit in September 2022.

This certificate is valid for

Annual surveillance audits are required to maintain this certification.

Manufacturing cGMP Requirements

Manufacturers of medical devices are required to comply with FDA manufacturing requirements contained in the FDA’s current Good Manufacturing Practices (cGMP) set forth in the quality system

regulations promulgated under section 520 of the Food, Drug and Cosmetic Act.

Manufacturers of medical devices are required to comply with FDA manufacturing requirements contained in the FDA’s current Good Manufacturing Practices (cGMP) set forth in the quality system regulations

promulgated under section 520 of the Federal Food, Drug and Cosmetic Act.

cGMP regulations require, among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation.

manufacturing facility for our products must meet cGMP requirements to the satisfaction of the FDA pursuant to a pre-PMA approval inspection before we can use it.

We and some of our third-party service providers are also subject to periodic

The manufacturing

facility for our products must meet cGMP requirements to the satisfaction of the FDA pursuant to a pre-PMA approval inspection before the Company can use it.

The Company and some of our third-party service providers are also subject to periodic

inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations.

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.

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

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.

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.

International Regulation

We are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of product standards, packaging

requirements, labeling requirements, import and export restrictions and tariff regulations, duties and tax requirements.

The time required to obtain clearance required by foreign countries may be longer or shorter than that required for FDA

clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

The primary regulatory environment in Europe is the European Union, which consists of 27 member states encompassing most of the major countries in Europe.

In the European Union,

the European Medicines Agency (EMA) and the European Union Commission have determined that dermaPACE ® , orthoPACE,

OssaTron and Evotron will be regulated as medical device products.

These devices have been determined to be Class IIb devices.

These devices are CE Marked and as such can be marketed and distributed within the European Economic Area.

The primary regulatory body in Canada is Health Canada.

In addition to needing appropriate data to obtain market licensing in Canada, we must have an ISO 13485 certification, as

well as meet additional requirements of Canadian laws.

We currently maintain this certification.

We maintain a device license for dermaPACE ® with Health Canada for the indication of “devices for application of shock waves (pulsed acoustic waves) on acute and chronic defects of the skin and subcutaneous soft tissue”.

The primary regulatory bodies and paths in Asia and Australia are determined by the requisite country authority.

In most cases, establishment registration and device licensing are applied for

at the applicable Ministry of Health through a local intermediary.

The requirements placed on the manufacturer are typically the same as those contained in ISO 9001 or ISO 13485.

The primary regulatory body in Brazil is ANVISA, all medical devices imported into or distributed within Brazil must first undergo registration with ANVISA.

Once ANVISA makes its

final decision on registration applications, the result is published in Brazil’s Official Diary, in addition to ANVISA, our products require additional certification via INMETRO.

We currently hold a Class II device licenses in BRAZIL for

dermaPACE ® and is in the process of registering our UltraMIST® product line

European Good Manufacturing Practices

In the European Union, the manufacture of medical devices is subject to current good manufacturing practice (cGMP), as set forth in the relevant laws and guidelines of the European Union and

its member states.

Compliance with cGMP is generally assessed by the competent regulatory authorities.

Typically, quality system evaluation is performed by a Notified Body, which also recommends to the relevant competent authority for the

European Community CE Marking of a device.

The Competent Authority may conduct inspections of relevant facilities, and review manufacturing procedures, operating systems and personnel qualifications.

In addition to obtaining approval for each

product, in many cases each device manufacturing facility must be audited on a periodic basis by the Notified Body.

Further inspections may occur over the life of the product.

We are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of product standards, packaging requirements,

labeling requirements, import and export restrictions and tariff regulations, duties and tax requirements.

The time required to obtain clearance required by foreign countries may be longer or shorter than that required for FDA clearance, and

requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

United States Anti-Kickback and False Claims Laws

In the United States, there are Federal and state anti-kickback laws that prohibit the payment or receipt of kickbacks, bribes or other remuneration intended to induce the purchase or

recommendation of healthcare products and services.

In the United States, there are Federal and state anti-kickback laws that prohibit the payment or receipt of kickbacks, bribes or other remuneration intended to induce the purchase or recommendation of

healthcare products and services.

Violations of these laws can lead to civil and criminal penalties, including exclusion from participation in Federal healthcare programs.

These laws are potentially applicable to manufacturers

of products regulated by the FDA as medical devices, such as us, and hospitals, physicians and other potential purchasers of such products.

Other provisions of Federal and state laws provide civil and criminal penalties for presenting, or causing

to be presented, to third-party payers for reimbursement, claims that are false or fraudulent, or which are for items or services that were not provided as claimed.

In addition, certain states have implemented regulations requiring medical device

and pharmaceutical companies to report all gifts and payments over $50 to medical practitioners.

These laws are potentially applicable to manufacturers of products regulated

by the FDA as medical devices, such as us, and hospitals, physicians, and other potential purchasers of such products.

Other provisions of Federal and state laws provide civil and criminal penalties for presenting, or causing to be presented, to

third-party payers for reimbursement, claims that are false or fraudulent, or which are for items or services that were not provided as claimed.

In addition, certain states have implemented regulations requiring medical device and pharmaceutical

companies to report all gifts and payments over $50 to medical practitioners.

This does not apply to instances involving clinical trials.

Although we intend to structure our future business relationships with clinical

investigators and purchasers of our products to comply with these and other applicable laws, it is possible that some of our business practices in the future could be subject to scrutiny and challenge by Federal or state enforcement officials

under these laws.

Although we intend to structure our future business relationships with clinical investigators and purchasers of

our products to comply with these and other applicable laws, it is possible that some of our business practices in the future could be subject to scrutiny and challenge by Federal or state enforcement officials under these laws.

Third Party Reimbursement

We anticipate that sales volumes and prices of the products we commercialize will depend in large part on the availability of coverage and reimbursement from third party payers.

payers include governmental programs such as Medicare and Medicaid, private insurance plans, and workers’ compensation plans.

These third-party payers may deny coverage and reimbursement for a product or therapy, in whole or in part, if they

determine that the product or therapy was not medically appropriate or necessary.

The third-party payers also may place limitations on the types of physicians or clinicians that can perform specific types of procedures.

In addition, third party

payers are increasingly challenging the prices charged for medical products and services.

Some third-party payers must also pre-approve coverage for new or innovative devices or therapies before they will reimburse healthcare providers who use

the products or therapies.

Even though a new product may have been approved or cleared by the FDA for commercial distribution, we may find limited demand for the device until adequate reimbursement has been obtained from governmental and private

Third party payers

include governmental programs such as Medicare and Medicaid, private insurance plans, and workers’ compensation plans.

Even though a new product may have been approved or cleared by the FDA for commercial distribution, we may find limited demand for

the device until adequate history of reimbursement has been obtained from governmental and private third-party payers.

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.

There can be no assurance that procedures using our products will be considered medically reasonable and necessary for a specific indication, that our products will be considered cost-effective by third party payers, that an adequate level of

reimbursement will be available or that the third-party payers’ reimbursement policies will not adversely affect our ability to sell our products profitably.

In the United States, some insured individuals are receiving their medical care through managed care programs, which monitor and often require pre-approval of the services that a member will

Some managed care programs are paying their providers on a per capita basis, which puts the providers at financial risk for the services provided to their patients by paying these providers a predetermined payment per member per month,

and consequently, may limit the willingness of these providers to use products, including ours.

One of the components in the reimbursement decision by most private insurers and governmental payers, including the Centers for Medicare & Medicaid Services, which administers Medicare, is

the assignment of a billing code.

Billing codes are used to identify the procedures performed when providers submit claims to third party payers for reimbursement for medical services.

They also generally form the basis for payment amounts.

will seek new billing codes for the wound care indications of our products as part of our efforts to commercialize such products.

The initial phase of establishing a professional billing code for a medical service typically includes applying for a CPT Category III code for both hospital and in-office procedures.

tracking code without relative value assigned that allows third party payers to identify and monitor the service as well as establish value if deemed medically necessary.

The process includes CPT application submission, clinical discussion with

Medical Professional Society CPT advisors as well as American Medical Association (AMA) CPT Editorial Panel review.

A new CPT Category III code will be assigned if the AMA CPT Editorial Panel committee deems it meets the applicable criteria and

is appropriate.

In 2017, we applied for two, new CPT Category III codes for extracorporeal shock wave therapy (ESWT) in wound healing.

These codes were published by AMA/CPT for use beginning January 1, 2019.

The secondary phase in the CPT billing code process includes the establishment of a permanent CPT Category I code in which relative value is analyzed and established by the AMA.

The approval of

this code is based on, among other criteria, widespread usage and established clinical efficacy of the medical service.

There are also billing codes that facilities, rather than health care professionals, utilize for the reimbursement of operating costs for a particular medical service.

For the hospital

outpatient setting, the Centers for Medicare & Medicaid Services automatically classified the new ESWT wound healing CPT Category III codes into interim APC groups.

The APC groups are services grouped together based on clinical

characteristics and similar costs.

An APC classification does not guarantee payment.

We believe that the overall escalating costs of medical products and services has led to, and will continue to lead to, increased pressures on the healthcare industry to reduce the costs of

products and services.

can be no assurance that procedures using our products will be considered medically reasonable and necessary for a specific indication, that our products will be considered cost-effective by third party payers, that an adequate level of reimbursement

will be available or that the third-party payers’ reimbursement policies will not adversely affect our ability to sell our products profitably.

We believe that the overall escalating costs of medical products and services has led to, and will continue to lead to, increased pressures on the healthcare industry to reduce the costs of products and

In addition, recent healthcare reform measures, as well as legislative and regulatory initiatives at the Federal and state levels, create significant additional uncertainties.

There can be no assurance that third party

coverage and reimbursement will be available or adequate, or that future legislation, regulation, or reimbursement policies of third-party payers will not adversely affect the demand for our products or our ability to sell these products on a

profitable basis.

There can be no assurance that third party coverage and

reimbursement will be available or adequate, or that future legislation, regulation, or reimbursement policies of third-party payers will not adversely affect the demand for our products or our ability to sell these products on a profitable basis.

The unavailability or inadequacy of third-party payer coverage or reimbursement would have a material adverse effect on our business, operating results and financial condition.

Confidentiality and Security of Personal Health Information

The Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), contains provisions that protect individually identifiable health information from unauthorized use or

disclosure by covered entities and their business associates.

The Office for Civil Rights of 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

In addition, the American Recovery and Reinvestment Act (“ARRA”) enacted the HITECH Act, which extends the scope of HIPAA to permit enforcement against business associates for a violation, establishes new requirements to notify the Office

for Civil Rights of HHS of a breach of HIPAA, and allows the Attorneys General of the states to bring actions to enforce violations of HIPAA.

Rules implementing various aspects of HIPAA are continuing to be promulgated.

We anticipate that, as we expand our dermaPACE ®

business, we will in the future be a covered entity under HIPAA.

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

such regulations are in effect at such time.

In addition to the HIPAA Privacy Rule and Security Rule described above, we may become subject to state laws regarding the handling and disclosure of patient records and patient health

The Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA), contains provisions that protect individually identifiable health information from unauthorized use or disclosure by

covered entities and their business associates.

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).

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.

In addition, the American Recovery and Reinvestment Act enacted the HITECH Act, which extends the scope of HIPAA to permit enforcement against business associates for a violation, establishes new requirements

to notify the Office for Civil Rights of HHS of a breach of HIPAA, and allows the Attorneys General of the states to bring actions to enforce violations of HIPAA.

We anticipate that, as we expand our PACE business, we may in the future be a covered entity under HIPAA.

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 the HIPAA Privacy Rule and Security Rule described above, we may become subject to state laws regarding the handling and disclosure of patient records and patient health information.

These laws vary widely.

Penalties for violation include sanctions against a laboratory’s licensure as well as civil or criminal penalties.

Additionally, private individuals may have a right of action against us for a violation of a

state’s privacy laws.

We intend to adopt policies and procedures to ensure material compliance with state laws regarding the confidentiality of health information as such laws become applicable to us and to monitor and comply with new or changing

state laws on an ongoing basis.

Additionally, private individuals may have a right of action against us for a violation of a state’s privacy

ongoing basis.

Environmental and Occupational Safety and Health Regulations

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 Canada, Alberta Environment, 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.

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 Canada, Alberta Environment, 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.

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

to date needed to make material expenditures to comply with current environmental statutes, regulations and policies.

However, we cannot predict the impact and costs those possible future statutes, regulations and policies will have on our

We have not to date needed

to make material expenditures to comply with current environmental statutes, regulations and policies.

However, we cannot predict the impact and costs those possible future statutes, regulations and policies will have on our business.

As of December 31, 2022, we had a total of 38 full time employees in the United States.

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

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

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

our employees are represented by a labor union or covered by a collective bargaining agreement.

We believe our relationship with our employees is good.

1 unchanged sentence

We were formed as a Nevada corporation in 2004.

Our corporate headquarters address is 3360 Martin Farm Road, Suite 100 Suwanee, Georgia 30024, and our main telephone number is (770) 419-7525.

Our corporate headquarters address 11495 Valleyview Road, Eden Prairie, MN 55344, and our main telephone number is (770) 419-7525.

Available Information

We make available free of charge through our website - www.sanuwave.com - our periodic reports and registration statements filed with the United States Securities and Exchange Commission (the

“SEC”), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as

amended (the “Exchange Act”).

We maintain a website at www.sanuwave.com .

We make available on our website, free of charge, our periodic reports and registration statements

filed with the SEC, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of

1934, as amended (the “Exchange Act”).

We make these reports available through our website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to the SEC.

Our internet site and the information

contained on or connected to that site are not incorporated by reference into this Form 10-K.

The SEC also maintains a website at www.sec.gov that contains reports, proxy statements and other information regarding issuers that file electronically

with the SEC.

contained on or connected to that site are not incorporated by reference into this Annual Report on Form 10-K.

The SEC also maintains a website at www.sec.gov that contains reports, proxy statements and other information regarding issuers that file

electronically with the SEC.

Restatement of Previously Issued Consolidated Financial Statements

On March 28, 2023, the Audit Committee (the “Audit Committee”) of the Board of Directors of the Company, after consulting with management and the Company’s independent

registered public accounting firm, Marcum LLP, determined that the Company’s consolidated financial statements included in its 2022 Annual Report on Form 10-K as of December 31, 2022 and the Company’s previously issued condensed interim

consolidated financial statements as of and for the interim periods in 2022 as filed in the Company’s Quarterly Reports on Form 10-Q for the periods ended March 31, 2022, June 30, 2022, and September 30, 2022 should no longer be relied upon due to

material misstatements that are described in greater detail in Note 3 and Note 22.

Any previously filed reports, press releases, earnings releases, or investor presentations or other communications describing the Company’s financial statements and

other related financial information covering the previously mentioned periods should no longer be relied upon.

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