UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Nevada 20-4036208 (I.R.S. Employer Identification No.) (State or other jurisdiction of incorporation or organization) 407 Rear Mystic Avenue, Suite 34C, Medford, MA 02155 (Address of principal executive offices, including zip code) For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

Market Opportunity - There are over 150 million infertile couples globally, with only 1.5 million ART cycles performed annually, indicating a significant unmet market opportunity [31]. - The infertility treatment market is valued at approximately $6.6 billion annually, with a large portion of the market remaining untreated [33]. - The global need for ART is estimated at 1,500 cycles per million population per year, indicating a significant market opportunity for INVOcell [67]. - INVO Bioscience estimates that there are approximately 10 million infertile couples in Europe, with only about 800,000 receiving ART treatments, leaving over 9 million untreated [69]. - The company aims to penetrate 5% of the currently untreated infertility market in the U.S., which consists of over six million couples [68]. Product Overview - The INVOcell device offers a lower-cost infertility treatment option, costing less than half of traditional IVF treatments [27]. - The INVOcell device has demonstrated clinical pregnancy rates of 60% and live birth rates of 55% in U.S. clinical studies [34]. - The INVO procedure can be performed in a physician's office, avoiding the costs associated with IVF facilities [29]. - The INVOcell device is designed to provide a less expensive and simpler alternative to conventional IVF treatments, potentially increasing accessibility for patients [256]. - The INVOcell procedure requires approximately $100,000 in laboratory capital equipment, compared to at least $500,000 for traditional IVF setups [50]. Financial Performance - Total revenue for the year ended December 31, 2018, was $494,375, an increase of 75.2% compared to $282,145 for the year ended December 31, 2017 [248]. - Gross margin for 2018 was $404,008, representing a gross margin percentage of approximately 81.7% compared to 81.7% in 2017 [248]. - Net loss for the year ended December 31, 2018, was $3,076,091, significantly higher than the net loss of $702,163 for the previous year, indicating a 338.5% increase in losses [248]. - Total current assets increased to $731,109 as of December 31, 2018, compared to $234,385 as of December 31, 2017, reflecting a growth of 211.5% [246]. - Cash and cash equivalents at the end of the period increased to $212,243 from $25,759, marking an increase of 726.5% [253]. Regulatory and Distribution Agreements - The INVOcell device has received FDA clearance and is in the process of re-certifying the CE Mark for distribution in Europe [36][42]. - The company entered into a Distribution & Supply Agreement with Ferring, receiving an initial payment of $5 million and a potential second payment of $3 million [39]. - The company entered into a Distribution Agreement with Ferring on November 12, 2018, granting exclusive rights for the INVOcell device in the U.S. market [259]. - The FDA approval granted in 2015 allows INVO Bioscience to register and market INVO in countries such as Mexico, Australia, and China, expanding its international reach [72]. - The CE Mark, currently being renewed, enables the sale of the INVO device in Europe and certain South American and African countries, addressing the need for less costly fertility treatments [73]. Operational Developments - As of December 31, 2018, the company had approximately 100 INVOcell devices ready for sale and 3,600 in the assembly, sterilization, and packaging phase [34]. - The company plans to build five new centers in the U.S. to meet demand for the INVO procedure [65]. - Since receiving FDA clearance, over 3,800 INVOcells have been shipped in the U.S., with an additional 500 shipped internationally [57]. - The company has validated its manufacturing processes and is utilizing medical-grade materials for the INVOcell device [34]. - The company retained all commercialization rights for the INVOcell device outside of the United States, allowing for potential international market expansion [259]. Challenges and Risks - In the U.S., minimal insurance coverage for infertility treatments exists, with only 15 states mandating some form of reimbursement, impacting patient access to services [74]. - The company has generated minimal revenues and incurred significant expenses, indicating ongoing financial challenges as it establishes its business [258]. - The company had a working capital deficiency of $2,770,000 and a stockholder deficiency of $2,724,000 as of December 31, 2018, raising substantial doubt about its ability to continue as a going concern [290]. - The company reported a net loss of $3,076,091 for the year ended December 31, 2018, compared to a loss of $702,163 in 2017 [270]. Shareholder and Stock Information - The basic and diluted weighted-average number of common shares outstanding increased to 147,333,051 in 2018 from 141,305,050 in 2017 [270]. - The company issued 3,020,000 shares of common stock with a fair value of $1,540,000 to Dr. Kevin Doody for services previously provided [314]. - The Company issued 887,306 shares of common stock with a fair value of $349,602 to employees and service providers in December 2018 [316]. - The Company had no outstanding or committed stock options or warrants as of December 31, 2018 [321][322]. - The Company issued 793,335 shares of common stock for conversion of notes payable and accrued interest totaling $158,667 in December 2018 [316].