Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 09, 2018 | |
Document And Entity Information | ||
Entity Registrant Name | SANUWAVE Health, Inc. | |
Entity Central Index Key | 1,417,663 | |
Trading Symbol | snwv | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 155,533,303 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 72,311 | $ 730,184 |
Accounts receivable, net of allowance for doubtful accounts of $42,950 in 2018 and $92,797 in 2017 | 152,706 | 152,520 |
Inventory | 240,973 | 231,532 |
Prepaid expenses | 168,480 | 90,288 |
TOTAL CURRENT ASSETS | 634,470 | 1,204,524 |
PROPERTY AND EQUIPMENT, net | 72,637 | 60,369 |
OTHER ASSETS | 16,497 | 13,917 |
TOTAL ASSETS | 723,604 | 1,278,810 |
CURRENT LIABILITIES | ||
Accounts payable | 1,560,965 | 1,496,523 |
Accrued expenses (Note 4) | 746,083 | 673,600 |
Accrued employee compensation | 364,503 | 1,680 |
Contract liabilities (Note 5) | 353,115 | 0 |
Advances payable (Note 6) | 144,000 | 310,000 |
Line of credit, related parties (Note 7) | 524,869 | 370,179 |
Convertible promissory notes, net (Note 8) | 2,548,325 | 455,606 |
Short term note payable (Note 10) | 186,981 | 0 |
Accrued interest, related parties (Note 11) | 1,005,144 | 685,907 |
Warrant liability (Note 13) | 1,396,199 | 1,943,883 |
Notes payable, related parties, net (Note 11) | 5,335,243 | 5,222,259 |
TOTAL CURRENT LIABILITIES | 14,165,427 | 11,159,637 |
NON-CURRENT LIABILITIES | ||
Contract liabilities (Note 5) | 25,959 | 0 |
TOTAL NON-CURRENT LIABILITIES | 25,959 | 0 |
TOTAL LIABILITIES | 14,191,386 | 11,159,637 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' DEFICIT | ||
Preferred stock | 0 | 0 |
COMMON STOCK, par value $0.001, 350,000,000 shares authorized; 155,107,127 and 139,300,122 issued and outstanding in 2018 and 2017, respectively (Note 12) | 155,107 | 139,300 |
ADDITIONAL PAID-IN CAPITAL | 100,979,533 | 94,995,040 |
ACCUMULATED DEFICIT | (114,541,440) | (104,971,384) |
ACCUMULATED OTHER COMPREHENSIVE LOSS | (60,982) | (43,783) |
TOTAL STOCKHOLDERS' DEFICIT | (13,467,782) | (9,880,827) |
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | 723,604 | 1,278,810 |
Series A Convertible Preferred Stock [Member] | ||
STOCKHOLDERS' DEFICIT | ||
Preferred stock | 0 | 0 |
Series B Convertible Preferred Stock [Member] | ||
STOCKHOLDERS' DEFICIT | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Accounts receivable, allowance for doubtful accounts | $ 42,950 | $ 92,797 |
Preferred stock, par value | $ .001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ .001 | $ 0.001 |
Common stock, shares authorized | 350,000,000 | 350,000,000 |
Common stock, shares issued | 155,107,127 | 139,300,122 |
Common stock, shares outstanding | 155,107,127 | 139,300,122 |
Series A Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ .001 | $ 0.001 |
Preferred stock, shares authorized | 6,175 | 6,175 |
Preferred stock, shares issued | 6,175 | 6,175 |
Preferred stock, shares outstanding | 0 | 0 |
Series B Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ .001 | $ 0.001 |
Preferred stock, shares authorized | 293 | 293 |
Preferred stock, shares issued | 293 | 293 |
Preferred stock, shares outstanding | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
REVENUES | $ 595,789 | $ 161,585 | $ 1,393,271 | $ 422,199 |
COST OF REVENUES (exclusive of depreciation shown below) | 183,594 | 61,684 | 515,703 | 141,523 |
GROSS MARGIN | 412,195 | 99,901 | 877,568 | 280,676 |
OPERATING EXPENSES | ||||
Research and development | 661,736 | 266,837 | 1,379,517 | 965,084 |
General and administrative | 2,415,106 | 475,377 | 5,391,511 | 1,875,891 |
Depreciation | 5,709 | 5,465 | 16,733 | 17,543 |
Loss on sale of property and equipment | 0 | 0 | 3,170 | 0 |
TOTAL OPERATING EXPENSES | 3,082,551 | 747,679 | 6,790,931 | 2,858,518 |
OPERATING LOSS | (2,670,356) | (647,778) | (5,913,363) | (2,577,842) |
OTHER INCOME (EXPENSE) | ||||
Gain (loss) on warrant valuation adjustment | 2,241,008 | (41,681) | 428,846 | 316,952 |
Interest expense, net | (395,604) | (160,978) | (4,070,326) | (496,997) |
Loss on foreign currency exchange | (190) | (888) | (15,213) | (2,907) |
TOTAL OTHER INCOME (EXPENSE), NET | 1,845,214 | (203,547) | (3,656,693) | (182,952) |
NET LOSS | (825,142) | (851,325) | (9,570,056) | (2,760,794) |
OTHER COMPREHENSIVE INCOME | ||||
Foreign currency translation adjustments | (6,230) | 20,570 | (17,199) | 6,803 |
TOTAL COMPREHENSIVE LOSS | $ (831,372) | $ (830,755) | $ (9,587,255) | $ (2,753,991) |
LOSS PER SHARE: | ||||
Net loss - basic and diluted | $ (0.01) | $ (0.01) | $ (0.06) | $ (0.02) |
Weighted average shares outstanding - basic and diluted | 151,852,757 | 139,099,843 | 147,550,321 | 138,711,527 |
Product | ||||
REVENUES | $ 240,759 | $ 143,234 | $ 703,054 | $ 356,911 |
COST OF REVENUES (exclusive of depreciation shown below) | 151,624 | 56,415 | 413,477 | 105,027 |
License fees | ||||
REVENUES | 335,697 | 6,250 | 623,570 | 36,050 |
Other | ||||
REVENUES | 19,333 | 12,101 | 66,647 | 29,238 |
COST OF REVENUES (exclusive of depreciation shown below) | $ 31,970 | $ 5,269 | $ 102,256 | $ 36,496 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (9,570,056) | $ (2,760,794) |
Adjustments to reconcile loss from continuing operations to net cash used by operating activities | ||
Depreciation | 16,733 | 17,543 |
Bad debt expense (recovery) | (49,847) | 87,830 |
Stock-based compensation | 2,474,496 | 482,295 |
Loss (gain) on warrant valuation adjustment | (428,846) | (316,952) |
Amortization of debt issuance costs | 2,767,361 | 0 |
Amortization of debt discount | 112,984 | 71,298 |
Stock issued for consulting services | 106,500 | 0 |
Warrants issued for consulting services | 737,457 | 0 |
Loss on sale of fixed assets | 3,170 | 0 |
Accrued interest | 280,975 | 0 |
Changes in assets and liabilities | ||
Accounts receivable - trade | 49,661 | 200,850 |
Inventory | (9,441) | 55,844 |
Prepaid expenses | (76,871) | (15,716) |
Other | (3,901) | (136) |
Accounts payable | 184,442 | 722,467 |
Accrued expenses | 72,483 | 84,647 |
Accrued employee compensation | 362,823 | 294 |
Contract liabilties | 379,074 | 0 |
Interest payable, related parties | 319,237 | 425,699 |
NET CASH USED BY OPERATING ACTIVITIES | (2,271,566) | (944,831) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of property and equipment | (32,171) | |
NET CASH USED BY INVESTING ACTIVITIES | (32,171) | |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from convertible promissory notes, net of costs | 1,159,785 | 0 |
Proceeds from line of credit, related party | 280,500 | 0 |
Advances from related parties | 156,000 | 751,616 |
Proceeds from note payable, product | 96,708 | 0 |
Proceeds from short term note | 184,750 | 0 |
Proceeds from warrant exercise | 38,528 | 93,067 |
Payment on line of credit, related party | (144,500) | 0 |
Payments on note payable, product | (96,708) | 0 |
Payments on advances from related parties | (12,000) | 0 |
NET CASH PROVIDED BY FINANCING ACTIVITIES | 1,663,063 | 844,683 |
EFFECT OF EXCHANGE RATES ON CASH | (17,199) | 6,803 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (657,873) | (93,345) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 730,184 | 133,571 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 72,311 | 40,226 |
SUPPLEMENTAL INFORMATION | ||
Cash paid for interest, related parties | 151,227 | 0 |
NONCASH INVESTING ACTIVITIES | ||
Cashless exercise of warrants | 118,838 | 66,966 |
Advances from related and unrelated parties converted to Convertible promissory notes | 310,000 | 0 |
Accounts payable converted to Convertible promissory notes | 120,000 | 0 |
Beneficial conversion feature on convertible debt | 745,223 | 0 |
Warrants issued for debt | 844,562 | 0 |
Conversion of 10% convertible promissory notes | $ 844,562 | $ 0 |
Note 1 - Nature of the Business
Note 1 - Nature of the Business | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Nature of the Business | SANUWAVE Health, Inc. and subsidiaries (the “Company”) is a shock wave technology company using a patented system of noninvasive, high-energy, acoustic shock waves for regenerative medicine and other applications. The Company’s 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. The Company’s 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”) notified the Company to permit the marketing of the dermaPACE System for the treatment of diabetic foot ulcers in the United States. The Company’s 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. The Company intends to apply its Pulsed Acoustic Cellular Expression (PACE®) technology in wound healing, orthopedic, plastic/cosmetic and cardiac conditions. In 2018, the Company has started marketing the dermaPACE System for sale in the United States and the European Conformity Marking (CE Mark) devices and accessories in Europe, Canada, Asia and Asia/Pacific. The Company generates revenues streams from product sales, licensing transactions and other activities. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all the information and footnotes required by GAAP for complete financial statements. The financial information as of September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 is unaudited; however, in the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine month periods ended September 30, 2018 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2018. The condensed consolidated balance sheet at December 31, 2017 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. These financial statements should be read in conjunction with the Company's Form 10-K filed with the Securities and Exchange Commission on March 29, 2018. |
Note 2 - Going Concern
Note 2 - Going Concern | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Going Concern | The Company does not currently generate significant recurring revenue and will require additional capital during the fourth quarter of 2018 and the first quarter of 2019. As of September 30, 2018, the Company had an accumulated deficit of $114,541,440 and cash and cash equivalents of $72,311. For the nine months ended September 30, 2018 and 2017, the net cash used by operating activities was $2,271,566 and $944,831, respectively. The Company incurred a net loss of $9,470,056 for the nine months ended September 30, 2018 and a net loss of $5,537,936 for the year ended December 31, 2017. The operating losses and the events of default on the Company’s convertible promissory notes (see Note 8) and the notes payable, related parties (see Note 11) indicate substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the filing of this report. The continuation of the Company’s business is dependent upon raising additional capital during the fourth quarter of 2018 and the first quarter of 2019 to fund operations. Management’s plans are to obtain additional capital through investments by strategic partners for market opportunities, which may include strategic partnerships or licensing arrangements, or raise capital through the conversion of outstanding warrants, including through tender offers for the outstanding warrants, the issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt. These possibilities, to the extent available, may be on terms that result in significant dilution to the Company’s existing shareholders. Although no assurances can be given, management of the Company believes that potential additional issuances of equity or other potential financing transactions as discussed above should provide the necessary funding for the Company to continue as a going concern. If these efforts are unsuccessful, the Company may be forced to seek relief through a filing under the U.S. Bankruptcy Code. The condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. |
Note 3 - Summary of Significant
Note 3 - Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Summary of Significant Accounting Policies | Recently Issued or Adopted Accounting Standards In May 2014, the Financial Standards Board ("FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606) In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments (Topic 230) In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480): Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718) – Improvements to Nonemployee Share-Based Payment Accounting In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement |
Note 4 - Accrued Expenses
Note 4 - Accrued Expenses | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Accrued Expenses | Accrued expenses consist of the following: September 30, December 31, 2018 2017 Accrued outside services $ 194,585 $ 165,427 Accrued board of director's fees 150,000 125,000 Accrued executive severance 131,500 118,000 Accrued legal and professional fees 119,150 135,690 Accrued travel 69,926 39,926 Deferred rent 46,852 51,191 Accrued clinical study expenses 13,650 13,650 Deferred revenue 10,840 13,317 Accrued other 9,580 11,399 $ 746,083 $ 673,600 |
Note 5 - Contract Liabilities
Note 5 - Contract Liabilities | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Contract liabilities | As of September 30, 2018, the Company has contract liabilities from contracts with customers, due to the implementation of ASC 606, Revenue from Contracts with Customers Contract liabilities consist of the following: September 30, December 31, 2018 2017 Deposit on product $ 164,551 $ - Distribution license 141,110 Service agreement 40,991 Other 32,422 - Total Contract liabilities 379,074 - Non-Current (25,959 ) - Total Current $ 353,115 $ - The timing of the Company’s revenue recognition may differ from the timing of payment by its customers. A contract asset (receivable) is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the satisfaction of performance obligations, the Company records a contract liability (deferred revenue) until the performance obligations are satisfied. Of the aggregate $379,074 of contract liability balances as of September 30, 2018, the Company expects to satisfy its remaining performance obligations associated with $353,115 and $25,959 of contract liability balances within the next twelve months and following twelve months, respectively. Joint Venture On September 27, 2017, the Company entered into a binding term sheet with MundiMed Distribuidora Hospitalar LTDA (“MundiMed”), effective as of September 25, 2017, for a joint venture for the manufacture, sale and distribution of our dermaPACE device. Under the binding term sheet, MundiMed was to pay the Company an initial upfront distribution fee, with monthly upfront distribution fees payable thereafter over the following eighteen months. Profits from the joint venture were to be distributed as follows: 45% to the Company, 45% to MundiMed and 5% each to LHS Latina Health Solutions Gestão Empresarial Ltda. and Universus Global Advisors LLC, who acted as advisors in the transaction. The initial upfront distribution fee was received on October 6, 2017. Monthly upfront distribution fee payments have been received through May 2018. Through September 30, 2018, the Company received aggregate payments of $372,222. In August 2018, MundiMed advised the Company that it did not anticipate being able to make further payments under the binding term sheet due to operational and cash flow difficulties. On September 14, 2018, the Company sent a letter to MundiMed informing them of a breach in our agreement regarding payment of the upfront distribution fee. On September 28, 2018, the Company received a response letter stating that the Company was in default of the agreement. On October 9, 2018, the Company sent MundiMed a letter of termination of the agreement effective as of October 8, 2018. As of September 30, 2018, the Company derecognized the contract assets and contract liabilities associated with the MundiMed contract. |
Note 6 - Advances Payable
Note 6 - Advances Payable | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Advances Payable | The Company has received cash advances to help fund the Company’s operations. On January 10, 2018, the outstanding balance of the $310,000 of advances payable was converted into two 10% Convertible Promissory Notes (see Note 8). As of September 30, 2018, the Company had balances of $144,000 due to a related party. The advances are non-interest bearing ad have no stated terms. Imputed interest is de minimis to the financial statements. As of December 31, 2017, A. Michael Stolarski and Kevin A. Richardson II, both members of the Company’s board of directors and existing shareholders of the Company, had subscribed $130,000 and $140,000, respectively, to the Company as advances from related parties to be used to purchase 10% Convertible Promissory Notes. The convertible promissory notes for this balance were issued on January 10, 2018 (see Note 8). |
Note 7 - Line of Credit, Relate
Note 7 - Line of Credit, Related Parties | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Line of Credit, Related Parties | The Company is a party to a line of credit agreement with A. Michael Stolarski, a member of the Company’s board of directors and an existing shareholder of the Company. The line of credit is in the amount of $370,000 with an annualized interest rate of 6%. On June 26, 2018, the amount of the line of credit was increased by $280,500. The line of credit may be called for payment upon demand of the holder. As of September 30, 2018, $524,869 was outstanding under the agreement. Interest expense on the line of credit, related parties totaled $7,590 and $0 for the three months ended September 30, 2018 and 2017, respectively and $18,690 and $0 for the nine months ended September 30, 2018 and 2017, respectively. |
Note 8 - Convertible Promissory
Note 8 - Convertible Promissory Notes | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Convertible Promissory Notes | In 2017, the Company began offering subscriptions for 10% convertible promissory notes (the “10% Convertible Promissory Notes”) to selected accredited investors. The 10% Convertible Promissory Notes have a six month term from the subscription date and the note holders can convert the 10% Convertible Promissory Notes at any time during the term to the number of shares of Company common stock, $0.001 par value (the “Common Stock”), equal to the amount obtained by dividing (i) the amount of the unpaid principal and interest on the note by (ii) $0.11. During the nine months ended September 30, 2018, the Company issued $1,596,000 in the aggregate principal amount of 10% Convertible Promissory Notes, including $430,000 purchased by officers and directors. The 10% Convertible Promissory Notes include a warrant agreement (the “Class N Warrant”) to purchase Common Stock equal to the amount obtained by dividing the (i) sum of the principal amount by (ii) $0.11. The Class N Warrants expire March 17, 2019. On January 10, 2018 and February 2, 2018, the Company issued 13,599,999 and 909,091, respectively, Class N Warrants in connection with the closings of 10% Convertible Promissory Notes. Pursuant to the terms of a Registration Rights Agreement (the “Registration Rights Agreement”) that the Company entered with the accredited investors in connection with the 10% Convertible Promissory Notes, the Company is required to file a registration statement that covers the shares of Common Stock issuable upon conversion of the 10% Convertible Promissory Notes or upon exercise of the Class N Warrants. The failure on the part of the Company to satisfy certain deadlines described in the Registration Rights Agreement may subject the Company to payment of certain monetary penalties. As of the date of the filing of this report the registration statement has not yet been filed. At this time the monetary penalty has been determine by management to be de minimis. During the nine months ended September 30, 2018, the Company recorded $709,827 in debt discount for the beneficial conversion feature of the promissory notes, $808,458 in debt discount for the discount on the Class N Warrant agreement and $77,715 in debt issuance costs to be amortized over the lives of the 10% Convertible Promissory Notes. Additional debt issuance costs will be incurred and amortized over the remaining lives of the 10% Convertible Promissory Notes when Class N Warrants are issued per the engagement letter with West Park Capital. The calculated fair value of the Class N Warrants was determined using the Black-Scholes pricing model based on the following assumptions: 2018 Weighted average contractual term in years 1.13 - 1.19 Weighted average risk free interest rate 1.98% - 2.15% Weighted average volatility 94.43% - 98.63% Forfeiture rate 0.0% Expected dividend yield 0.0% On February 15, 2018, the Company defaulted on the 10% Convertible Promissory Notes issued on August 15, 2017 and began accruing interest at the default interest rate of 18%. On May 3, 2018, the Company defaulted on the 10% Convertible Promissory Notes issued on November 3, 2017 and began accruing interest at the default interest rate of 18%. On May 30, 2018, the Company defaulted on the 10% Convertible Promissory Notes issued on November 30, 2017 and began accruing interest at the default interest rate of 18%. On June 22, 2018, the Company defaulted on the 10% Convertible Promissory Notes issued on December 22, 2017 and began accruing interest at the default interest rate of 18%. On July 10, 2018, the Company defaulted on the 10% Convertible Promissory Notes issued on January 10, 2018 and began accruing interest at the default interest rate of 18%. On August 2, 2018, the Company defaulted on the 10% Convertible Promissory Notes issued on February 2, 2018 and began accruing interest at the default interest rate of 18%. On January 29, 2018, the Company entered into an additional 10% Convertible Promissory Note with an accredited investor in the amount of $71,500 and issued 650,000 Class N Warrants in connection with such 10% Convertible Promissory Note. The Company intends to use the proceeds from such 10% Convertible Promissory Note for payment of services to an investor relations company and the account of the attorney updating the Registration Statement on Form S-1 of the Company filed under the Securities Act of 1933, as amended, on January 3, 2017 (File No. 333-213774), which registration statement shall also register the shares issuable upon conversion of such 10% Convertible Promissory Note and issuable upon the exercise of a Class N Warrants issued concurrently with the issuance of such 10% Convertible Promissory Note. The Company recorded $35,396 debt discount for the beneficial conversion feature of the 10% Convertible Promissory Note and $36,104 in debt discount for the discount on the Class N Warrant agreement to be amortized over the life of the 10% Convertible Promissory Note. The 10% Convertible Promissory Note had an aggregate outstanding principal balance of $2,548,325 at September 30, 2018. The 10% Convertible Promissory Notes had an aggregate outstanding principal balance of $455,606, net of $1,099,861 beneficial conversion feature, warrant discount and debt issuance costs at December 31, 2017. |
Note 9 - Note Payable, Product,
Note 9 - Note Payable, Product, Related Party | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Note payable, product, related party | On January 26, 2018, the Company entered into a Master Equipment Lease with NFS Leasing Inc. to provide financing for equipment purchases to enable the Company to begin placing the dermaPACE System in the marketplace. This agreement provides for a lease line of credit up to $1,000,000 with a term of 36 months, and grants NFS a security interest in the Company’s accounts receivable, tangible and intangible personal property and cash and deposit accounts of the Company. NFS Leasing Inc. was a purchaser of the 10% Convertible Promissory Notes (see Note 8). On March 1, 2018, the Company entered into the first drawdown of the Master Equipment Lease in the amount of $96,708. Interest expense on note payable, product totaled $0 for the three months ended September 30, 2018 and $20,909 for the nine months ended September 30, 2018, respectively. As of February 27, 2018, we were in default of Master Equipment Lease due to the sale of equipment purchased under the Master Lease Agreement to a third party and, as a result, the note was callable by NFS Leasing, Inc. or NFS Leasing, Inc. could have notified the Company to assemble all equipment for pick up. The notes payable, product was paid in full on June 27, 2018. |
Note 10 - Short Term Note Payab
Note 10 - Short Term Note Payable | 9 Months Ended |
Sep. 30, 2018 | |
Note 10 - Short Term Note Payable | |
Short Term Note Payable | The Company entered into short term notes payable with six individuals between June 26, 2018 and July 30, 2018 in the total principal amount of $184,750 with an interest rate of 5% per annum. The principal and accrued interest of $186,981 as of September 30, 2018 are due and payable six months from the date of issuance of the respective notes. |
Note 11 - Notes Payable, Relate
Note 11 - Notes Payable, Related Parties | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Notes Payable, Related Parties | The notes payable, related parties as amended were issued in conjunction with the Company’s purchase of the orthopedic division of HealthTronics, Inc. The notes payable, related parties bear interest at 8% per annum, as amended. All remaining unpaid accrued interest and principal is due on December 31, 2018, as amended. HealthTronics, Inc. is a related party because they are a shareholder in the Company and have a security agreement with the Company detailed below. On June 15 2015, the Company entered into a security agreement with HealthTronics, Inc. to provide a first security interest in the assets of the Company. During any period when an Event of Default occurs, the applicable interest rate shall increase by 2% per annum. Events of Default under the notes payable, related parties have occurred and are continuing on account of the failure of SANUWAVE, Inc., a Delaware corporation, a wholly owned subsidiary of the Company and the borrower under the notes payable, related parties, to make the required payments of interest which were due on December 31, 2016, March 31, 2017, June 30, 2017, September 30, 2017, December 31, 2017, June 30, 2018 and September 30, 2018 (collectively, the “Defaults”). As a result of the Defaults, the notes payable, related parties have been accruing interest at the rate of 10% per annum since January 2, 2017 and continue to accrue interest at such rate. The Company will be required to make mandatory prepayments of principal on the notes payable, related parties equal to 20% of the proceeds received by the Company through the issuance or sale of any equity securities in cash or through the licensing of the Company’s patents or other intellectual property rights. The notes payable, related parties had an aggregate outstanding principal balance of $5,335,243, net of $37,500 debt discount at September 30, 2018 and $5,222,259, net of $150,484 debt discount at December 31, 2017, respectively. Accrued interest, related parties currently payable totaled $1,005,144 at September 30, 2018 and $685,907 at December 31, 2017. Interest expense on notes payable, related parties totaled $199,991 and $160,979 for the three months ended September 30, 2018 and 2017, respectively, and $583,448 and $444,437 for the nine months ended September 30, 2018 and 2017, respectively. |
Note 12 - Equity Transactions
Note 12 - Equity Transactions | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Equity Transactions | Conversion of 10% Convertible Promissory Notes During the nine months ended September 30, 2018, the Company issued 8,497,238 shares of Common Stock upon the conversion of 10% Convertible Promissory Notes in the amount of $902,500 plus accrued interest of $32,197 at the conversion price of $0.11 per share per the terms of the 10% Convertible Promissory Notes agreement. Warrant Exercise During the nine months ended September 30, 2018, the Company issued 402,939 shares of restricted Common Stock upon the exercise of 402,939 Class N Warrants, Series A Warrants and Class O Warrants to purchase shares of stock under the terms of the respective warrant agreements. Cashless Warrant Exercise During the nine months ended September 30, 2018, the Company issued 6,283,664 shares of Common Stock upon the cashless exercise of 7,739,425 Class N Warrants, Series A Warrants and Class L Warrants to purchase shares of stock under the terms of the respective warrant agreements. Consulting Agreement In April 2018, the Company verbally entered into a month-to-month consulting agreement with a consultant for which a portion of the fee for the services was to be paid with Common Stock. The number of shares to be paid with Common Stock was calculated by dividing the amount of the fee to be paid with Common Stock of $4,000 by the Company stock price at the close of business on the eighth business day of each month. The Company issued 74,714 shares of Common Stock for services performed from January through June 2018. The $20,000 was recorded as a non-cash general and administrative expense upon issuance in June 2018. On March 27, 2018, the Company issued 533,450 shares of Common Stock for services rendered, pursuant to a consulting agreement, May 2017 through February 2018. On June 28, 2018, the Company issued 15,000 shares of Common Stock for services rendered in March 2018. Non-cash general and administrative expense of $22,500 and $60,000 was recorded in 2018 and 2017, respectively. |
Note 13 - Warrants
Note 13 - Warrants | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Warrants | A summary of the warrant activity during the nine months ended September 30, 2018, is presented as follows: Outstanding Outstanding as of as of December 31, September 30, Warrant class 2017 Issued Exercised Expired 2018 Class F Warrants 300,000 - - (300,000 ) - Class G Warrants 1,503,409 - - (1,503,409 ) - Class H Warrants 1,988,095 - - (1,988,095 ) - Class I Warrants 1,043,646 - - (1,043,646 ) - Class K Warrants 7,200,000 - - - 7,200,000 Class L Warrants 63,898,173 - (6,500,334 ) - 57,397,839 Class N Warrants 13,943,180 (1,136,364) - - - Class O Warrants 6,540,000 1,509,091 (100,000 ) - 7,949,091 Series A Warrants 1,561,348 - (405,666 ) - 1,155,682 97,977,851 17,911,136 (8,142,364 ) (4,835,150 ) 102,911,473 A summary of the warrant exercise price per share and expiration date is presented as follows: Exercise Expiration price/share date Class K Warrants $ 0.08 June 2025 Class K Warrants $ 0.11 August 2027 Class L Warrants $ 0.08 March 2019 Class N Warrants $ 0.11 March 2019 Class O Warrants $ 0.11 March 2019 Series A Warrants $ 0.03 March 2019 The exercise price of the Class K Warrants and the Series A Warrants are subject to a “down-round” anti-dilution adjustment if the Company issues or is deemed to have issued certain securities at a price lower than the then applicable exercise price of the warrants. Accordingly, the Company has classified such warrants as derivative liabilities. The Class K Warrants may be exercised on a physical settlement or on a cashless basis. The Series A Warrants may be exercised on a physical settlement basis if a registration statement underlying the warrants is effective. If a registration statement is not effective (or the prospectus contained therein is not available for use) for the resale by the holder of the Series A Warrants, then the holder may exercise the warrants on a cashless basis. During the nine months ended September 30, 2018, the Company granted Class O Warrant Agreements to various vendors to purchase 1,509,091 shares of common stock at an exercise price of $0.11 per share for consulting services rendered. Each Class O Warrant represents the right to purchase one share of Common Stock. The estimated fair value of the Class O Warrants at the grant dates totaled $319,885 and was recorded as general and administrative expense and an increase to additional paid-in capital when the warrants were issued. The warrants vested upon issuance and expire on various dates between March 17, 2019 and January 25, 2022. The Class K Warrants and the Series A Warrants are derivative financial instruments. The estimated fair value of the Class K Warrants at the date of grant was $36,989 and recorded as debt discount, which is accreted to interest expense through the maturity date of the related notes payable, related parties. The estimated fair values of the Series A Warrants and the Series B Warrants at the date of grant were $557,733 for the warrants issued in conjunction with the 2014 Private Placement and $47,974 for the warrants issued in conjunction with the 18% Convertible Promissory Notes. The fair value of the Series A Warrants and Series B Warrants were recorded as equity issuance costs in 2014, a reduction of additional paid-in capital. The Series B Warrants expired unexercised in March 2015. The estimated fair values were determined using a binomial option pricing model based on various assumptions. The Company’s derivative liabilities have been classified as Level 3 instruments and are adjusted to reflect estimated fair value at each period end, with any decrease or increase in the estimated fair value being recorded in other income or expense accordingly, as adjustments to the fair value of derivative liabilities. Various factors are considered in the pricing models the Company uses to value the warrants, including the Company’s current common stock price, the remaining life of the warrants which ranged from 0.5 to 8.85 years, the volatility of the Company’s common stock price which ranged from 112% to 136%, and the risk-free interest rate which ranged from 2.33% to 3.03%. In addition, as of the valuation dates, management assessed the probabilities of future financing and other re-pricing events in the binominal valuation models. A summary of the changes in the warrant liability during the nine months ended September 30, 2018, is presented as follows: Class K Series A Warrants Warrants Total Warrant liability as of December 31, 2017 $ 1,616,000 $ 327,883 $ 1,943,883 Issued - - - Redeemed - (118,838 ) (118,838 ) Change in fair value (412,800 ) (16,046 ) (428,846 ) Warrant liability as of September 30, 2018 $ 1,203,200 $ 192,999 $ 1,396,199 |
Note 14 - Commitments and Conti
Note 14 - Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Commitments and Contingencies | Operating Leases The Company is a party to certain operating leases. Rent expense for the three months ended September 30, 2018 and 2017 was $36,755 and $33,572, respectively and for the nine months ended September 30, 2018 and 2017 was $108,776 and $99,800, respectively. Minimum future lease payments under the operating lease consist of the following: Year ending December 31, Amount 2018 (remainder) $ 35,387 2019 143,318 2020 147,617 2021 152,046 Total $ 478,368 Litigation The Company is a defendant in various legal actions, claims and proceedings arising in the ordinary course of business, including claims related to breach of contracts and intellectual property matters resulting from our business activities. As with most actions such as these, an estimation of any possible and/or ultimate liability cannot always be determined. We believe that all pending claims, if adversely decided, would not have a material adverse effect on our business, financial position or results of operations. |
Note 15 - Revenue
Note 15 - Revenue | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Revenue | The Company began accounting for revenue in accordance with ASC 606, which we adopted beginning January 1, 2018, using the modified retrospective method (see Note 3). The core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under GAAP, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. Pursuant to ASC 606, we apply the following the five-step model: 1. Identify the contract(s) with a customer. A contract with a customer exists when (i) we enter into an enforceable contract with a customer that defines each party’s rights regarding the goods to be transferred and identifies the payment terms related to these goods, (ii) the contract has commercial substance and, (iii) we determine that collection of substantially all consideration for services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration. 2. Identify the performance obligation(s) in the contract. If a contract promises to transfer more than one good or service to a customer, each good or service constitutes a separate performance obligation if the good or service is distinct or capable of being distinct. 3. Determine the transaction price. The transaction price is the amount of consideration to which the entity expects to be entitled in exchanging the promised goods or services to the customer. 4. Allocate the transaction price to the performance obligations in the contract. For a contract that has more than one performance obligation, an entity should allocate the transaction price to each performance obligation in an amount that depicts the amount of consideration to which an entity expects to be entitled in exchange for satisfying each performance obligation. 5. Recognize revenue when (or as) the Company satisfies a performance obligation. For each performance obligation, an entity should determine whether the entity satisfies the performance obligation at a point in time or over time. Appropriate methods of measuring progress include output methods and input methods. The Company recognizes revenue primarily from the following types of contracts: Product sales Product sales include devices and applicators (new and refurbished). Product sales revenue is recognized at the point in time where the customer obtains control of the goods and the Company satisfies its performance obligation, which is generally at the time the Company ships the product to the customer. Licensing transactions Licensing transaction include distribution licenses and intellectual property licenses. The Company’s licenses are primarily symbolic licenses, with no significant stand-alone functionality. Symbolic licensing fee revenue is recognized over the time period that the Company satisfies its performance obligations, which is generally the term of the licensing agreement. Other activities Other activities primarily include warranties, repairs and billed freight. Device product sales are bundled with an initial one-year warranty and the Company offers a separately priced second-year warranty. The Company allocates the device sales price to the product and the embedded warranty by reference to the stand-alone extended warranty price. Because the warranty represents a stand-ready obligation, revenue is recognized over the time period that the Company satisfies its performance obligations, which is generally the warranty term. Repairs (parts and labor) and billed freight revenue are recognized at the point in time that the service is performed, or the product is shipped, respectively. Disaggregation of Revenue The disaggregation of revenue is based on geographical region. The following table presents revenue from contracts with customers for the three and nine months ended September 30, 2018 and 2017: Three months ended September 30, 2018 Three months ended September 30, 2017 United States International Total United States International Total Product $ 5,891 $ 234,868 $ 240,759 $ — $ 143,234 $ 143,234 License fees 6,250 329,447 335,697 6,250 — 6,250 Other Revenue — 19,333 19,333 — 12,101 12,101 $ 12,141 $ 583,648 $ 595,789 $ 6,250 $ 155,335 $ 161,585 Nine months ended September 30, 2018 Nine months ended September 30, 2017 United States International Total United States International Total Product $ 141,231 $ 561,823 $ 703,054 $ — $ 356,911 $ 356,911 License fees 18,750 604,820 623,570 18,750 17,300 36,050 Other Revenue — 66,647 66,647 — 29,238 29,238 $ 159,981 $ 1,233,290 $ 1,393,271 $ 18,750 $ 403,449 $ 422,199 Management routinely assesses the financial strength of its customers and, as a consequence, believes accounts receivable are stated at the net realizable value and credit risk exposure is limited. Five distributors accounted for 7%, 24%, 20%, 9% and 27% of revenues for the nine months ended September 30, 2018, and 0%, 60%, 0%, 0% and 6% of accounts receivable at September 30, 2018. Three distributors accounted for 8%, 38% and 24% of revenues for the year ended December 31, 2017, and 69%, 17% and 0% of accounts receivable at December 31, 2017. |
Note 16 - Related Party Transa
Note 16 - Related Party Transactions | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Related Party Transactions | On February 13, 2018, the Company entered into an Agreement for Purchase and Sale, Limited Exclusive Distribution and Royalties, and Servicing and Repairs with Premier Shockwave Wound Care, Inc., a Georgia Corporation ("PSWC"), and Premier Shockwave, Inc., a Georgia Corporation ("PS"). The agreement provides for the purchase by PSWC and PS of dermaPACE System and related equipment sold by the Company and includes a minimum purchase of 100 units over 3 years. The agreement grants PSWC and PS limited but exclusive distribution rights to provide dermaPACE Systems to certain governmental healthcare facilities in exchange for the payment of certain royalties to the Company. Under the agreement, the Company is responsible for the servicing and repairs of such dermaPACE Systems and equipment. The agreement also contains provisions whereby in the event of a change of control of the Company (as defined in the agreement), the stockholders of PSWC have the right and option to cause the Company to purchase all of the stock of PSWC, and whereby the Company has the right and option to purchase all issued and outstanding shares of PSWC, in each case based upon certain defined purchase price provisions and other terms. The agreement also contains certain transfer restrictions on the stock of PSWC. Each of PS and PSWC is owned by A. Michael Stolarski, a member of the Company’s board of directors and an existing shareholder of the Company. During the period ended September 30, 2018, the Company recorded $141,231 in revenue from this related party. The Contract liabilities balance includes a balance of $47,791 and the Accrued expenses balance includes a balance of $154,500 from this related party. |
Note 17 - Stock-based Compensat
Note 17 - Stock-based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Stock-based Compensation | On November 1, 2010, the Company approved the Amended and Restated 2006 Stock Incentive Plan of SANUWAVE Health, Inc. effective as of January 1, 2010 (the “Stock Incentive Plan”). The Stock Incentive Plan permits grants of awards to selected employees, directors and advisors of the Company in the form of restricted stock or options to purchase shares of common stock. Options granted may include non-statutory options as well as qualified incentive stock options. The Stock Incentive Plan is administered by the board of directors of the Company. The Stock Incentive Plan gives broad powers to the board of directors of the Company to administer and interpret the particular form and conditions of each option. The stock options granted under the Stock Incentive Plan are non-statutory options which generally vest over a period of up to three years and have a ten year term. The options are granted at an exercise price determined by the board of directors of the Company to be the fair market value of the common stock on the date of the grant. At September 30, 2018, the Stock Incentive Plan reserved 35,000,000 shares of common stock for grant and 4,658,281 shares are available for issuance. During the nine months ended September 30, 2018, the Company granted to employees, members of the board of directors and members of the Company’s Medical Advisory Board options to purchase an aggregate of 10,080,000 shares of common stock under a previously issued incentive plan. The options have an exercise price between $0.11 and $0.42 per share for an aggregate grant date value of $2,474,496. The options vested upon issuance and have a term of ten years. The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model using the following weighted average assumptions for the nine months ended September 30, 2018 and 2017: 2018 2017 Weighted average expected life in years 5.0 5.0 Weighted average risk free interest rate 3.02 % 1.76 % Weighted average volatility 141.87 % 120.00 % Forfeiture rate 0.0 % 0.0 % Expected dividend yield 0.0 % 0.0 % The Company recognized as compensation cost for all outstanding stock options granted to employees, directors and advisors, $1,637,700 and $0 for the three months ended September 30, 2018 and 2017, respectively, and $2,474,496 and $482,295 for the nine months ended September 30, 2018 and 2017, respectively, as a component of operating expenses. As of September 30, 2018, there is no unamortized compensation expense for unvested options. A summary of option outstanding as of September 30, 2018 and December 31, 2017, and the changes during the three months ended March 31, 2018, June 30, 2018 and September 30, 2018, is presented as follows: Weighted Average Exercise Price Options per share Outstanding at December 31, 2017 21,593,385 $ 0.31 Granted - $ - Exercised - $ - Forfeited or expired - $ - Outstanding at March 31, 2018 21,593,385 $ 0.31 Granted 2,130,000 $ 0.41 Exercised - $ - Forfeited or expired - $ - Outstanding at June 30, 2018 23,723,385 $ 0.32 Granted 7,950,000 $ 0.21 Exercised - $ - Forfeited or expired - $ - Outstanding at September 30, 2018 31,673,385 $ 0.29 Vested and exercisable at September 30, 2018 31,673,385 $ 0.29 The range of exercise prices for options was $0.04 to $2.00 for options outstanding at September 30, 2018 and December 31, 2017, respectively. The aggregate intrinsic value for all vested and exercisable options was $1,456,116 and $2,073,641 at September 30, 2018 and December 31, 2017, respectively. The weighted average remaining contractual term for outstanding exercisable stock options was 7.65 and 7.37 years as of September 30, 2018 and December 31, 2017, respectively. |
Note 18 - Earnings (Loss) Per S
Note 18 - Earnings (Loss) Per Share | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Earnings (Loss) Per Share | Basic net income (loss) per share is computed by dividing the net income (loss) attributable to common stockholders for the period by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per share is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of shares of common stock and dilutive common stock equivalents then outstanding. To the extent that securities are “anti-dilutive,” they are excluded from the calculation of diluted net income (loss) per share. As a result of the net loss for the nine months ended September 30, 2018 and 2017, all potentially dilutive shares were anti-dilutive and therefore excluded from the computation of diluted net loss per share. The anti-dilutive equity securities totaled 158,075,531 shares and 99,388,222 shares at September 30, 2018 and 2017, respectively. |
Note 19 - Subsequent Events
Note 19 - Subsequent Events | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Subsequent Events | The Company evaluates events that have occurred after the balance sheet date but before the financial statements are issued. Short term notes payable – related party On October 10, 2018, the Company entered into short term notes payable with Shri P. Parikh, the President of the Company, in the total principal amount of $100,000 with an interest rate of 5% per annum. The principal and accrued interest are due and payable on the earlier of (i) one day after receipt of payment from Johnfk Medical Inc. and (ii) six months from the date of issuance and (iii) the acceleration of the maturity of the short term note by the holder upon the occurrence of an event of default. Consulting agreement On October 17, 2018, the Company and a vendor agreed to settle a portion of a previously incurred fee for services in Common Stock in lieu of cash. On October 17, 2018, the Company issued 426,176 shares for services rendered May 2017 through February 2018. Non-cash general and administrative expense of $15,000 and $60,000 was recorded in 2018 and 2017, respectively. Line of credit – related parties On November 12, 2018, the Company entered into an amendment to the line of credit agreement with A. Michael Stolarski, a member of the Company’s board of directors and an existing shareholder of the Company. The line of credit was increased to $1,000,000 with an annualized interest rate of 6%. The line of credit may be called for payment upon demand of the holder. On October 5, 2018 and October 23, 2018, the Company received $15,000 and $40,000, respectively, as an increase in the line of credit. Short term notes payable On November 8, 2018, the Company entered into short term notes payable with five individuals in the total principal amount of $306,000 with an interest rate of 10% per annum. The principal and accrued interest are due and payable six months from the date of issuance or receipt of notice of warrant exercise. Joint venture incorporated On November 9, 2018, the joint venture entity with Johnfk Medical Inc. ("FKS") was incorporated in the Republic of Singapore with the name of Holistic Wellness Alliance Pte. Ltd. (“HWA”). The Company previously was a party to a distribution and licensing agreement with FKS. HWA was formed as a joint venture of the Company and FKS for the manufacture, sale and distribution of the Company’s dermaPACE® and orthoPACE® devices. Under the JV Agreement, the Company and FKS each hold shares constituting fifty percent of the issued share capital of HWA. The Company provides to HWA FDA and CE approved products for an agreed cost, access to treatment protocols, training, marketing and sales materials and management expertise, and FKS provides to HWA capital, human capital and sales resources in Singapore, Malaysia, Brunei, Cambodia, Myanmar, Laos, Indonesia, Thailand, Philippines and Vietnam, certain reports and identification of new key opinion leaders as well as clinical trial and poster access availability. The JV Agreement also established the corporate governance of HWA, including a five-person board of directors consisting of two directors designated by the Company, two directors designated by FKS, and a third director appointed jointly by the parties. |
Note 3 - Summary of Significa_2
Note 3 - Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Recently Issued Accounting Standards | Recently Issued or Adopted Accounting Standards In May 2014, the Financial Standards Board ("FASB") issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606) In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments (Topic 230) In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480): Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation (Topic 718) – Improvements to Nonemployee Share-Based Payment Accounting In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement |
Note 4 - Accrued Expenses (Tabl
Note 4 - Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Accrued expenses | September 30, December 31, 2018 2017 Accrued outside services $ 194,585 $ 165,427 Accrued board of director's fees 150,000 125,000 Accrued executive severance 131,500 118,000 Accrued legal and professional fees 119,150 135,690 Accrued travel 69,926 39,926 Deferred rent 46,852 51,191 Accrued clinical study expenses 13,650 13,650 Deferred revenue 10,840 13,317 Accrued other 9,580 11,399 $ 746,083 $ 673,600 |
Note 5 - Contract Liabilities (
Note 5 - Contract Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Contract liabilities | September 30, December 31, 2018 2017 Deposit on product $ 164,551 $ - Distribution license 141,110 Service agreement 40,991 Other 32,422 - Total Contract liabilities 379,074 - Non-Current (25,959 ) - Total Current $ 353,115 $ - |
Note 8 - Convertible Promisso_2
Note 8 - Convertible Promissory Notes (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Note 8 - Convertible Promissory Notes | |
Fair value assumptions | 2018 Weighted average contractual term in years 1.13 - 1.19 Weighted average risk free interest rate 1.98% - 2.15% Weighted average volatility 94.43% - 98.63% Forfeiture rate 0.0% Expected dividend yield 0.0% |
Note 13 - Warrants (Tables)
Note 13 - Warrants (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Summary of the warrant activity | Outstanding Outstanding as of as of December 31, September 30, Warrant class 2017 Issued Exercised Expired 2018 Class F Warrants 300,000 - - (300,000 ) - Class G Warrants 1,503,409 - - (1,503,409 ) - Class H Warrants 1,988,095 - - (1,988,095 ) - Class I Warrants 1,043,646 - - (1,043,646 ) - Class K Warrants 7,200,000 - - - 7,200,000 Class L Warrants 63,898,173 - (6,500,334 ) - 57,397,839 Class N Warrants 13,943,180 (1,136,364) - - - Class O Warrants 6,540,000 1,509,091 (100,000 ) - 7,949,091 Series A Warrants 1,561,348 - (405,666 ) - 1,155,682 97,977,851 17,911,136 (8,142,364 ) (4,835,150 ) 102,911,473 |
Summary of the warrant exercise price per share | <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td colspan="2" style="text-align: center"><font style="font-size: 8pt"><b> Exercise</b></font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"><b> Expiration</b></font></td></tr> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center"><font style="font-size: 8pt"><b> price/share</b></font></td> <td style="padding-bottom: 1.5pt"> </td> <td> <p style="font: 8pt Times New Roman, Times, Serif; margin: 0; text-align: center; border-bottom: black 0.75pt solid"><b> date</b></p></td></tr> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td></tr> <tr style="vertical-align: bottom"> <td style="width: 76%"><font style="font-size: 8pt">Class K Warrants</font></td> <td style="width: 1%"> </td> <td style="width: 1%"><font style="font-size: 8pt">$</font></td> <td style="width: 9%; text-align: right"><font style="font-size: 8pt">0.08</font></td> <td style="width: 1%"> </td> <td style="width: 12%; text-align: center"><font style="font-size: 8pt">June 2025</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class K Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.11</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt">August 2027</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class L Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.08</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class N Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.11</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class O Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.11</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Series A Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.03</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> </table>" id="sjs-B5"><table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%"> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td colspan="2" style="text-align: center"><font style="font-size: 8pt"><b> Exercise</b></font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"><b> Expiration</b></font></td></tr> <tr style="vertical-align: bottom"> <td> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1pt solid; text-align: center"><font style="font-size: 8pt"><b> price/share</b></font></td> <td style="padding-bottom: 1.5pt"> </td> <td> <p style="font: 8pt Times New Roman, Times, Serif; margin: 0; text-align: center; border-bottom: black 0.75pt solid"><b> date</b></p></td></tr> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td colspan="2" style="text-align: center"> </td> <td> </td> <td> </td></tr> <tr style="vertical-align: bottom"> <td style="width: 76%"><font style="font-size: 8pt">Class K Warrants</font></td> <td style="width: 1%"> </td> <td style="width: 1%"><font style="font-size: 8pt">$</font></td> <td style="width: 9%; text-align: right"><font style="font-size: 8pt">0.08</font></td> <td style="width: 1%"> </td> <td style="width: 12%; text-align: center"><font style="font-size: 8pt">June 2025</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class K Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.11</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt">August 2027</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class L Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.08</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class N Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.11</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Class O Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.11</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> <tr style="vertical-align: bottom"> <td><font style="font-size: 8pt">Series A Warrants</font></td> <td> </td> <td><font style="font-size: 8pt">$</font></td> <td style="text-align: right"><font style="font-size: 8pt">0.03</font></td> <td> </td> <td style="text-align: center"><font style="font-size: 8pt"> March 2019</font></td></tr> </table> |
Summary of changes in warrant liability | Class K Series A Warrants Warrants Total Warrant liability as of December 31, 2017 $ 1,616,000 $ 327,883 $ 1,943,883 Issued - - - Redeemed - (118,838 ) (118,838 ) Change in fair value (412,800 ) (16,046 ) (428,846 ) Warrant liability as of September 30, 2018 $ 1,203,200 $ 192,999 $ 1,396,199 |
Note 14 - Commitments and Con_2
Note 14 - Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Future minimum lease payments | Year ending December 31, Amount 2018 (remainder) $ 35,387 2019 143,318 2020 147,617 2021 152,046 Total $ 478,368 |
Note 15 - Revenue (Tables)
Note 15 - Revenue (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Disaggregation of revenue | Three months ended September 30, 2018 Three months ended September 30, 2017 United States International Total United States International Total Product $ 5,891 $ 234,868 $ 240,759 $ — $ 143,234 $ 143,234 License fees 6,250 329,447 335,697 6,250 — 6,250 Other Revenue — 19,333 19,333 — 12,101 12,101 $ 12,141 $ 583,648 $ 595,789 $ 6,250 $ 155,335 $ 161,585 Nine months ended September 30, 2018 Nine months ended September 30, 2017 United States International Total United States International Total Product $ 141,231 $ 561,823 $ 703,054 $ — $ 356,911 $ 356,911 License fees 18,750 604,820 623,570 18,750 17,300 36,050 Other Revenue — 66,647 66,647 — 29,238 29,238 $ 159,981 $ 1,233,290 $ 1,393,271 $ 18,750 $ 403,449 $ 422,199 |
Note 17 - Stock-based Compens_2
Note 17 - Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Notes To Financial Statements [Abstract] | |
Schedule of Assumptions | 2018 2017 Weighted average expected life in years 5.0 5.0 Weighted average risk free interest rate 3.02 % 1.76 % Weighted average volatility 141.87 % 120.00 % Forfeiture rate 0.0 % 0.0 % Expected dividend yield 0.0 % 0.0 % |
Summary of Option Activity | Weighted Average Exercise Price Options per share Outstanding at December 31, 2017 21,593,385 $ 0.31 Granted - $ - Exercised - $ - Forfeited or expired - $ - Outstanding at March 31, 2018 21,593,385 $ 0.31 Granted 2,130,000 $ 0.41 Exercised - $ - Forfeited or expired - $ - Outstanding at June 30, 2018 23,723,385 $ 0.32 Granted 7,950,000 $ 0.21 Exercised - $ - Forfeited or expired - $ - Outstanding at September 30, 2018 31,673,385 $ 0.29 Vested and exercisable at September 30, 2018 31,673,385 $ 0.29 |
Note 2 - Going Concern (Details
Note 2 - Going Concern (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Note 2 - Going Concern | ||||||
Accumulated Deficit | $ (114,541,440) | $ (114,541,440) | $ (104,971,384) | |||
Cash and Cash Equivalents | 72,311 | $ 40,226 | 72,311 | $ 40,226 | 730,184 | $ 133,571 |
Net Cash Used in Operating Activities | (2,271,566) | (944,831) | ||||
Net Loss | $ (825,142) | $ (851,325) | $ (9,570,056) | $ (2,760,794) | $ (5,537,936) |
Note 4 - Accrued Expenses (Deta
Note 4 - Accrued Expenses (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Note 4 - Accrued Expenses | ||
Accrued Outside Services | $ 194,585 | $ 165,427 |
Accrued Board of Director's Fees | 150,000 | 125,000 |
Accrued Executive Severance | 131,500 | 118,000 |
Accrued Legal Professional Fees | 119,150 | 135,690 |
Accrued Travel | 69,926 | 39,926 |
Deferred Rent | 46,852 | 51,191 |
Accrued Clinical Study Expenses | 13,650 | 13,650 |
Deferred Revenue | 10,840 | 13,317 |
Accrued Other | 9,580 | 11,399 |
Total Accrued Expenses | $ 746,083 | $ 673,600 |
Note 5 - Contract Liabilities_2
Note 5 - Contract Liabilities (Details) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Total contract liabilities | $ 379,074 | $ 0 |
Non-current contract liabilities | (25,959) | 0 |
Current contract liabilities | 353,115 | 0 |
Deposit on product | ||
Total contract liabilities | 164,551 | 0 |
Distribution license | ||
Total contract liabilities | 141,110 | 0 |
Service agreement | ||
Total contract liabilities | 40,991 | 0 |
Other | ||
Total contract liabilities | $ 32,422 | $ 0 |
Note 7 - Line of Credit, Rela_2
Note 7 - Line of Credit, Related Parties (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Note 7 - Line Of Credit Related Parties | ||||
Line of credit, related parties | $ 280,500 | $ 0 | ||
Interest expense on line of credit, related parties | $ 7,590 | $ 0 | $ 18,690 | $ 0 |
Note 8 - Convertible Promisso_3
Note 8 - Convertible Promissory Notes (Details) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Forfeiture rate | 0.00% | |
Expected dividend yield | 0.00% | |
Minimum | ||
Weighted average expected life in years | 1 year 1 month 17 days | 1 year 2 months 8 days |
Weighted average risk free interest rate | 1.98% | 2.15% |
Weighted average volatility 94.43% - 98.63% | 94.43% | 98.63% |
Note 8 - Convertible Promisso_4
Note 8 - Convertible Promissory Notes (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Convertible promissory notes | $ 2,548,325 | $ 455,606 | |
Beneficial conversion feature | 745,223 | $ 0 | |
10% Convertible Promissory Notes | |||
Convertible promissory notes | 2,548,325 | 455,606 | |
Beneficial conversion feature | 709,827 | $ 1,099,861 | |
Interest expense on convertible promissory note | 417,633 | ||
Convertible Promissory Note | |||
Convertible promissory notes | $ 1,596,000 |
Note 11 - Notes Payable, Rela_2
Note 11 - Notes Payable, Related Party (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Note 11 - Notes Payable Related Party | |||||
Notes Payable Principal | $ 5,335,243 | $ 5,335,243 | $ 5,222,259 | ||
Debt Discount | 37,500 | 37,500 | 150,484 | ||
Interest Payable, Current | 1,005,144 | 1,005,144 | $ 685,907 | ||
Interest Expense, Related Party | $ 199,991 | $ 160,979 | $ 583,448 | $ 444,437 |
Note 13 - Warrants (Details)
Note 13 - Warrants (Details) | 9 Months Ended |
Sep. 30, 2018shares | |
Warrants Outstanding, Beginning | 97,977,851 |
Warrants Issued | 17,911,136 |
Warrants Exercised | (8,142,364) |
Warrants Expired | (4,835,150) |
Warrants Outstanding, Ending | 102,911,473 |
Class F Warrants [Member] | |
Warrants Outstanding, Beginning | 300,000 |
Warrants Issued | 0 |
Warrants Exercised | 0 |
Warrants Expired | (300,000) |
Warrants Outstanding, Ending | 0 |
Class G Warrants [Member] | |
Warrants Outstanding, Beginning | 1,503,409 |
Warrants Issued | 0 |
Warrants Exercised | 0 |
Warrants Expired | (1,503,409) |
Warrants Outstanding, Ending | 0 |
Class H Warrants [Member] | |
Warrants Outstanding, Beginning | 1,988,095 |
Warrants Issued | 0 |
Warrants Exercised | 0 |
Warrants Expired | (1,988,095) |
Warrants Outstanding, Ending | 0 |
Class I Warrants [Member] | |
Warrants Outstanding, Beginning | 1,043,646 |
Warrants Issued | 0 |
Warrants Exercised | 0 |
Warrants Expired | (1,043,646) |
Warrants Outstanding, Ending | 0 |
Class K Warrants [Member] | |
Warrants Outstanding, Beginning | 7,200,000 |
Warrants Issued | 0 |
Warrants Exercised | 0 |
Warrants Expired | 0 |
Warrants Outstanding, Ending | 7,200,000 |
Class L Warrants [Member] | |
Warrants Outstanding, Beginning | 63,898,173 |
Warrants Issued | 0 |
Warrants Exercised | (6,500,334) |
Warrants Expired | 0 |
Warrants Outstanding, Ending | 57,397,839 |
Class N Warrants [Member] | |
Warrants Outstanding, Beginning | 13,943,180 |
Warrants Issued | (1,136,364) |
Warrants Exercised | 0 |
Warrants Expired | 0 |
Warrants Outstanding, Ending | 0 |
Class O Warrants [Member] | |
Warrants Outstanding, Beginning | 6,540,000 |
Warrants Issued | 1,509,091 |
Warrants Exercised | (100,000) |
Warrants Expired | 0 |
Warrants Outstanding, Ending | 7,949,091 |
Series A Warrants [Member] | |
Warrants Outstanding, Beginning | 1,561,348 |
Warrants Issued | 0 |
Warrants Exercised | (405,666) |
Warrants Expired | 0 |
Warrants Outstanding, Ending | 1,155,682 |
Note 13 - Warrants (Details 1)
Note 13 - Warrants (Details 1) | 9 Months Ended |
Sep. 30, 2018$ / shares | |
Class K Warrants [Member] | |
Warrant Exercise Price/share | $ 0.08 |
Warrant Expiration Date | June 2,025 |
Class K Warrants [Member] | |
Warrant Exercise Price/share | $ 0.11 |
Warrant Expiration Date | August 2,027 |
Class L Warrants [Member] | |
Warrant Exercise Price/share | $ 0.08 |
Warrant Expiration Date | March 2,019 |
Class N Warrants [Member] | |
Warrant Exercise Price/share | $ 0.11 |
Warrant Expiration Date | March 2,019 |
Class O Warrants [Member] | |
Warrant Exercise Price/share | $ 0.11 |
Warrant Expiration Date | March 2,019 |
Series A Warrants [Member] | |
Warrant Exercise Price/share | $ 0.03 |
Warrant Expiration Date | March 2,019 |
Note 13 - Warrants (Details 2)
Note 13 - Warrants (Details 2) | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Warrant Liability, Beginning | $ 1,943,883 |
Issued | 0 |
Redeemed | (118,838) |
Change in Fair Value | (428,846) |
Warrant Liability, Ending | 1,396,199 |
Class K Warrants [Member] | |
Warrant Liability, Beginning | 1,616,000 |
Issued | 0 |
Redeemed | 0 |
Change in Fair Value | (412,800) |
Warrant Liability, Ending | 1,203,200 |
Series A Warrants [Member] | |
Warrant Liability, Beginning | 327,883 |
Issued | 0 |
Redeemed | (118,838) |
Change in Fair Value | (16,046) |
Warrant Liability, Ending | $ 192,999 |
Note 14 - Commitments and Con_3
Note 14 - Commitments and Contingencies (Details) | Sep. 30, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Remainder of 2018 | $ 35,387 |
2,019 | 143,318 |
2,020 | 147,617 |
2,021 | 152,046 |
Total | $ 478,368 |
Note 14 - Commitments and Con_4
Note 14 - Commitments and Contingencies (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Rent Expense | $ 36,755 | $ 33,572 | $ 108,776 | $ 99,800 |
Note 15 - Revenue (Details)
Note 15 - Revenue (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
REVENUES | $ 595,789 | $ 161,585 | $ 1,393,271 | $ 422,199 |
Product | ||||
REVENUES | 240,759 | 143,234 | 703,054 | 356,911 |
License fees | ||||
REVENUES | 335,697 | 6,250 | 623,570 | 36,050 |
Other | ||||
REVENUES | 19,333 | 12,101 | 66,647 | 29,238 |
United States | ||||
REVENUES | 12,141 | 6,250 | 159,981 | 18,750 |
United States | Product | ||||
REVENUES | 5,891 | 0 | 141,231 | 0 |
United States | License fees | ||||
REVENUES | 6,250 | 6,250 | 18,750 | 18,750 |
United States | Other | ||||
REVENUES | 0 | 0 | 0 | 0 |
International | ||||
REVENUES | 583,648 | 155,335 | 1,233,290 | 403,449 |
International | Product | ||||
REVENUES | 234,868 | 143,234 | 561,823 | 356,911 |
International | License fees | ||||
REVENUES | 329,447 | 0 | 604,820 | 17,300 |
International | Other | ||||
REVENUES | $ 19,333 | $ 12,101 | $ 66,647 | $ 29,238 |
Note 17 - Stock-based Compens_3
Note 17 - Stock-based Compensation (Details) - Employee Stock Option [Member] | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Weighted Average Expected Life in Years | 5 years | 5 years |
Weighted Average Risk Free Interest Rate | 3.02% | 1.76% |
Weighted Average Volatility | 141.87% | 120.00% |
Forfeiture Rate | 0.00% | 0.00% |
Expected Dividend Yield | 0.00% | 0.00% |
Note 17 - Stock-based Compens_4
Note 17 - Stock-based Compensation (Details 1) - $ / shares | 3 Months Ended | ||
Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | |
Share-based Compensation [Abstract] | |||
Options Outstanding, Beginning | 23,723,385 | 21,593,385 | 21,593,385 |
Options Granted | 7,950,000 | 2,130,000 | 0 |
Options Exercised | 0 | 0 | 0 |
Options Forfeited or Expired | 0 | 0 | 0 |
Options Outstanding, Ending | 31,673,385 | 23,723,385 | 21,593,385 |
Options Vested and Exercisable | 31,673,385 | ||
Weighted Average Exercise Price, Outstanding, Beginning | $ 0.32 | $ 0.31 | $ 0.31 |
Weighted Average Exercise Price, Granted | 0.21 | 0.41 | 0 |
Weighted Average Exercise Price, Exercised | 0 | 0 | 0 |
Weighted Average Exercise Price, Forfeited or Expired | 0 | 0 | 0 |
Weighted Average Exercise Price, Outstanding, Ending | 0.29 | $ 0.32 | $ 0.31 |
Weighted Average Exercise Price, Vested and Exercisable | $ 0.29 |
Note 17 - Stock-based Compens_5
Note 17 - Stock-based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Allocated Share-based Compensation Expense | $ 1,637,000 | $ 0 | $ 2,474,496 | $ 482,295 | |
Stock Incentive Plan [Member] | |||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | $ 0.04 | $ 0.04 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 2 | $ 2 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Exercisable, Intrinsic Value | $ 1,456,116 | $ 1,456,116 | $ 2,073,641 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 7 years 7 months 24 days | 7 years 4 months 13 days |
Note 18 - Earnings (Loss) Per_2
Note 18 - Earnings (Loss) Per Share (Details Narrative) - shares | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
LOSS PER SHARE: | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 158,075,531 | 99,388,222 |