Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | May 16, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-39701 | |
Entity Registrant Name | INVO Bioscience, Inc. | |
Entity Central Index Key | 0001417926 | |
Entity Tax Identification Number | 20-4036208 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 5582 Broadcast Court | |
Entity Address, City or Town | Sarasota | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 34240 | |
City Area Code | (978) | |
Local Phone Number | 878-9505 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | INVO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,096,798 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash | $ 3,839,862 | $ 5,684,871 |
Accounts receivable | 58,720 | 50,470 |
Inventory | 294,631 | 287,773 |
Prepaid expenses and other current assets | 228,178 | 282,751 |
Total current assets | 4,421,391 | 6,305,865 |
Property and equipment, net | 491,995 | 501,436 |
Intangible Assets, net | 132,551 | 132,093 |
Lease right of use | 1,980,153 | 2,037,052 |
Investment in joint ventures | 1,494,143 | 1,489,934 |
Total assets | 8,520,233 | 10,466,380 |
Current liabilities | ||
Accounts payable and accrued liabilities | 462,211 | 443,422 |
Accrued compensation | 391,877 | 581,689 |
Deferred revenue, current portion | 5,793 | 5,900 |
Lease liability, current portion | 224,361 | 221,993 |
Total current liabilities | 1,084,242 | 1,253,004 |
Lease liability, net of current portion | 1,844,784 | 1,901,557 |
Deferred tax liability | 1,139 | 1,139 |
Total liabilities | 2,930,165 | 3,155,700 |
Stockholders’ equity | ||
Common Stock, $.0001 par value; 125,000,000 shares authorized; 12,096,798 and 11,929,147 issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 1,210 | 1,193 |
Additional paid-in capital | 47,254,192 | 46,200,509 |
Accumulated deficit | (41,665,334) | (38,891,022) |
Total stockholders’ equity | 5,590,068 | 7,310,680 |
Total liabilities and stockholders’ equity | $ 8,520,233 | $ 10,466,380 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock shares authorized | 125,000,000 | 125,000,000 |
Common stock shares issued | 12,096,798 | 11,929,147 |
Common stock shares outstanding | 12,096,798 | 11,929,147 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue: | ||
Total revenue | $ 162,598 | $ 684,523 |
Cost of goods sold: | ||
Production costs | 57,533 | 60,314 |
Depreciation | 7,428 | 2,431 |
Total cost of goods sold | 64,961 | 62,745 |
Gross profit | 97,637 | 621,778 |
Operating expenses | ||
Selling, general and administrative expenses | 2,694,395 | 2,115,303 |
Research and development expenses | 104,180 | 66,267 |
Total operating expenses | 2,798,575 | 2,181,570 |
Loss from operations | (2,700,938) | (1,559,792) |
Other income (expense): | ||
Loss from equity method joint ventures | (71,117) | |
Interest income | 225 | 2,013 |
Interest expense | (1,456) | (895,226) |
Foreign currency exchange loss | (1,026) | (464) |
Total other expenses | (73,374) | (893,677) |
Net loss | $ (2,774,312) | $ (2,453,469) |
Net loss per common share: | ||
Basic | $ (0.23) | $ (0.25) |
Diluted | $ (0.23) | $ (0.25) |
Weighted average number of common shares outstanding: | ||
Basic | 12,050,696 | 9,888,025 |
Diluted | 12,050,696 | 9,888,025 |
Product Revenue [Member] | ||
Revenue: | ||
Total revenue | $ 56,750 | $ 505,952 |
Clinic Revenue [Member] | ||
Revenue: | ||
Total revenue | 105,848 | |
License Revenue [Member] | ||
Revenue: | ||
Total revenue | $ 178,571 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 964 | $ 37,978,224 | $ (32,236,082) | $ 5,743,106 |
Beginning balance, shares at Dec. 31, 2020 | 9,639,268 | |||
Common stock issued to directors and employees | $ 3 | 97,450 | 97,453 | |
Common stock issued to directors and employees, shares | 30,000 | |||
Common stock issued for services providers | $ 7 | 221,243 | 221,250 | |
Common stock issued to service providers, shares | 71,500 | |||
Conversion of notes payable and accrued interest | $ 39 | 1,243,749 | 1,243,788 | |
Conversion of notes payable and accrued interest, shares | 388,684 | |||
Proceeds from warrant exercise | $ 4 | 123,558 | 123,562 | |
Proceeds from warrant exercise, shares | 39,095 | |||
Proceeds from unit purchase option exercise | $ 8 | 246,270 | 246,278 | |
Proceeds from unit purchase option exercise, shares | 77,444 | |||
Cashless warrant exercise | $ 9 | (9) | ||
Cashless warrant exercise, shares | 91,709 | |||
Cashless unit purchase option exercise | $ 8 | (8) | ||
Cashless unit purchase option exercise, shares | 86,529 | |||
Stock options issued to directors and employees | 376,523 | 376,523 | ||
Net loss | (2,453,469) | (2,453,469) | ||
Ending balance, value at Mar. 31, 2021 | $ 1,042 | 40,287,000 | (34,689,551) | 5,598,491 |
Ending balance, shares at Mar. 31, 2021 | 10,424,229 | |||
Beginning balance, value at Dec. 31, 2021 | $ 1,193 | 46,200,509 | (38,891,022) | 7,310,680 |
Beginning balance, shares at Dec. 31, 2021 | 11,929,147 | |||
Common stock issued to directors and employees | $ 6 | 243,356 | 243,362 | |
Common stock issued to directors and employees, shares | 51,528 | |||
Common stock issued for services providers | $ 2 | 66,848 | 66,850 | |
Common stock issued to service providers, shares | 21,500 | |||
Stock options issued to directors and employees | 428,488 | 428,488 | ||
Net loss | (2,774,312) | (2,774,312) | ||
Proceeds from the sale of common stock, net of fees and expenses | $ 9 | 314,991 | 315,000 | |
Stock issued for cash, shares | 94,623 | |||
Ending balance, value at Mar. 31, 2022 | $ 1,210 | $ 47,254,192 | $ (41,665,334) | $ 5,590,068 |
Ending balance, shares at Mar. 31, 2022 | 12,096,798 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (2,774,312) | $ (2,453,469) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash stock compensation issued for services | 66,850 | 94,611 |
Non-cash stock compensation issued to directors and employees | 243,362 | 97,453 |
Fair value of stock options issued to employees | 428,488 | 376,523 |
Amortization of discount on notes payable | 860,155 | |
Amortization of leasehold right of use asset | 56,899 | 5,675 |
Loss from equity method investment | 71,117 | |
Depreciation and amortization | 15,547 | 2,979 |
Changes in assets and liabilities: | ||
Accounts receivable | (8,250) | (505,952) |
Interest receivable | (160) | |
Inventory | (6,858) | (2,977) |
Prepaid expenses and other current assets | 54,573 | 18,694 |
Accounts payable and accrued expenses | 18,789 | 183,117 |
Accrued compensation | (189,812) | (259,936) |
Deferred revenue | (107) | (178,572) |
Leasehold liability | (54,405) | (5,491) |
Accrued interest | 33,028 | |
Income taxes payable | (1,062) | |
Net cash used in operating activities | (2,078,119) | (1,735,384) |
Cash from investing activities: | ||
Payments to acquire property, plant, and equipment | (5,654) | |
Payments to acquire patents | (17,631) | |
Payments to acquire trademarks | (910) | (11,349) |
Investment in joint ventures | (75,326) | |
Payment for notes receivable | (280,000) | |
Net cash used in investing activities | (81,890) | (308,980) |
Cash from financing activities: | ||
Proceeds from the sale of common stock, net of offering costs | 315,000 | |
Proceeds from warrant exercise | 123,562 | |
Proceeds from unit purchase option exercise | 246,278 | |
Net cash provided by financing activities | 315,000 | 369,840 |
Increase (decrease) in cash and cash equivalents | (1,845,009) | (1,674,524) |
Cash and cash equivalents at beginning of period | 5,684,871 | 10,097,760 |
Cash and cash equivalents at end of period | 3,839,862 | 8,423,236 |
Supplemental disclosure of cash flow information: | ||
Interest | 2,043 | |
Taxes | 912 | |
Noncash activities: | ||
Common stock issued upon note payable and accrued interest conversion | 1,243,788 | |
Common stock issued for prepaid services | 168,850 | |
Cashless exercise of warrants | 9 | |
Cashless exercise of unit purchase options | $ 8 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 1 – Summary of Significant Accounting Policies Description of Business INVO Bioscience, Inc. (“INVO” or the “Company”) is a commercial-stage fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around the world. The Company’s primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. The Company’s flagship product is INVOcell, a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as “IVC,” provides patients a more connected and intimate experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a lower cost than traditional in vitro Basis of Presentation The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation. The Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but cannot control the entity’s operations. The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. The Company considers events or transactions that have occurred after the consolidated balance sheet date of March 31, 2022, but prior to the filing of the consolidated financial statements with the SEC in this Quarterly Report on Form 10-Q, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Quarterly Report on Form 10-Q. Business Segments The Company operates in one Variable Interest Entities The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the Company’s VIEs. Equity Method Investments Investments in unconsolidated affiliates in which the Company exerts significant influence but does not control or otherwise consolidate are accounted for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records reductions in carrying values when necessary. Use of Estimates In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates. Cash and Cash Equivalents For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation. Inventory Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out method as a cost flow method. Property and Equipment The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 10 Long- Lived Assets Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized. There was no Fair Value of Financial Instruments ASC 825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. Effective January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs. Income Taxes The Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset will be recovered, a valuation allowance is established. Concentration of Credit Risk Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”) limits. As of March 31, 2022, the Company had cash balances in excess of FDIC limits. Revenue Recognition The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach: 1. Identify the contract with the customer. 2. Identify the performance obligations in the contract. 3. Determine the total transaction price. 4. Allocate the total transaction price to each performance obligation in the contract. 5. Recognize as revenue when (or as) each performance obligation is satisfied. Revenue generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. Revenue generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the service is performed. On November 12, 2018, the Company entered into a U.S. Distribution Agreement (the “Ferring Agreement”) with Ferring International Center S.A. (“Ferring”), pursuant to which it granted Ferring an exclusive license in the United States market only, with rights to sublicense under patents related to our proprietary intravaginal culture device (INVOcell), together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including fertility treatment) in humans. On November 2, 2021, Ferring notified the Company of its intention to terminate the Ferring Agreement, which required 90-days prior written notice. Accordingly, the Ferring Agreement officially terminated on January 31, 2022. The Ferring license was deemed to be a functional license that provides a customer with a “right to access” to the Company’s intellectual property during the subscription period and accordingly, under ASC 606-10-55-60 revenue is recognized over a period of time, which is generally the subscription period. The initial upfront payment of $ 5,000,000 7 As of March 31, 2022, the Company had no deferred revenue related to the Ferring Agreement as it was recognized in the fourth quarter of fiscal year 2021 in relation to the contract termination. Per ASC 606-10-55-48 the likelihood of Ferring exercising its rights became remote at the time notice of termination was received so INVO recognized the full remaining amount of the deferred revenue. Stock Based Compensation The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period. Loss Per Share Basic loss per share calculations are computed by dividing net loss attributable to the Company’s common shareholders by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the three months ended March 31, 2022, and 2021, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss. Schedule of Earnings Per Share Basic and Diluted Three Months Ended March 31, 2022 2021 Net loss (numerator) $ (2,774,312 ) $ (2,453,469 ) Basic and diluted weighted-average number of common shares outstanding (denominator) 12,050,696 9,888,025 Basic and diluted net loss per common share (0.23 ) (0.25 ) The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive: Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share As of March 31, 2022 2021 Options 1,474,605 1,102,672 Convertible notes and interest - 160,504 Unit purchase options and warrants 260,165 216,193 Total 1,734,770 1,479,369 Recently Adopted Accounting Pronouncements The Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption of any such pronouncements will have a material impact on its financial condition or the results of its operations. |
Liquidity
Liquidity | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity | Note 2 – Liquidity Historically, the Company has funded its cash and liquidity needs through operating cash flow, equity financings, and convertible notes. For the three months ended March 31, 2022 and 2021, the Company incurred a net loss of approximately $ 2.8 million and $ 2.5 million, respectively, and has an accumulated deficit of approximately $ 41.7 million as of March 31, 2022. Approximately $ 0.9 million of the net loss was related to non-cash expenses for the three months ended March 31, 2022, compared to $ 1.4 million for the three months ended March 31, 2021. The Company has been dependent on raising capital from debt and equity financings to meet its needs for cash flow used in operating and investing activities. During the first three months of 2021, the Company received approximately $ 0.4 million of proceeds from unit purchase option and warrant exercises. During the first three months of 2022, the Company received proceeds of approximately $ 0.3 million for the sale of common stock. The Company’s current plan includes opening additional INVO Centers over the next 12 months. Until the Company can generate a sufficient amount of cash from operations and to the extent additional funds are necessary to meet the Company’s longer-term liquidity needs and to execute the Company’s business strategy, it may need to raise additional funding, as it has done in the past, by way of debt and/or equity financings. Such additional funding may not be available on reasonable terms, if at all. Although the Company’s audited financial statements for the year ended December 31, 2021 were prepared under the assumption that it would continue operations as a going concern, the report of the Company’s independent registered public accounting firm that accompanies the Company’s financial statements for the year ended December 31, 2021 contains a going concern qualification in which such firm expressed substantial doubt about the Company’s ability to continue as a going concern, based on the financial statements at that time. Specifically, as noted above, the Company has incurred significant operating losses and the Company expects to continue to incur significant expenses and operating losses as it continues to ramp up the commercialization of INVOcell and develop new INVO Centers. These prior losses and expected future losses have had, and will continue to have, an adverse effect on the Company’s financial condition. If the Company cannot continue as a going concern, its stockholders would likely lose most or all of their investment in the Company. |
Variable Interest Entities
Variable Interest Entities | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Variable Interest Entities | Note 3 – Variable Interest Entities Consolidated VIEs Bloom INVO, LLC On June 28, 2021, INVO CTR entered into a limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center (the “Atlanta Clinic”) in the Atlanta, Georgia metropolitan area. In consideration for INVO’s commitment to contribute up to $ 800,000 within the 24-month period following the execution of the Bloom Agreement to support the start-up operations of the Georgia JV, the Georgia JV issued 800 of its units to INVO CTR and in consideration for Bloom’s commitment to contribute physician services having an anticipated value of up to $ 1,200,000 over the course of a 24-month vesting period, the Georgia JV issued 1,200 of its units to Bloom. The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell to the Georgia JV. INVO CTR also performs all required, industry specific compliance and accreditation functions, and product documentation for product registration. The Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest, states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario, liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions and distributions equals $0; (b) to Bloom until its distributions equal 150 The Georgia JV opened to patients on September 7, 2021, and commenced initial treatment cycles in November 2021. The Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to absorb losses that are potentially significant and the Company controls the majority of the activities that impact the Georgia JV’s economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated the Georgia JV’s results with its own. As of March 31, 2022, the Company invested $ 0.7 0.5 0.2 0 Unconsolidated VIEs HRCFG INVO, LLC On March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture entity is HRCFG INVO, LLC (the “Alabama JV”). The Company also provides certain funding to the Alabama JV. Each party owns 50 The Alabama JV opened to patients on August 9, 2021, and initial treatment cycles commenced in September 2021. The Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method to account for its interest in the Alabama JV. As of March 31, 2022, the Company invested $ 1.7 0.1 0.05 Positib Fertility, S.A. de C.V. On September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”). The Mexico JV opened to patients on November 1, 2021, and commenced initial treatment cycles beginning in January 2022. The Company determined the Mexico JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method to account for its interest in the Mexico JV. As of March 31,2022, the Company invested $ 0.2 0.05 0.02 The following table summarizes our investments in unconsolidated VIEs: Schedule of Investments in Unconsolidated Variable Interest Entities Carrying Value as of Location Percentage Ownership March 31, 2022 December 31, 2021 HRCFG INVO, LLC Alabama, United States 50 % $ 1,332,574 1,387,495 Positib Fertility, S.A. de C.V. Mexico 33 % 161,569 102,439 Total investment in unconsolidated VIEs $ 1,494,143 1,489,934 Earnings from investments in unconsolidated VIEs were as follows: Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities Three Months Ended March 31, 2022 2021 HRCFG INVO, LLC $ (54,920 ) - Positib Fertility, S.A. de C.V. (16,197 ) - Total earnings from unconsolidated VIEs $ (71,117 ) - The following tables summarize the combined unaudited financial information of our investments in unconsolidated VIEs: Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities Three Months Ended March 31, 2022 2021 Statements of operations: Operating revenue $ 169,835 - Operating expenses (328,756 ) - Net loss $ (158,921 ) - March 31, 2022 December 31, 2021 Balance sheets: Current assets $ 474,379 456,967 Long-term assets 1,133,071 1,302,067 Current liabilities (407,425 ) (404,155 ) Long-term liabilities (146,515 ) (142,321 ) Net assets $ 1,053,510 1,212,558 |
Agreements and Transactions wit
Agreements and Transactions with VIE’s | 3 Months Ended |
Mar. 31, 2022 | |
Agreements And Transactions With Vies | |
Agreements and Transactions with VIE’s | Note 4 – Agreements and Transactions with VIE’s The Company sells the INVOcell to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements. Per ASC 323-10-35-8 the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining on the books at period end. The following table summarizes the Company’s transactions with VIEs: Summary of Transaction with Variable Interest Entities Three Months Ended March 31, 2022 2021 Bloom Invo, LLC INVOcell revenue $ - - Unconsolidated VIEs INVOcell revenue $ 7,500 - The Company had balances with VIEs as follows: Summary of Balances with Variable Interest Entities March 31, 2022 December 31, 2021 Bloom Invo, LLC Accounts receivable $ 21,600 21,600 Notes payable 457,012 453,406 Unconsolidated VIEs Accounts receivable $ 23,810 16,310 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 5 – Inventory Components of inventory are: Schedule of Inventory March 31, 2022 December 31, 2021 Raw materials $ 77,909 $ 67,605 Finished goods 216,722 220,168 Total inventory $ 294,631 $ 287,773 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 6 – Property and Equipment The estimated useful lives and accumulated depreciation for equipment are as follows as of March 31, 2022, and December 31, 2021: Schedule of Estimated Useful Lives of Property and Equipment Estimated Useful Life Manufacturing equipment 6 10 Medical equipment 7 10 Office equipment 3 7 Schedule of Property and Equipment March 31, 2022 December 31, 2021 Manufacturing equipment $ 132,513 $ 132,513 Medical equipment 282,811 275,423 Office equipment 75,589 74,891 Leasehold improvements 96,817 96,817 Less: accumulated depreciation (95,735 ) (78,208 ) Total equipment, net $ 491,995 $ 501,436 During the three months ended March 31, 2022, and 2021, the Company recorded depreciation expense of $ 15,095 2,527 |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Note 7 – Intangible Assets Components of intangible assets are as follows: Schedule of Finite-Lived Intangible Assets March 31, 2022 December 31, 2021 Trademarks $ 111,752 $ 110,842 Patents 95,355 95,355 Accumulated amortization (74,556 ) (74,104 ) Total patent costs, net $ 132,551 $ 132,093 The Company capitalizes the initial expense related to establishing patents by country and then amortizes the expense over the life of the patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of its patents in the marketplace in proportion to the expense it must spend to maintain the patent. During the three months ended March 31, 2022, and 2021, the Company recorded amortization expenses related to patents of $ 452 452 The trademarks have an indefinite life and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. The trademark assets were created in 2019, and no material adverse changes have occurred since their creation. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases | |
Leases | Note 8 – Leases The Company has various operating lease agreements in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases Topic 842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding liability to report the present value of the total lease payments, with appropriate interest calculation. Per the terms of ASU 2016-02, the Company can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Company’s implicit interest rate was not readily determinable, the Company utilized the applicable federal rate, as of the commencement of the lease. Lease renewal options included in any lease are considered in the lease term if it is reasonably certain the Company will exercise the option to renew. The Company’s operating lease agreements do not contain any material restrictive covenants. As of March 31, 2022, the Company’s lease components included in the consolidated balance sheet were as follows: Schedule of Lease Components Lease component Balance sheet classification March 31, 2022 Assets ROU assets – operating lease Other assets $ 1,980,153 Total ROU assets $ 1,980,153 Liabilities Current operating lease liability Current liabilities $ 224,361 Long-term operating lease liability Other liabilities 1,844,784 Total lease liabilities $ 2,069,145 Future minimum lease payments as of March 31, 2022 were as follows: Schedule of Future Minimum Lease Payments 2022 $ 194,542 2023 264,108 2024 251,671 2025 247,960 2026 and beyond 1,316,245 Total future minimum lease payments $ 2,274,526 Less: Interest (205,381 ) Total operating lease liabilities $ 2,069,145 |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Notes Payable | Note 9 – Notes Payable 2020 Convertible Notes Payable From May 15, 2020, through July 1, 2020, the Company entered into agreements with accredited investors for their purchase of secured convertible notes issued by the Company in the aggregate original principal amount of $ 3,494,840 Interest on the 2020 Convertible Notes accrued at a rate of 10 the maturity dates of November 15, 2021, December 22, 2021, and December 30, 2021 All amounts of principal and interest due under the 2020 Convertible Notes were convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders, into the Company’s common stock at a fixed conversion price of $ 3.20 As of March 31, 2022, all 2020 Convertible Notes had either converted or been repaid by the Company. Interest expense on the 2020 Convertible Notes was $ 0 35,070 Amortization of options discount on the 2020 Convertible Notes was $ 0 161,339 Amortization of warrant discount on the 2020 Convertible Notes was $ 0 163,580 Amortization of beneficial conversion feature on the 2020 Convertible Notes was $ 0 461,120 Amortization of issuance costs on the 2020 Convertible Notes was $ 0 74,116 Paycheck Protection Program On July 1, 2020, the Company received a loan in the principal amount of $ 157,620 The loan matured 18 months from the date of funding, was payable over 18 equal monthly installments, and had an interest of 1% per annum Up to 100% of the principal balance of the loan was forgivable based upon satisfaction of certain criteria under the Paycheck Protection Program 1,506 159,126 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 10 – Related Party Transactions In October 2021, Paulson Investment Company served as a placement agent for the Company’s registered direct offering and received fees and commissions for such role in the amount of $ 323,584 30,674 199,994 |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 11 – Stockholders’ Equity Reverse Stock Splits On December 16, 2019, the Company’s stockholders approved a reverse stock split at a ratio of between 1-for-5 and 1-for-25 1-for-20 1-for-20 On October 22, 2020, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 5-for-8 125,000,000 200,000,000 5-for-8 133 The consolidated financial statements presented reflect the reverse splits. Public offerings On November 12, 2020, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC, as representative of the several underwriters (the “Underwriters”), in connection with the Company’s public offering (the “Offering”) of 3,625,000 3.20 3,625,000 528,750 1.5 4,153,750 11.8 On October 1, 2021, the Company and certain institutional and accredited investors and members of the Company’s management team (the “Investors”) entered into a securities purchase agreement pursuant to which the Company agreed to issue and sell to the Investors 1,240,737 4,044,803 3.26 3.65 323,584 37,222 3.912 Three Months Ended March 31, 2022 During the first three months of 2022, the Company issued 51,528 18,500 186,000 57,370 During the first three months of 2022, the Company issued 3,000 shares of its common stock to consultants in consideration of services rendered with a fair value of $ 9,480 . These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance. In January 2022, the Company issued 94,623 315,000 During the first three months of 2022, the Company granted 86,333 50% 50% 40,474 |
Equity-Based Compensation
Equity-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Equity-Based Compensation | Note 12 – Equity-Based Compensation Equity Incentive Plans In October 2019, the Company adopted the 2019 Plan. Under the 2019 Plan, the Company’s board of directors is authorized to grant stock options to purchase common stock, restricted stock units, and restricted shares of common stock to its employees, directors, and consultants. The 2019 Plan initially provided for the issuance of 500,000 shares. A provision in the 2019 Plan provides for an automatic annual increase equal to 6% of the total number of shares of Company common stock outstanding on December 31 of the preceding calendar year. 715,749 2,087,198 Options granted under the 2019 Plan generally have a life of 3 10 three-year The following table sets forth the activity of the options to purchase common stock under the 2019 Plan. Schedule of Stock Options Activity Number of Weighted Aggregate Outstanding as of December 31, 2021 1,055,894 $ 5.09 $ 133,022 Granted 418,711 3.78 - Exercised - - - Canceled - - - Balance as of March 31, 2022 1,474,605 $ 4.90 - Exercisable as of March 31, 2022 740,495 5.78 - The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions: Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions Three Months ended 2022 2021 Risk-free interest rate range 1.6 1.9 % 0.22 0.31 % Expected life of option-years 5.25 5.75 5.3 6.5 Expected stock price volatility 110.4 113.2 % 107.4 % Expected dividend yield - % - % The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options. Expected volatility is based upon the average historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on its common stock, nor does it expect to do so in the foreseeable future. Schedule of Share Based Payments Arrangements Options Exercised and Options Vested Total Intrinsic Total Fair Year ended December 31, 2021 $ - $ 1,543,912 Three months ended March 31, 2022 $ - $ 428,488 For the three months ended March 31, 2021, the weighted average grant date fair value of options granted was $ 3.08 1.3 Restricted Stock and Restricted Stock Units In the three months ended March 31, 2022, the Company granted 156,361 in restricted stock units and shares of restricted stock to certain employees, directors, and consultants under the 2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either at grant or vest over a period of one year from the date of grant. The following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the three months ended March 31, 2022: Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity Number of Unvested Shares Weighted Average Grant Date Aggregate Value of Shares Balance as of December 31, 2021 9,730 $ 3.72 $ 36,148 Granted 159,361 3.40 532,167 Vested (76,841 ) 3.52 (265,847 ) Forfeitures - - - Balance as of March 31, 2022 92,250 $ 3.39 $ 302,468 |
Unit Purchase Options and Warra
Unit Purchase Options and Warrants | 3 Months Ended |
Mar. 31, 2022 | |
Unit Purchase Options And Warrants | |
Unit Purchase Options and Warrants | Note 13 – Unit Purchase Options and Warrants In connection with the issuance of the 2020 Convertible Notes, the Company also issued unit purchase options to purchase 303,623 3.20 one 3.20 five years In connection with the issuance of the 2020 Convertible Notes, the Company agreed to issue the placement agent and the selling agent five 6,750 3.20 A Monte Carlo model was used because the investor unit purchase options and warrants contain fundamental transaction payouts and reset events that cannot be modeled with a Black Scholes model. The fair value of the unit purchase options and warrants issued to the convertible debt holders is estimated as of the issue date using a Monte Carlo model with the following assumptions: Schedule of Fair Value Measurement Inputs and Valuation Techniques Risk-free interest rate range 0.33 0.39 % Stock price $ 3.00 3.95 Expected life of warrants and unit purchase options (years) 5.00 Expected stock price volatility 108.2 112.5 % Expected dividend yield 0 % The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the unit purchase options and warrants. Expected volatility is based upon the historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The unit purchase options and warrants are valued assuming projected reset events adjusting the exercise price and a forced exercise upon a projected fundamental transaction by management. The unit purchase options and warrants early exercise are modeled assuming registration after 180 days. The Company does not currently pay dividends on its common stock, nor does it expect to in the foreseeable future. The following table sets forth the activity of unit purchase options: Schedule of Unit Purchase Stock Options Activity Number of Weighted Aggregate Outstanding as of December 31, 2021 92,893 $ 3.20 $ 5,647 Granted - - - Exercised - - - Canceled - - - Balance as of March 31, 2022 92,893 $ 3.20 $ - The following table sets forth the activity of warrants: Schedule of Warrants Activity Number of Weighted Aggregate Outstanding as of December 31, 2021 167,272 $ 3.62 $ 16,029 Granted - - - Exercised - - - Canceled - - - Balance as of March 31, 2022 167,272 $ 3.62 $ - |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 14 – Income Taxes The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If a carryforward exists, the Company decides as to whether the carryforward will be utilized in the future. Currently, a valuation allowance is established for all deferred tax assets and carryforwards as their recoverability is deemed to be uncertain. If the Company’s expectations for future operating results at the federal or at the state jurisdiction level vary from actual results due to changes in healthcare regulations, general economic conditions, or other factors, it may need to adjust the valuation allowance, for all or a portion of the Company’s deferred tax assets. The Company’s income tax expense in future periods will be reduced or increased to the extent of offsetting decreases or increases, respectively, in the Company’s valuation allowance in the period when the change in circumstances occurs. These changes could have a significant impact on the Company’s future earnings. Income tax expense was $ 0 0 0 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 15 – Commitments and Contingencies Insurance The Company’s insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party exposures; (ii) statutory workers’ compensation insurance; (iv) excess liability insurance above the established primary limits for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal property and includes business interruption; and (vi) insurance covering our directors and officers for acts related to our business activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with similar types of operations. Legal Matters The Company is not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 16 – Subsequent Events On May 13, 2022, the Company entered into an Exclusive Distribution Agreement (the “Onesky Agreement”) with Onesky Holdings Limited (“Onesky”), pursuant to which, among other things, the Company granted to Onesky an exclusive right to distribute INVOcell in the People’s Republic of China, excluding Hong Kong, Macau and Taiwan (the “Territory”). The Onesky Agreement became effective on May 13, 2022, and will remain in effect for a period of five years |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business INVO Bioscience, Inc. (“INVO” or the “Company”) is a commercial-stage fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around the world. The Company’s primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. The Company’s flagship product is INVOcell, a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as “IVC,” provides patients a more connected and intimate experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a lower cost than traditional in vitro |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation. The Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but cannot control the entity’s operations. The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. The Company considers events or transactions that have occurred after the consolidated balance sheet date of March 31, 2022, but prior to the filing of the consolidated financial statements with the SEC in this Quarterly Report on Form 10-Q, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Quarterly Report on Form 10-Q. |
Business Segments | Business Segments The Company operates in one |
Variable Interest Entities | Variable Interest Entities The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the Company’s VIEs. |
Equity Method Investments | Equity Method Investments Investments in unconsolidated affiliates in which the Company exerts significant influence but does not control or otherwise consolidate are accounted for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records reductions in carrying values when necessary. |
Use of Estimates | Use of Estimates In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation. |
Inventory | Inventory Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out method as a cost flow method. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 10 |
Long- Lived Assets | Long- Lived Assets Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized. There was no |
Fair Value of Financial Instruments | Fair Value of Financial Instruments ASC 825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. Effective January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs. |
Income Taxes | Income Taxes The Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset will be recovered, a valuation allowance is established. |
Segment Reporting, Policy [Policy Text Block] | |
Concentration of Credit Risk | Concentration of Credit Risk Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”) limits. As of March 31, 2022, the Company had cash balances in excess of FDIC limits. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach: 1. Identify the contract with the customer. 2. Identify the performance obligations in the contract. 3. Determine the total transaction price. 4. Allocate the total transaction price to each performance obligation in the contract. 5. Recognize as revenue when (or as) each performance obligation is satisfied. Revenue generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. Revenue generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the service is performed. On November 12, 2018, the Company entered into a U.S. Distribution Agreement (the “Ferring Agreement”) with Ferring International Center S.A. (“Ferring”), pursuant to which it granted Ferring an exclusive license in the United States market only, with rights to sublicense under patents related to our proprietary intravaginal culture device (INVOcell), together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including fertility treatment) in humans. On November 2, 2021, Ferring notified the Company of its intention to terminate the Ferring Agreement, which required 90-days prior written notice. Accordingly, the Ferring Agreement officially terminated on January 31, 2022. The Ferring license was deemed to be a functional license that provides a customer with a “right to access” to the Company’s intellectual property during the subscription period and accordingly, under ASC 606-10-55-60 revenue is recognized over a period of time, which is generally the subscription period. The initial upfront payment of $ 5,000,000 7 As of March 31, 2022, the Company had no deferred revenue related to the Ferring Agreement as it was recognized in the fourth quarter of fiscal year 2021 in relation to the contract termination. Per ASC 606-10-55-48 the likelihood of Ferring exercising its rights became remote at the time notice of termination was received so INVO recognized the full remaining amount of the deferred revenue. |
Stock Based Compensation | Stock Based Compensation The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period. |
Loss Per Share | Loss Per Share Basic loss per share calculations are computed by dividing net loss attributable to the Company’s common shareholders by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the three months ended March 31, 2022, and 2021, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss. Schedule of Earnings Per Share Basic and Diluted Three Months Ended March 31, 2022 2021 Net loss (numerator) $ (2,774,312 ) $ (2,453,469 ) Basic and diluted weighted-average number of common shares outstanding (denominator) 12,050,696 9,888,025 Basic and diluted net loss per common share (0.23 ) (0.25 ) The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive: Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share As of March 31, 2022 2021 Options 1,474,605 1,102,672 Convertible notes and interest - 160,504 Unit purchase options and warrants 260,165 216,193 Total 1,734,770 1,479,369 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption of any such pronouncements will have a material impact on its financial condition or the results of its operations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Earnings Per Share Basic and Diluted | Schedule of Earnings Per Share Basic and Diluted Three Months Ended March 31, 2022 2021 Net loss (numerator) $ (2,774,312 ) $ (2,453,469 ) Basic and diluted weighted-average number of common shares outstanding (denominator) 12,050,696 9,888,025 Basic and diluted net loss per common share (0.23 ) (0.25 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive: Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share As of March 31, 2022 2021 Options 1,474,605 1,102,672 Convertible notes and interest - 160,504 Unit purchase options and warrants 260,165 216,193 Total 1,734,770 1,479,369 |
Variable Interest Entities (Tab
Variable Interest Entities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Investments in Unconsolidated Variable Interest Entities | The following table summarizes our investments in unconsolidated VIEs: Schedule of Investments in Unconsolidated Variable Interest Entities Carrying Value as of Location Percentage Ownership March 31, 2022 December 31, 2021 HRCFG INVO, LLC Alabama, United States 50 % $ 1,332,574 1,387,495 Positib Fertility, S.A. de C.V. Mexico 33 % 161,569 102,439 Total investment in unconsolidated VIEs $ 1,494,143 1,489,934 |
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities | Earnings from investments in unconsolidated VIEs were as follows: Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities Three Months Ended March 31, 2022 2021 HRCFG INVO, LLC $ (54,920 ) - Positib Fertility, S.A. de C.V. (16,197 ) - Total earnings from unconsolidated VIEs $ (71,117 ) - |
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities | The following tables summarize the combined unaudited financial information of our investments in unconsolidated VIEs: Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities Three Months Ended March 31, 2022 2021 Statements of operations: Operating revenue $ 169,835 - Operating expenses (328,756 ) - Net loss $ (158,921 ) - March 31, 2022 December 31, 2021 Balance sheets: Current assets $ 474,379 456,967 Long-term assets 1,133,071 1,302,067 Current liabilities (407,425 ) (404,155 ) Long-term liabilities (146,515 ) (142,321 ) Net assets $ 1,053,510 1,212,558 |
Agreements and Transactions w_2
Agreements and Transactions with VIE’s (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Agreements And Transactions With Vies | |
Summary of Transaction with Variable Interest Entities | The following table summarizes the Company’s transactions with VIEs: Summary of Transaction with Variable Interest Entities Three Months Ended March 31, 2022 2021 Bloom Invo, LLC INVOcell revenue $ - - Unconsolidated VIEs INVOcell revenue $ 7,500 - |
Summary of Balances with Variable Interest Entities | The Company had balances with VIEs as follows: Summary of Balances with Variable Interest Entities March 31, 2022 December 31, 2021 Bloom Invo, LLC Accounts receivable $ 21,600 21,600 Notes payable 457,012 453,406 Unconsolidated VIEs Accounts receivable $ 23,810 16,310 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Components of inventory are: Schedule of Inventory March 31, 2022 December 31, 2021 Raw materials $ 77,909 $ 67,605 Finished goods 216,722 220,168 Total inventory $ 294,631 $ 287,773 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Estimated Useful Lives of Property and Equipment | The estimated useful lives and accumulated depreciation for equipment are as follows as of March 31, 2022, and December 31, 2021: Schedule of Estimated Useful Lives of Property and Equipment Estimated Useful Life Manufacturing equipment 6 10 Medical equipment 7 10 Office equipment 3 7 |
Schedule of Property and Equipment | Schedule of Property and Equipment March 31, 2022 December 31, 2021 Manufacturing equipment $ 132,513 $ 132,513 Medical equipment 282,811 275,423 Office equipment 75,589 74,891 Leasehold improvements 96,817 96,817 Less: accumulated depreciation (95,735 ) (78,208 ) Total equipment, net $ 491,995 $ 501,436 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | Components of intangible assets are as follows: Schedule of Finite-Lived Intangible Assets March 31, 2022 December 31, 2021 Trademarks $ 111,752 $ 110,842 Patents 95,355 95,355 Accumulated amortization (74,556 ) (74,104 ) Total patent costs, net $ 132,551 $ 132,093 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases | |
Schedule of Lease Components | As of March 31, 2022, the Company’s lease components included in the consolidated balance sheet were as follows: Schedule of Lease Components Lease component Balance sheet classification March 31, 2022 Assets ROU assets – operating lease Other assets $ 1,980,153 Total ROU assets $ 1,980,153 Liabilities Current operating lease liability Current liabilities $ 224,361 Long-term operating lease liability Other liabilities 1,844,784 Total lease liabilities $ 2,069,145 |
Schedule of Future Minimum Lease Payments | Future minimum lease payments as of March 31, 2022 were as follows: Schedule of Future Minimum Lease Payments 2022 $ 194,542 2023 264,108 2024 251,671 2025 247,960 2026 and beyond 1,316,245 Total future minimum lease payments $ 2,274,526 Less: Interest (205,381 ) Total operating lease liabilities $ 2,069,145 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of Stock Options Activity | The following table sets forth the activity of the options to purchase common stock under the 2019 Plan. Schedule of Stock Options Activity Number of Weighted Aggregate Outstanding as of December 31, 2021 1,055,894 $ 5.09 $ 133,022 Granted 418,711 3.78 - Exercised - - - Canceled - - - Balance as of March 31, 2022 1,474,605 $ 4.90 - Exercisable as of March 31, 2022 740,495 5.78 - |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions | The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions: Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions Three Months ended 2022 2021 Risk-free interest rate range 1.6 1.9 % 0.22 0.31 % Expected life of option-years 5.25 5.75 5.3 6.5 Expected stock price volatility 110.4 113.2 % 107.4 % Expected dividend yield - % - % |
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested | Schedule of Share Based Payments Arrangements Options Exercised and Options Vested Total Intrinsic Total Fair Year ended December 31, 2021 $ - $ 1,543,912 Three months ended March 31, 2022 $ - $ 428,488 |
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity | The following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the three months ended March 31, 2022: Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity Number of Unvested Shares Weighted Average Grant Date Aggregate Value of Shares Balance as of December 31, 2021 9,730 $ 3.72 $ 36,148 Granted 159,361 3.40 532,167 Vested (76,841 ) 3.52 (265,847 ) Forfeitures - - - Balance as of March 31, 2022 92,250 $ 3.39 $ 302,468 |
Unit Purchase Options and War_2
Unit Purchase Options and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Unit Purchase Options And Warrants | |
Schedule of Fair Value Measurement Inputs and Valuation Techniques | The fair value of the unit purchase options and warrants issued to the convertible debt holders is estimated as of the issue date using a Monte Carlo model with the following assumptions: Schedule of Fair Value Measurement Inputs and Valuation Techniques Risk-free interest rate range 0.33 0.39 % Stock price $ 3.00 3.95 Expected life of warrants and unit purchase options (years) 5.00 Expected stock price volatility 108.2 112.5 % Expected dividend yield 0 % |
Schedule of Unit Purchase Stock Options Activity | The following table sets forth the activity of unit purchase options: Schedule of Unit Purchase Stock Options Activity Number of Weighted Aggregate Outstanding as of December 31, 2021 92,893 $ 3.20 $ 5,647 Granted - - - Exercised - - - Canceled - - - Balance as of March 31, 2022 92,893 $ 3.20 $ - |
Schedule of Warrants Activity | The following table sets forth the activity of warrants: Schedule of Warrants Activity Number of Weighted Aggregate Outstanding as of December 31, 2021 167,272 $ 3.62 $ 16,029 Granted - - - Exercised - - - Canceled - - - Balance as of March 31, 2022 167,272 $ 3.62 $ - |
Schedule of Earnings Per Share
Schedule of Earnings Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Accounting Policies [Abstract] | ||
Net loss (numerator) | $ (2,774,312) | $ (2,453,469) |
Basic and diluted weighted-average number of common shares outstanding (denominator) | 12,050,696 | 9,888,025 |
Basic and diluted net loss per common share | $ (0.23) | $ (0.25) |
Schedule of Antidilutive Securi
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,734,770 | 1,479,369 |
Equity Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,474,605 | 1,102,672 |
Convertible Debt Securities [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 160,504 | |
Unit Purchase Option And Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 260,165 | 216,193 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) | Nov. 02, 2021USD ($) | Mar. 31, 2022USD ($)Segment | Mar. 31, 2021USD ($) |
Property, Plant and Equipment [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Impairment of intangible assets | $ 0 | $ 0 | |
Initial upfront payment | $ 5,000,000 | ||
Term of license | 7 years | ||
Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment estimated useful life | 3 | ||
Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment estimated useful life | 10 |
Liquidity (Details Narrative)
Liquidity (Details Narrative) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Net Income (Loss) Attributable to Parent | $ 2,774,312 | $ 2,453,469 | |
Retained Earnings (Accumulated Deficit) | 41,665,334 | $ 38,891,022 | |
[custom:NetIncomeLossRelatedToNonCashExpenses] | 900,000 | 1,400,000 | |
[custom:ProceedsFromPurchaseOptionAndWarrantExercises] | $ 400,000 | ||
Proceeds from Sale of Treasury Stock | $ 300,000 |
Schedule of Investments in Unco
Schedule of Investments in Unconsolidated Variable Interest Entities (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||
Investment in unconsolidated variable interest entities | $ 1,494,143 | $ 1,489,934 |
HRCFG INVO, LLC [Member] | ||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||
Ownership percentage | 50.00% | 50.00% |
Investment in unconsolidated variable interest entities | $ 1,332,574 | $ 1,387,495 |
Positib Fertility S.A. de C.V. [Member] | ||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||
Ownership percentage | 33.00% | 33.00% |
Investment in unconsolidated variable interest entities | $ 161,569 | $ 102,439 |
Schedule of Earnings from Inves
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||
Total earnings from unconsolidated VIEs | $ (71,117) | |
HRCFG INVO, LLC [Member] | ||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||
Total earnings from unconsolidated VIEs | (54,920) | |
Positib Fertility S.A. de C.V. [Member] | ||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | ||
Total earnings from unconsolidated VIEs | $ (16,197) |
Schedule of Financial Informati
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |||
Operating revenue | $ (2,700,938) | $ (1,559,792) | |
Net loss | (2,774,312) | (2,453,469) | |
Current assets | 4,421,391 | $ 6,305,865 | |
Current liabilities | (1,084,242) | (1,253,004) | |
Variable Interest Entity, Primary Beneficiary [Member] | |||
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] | |||
Operating revenue | 169,835 | ||
Operating expenses | (328,756) | ||
Net loss | (158,921) | ||
Current assets | 474,379 | 456,967 | |
Long-term assets | 1,133,071 | 1,302,067 | |
Current liabilities | (407,425) | (404,155) | |
Long-term liabilities | (146,515) | (142,321) | |
Net assets | $ 1,053,510 | $ 1,212,558 |
Variable Interest Entities (Det
Variable Interest Entities (Details Narrative) - USD ($) | Jun. 28, 2021 | Mar. 10, 2021 | Mar. 31, 2022 | Mar. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Variable interest entity ownership, percentage | 150.00% | |||
Net income loss | $ (2,774,312) | $ (2,453,469) | ||
Georgia JV [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Investment | 700,000 | |||
Notes receivable | 500,000 | |||
Net income loss | 200,000 | |||
Minority interest | 0 | |||
Alabama JV [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Investment | 1,700,000 | |||
Net income loss | 100,000 | |||
Loss from equity investment | 50,000 | |||
Mexico JV [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Investment | 200,000 | |||
Net income loss | 50,000 | |||
Loss from equity investment | $ 20,000 | |||
Bloom Invo LLC [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
[custom:VariableInterestEntityCommitmentContribution] | $ 1,200,000 | |||
[custom:VariableInterestEntityUnitsIssued] | 1,200 | |||
Bloom Invo LLC [Member] | Bloom Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
[custom:VariableInterestEntityCommitmentContribution] | $ 800,000 | |||
[custom:VariableInterestEntityUnitsIssued] | 800 | |||
Alabama JV [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Variable interest entity ownership, percentage | 50.00% |
Summary of Transaction with Var
Summary of Transaction with Variable Interest Entities (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Bloom Invo LLC [Member] | ||
INVOcell revenue | ||
Variable Interest Entity, Not Primary Beneficiary [Member] | ||
INVOcell revenue | $ 7,500 |
Summary of Balances with Variab
Summary of Balances with Variable Interest Entities (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Bloom Invo LLC [Member] | ||
Accounts receivable | $ 21,600 | $ 21,600 |
Notes payable | 457,012 | 453,406 |
Variable Interest Entity, Not Primary Beneficiary [Member] | ||
Accounts receivable | $ 23,810 | $ 16,310 |
Schedule of Inventory (Details)
Schedule of Inventory (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 77,909 | $ 67,605 |
Finished goods | 216,722 | 220,168 |
Total inventory | $ 294,631 | $ 287,773 |
Schedule of Estimated Useful Li
Schedule of Estimated Useful Lives of Property and Equipment (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Minimum [Member] | Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 6 years | 6 years |
Minimum [Member] | Medical Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 7 years | 7 years |
Minimum [Member] | Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 3 years | 3 years |
Maximum [Member] | Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Maximum [Member] | Medical Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Maximum [Member] | Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 7 years | 7 years |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Less: accumulated depreciation | $ (95,735) | $ (78,208) |
Total equipment, net | 491,995 | 501,436 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements | 132,513 | 132,513 |
Medical Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements | 282,811 | 275,423 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements | 75,589 | 74,891 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements | $ 96,817 | $ 96,817 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 15,095 | $ 2,527 |
Schedule of Finite-Lived Intang
Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Mar. 03, 2022 | Dec. 31, 2021 |
Indefinite-Lived Intangible Assets [Line Items] | ||
Accumulated amortization | $ (74,556) | $ (74,104) |
Total patent costs, net | 132,551 | 132,093 |
Patents [Member] | ||
Indefinite-Lived Intangible Assets [Line Items] | ||
Patents | 95,355 | 95,355 |
Trademarks [Member] | ||
Indefinite-Lived Intangible Assets [Line Items] | ||
Patents | $ 111,752 | $ 110,842 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of intangible assets | $ 452 | $ 452 |
Schedule of Lease Components (D
Schedule of Lease Components (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Assets | ||
ROU assets – operating lease | $ 1,980,153 | $ 2,037,052 |
Total ROU assets | 1,980,153 | |
Liabilities | ||
Current operating lease liability | 224,361 | 221,993 |
Long-term operating lease liability | 1,844,784 | $ 1,901,557 |
Total lease liabilities | $ 2,069,145 |
Schedule of Future Minimum Leas
Schedule of Future Minimum Lease Payments (Details) | Mar. 31, 2022USD ($) |
Leases | |
2022 | $ 194,542 |
2023 | 264,108 |
2024 | 251,671 |
2025 | 247,960 |
2026 and beyond | 1,316,245 |
Total future minimum lease payments | 2,274,526 |
Less: Interest | (205,381) |
Total operating lease liabilities | $ 2,069,145 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | Jun. 16, 2021 | Jul. 02, 2020 | Mar. 31, 2022 | Mar. 31, 2021 |
Short-Term Debt [Line Items] | ||||
Amortization of debt discount | $ 860,155 | |||
Paycheck Protection Program [Member] | ||||
Short-Term Debt [Line Items] | ||||
Principal amount | $ 157,620 | |||
Debt maturity date description | The loan matured 18 months from the date of funding, was payable over 18 equal monthly installments, and had an interest of 1% per annum | |||
Debt instrument description | Up to 100% of the principal balance of the loan was forgivable based upon satisfaction of certain criteria under the Paycheck Protection Program | |||
Debt instrument accrued interest | $ 1,506 | |||
Extinguishment of debt | 159,126 | |||
2020 Convertible Notes Payable [Member] | ||||
Short-Term Debt [Line Items] | ||||
Principal amount | $ 3,494,840 | |||
Interest rate | 10.00% | |||
Debt maturity date description | the maturity dates of November 15, 2021, December 22, 2021, and December 30, 2021 | |||
Conversion price | $ 3.20 | |||
Interest expense, debt | 0 | 35,070 | ||
Amortization of debt discount | 0 | 161,339 | ||
Amortization of warrant discount | 0 | 163,580 | ||
Amortization of beneficial conversion feature | 0 | 461,120 | ||
Amortization of debt issuance costs | $ 0 | $ 74,116 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) | 1 Months Ended |
Oct. 31, 2021USD ($)shares | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
Amounts of transaction | $ 323,584 |
Chief Executive Officer and Chief Financial Officer [Member] | |
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items] | |
Number of shares issued | shares | 30,674 |
Proceeds from related party | $ 199,994 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | Oct. 02, 2021 | Nov. 20, 2020 | Nov. 18, 2020 | Nov. 17, 2020 | Nov. 12, 2020 | Nov. 05, 2020 | Oct. 22, 2020 | May 21, 2020 | Feb. 19, 2020 | Dec. 16, 2019 | Jan. 31, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Reverse stock split | 5-for-8 | |||||||||||||
Common stock, shares authorized | 125,000,000 | 125,000,000 | ||||||||||||
Reverse stock splits, shares issued | 133 | |||||||||||||
Proceeds from issuance of common stock | $ 315,000 | |||||||||||||
Stock issued during period value | $ 66,850 | $ 221,250 | ||||||||||||
Common Stock [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Number of new stock issued during the period | 94,623 | |||||||||||||
Proceeds from issuance of common stock | $ 315,000 | |||||||||||||
Number of stock issued for service | 21,500 | 71,500 | ||||||||||||
Stock issued during period value | $ 2 | $ 7 | ||||||||||||
Number of shares granted to employees | 86,333 | |||||||||||||
Amortized fair value of stock | $ 40,474 | |||||||||||||
Common Stock [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Shares vesting percentage | 50.00% | |||||||||||||
Common Stock [Member] | Share-Based Payment Arrangement, Tranche Two [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Shares vesting percentage | 50.00% | |||||||||||||
2019 Stock Incentive Plan [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Number of shares granted to employees | 715,749 | |||||||||||||
IPO [Member] | Underwriting Agreement [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Number of new stock issued during the period | 3,625,000 | 3,625,000 | ||||||||||||
Share price | $ 3.20 | |||||||||||||
Number of additional purchase shares of common stock | 528,750 | |||||||||||||
Proceeds from issuance of common stock | $ 1,500,000 | |||||||||||||
Sale of stock, number of shares issued in transaction | 4,153,750 | |||||||||||||
Sale of stock, consideration received on transaction | $ 11,800,000 | |||||||||||||
Board of Directors [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Reverse stock split | 5-for-8 | 1-for-20 | 1-for-20 | 1-for-5 and 1-for-25 | ||||||||||
Common stock, shares authorized | 200,000,000 | 125,000,000 | ||||||||||||
Investors [Member] | IPO [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Sale of stock, number of shares issued in transaction | 1,240,737 | |||||||||||||
Sale of stock, consideration received on transaction | $ 4,044,803 | |||||||||||||
Sale of stock, price per share | $ 3.26 | |||||||||||||
Net proceeds from offering | $ 3,650,000 | |||||||||||||
Amount of fee received | $ 323,584 | |||||||||||||
Warrants to purchase shares | 37,222 | |||||||||||||
Warrant excercise price per share | $ 3.912 | |||||||||||||
Employees and Directors [Member] | 2019 Stock Incentive Plan [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Number of stock issued for service | 51,528 | |||||||||||||
Stock issued during period value | $ 186,000 | |||||||||||||
Consultant [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Number of stock issued for service | 3,000 | |||||||||||||
Stock issued during period value | $ 9,480 | |||||||||||||
Consultant [Member] | 2019 Stock Incentive Plan [Member] | ||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||
Number of stock issued for service | 18,500 | |||||||||||||
Stock issued during period value | $ 57,370 |
Schedule of Stock Options Activ
Schedule of Stock Options Activity (Details) | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Equity [Abstract] | |
Number of Shares, Options Outstanding, Beginning balance | shares | 1,055,894 |
Weighted Average Exercise Price, Options Outstanding, Beginning balance | $ / shares | $ 5.09 |
Aggregate Intrinsic Value, Options Outstanding, Beginning balance | $ | $ 133,022 |
Number of Shares, Options Outstanding, Granted | shares | 418,711 |
Weighted Average Exercise Price, Options Outstanding, Granted | $ / shares | $ 3.78 |
Number of Shares, Options Outstanding, Exercised | shares | |
Weighted Average Exercise Price, Options Outstanding, Exercised | $ / shares | |
Number of Shares, Options Outstanding, Canceled | shares | |
Weighted Average Exercise Price, Options Outstanding, Canceled | $ / shares | |
Number of Shares, Options Outstanding, Ending balance | shares | 1,474,605 |
Weighted Average Exercise Price, Options Outstanding, Ending balance | $ / shares | $ 4.90 |
Aggregate Intrinsic Value, Options Outstanding, Ending balance | $ | |
Number of Shares, Options Exercisable, Ending balance | shares | 740,495 |
Weighted Average Exercise Price, Options Exercisable, Ending balance | $ / shares | $ 5.78 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value | $ |
Schedule of Share-Based Payment
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions (Details) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum | 1.60% | 0.22% |
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Maximum | 1.90% | 0.31% |
Expected stock price volatility, minimum | 110.40% | |
Expected stock price volatility, maximum | 113.20% | |
Expected stock price volatility | 107.40% | |
Expected dividend yield | ||
Minimum [Member] | ||
Expected life of option-years | 5 years 3 months | 5 years 3 months 18 days |
Maximum [Member] | ||
Expected life of option-years | 5 years 9 months | 6 years 6 months |
Schedule of Share Based Payment
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Equity [Abstract] | ||
Total Intrinsic Value of Options Exercised | ||
Total Fair Value of Options Vested | $ 428,488 | $ 1,543,912 |
Schedule of Aggregate Restricte
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity (Details) | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Equity [Abstract] | |
Number of Unvested Shares, Beginning balance | shares | 9,730 |
Weighted Average Exercise Price, Beginning balance | $ / shares | $ 3.72 |
Aggregate Value of Unvested Shares, Beginning balance | $ | $ 36,148 |
Number of Unvested Shares, Granted | shares | 159,361 |
Weighted Average Exercise Price, Granted | $ / shares | $ 3.40 |
Aggregate Value of Unvested Shares, Granted | $ | $ 532,167 |
Number of Unvested Shares, Vested | shares | (76,841) |
Weighted Average Exercise Price, Vested | $ / shares | $ 3.52 |
Aggregate Value of Unvested Shares, Vested | $ | $ (265,847) |
Number of Unvested Shares, Forfeitures | shares | |
Weighted Average Exercise Price, Forfeitures | $ / shares | |
Aggregate Value of Unvested Shares, Forfeitures | $ | |
Number of Unvested Shares, Ending balance | shares | 92,250 |
Weighted Average Exercise Price, Ending balance | $ / shares | $ 3.39 |
Aggregate Value of Unvested Shares, Ending balance | $ | $ 302,468 |
Equity-Based Compensation (Deta
Equity-Based Compensation (Details Narrative) - $ / shares | 3 Months Ended | |||
Mar. 31, 2022 | Mar. 31, 2021 | Jan. 31, 2022 | Oct. 31, 2019 | |
Share-Based Payment Arrangement [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Options granted per share | $ 3.08 | |||
Weighted average remaining service period | 1 year 3 months 18 days | |||
Restricted Stock [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Vesting period | one year | |||
Restricted Stock [Member] | Consultants [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 156,361 | |||
2019 Stock Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 2,087,198 | 500,000 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Description | A provision in the 2019 Plan provides for an automatic annual increase equal to 6% of the total number of shares of Company common stock outstanding on December 31 of the preceding calendar year. | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 715,749 | |||
Vesting period | three-year | |||
2019 Stock Incentive Plan [Member] | Minimum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Options life | 3 years | |||
2019 Stock Incentive Plan [Member] | Maximum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Options life | 10 years |
Schedule of Fair Value Measurem
Schedule of Fair Value Measurement Inputs and Valuation Techniques (Details) | Mar. 31, 2022$ / shares |
Measurement Input, Expected Term [Member] | |
Expected life of warrants and unit purchase options (years) | 5 years |
Measurement Input, Expected Dividend Rate [Member] | |
Warrants measurement input | 0 |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
Warrants measurement input | 0.33 |
Minimum [Member] | Measurement Input, Share Price [Member] | |
Stock Price | $ 3 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | |
Warrants measurement input | 108.2 |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
Warrants measurement input | 0.39 |
Maximum [Member] | Measurement Input, Share Price [Member] | |
Stock Price | $ 3.95 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | |
Warrants measurement input | 112.5 |
Schedule of Unit Purchase Stock
Schedule of Unit Purchase Stock Options Activity (Details) | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Options Outstanding, Beginning balance | shares | 1,055,894 |
Weighted Average Exercise Price, Options Outstanding, Beginning balance | $ 5.09 |
Aggregate Intrinsic Value, Options Outstanding, Beginning balance | $ | $ 133,022 |
Number of unit purchase options, granted | shares | 418,711 |
Weighted average exercise price, granted | $ 3.78 |
Number of unit purchase options, canceled | shares | |
Weighted average exercise price, canceled | |
Number of Shares, Options Outstanding, Ending balance | shares | 1,474,605 |
Weighted Average Exercise Price, Options Outstanding, Ending balance | $ 4.90 |
Aggregate Intrinsic Value, Options Outstanding, Ending balance | $ | |
Unit Purchase Options [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Options Outstanding, Beginning balance | shares | 92,893 |
Weighted Average Exercise Price, Options Outstanding, Beginning balance | $ 3.20 |
Aggregate Intrinsic Value, Options Outstanding, Beginning balance | $ | $ 5,647 |
Number of unit purchase options, granted | shares | |
Weighted average exercise price, granted | |
Aggregate intrinsic value, granted | |
Number of unit purchase options, exercised | shares | |
Weighted average exercise price, exercised | |
Aggregate intrinsic value, exercised | $ | |
Number of unit purchase options, canceled | shares | |
Weighted average exercise price, canceled | |
Aggregate intrinsic value, canceled | |
Number of Shares, Options Outstanding, Ending balance | shares | 92,893 |
Weighted Average Exercise Price, Options Outstanding, Ending balance | $ 3.20 |
Aggregate Intrinsic Value, Options Outstanding, Ending balance | $ |
Schedule of Warrants Activity (
Schedule of Warrants Activity (Details) | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Unit Purchase Options And Warrants | |
Number of warrants, outstanding, beginning balance | shares | 167,272 |
Weighted average exercise price, outstanding, beginning balance | $ / shares | $ 3.62 |
Aggregate intrinsic value, outstanding, beginning balance | $ | $ 16,029 |
Number of warrants, granted | shares | |
Weighted average exercise price, granted | $ / shares | |
Aggregate intrinsic value, granted | $ | |
Number of warrants, exercised | shares | |
Weighted average exercise price, exercised | $ / shares | |
Aggregate intrinsic value, exercised | $ | |
Number of warrants, canceled | shares | |
Weighted average exercise price, canceled | $ / shares | |
Aggregate intrinsic value, canceled | $ | |
Number of warrants, outstanding, ending balance | shares | 167,272 |
Weighted average exercise price, outstanding, ending balance | $ / shares | $ 3.62 |
Aggregate intrinsic value, outstanding, ending balance | $ |
Unit Purchase Options and War_3
Unit Purchase Options and Warrants (Details Narrative) - 2020 Convertible Notes Payable [Member] | Mar. 31, 2022$ / sharesshares |
Warrant [Member] | |
Warrants to purchase | shares | 1 |
Warrants exercise price | $ / shares | $ 3.20 |
Warrant term | 5 years |
Warrant [Member] | Tribal Capital Markets L L C [Member] | |
Warrants to purchase | shares | 6,750 |
Warrants exercise price | $ / shares | $ 3.20 |
Warrant term | 5 years |
Unit Purchase Options [Member] | |
Number of unit option issued | shares | 303,623 |
Shares Issued, Price Per Share | $ / shares | $ 3.20 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 0 | $ 0 |
Income tax rate | 0.00% |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - Subsequent Event [Member] | May 13, 2022 |
Subsequent Event [Line Items] | |
Subsequent event description | The Onesky Agreement became effective on May 13, 2022, and will remain in effect for a period of five years after the date of National Medical Products Administration approval and automatically renews for successive two year period unless written notice is given by either party 90 days’ prior to the expiry of any term. If either party defaults in the performance of any of its obligations under the Onesky Agreement, including Onesky’s minimum purchase obligations, the other party may give written notice of default and the other party has 30 days to cure. If such default is not cured, then the Onesky Agreement may be terminated immediately thereafter. |
Debt instrument term | 5 years |