SNWV 10-K Fiscal year ended Dec. 31, 2020

Nevada		20-1176000
(State or Other Jurisdiction of Incorporation)		(I.R.S. Employer Identification No.)

3360 Martin Farm Road, Suite 100 Suwanee, Georgia		30024
(Address of Principal Executive Offices)		(Zip Code)

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001	SNWV	OTC Expert

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

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

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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;

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

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

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

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

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

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Support the global distribution of our products.

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

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Class II: special controls, pre-market notification (510(k)), specific controls such as performance standards, patient registries, and post market surveillance, and additional controls such as labeling and adherence to quality system regulations; and

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Class III: special controls and approval of a pre-market approval (PMA) application.

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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;

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

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

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

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unanticipated expenditures in research and development or manufacturing activities;

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delayed market acceptance of any approved product;

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unanticipated expenditures in the acquisition and defense of intellectual property rights;

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the failure to develop strategic alliances for the marketing of some of our product candidates;

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additional inventory builds to adequately support the launch of new products;

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unforeseen changes in healthcare reimbursement for procedures using any of our approved products;

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inability to train a sufficient number of physicians to create a demand for any of our approved products;

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lack of financial resources to adequately support our operations;

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difficulties in maintaining commercial scale manufacturing capacity and capability;

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unforeseen problems with our third party manufacturers, service providers or specialty suppliers of certain raw materials;

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unanticipated difficulties in operating in international markets;

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unanticipated financial resources needed to respond to technological changes and increased competition;

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unforeseen problems in attracting and retaining qualified personnel;

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the impact of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively the PPACA) on our operations;

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the impact of changes in U.S. health care law and policy on our operations;

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enactment of new legislation or administrative regulations;

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the application to our business of new court decisions and regulatory interpretations;

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claims that might be brought in excess of our insurance coverage;

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delays in timing of receipt of required regulatory approvals;

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the failure to comply with regulatory guidelines; and

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the uncertainty in industry demand and patient wellness behavior.

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the FDA or a foreign regulatory authority finds our product candidates ineffective or unsafe;

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we do not receive necessary regulatory approvals;

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the regulatory review and approval process may take much longer than anticipated, requiring additional time, effort and expense to respond to regulatory comments and/or directives;

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the reimbursement for our products is difficult to obtain or is too low, which can hinder the introduction and acceptance of our products in the market;

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we are unable to get our product candidates in commercial quantities at reasonable costs; and

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the patient and physician community does not accept our product candidates.

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adverse or ambiguous results;

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undesirable side effects that delay or extend the trials;

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the inability to locate, recruit, qualify and retain a sufficient number of clinical investigators or patients for our trials; and

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regulatory delays or other regulatory actions.

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required compliance with existing and changing foreign healthcare and other regulatory requirements and laws, such as those relating to patient privacy or handling of bio-hazardous waste;

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required compliance with anti-bribery laws, data privacy requirements, labor laws and anti-competition regulations;

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export or import restrictions;

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various reimbursement and insurance regimes;

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laws and business practices favoring local companies;

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political and economic instability;

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potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers;

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foreign exchange controls; and

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difficulties protecting or procuring intellectual property rights.

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stockholders may not vote by written consent;

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advance notice of business to be brought is required for a meeting of the Company’s stockholders;

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no cumulative voting rights for the holders of common stock in the election of directors; and

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vacancies in the board of directors may be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum.

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the product candidate may not prove to be safe or effective;

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the product candidate’s benefits may not outweigh its risks;

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the results from advanced clinical trials may not confirm the positive results from pre-clinical studies and early clinical trials;

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the FDA or comparable foreign regulatory authorities may interpret data from pre-clinical and clinical testing in different ways than us; and

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the FDA or other regulatory agencies may require additional or expanded trials and data.

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warning letters;

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fines and other monetary penalties;

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unanticipated expenditures;

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delays in FDA approval and clearance, or FDA refusal to approve or clear a product candidate;

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product recall or seizure;

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interruption of manufacturing or clinical trials;

•

operating restrictions;

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injunctions; and

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criminal prosecutions.

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testing;

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manufacturing;

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quality control;

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labeling;

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advertising;

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promotion;

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distribution;

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export;

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reporting to the FDA certain adverse experiences associated with the use of the products; and

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obtaining additional approvals or clearances for certain modifications to the products or their labeling or claims.

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the size of the patient population;

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the nature of the clinical protocol requirements;

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the availability of other treatments or marketed therapies (whether approved or experimental);

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our ability to recruit and manage clinical centers and associated trials;

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the proximity of patients to clinical sites; and

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the patient eligibility criteria for the study.

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required refunding or retroactive adjustment of amounts we have been paid by governmental or private payors;

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state or Federal agencies imposing fines, penalties and other sanctions on us;

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loss of our right to participate in the Medicare program, state programs, or one or more private payor networks; or

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damage to our business and reputation in various markets.

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obtain and/or maintain protection for our product candidates under the patent laws of the United States and other countries;

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defend and enforce our patents once obtained;

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obtain and/or maintain appropriate licenses to patents, patent applications or other proprietary rights held by others with respect to our technology, both in the United States and other countries;

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maintain trade secrets and other intellectual property rights relating to our product candidates; and

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operate without infringing upon the patents, trademarks, copyrights and proprietary rights of third parties.

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we or the owners or other inventors of the patents that we own or that have been licensed to us, or that may be issued or licensed to us in the future, were the first to file patent applications or to invent the subject matter claimed in patent applications relating to the technologies upon which we rely;

•

others will not independently develop similar or alternative technologies or duplicate any of our technologies;

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any of our patent applications will result in issued patents;

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the patents and patent applications that we own or that have been licensed to us, or that may be issued or licensed to us in the future, will provide a basis for commercially viable products or will provide us with any competitive advantages, or will not be challenged by third parties;

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the patents and patent applications that have been licensed to us are valid and enforceable;

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we will develop additional proprietary technologies that are patentable;

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we will be successful in enforcing the patents that we own or license and any patents that may be issued or licensed to us in the future against third parties;

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the patents of third parties will not have an adverse effect on our ability to do business; or

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our trade secrets and proprietary rights will remain confidential.

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our ability to obtain additional financing and, if available, the terms and conditions of the financing;

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changes in the timing of on-going clinical trial enrollment, the results of our clinical trials and regulatory approvals for our product candidates or failure to obtain such regulatory approvals;

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changes in our industry;

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additions or departures of key personnel;

•

sales of our common stock;

•

our ability to execute our business plan;

•

operating results that fall below expectations;

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period-to-period fluctuations in our operating results;

•

new regulatory requirements and changes in the existing regulatory environment; and

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general economic conditions and other external factors.

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investors may have difficulty buying and selling, or obtaining market quotations for our common stock;

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market visibility for our common stock may be limited; and

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a lack of visibility for our common stock may have a depressive effect on the market for our common stock.

Plan Category		Number of securities to be issued upon exercise of outstanding options, warrants and rights				Weighted -average exercise price of outstanding options, warrants and rights				Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
		(a)				(b)				(c)
Equity compensation plans approved by security holders			-			$	0.00				-
Equity compensation plans not approved by security holders			31,588,685			$	0.28				3,061,615
Total			31,588,685			$	0.28				3,061,615

Item 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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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;

•

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

•

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

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the scope, rate of progress and cost of our clinical trials;

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future clinical trial results;

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the cost and timing of regulatory approvals;

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the establishment of successful marketing, sales and distribution channels and partnerships, including our efforts to expand our marketing, sales and distribution reach through joint ventures and other contractual arrangements;

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the cost and timing associated with establishing reimbursement for our products;

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the effects of competing technologies and market developments; and

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the industry demand and patient wellness behavior.

	Page
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm	F-1
Consolidated Balance Sheets as of December 31, 2020 and 2019	F-2
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2020 and 2019	F-3
Consolidated Statements of Stockholders’ Deficit for the years ended December 31, 2020 and 2019	F-4
Consolidated Statements of Cash Flows for the years ended December 31, 2020 and 2019	F-5
Notes to Consolidated Financial Statements	F-6

		2020				2019
ASSETS
CURRENT ASSETS
Cash		$	2,436,984			$	1,760,455
Accounts receivable, net of allowance for doubtful accounts of $342,898 in 2020 and $72,376 in 2019			2,355,396				75,543
Inventory			2,956,344				542,955
Prepaid expenses and other current assets			179,343				125,405
TOTAL CURRENT ASSETS			7,928,067				2,504,358
PROPERTY AND EQUIPMENT, net			470,981				93,954
RIGHT OF USE ASSETS, net			794,831				741,749
OTHER INTANGIBLE ASSETS, net			6,545,284				-
GOODWILL			7,259,795				-
OTHER ASSETS			28,602				41,931
TOTAL ASSETS		$	23,027,560			$	3,381,992
LIABILITIES
CURRENT LIABILITIES
Senior secured promissory note payable, in default		$	10,675,637			$	-
Convertible promissory notes payable, in default			4,000,000				-
Convertible promissory notes, related parties, in default			1,596,254				-
Accounts payable			4,454,385				1,439,413
Accrued expenses			2,126,768				957,109
Accrued employee compensation			2,540,675				1,606,910
Warrant liability			8,855,379				-
Current portion of SBA loans			320,707				-
Accrued interest			1,021,495				-
Accrued interest, related parties			77,145				1,859,977
Current portion of lease liabilities			450,787				294,904
Current portion of contract liabilities			32,258				66,577
Notes payable, related parties, net			-				5,372,743
Short term notes payable			-				587,233
Line of credit, related parties			-				212,388
Advances from related parties			22,500				18,098
TOTAL CURRENT LIABILITIES			36,173,990				12,415,352
NON-CURRENT LIABILITIES
SBA loans			143,628				-
Lease liabilities			391,310				457,017
Contract liabilities			37,514				573,224
TOTAL NON-CURRENT LIABILITIES			572,452				1,030,241
TOTAL LIABILITIES			36,746,442				13,445,593
CONTINGENCIES
STOCKHOLDERS’ DEFICIT
PREFERRED STOCK, par value $0.001, 5,000,000 shares authorized; 6,175, 293, 90 and 8 shares designated Series A, Series B, Series C and Series D, respectively; no shares issued and outstanding at December 31, 2020 and 2019			-				-
COMMON STOCK, par value $0.001, 800,000,000 shares authorized; 470,694,621 and 293,780,400 issued and outstanding at December 31, 2020 and 2019, respectively			470,695				293,781
ADDITIONAL PAID-IN CAPITAL			142,562,694				115,457,808
ACCUMULATED DEFICIT			(156,689,989	)			(125,752,956	)
ACCUMULATED OTHER COMPREHENSIVE LOSS			(62,282	)			(62,234	)
TOTAL STOCKHOLDERS’ DEFICIT			(13,718,882	)			(10,063,601	)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT		$	23,027,560			$	3,381,992

		2020				2019
REVENUES
Product		$	2,267,259			$	645,169
Accessory and parts revenue			1,637,997				12,021
License fees and other			152,215				371,540
TOTAL REVENUES			4,057,471				1,028,730
COST OF REVENUES			1,162,021				538,923
GROSS MARGIN			2,895,450				489,807
OPERATING EXPENSES
Research and development			1,245,507				1,181,892
Selling and marketing			5,159,740				1,590,957
General and administrative			13,723,888				6,440,093
Impairment of intangible assets			7,185,120				-
Depreciation and amortization			781,002				71,213
TOTAL OPERATING EXPENSES			28,095,257				9,284,155
OPERATING LOSS			(25,199,807	)			(8,794,348	)
OTHER INCOME (EXPENSE)
Change in warrant valuation			(3,192,620	)			227,669
Loss on extinguishment of debt			(565,374	)			-
Partnership fee income			600,000				-
Interest expense			(2,025,017	)			(1,147,986	)
Interest expense, related party			(516,014	)			(688,195	)
Loss on foreign currency exchange			(38,201	)			(26,979	)
TOTAL OTHER INCOME (EXPENSE), NET			(5,737,226	)			(1,635,491	)
NET LOSS			(30,937,033	)			(10,429,839	)
OTHER COMPREHENSIVE INCOME (LOSS)
Foreign currency translation adjustments			(48	)			19,844
TOTAL COMPREHENSIVE LOSS		$	(30,937,081	)		$	(10,409,995	)
LOSS PER SHARE:
Net loss per share, basic and diluted		$	(0.08	)		$	(0.05	)
Weighted average shares outstanding, basic and diluted			378,128,645				203,588,106

Years Ended December 31, 2020 and 2019
		Preferred Stock								Common Stock
		Number of Shares Issued and Outstanding				Par Value				Number of Shares Issued and Outstanding				Par Value				Additional Paid- in Capital				Accumulated Deficit				Accumulated Other Comprehensive Loss				Total
Balances as of December 31, 2018			-			$	-				155,665,138			$	155,665			$	101,153,882			$	(116,602,778	)		$	(62,868	)		$	(15,356,099	)
Net loss			-				-				-				-				-				(10,429,839	)			-				(10,429,839	)
Cashless warrant exercises			-				-				4,962,157				4,962				(4,962	)			-				-				-
Cashless warrant exercises with waived proceeds			-				-				450,000				450				35,550				-				-				36,000
Proceeds from warrant exercise			-				-				40,284,422				40,285				3,581,674				-				-				3,621,959
Conversion of short term notes and convertible notes payable			-				-				65,247,517				65,248				6,427,607				-				-				6,492,855
Reclassification of warrant liability to equity due to adoption of ASU 2017-11			-				-				-				-				262,339				1,279,661				-				1,542,000
Conversion of line of credit, related parties to equity			-				-				7,020,455				7,020				672,980				-				-				680,000
Warrants issued for services			-				-				-				-				186,867				-				-				186,867
Shares issued for services			-				-				150,000				150				28,350				-				-				28,500
Proceeds from PIPE offering			-				-				20,000,711				20,001				2,780,099				-				-				2,800,100
Stock-based compensation			-				-				-				-				333,422				-				-				333,422
Foreign currency translation adjustment			-				-				-				-				-				-				634				634
Balances as of December 31, 2019			-			$	-				293,780,400			$	293,781			$	115,457,808			$	(125,752,956	)		$	(62,234	)		$	(10,063,601	)
Net loss			-				-				-				-				-				(30,937,033	)			-				(30,937,033	)
Proceeds from warrant exercise			-				-				1,000,000				1,000				9,000				-				-				10,000
Conversion of short term notes and convertible notes payable			-				-				4,829,789				4,829				559,900				-				-				564,729
Reclassification of warrant liability to equity			-				-				-				-				6,292,695				-				-				6,292,695
Conversion of advances from related parties			-				-				262,811				263				17,835				-				-				18,098
Conversion of notes payable, related parties			-				-				15,475,235				15,475				2,275,572				-				-				2,291,047
Shares issued for services			-				-				12,700,000				12,700				2,533,492				-				-				2,546,192
Proceeds from PIPE offering, net of offering costs			-				-				124,621,428				124,621				12,557,895				-				-				12,682,516
Stock-based compensation			-				-				-				-				21,900				-				-				21,900
Proceeds from stock option exercise			-				-				325,000				325				47,925				-				-				48,250
Beneficial conversion feature on convertible debt			-				-				-				-				560,682				-				-				560,682
LGH warrant liability			-				-				-				-				(249,049	)			-				-				(249,049	)
Series C and Series D preferred stock converted to common stock			-				-				17,499,958				17,501				2,432,499				-				-				2,450,000
Inducement shares issued			-				-				200,000				200				44,540				-				-				44,740
Foreign currency translation adjustment			-				-				-				-				-				-				(48	)			(48	)
Balances as of December 31, 2020			-			$	-				470,694,621			$	470,695			$	142,562,694			$	(156,689,989	)		$	(62,282	)		$	(13,718,882	)

		2020				2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss		$	(30,937,033	)		$	(10,429,839	)
Adjustments to reconcile net loss to net cash used by operating activities
Amortization of intangibles			713,021				-
Depreciation			298,741				71,213
Bad Debt Expense			302,193				39,331
Impairment of Intangible Assets			7,185,120				-
Stock-based compensation			21,900				333,422
Shares issued for services			2,546,192				28,500
Shares issued for inducement shares			44,740				-
Loss on extinguishment of debt			565,374				-
Warrants issued for consulting services			-				186,867
Change in warrant valuation			3,192,620				(227,669	)
Amortization of debt issuance costs and debt discount			484,185				-
Accrued interest			1,097,577				1,159,713
Interest payable, related parties			401,081				688,195
Waived proceeds from warrant exercise			-				36,000
Changes in operating assets and liabilities
Accounts receivable - trade			(2,582,046	)			(8,600	)
Inventory			(553,424	)			(185,135	)
Prepaid expenses			(53,938	)			(294	)
Due from related parties			-				1,228
Other assets			13,328				(25,440	)
Operating leases			(6,290	)			35,386
Accounts payable			3,014,972				(138,730	)
Accrued expenses			1,169,659				267,829
Accrued employee compensation			933,765				1,288,497
Contract liabilties			(570,029	)			468,768
NET CASH USED BY OPERATING ACTIVITIES			(12,718,292	)			(6,410,758	)
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of UltraMIST, net of $4,000,000 note payable to seller			(20,000,000	)			-
Purchases of property and equipment			(52,870	)			(53,939	)
NET CASH USED BY INVESTING ACTIVITIES			(20,052,870	)			(53,939	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of convertible preferred stock			2,450,000				-
Proceeds from convertible promissory note			1,100,000				-
Proceeds from SBA loan			614,335				-
Proceeds from PIPE offering, net of offering costs			21,456,468				2,800,100
Proceeds from senior secured promissory note payable			13,346,547				-
Proceeds from stock option exercises			48,250				-
Proceeds from short term note			-				1,215,000
Proceeds from line of credit, related party			-				90,000
Proceeds from warrant exercises			10,000				1,758,142
Advances from related parties			22,500				2,055,414
Repayments of debt principal on convertible promissory notes, related parties, convertible promissory notes and SBA loans			(5,457,662	)			-
Payments of principal on finance leases			(142,699	)			(58,687	)
NET CASH PROVIDED BY FINANCING ACTIVITIES			33,447,739				7,859,969
EFFECT OF EXCHANGE RATES ON CASH			(48	)			634
NET INCREASE IN CASH AND CASH EQUIVALENTS			676,529				1,395,906
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD			1,760,455				364,549
CASH AND CASH EQUIVALENTS, END OF PERIOD		$	2,436,984			$	1,760,455
			-				-
SUPPLEMENTAL INFORMATION
Cash paid for interest		$	436,333			$	-
NONCASH INVESTING AND FINANCING ACTIVITIES
Reclassification of warrant liabilities to equity		$	6,292,695			$	1,542,000
Acquistion of UltraMIST partially financed with convertible promissory note			4,000,000				-
Conversion of short-term notes payable to equity			564,729				3,559,542
Beneficial conversion feature on convertible debt			560,682				-
Conversion of advance from related parties		$	18,098				-
Conversion of notes payable, related parties		$	2,291,047				-
Series C and Series D preferred stock converted to common stock		$	2,450,000				-
Exchange line of credit and notes payable, related parties, for convertible promissory notes, related parties		$	1,596,254				-
Conversion of convertible promissory notes to equity			-				2,933,313
Conversion of line of credit, related party to equity			-				680,000
Conversion of line of credit, related party to accounts receivable			-				121,000
Accounts payable and accrued employee compensation converted to equity			-				36,500
Other warrant exercise			-				1,863,815

•

Expertise and resources to analyze and properly apply generally accepted accounting principles to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distribution agreements.

•

A lack of internal resources to analyze and properly apply generally accepted accounting principles to accounting for financial instruments included in service agreements with select vendors.

•

The Company has failed to design and implement controls around all of its accounting and IT processes and procedures and, as such, it believes that all of its accounting and IT processes and procedures need to re-designed and tested for operating effectiveness.

Name		Age		Position Held
Kevin A. Richardson, II		53		Director, Chairman and Chief Executive Officer
Lisa E. Sundstrom		51		Chief Financial Officer and Chief Talent Officer
Peter Stegagno		61		Chief Operating Officer
Iulian Cioanta, PhD		59		Chief Science and Technology Officer
John Schlechtweg		41		Chief Revenue Officer
John F. Nemelka		56		Director
A. Michael Stolarski		51		Director

Name and Principal Position	Year		Salary ($)				Option Awards ($) (3)				All Other Compensation ($) (4)				Total ($)
Kevin A. Richardson, II	2020		$	335,417	(1)			-			$	37,180			$	372,596
Chairman of the Board and Chief Executive Officer (principal executive officer)	2019		$	401,619	(2)		$	6,500			$	31,288			$	439,407
Shri P. Parikh (5)	2020		$	305,301				-			$	23,699			$	329,000
President, Healthcare	2019		$	311,000			$	6,500			$	30,960			$	348,460
Peter Stegano	2020		$	188,333				-			$	28,905			$	217,239
Chief Operating Officer	2019		$	231,295			$	6,500			$	21,519			$	259,314
Lisa E. Sundstrom	2020		$	191,667				-			$	23,347			$	215,014
Chief Financial Officer (prinipal financial officer)	2019		$	200,000			$	6,500			$	24,589			$	231,089

		Option Awards																	Stock Awards
Name		Number of Securities Underlying Unexercised Options/ Warrants (#) Exercisable				Number of Securities Underlying Unexercised Options/ Warrants (#) Unexercisable				Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)				Option/ Warrant Exercise Price ($)			Option/ Warrant Expiration Date		Number of Shares or Units of Stock That Have Not Vested (#)				Market Value of Shares or Units of Stock That Have Not Vested ($)				Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#)				Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($)
(a)		(b)				(c)				(d)				(e)			(f)		(g)				(h)				(i)				(j)
Kevin A. Richardson, II			115,000	(1)			-				-			$	0.35		02/21/2023			-				-				-				-
Chairman of the Board and Chief Executive Officer (principal executive officer)			452,381	(3)			-				-			$	0.11		10/1/2025			-				-				-				-
			297,619	(3)			-				-			$	0.06		10/1/2025			-				-				-				-
			700,000	(4)			-				-			$	0.04		6/16/2026			-				-				-				-
			594,300	(5)			-				-			$	0.18		11/9/2026			-				-				-				-
			900,000	(6)			-				-			$	0.11		6/14/2027			-				-				-				-
			1,100,000	(7)			-				-			$	0.21		9/20/2028			-				-				-				-
			50,000	(9)			-				-			$	0.15		8/26/2029			-				-				-				-
Lisa E. Sundstrom			65,000	(1)			-				-			$	0.35		02/21/2023			-				-				-				-
Chief Financial Officer (principal financial officer)			25,000	(2)			-				-			$	0.55		5/7/2024			-				-				-				-
			301,587	(3)			-				-			$	0.11		10/1/2025			-				-				-				-
			198,413	(3)			-				-			$	0.06		10/1/2025			-				-				-				-
			500,000	(4)			-				-			$	0.04		6/16/2026			-				-				-				-
			424,500	(5)			-				-			$	0.18		11/9/2026			-				-				-				-
			600,000	(6)			-				-			$	0.11		6/14/2027			-				-				-				-
			750,000	(7)			-				-			$	0.21		9/20/2028			-				-				-				-
			50,000	(9)			-				-			$	0.15		8/26/2029			-				-				-				-
Shri Parikh			2,000,000	(8)			-				-			$	0.42		5/31/2028			-				-				-				-
President, Healthcare			1,000,000	(7)			-				-			$	0.21		9/20/2028			-				-				-				-
			50,000	(9)			-				-			$	0.15		8/26/2029			-				-				-				-
Peter Stegano			333,644	(1)			-				-			$	0.35		02/21/2023			-				-				-				-
Chief Operating Officer			50,000	(2)			-				-			$	0.55		5/7/2024			-				-				-				-
			301,587	(3)			-				-			$	0.11		10/1/2025			-				-				-				-
			198,413	(3)			-				-			$	0.06		10/1/2025			-				-				-				-
			500,000	(4)			-				-			$	0.04		6/16/2026			-				-				-				-
			424,500	(5)			-				-			$	0.18		11/9/2026			-				-				-				-
			600,000	(6)			-				-			$	0.11		6/14/2027			-				-				-				-
			750,000	(7)			-				-			$	0.21		9/20/2028			-				-				-				-
			50,000	(9)			-				-			$	0.15		8/26/2029			-				-				-				-

Name		Fees Earned or Paid in Cash ($)				Option Awards($) (2)				Total ($)
Kevin A. Richardson, II (1)		$	60,000			$	-			$	60,000
John F. Nemelka		$	60,000			$	-			$	60,000
Alan L. Rubino (2)		$	60,000			$	-			$	60,000
A. Michael Stolarski		$	60,000			$	-			$	60,000
Maj-Britt Kaltoft (3)		$	60,000			$	-			$	60,000
Thomas Price, MD (4)		$	16,667			$	-			$	16,667

Name of Beneficial Owner (1)	Number of Shares Beneficially Owned		Percent of Shares Outstanding (2)
A. Michael Stolarski (3)	18,331,290		3.8%
Kevin A. Richardson II (4)	16,795,993		3.5%
Peter Stegagno (5)	4,418,007		0.9%
Iulian Cioanta (6)	3,636,146		0.8%
Lisa E. Sundstrom (7)	3,364,500		0.7%
John F. Nemelka (8)	1,696,055		0.4%
All directors and executive officers as a group (6 persons)	48,241,991		10.0%

Fee Category		2020				2019
Audit fees		$	573,000			$	184,000
Tax fees			25,000				18,000
Audit related fees			192,000				-
All other fees			-				-
Total fees		$	790,000			$	202,000

•

Audit fees consist of fees for the annual audit of our consolidated financial statements, the review of the interim financial statements included in our quarterly reports on Form 10-Q, and other professional services provided in connection with statutory and regulatory filings and consents related to capital markets transactions and engagements for those fiscal years.

•

Tax fees consist of fees for tax compliance, tax advice and tax planning services for those fiscal years.

•

Audit related fees consist of fees for assurance and related services that are reasonably related to the performance of the audit or review.

•

All other fees consist of fees for all other products and services.

	The Audit Committee
	John F. Nemelka (Chair)
	Kevin A. Richardson, II A.  Michael Stolarski
	October 21, 2021

	Page
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm	F-1
Consolidated Balance Sheets as of December 31, 2020 and 2019	F-2
Consolidated Statements of Comprehensive Loss for the years ended December 31, 2020 and 2019	F-3
Consolidated Statements of Stockholders’ Deficit for the years ended December 31, 2020 and 2019	F-4
Consolidated Statements of Cash Flows for the years ended December 31, 2020 and 2019	F-5
Notes to Consolidated Financial Statements	F-6

Exhibit No.	Description
2.1	Agreement and Plan of Merger, dated as of September 25, 2009, by and between Rub Music Enterprises, Inc., RME Delaware Merger Sub, Inc. and SANUWAVE, Inc. (Incorporated by reference to Form 8-K filed with the SEC on September 30, 2009).
3.1	Articles of Incorporation (Incorporated by reference to the Form 10-SB filed with the SEC on December 18, 2007).
3.2	Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Appendix A to the Definitive Schedule 14C filed with the SEC on October 16, 2009).
3.3	Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Appendix A to the Definitive Schedule 14C filed with the SEC on April 16, 2012).
3.4	Bylaws (Incorporated by reference to the Form 10-SB filed with the SEC on December 18, 2007).
3.5	Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company dated March 14, 2014 (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
3.6	Certificate of Amendment to the Articles of Incorporation, dated September 8, 2015 (Incorporated by reference to the Form 10-K filed with the SEC on March 30, 2016).
3.7	Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock of the Company dated January 12, 2016 (Incorporated by reference to the Form 8-K filed with the SEC on January 19, 2016).
3.8	Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on February 6, 2020).
3.9	Certificate of designation of Series C Convertible Preferred Stock. (incorporated by reference to the Form 8-K filed with the SEC on February 6, 2020).
3.10	Certificate of Designation of Series D Convertible Preferred Stock. (incorporated by reference to the Form 8-K filed with the SEC on May 20, 2020).
3.11	Certificate of Amendment of the Articles of Incorporation. (incorporated by reference to the Form 8-K filed with the SEC on January 5, 2021).
4.1	Form of Class A Warrant Agreement (Incorporated by reference to Form 8-K filed with the SEC on September 30, 2009).
4.2	Form of Class B Warrant Agreement (Incorporated by reference to Form 8-K filed with the SEC on September 30, 2009).
4.3	Form of Class D Warrant Agreement (Incorporated by reference to Form 8-K filed with the SEC on October 14, 2010).

4.4	Form of Class E Warrant Agreement (Incorporated by reference to Form 8-K filed with the SEC on April 7, 2011).
4.5	Form of Series A Warrant (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
4.6	Form of Series B Warrant (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
4.7	Form of 18% Senior Secured Convertible Promissory Note issued by the Company to select accredited investors (Incorporated by reference to Form 8-K filed with the SEC on February 27, 2013).
4.8	Form of Convertible Promissory Note between the Company and accredited investors party thereto (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
4.9	Amendment No. 1 to the Convertible Note Agreement between the Company and accredited investors party thereto (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
4.10	Class K Warrant Agreement by and between the Company and HealthTronics, Inc., dated June 15, 2015 (Incorporated by reference to the Form 8-K filed with the SEC on June 18, 2015).
4.11	Amendment No. 1 to Class K Warrant Agreement by and between the Company and HealthTronics, Inc., dated June 28, 2016 (Incorporated by reference to the Form 10-Q filed with the SEC on August 15, 2016).
4.12	Form of Class L Warrant Common Stock Purchase Warrant (Incorporated by reference to the Form 8-K filed with the SEC on March 17, 2016).
4.13	Second Form of Class L Warrant Common Stock Purchase Warrant (Incorporated by reference to the Form 8-K filed with the SEC on August 24, 2016).
4.14	Registration Rights Agreement dated January 13, 2016 among the Company and the investors listed therein (Incorporated by reference to the Form 8-K filed with the SEC on January 19, 2016).
4.15	Class K Warrant Agreement dated as of August 3, 2017, between the Company and HealthTronics, Inc. (Incorporated by reference to Form 8-K filed with the SEC on August 4, 2017).
4.16	Form of Class N Warrant.  (Incorporated by reference to Form 8-K filed with the SEC on November 9, 2017).
4.17	Letter to Series A Warrantholders, Class N Warrantholders and Class L Warrantholders, dated January 29, 2019. (Incorporated by reference to Form 8-K filed with the SEC on January 25, 2019).

4.18	Form of Class O Warrant.  (Incorporated by reference to Form 8-K filed with the SEC on March 15, 2019).
4.19	Letter to Class N Warrantholders and Class O Warrantholders, dated March 14, 2019.  (Incorporated by Reference to Form 8-K filed with the SEC on March 15, 2019).
4.20	Letter to Class N Warrant Holders, dated June 5, 2019 (incorporated by reference to the Company’s Current Report on Form 8-K, filed with the SEC on June 7, 2019).
4.21	Letter to Class O Warrant Holders, dated June 5, 2019 (incorporated by reference to the Company’s Current Report on Form 8-K, filed with the SEC on June 7, 2019).
4.22	Description of Registrant’s Common Stock. (incorporated by reference to the Form 10-K filed with the SEC on March 30, 2020
4.23	Form of Class E Warrant (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
4.24	Form of Secured Promissory Note issued to NH Expansion Credit Fund Holdings LP, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
4.25	Warrant issued to NH Expansion Credit Fund Holdings LP, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
4.26	Warrant issued to HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
4.27	Warrant issued to Leviston Resources, LLC, dated April 20, 2021. (incorporated by reference to the Form 8-K filed with the SEC on April 27, 2020).
4.28	Future Advance Convertible Promissory Note issued to Leviston Resources, LLC, dated April 2020, 2021. (incorporated by reference to the Form 8-K filed with the SEC on April 27, 2020).
10.1 ∞	Amended and Restated 2006 Stock Option Incentive Plan of SANUWAVE Health, Inc.  (Incorporated by reference to Form 8-K filed with the SEC on November 3, 2010).
10.2	Form of Securities Purchase Agreement, by and among the Company and the accredited investors party thereto, dated March 17, 2014 (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
10.3	Form of Registration Rights Agreement, by and among the Company and the holders party thereto, dated March 17, 2014 (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
10.4	Form of Subscription Agreement for the 18% Convertible Promissory Notes between the Company and the accredited investors a party thereto (Incorporated by reference to the Form 8-K filed with the SEC on March 18, 2014).
10.5	Amendment to certain Promissory Notes that were dated August 1, 2005, by and among the Company, SANUWAVE, Inc. and HealthTronics, Inc., dated June 15, 2015 (Incorporated by reference to the Form 8-K filed with the SEC on June 18, 2015.)

10.6	Security Agreement, by and between the Company and HealthTronics, Inc., dated June 15, 2015 (Incorporated by reference to the Form 8-K filed with the SEC on June 18, 2015).
10.7	Exchange Agreement dated January 13, 2016 among the Company and the investors listed therein (Incorporated by reference to the Form 8-K filed with the SEC on January 19, 2016).
10.8	Escrow Deposit Agreement dated January 25, 2016 among the Company, Newport Coast Securities, Inc. and Signature Bank (Incorporated by reference to the Form S-1/A filed with the SEC on February 3, 2016).
10.9	Second Amendment to Certain Promissory Notes entered into as of June 28, 2016 by and among the Company, SANUWAVE, Inc. and HealthTronics, Inc. (Incorporated by reference to the Form 10-Q filed with the SEC on August 15, 2016).
10.10	Form of Securities Purchase Agreement, by and among the Company and the accredited investors a party thereto, dated March 11, 2016 (Incorporated by reference to the Form 8-K filed with the SEC on March 17, 2016).
10.11	Form of Securities Purchase Agreement, by and between the Company and the accredited investors a party thereto, dated August 24, 2016 (Incorporated by reference to the Form 8-K filed with the SEC on J August 25, 2016).
10.12	Form of Registration Rights Agreement, by and between the Company and the holders a party thereto, dated August 24, 2016 (Incorporated by reference to the Form 8-K filed with the SEC on August 25, 2016).
10.13	Third Amendment to promissory notes entered into as of August 3, 2017 by and among the Company, SANUWAVE, Inc. and HealthTronics, Inc. (Incorporated by reference to Form 8-K filed with the SEC on August 4, 2017).
10.14 #	Binding Term Sheet for Joint Venture Agreement between the Company and MundiMed Distribuidora Hospitalar LTDA effective as of September 25, 2017 (Incorporated by reference to Form 10-Q filed with the SEC on November 15, 2017).
10.15	Form of 10% Convertible Promissory Note, by and among the Company and the accredited investors a party thereto.  (Incorporated by reference to Form 8-K filed with the SEC on November 9, 2017).
10.16	Form of Registration Rights Agreement, by and among the Company and the accredited investors a party thereto (Incorporated by reference to Form 8-K filed with the SEC on November 9, 2017).
10.17 #	Agreement for Purchase and Sale, Limited Exclusive Distribution and Royalties, and Servicing and Repairs of dermaPACE Systems and Equipment among the Company, and Premier Shockwave Wound Care, Inc. and Premier Shockwave, Inc. dated as of February 13, 2018.  (Incorporated by reference to Form 10-K filed with the SEC on March 29, 2018).

10.18	Agreement, dated June 14, 2018, by and among the Company and Johnfk Medical Inc. (Incorporated by reference to Form 8-K filed with the SEC on June 29, 2018).
10.19	Joint Venture Agreement, dated September 21, 2018, by and among the Company, Johnfk Medical Inc. and Holistic Health Institute Pte. Ltd. (Incorporated by reference to Form 8-K filed with the SEC on September 27, 2018).
10.20	Master Equipment Lease, dated January 26, 2018, by and among the Company and NFS Leasing, Inc. (Incorporated by reference to Form 8-K filed with the SEC on February 15, 2018).
10.21	Offer Letter, dated as of November 30, 2018, by and between SANUWAVE Health, Inc. and Kevin Richardson. (Incorporated by reference to Form 8-K filed with the SEC on December 4, 2018).
10.22	Offer Letter, dated as of April 15, 2018, by and between SANUWAVE Health, Inc,, and Shri Parikh. (Incorporated by reference to Form 8-K filed with the SEC on June 7, 2018).
10.23	Deed of Termination of Joint Venture Agreement, dated June 4, 2019, by and among the Company, Johnfk Medical Inc. and Holistic Wellness Alliance Pte. Ltd. (incorporated by reference to the Company’s Current Report on Form 8-K, filed with the SEC on June 17, 2019).
10.24	Common Stock Purchase Agreement, by and among the Company and the accredited investors party thereto, dated December 11, 2019 (incorporated by reference to the Company’s Current Report on Form 8-K, filed with the SEC on December 27, 2019).
10.25	Registration Rights Agreement, by and among the Company and the accredited investors party thereto, dated December 11, 2019 (incorporated by reference to the Company’s Current Report on Form 8-K, filed with the SEC on December 27, 2019).
10.26 *β	Joint Venture Agreement, dated December 13, 2019, by and among the Company, Universus Global Advisors LLC, Versani Health Consulting Consultoria Em Gestao De Negocios Eireli, and the IDIC Group as set forth therein. (incorporated by reference to the Form 8-K filed with the SEC on January 28, 2020).
10.27	Separation Agreement and General Release, dated as of May 14, 2020 by and between SANUWAVE Health, Inc. and Shri P. Parikh. (incorporated by reference to the Form 8-K filed with the SEC on May 18, 2020)
10.28	Series D Preferred Stock Purchase Agreement, by and among the Company and the accredited investors party thereto, dated May 14, 2020. (incorporated by reference to the Form 8-K filed with the SEC on May 20, 2020).
10.29	Promissory Note by and between SANUWAVE Health, Inc. and Truist Bank, dated May 28, 2020. (incorporated by reference to the Form 8-K filed with the SEC on June 1, 2020).
10.30	Securities Purchase Agreement, dated as of June 5, 2020, by and between the Company and LGH Investments, LLC. (incorporated by reference to the Form 8-K filed with the SEC on June 11, 2020).
10.31	Convertible Promissory Note, dated as of June 5, 2020, issued by the Company to LGH Investments, LLC. (incorporated by reference to the Form 8-K filed with the SEC on June 11, 2020) .

10.32	Common Stock Purchase Warrant, dated as of June 5, 2020, issued by the Company to LGH Investments, LLC. (incorporated by reference to the Form 8-K filed with the SEC on June 11, 2020).
10.33	Asset Purchase Agreement by and between the Company and Celularity Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.34	License and Marketing Agreement by and between the Company and Celularity Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.35	Convertible Promissory Note issued to Celularity Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.36	Form of Securities Purchase Agreement by and among the Company and the accredited investors a party thereto, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.37	Note and Warrant Purchase and Security Agreement by and among the Company, the noteholder party thereto and NH Expansion Credit Fund Holdings LP, as agent, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.38	Letter Agreement by and between the Company and HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.39	Convertible Promissory Note issued to HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.40	Securities Purchase Agreement by and between the Company and HealthTronics, Inc., dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.41	Convertible Promissory Note issued to A. Michael Stolarski, dated August 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on August 12, 2020).
10.42	Securities Purchase agreement by and between the Company and Leviston Resources, LLC, dated April 20, 2021. (incorporated by reference to the Form 8-K filed with the SEC on April 27, 2021).
10.43	Subordination Agreement by and among the Company, Leviston Resources, LLC and NH Expansion Credit Fund Holdings LP, dated April 20, 2021. (incorporated by reference to the Form 8-K filed with the SEC on April 27, 2021) .
10.44	Registration Rights Agreement by and between the Company and Leviston Resources, LLC, dated April 20, 2021. (incorporated by reference to the Form 8-K filed with the SEC on April 27, 2021).
14.1	Code of Business Conduct and Ethics of SANUWAVE Health, Inc. (Incorporated by reference to the Form 10-K filed with the SEC on March 30, 2016).

21.1*	List of subsidiaries
23.1*	Consent of Marcum LLP, independent registered public accountants.
24.1*	Power of Attorney (included on signature page).
31.1*	Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer.
31.2*	Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer.
32.1*	Section 1350 Certification of the Chief Executive Officer.
32.2*	Section 1350 Certification of the Chief Financial Officer.
101.INS**	XBRL Instance
101.SCH**	XBRL Taxonomy Extension Schema
101.CAL**	XBRL Taxonomy Extension Calculation
101.DEF**	XBRL Taxonomy Extension Definition
101.LAB**	XBRL Taxonomy Extension Labels
101.PRE**	XBRL Taxonomy Extension Presentation

Item 16.

Form 10-K Summary

	SANUWAVE HEALTH, INC.
Dated: October 21, 2021	By: /s/ Kevin A. Richardson, II
	Name: Kevin A. Richardson, II
	Title:   Chief Executive Officer

Signatures		Capacity		Date
By: /s/ Kevin A. Richardson, II Name: Kevin A. Richardson, II		Chief Executive Officer and Chairman of the Board of Directors (principal executive officer)		October 21, 2021
By: /s/ Lisa E. Sundstrom Name: Lisa E. Sundstrom		Chief Financial Officer (principal financial and accounting officer)		October 21, 2021

By: /s/ John F. Nemelka Name: John F. Nemelka		Director		October 21, 2021
By: /s/ A. Michael Stolarski Name: A. Michael Stolarski		Director		October 21, 2021