{"url_path":"/sec/ivf/10-k/2026/item-1","section_key":"item-1","section_title":"Item 1 Business**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-06-02","source_url":"https://www.sec.gov/Archives/edgar/data/1417926/0001493152-26-026775-index.html","accession_number":"0001493152-26-026775","cik":"0001417926","ticker":"IVF","issuer_name":"INVO Fertility, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1417926/0001493152-26-026775-index.html","primary_entity_key":"0001417926","primary_entity_name":"INVO Fertility, Inc."},"word_count":8012,"has_tables":true,"body_markdown":"**Item\n1. Business**\n\n \n\n**Introduction**\n\n \n\nThis\nAnnual Report on Form 10-K should be read together and in connection with the other reports that have been filed by us with the SEC for\na comprehensive description of our financial condition and operating results. In the interest of disclosure, we have included in this\nForm 10-K certain material events and developments that have taken place through the date of filing of this Form 10-K with the SEC.\n\n \n\nIn\nthis Annual Report on Form 10-K, INVO Fertility, Inc., (INVO Fertility, Inc., together with its subsidiaries, is referred to in this\ndocument as “we”, “us”, “INVO Fertility”, “INVO”, or the “Company”), incorporates\nby reference certain information from parts of other documents filed with the SEC. The SEC allows us to disclose important information\nby referring to it in that manner. Please refer to all such information when reading this Annual Report on Form 10-K. All information\nis as of December 31, 2025, unless otherwise indicated. For a description of the risk factors affecting or applicable to our business,\nsee “Risk Factors,” below.\n\n \n\n**The\nCompany**\n\n \n\nWe\nare a healthcare services and technology company focused on the fertility marketplace and dedicated to expanding access to assisted\nreproductive technology (“ART”) care to patients in need. Our principal commercial strategy is focused on acquiring,\nestablishing, and operating fertility clinics and related businesses and technologies. Our acquisition strategy focuses on US-based,\nprofitable fertility clinics. Our clinics offer a variety of fertility services including in vitro fertilization (“IVF”)\nand the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”). As\nof the date of this filing, we have four fertility clinics in the United States. We also continue to engage in the sale and\ndistribution of our INVOcell technology solution into third-party owned and operated fertility clinics. We also intend to seek out\nadditional, innovative fertility-focused technologies, to license or acquire in order to utilize within our clinics.\n\n \n\n*Fertility\nClinics*\n\n \n\nOn February 18, 2026, we completed our acquisition\nof Family Beginnings, an Indiana based fertility clinic that offers both IVF and IVC. (See below in Recent Developments for additional\ninformation on the acquisition of Family Beginnings.)\n\n \n\nOn\nAugust 10, 2023, we consummated the first acquisition of an existing fertility clinic, the Wisconsin Fertility Institute (“WFI”).\nAs an established and profitable clinic, the closing of the WFI acquisition more than tripled our annual revenue and became a major part\nof our clinic-based operations. The acquisition accelerated our transformation from a medical device company to a healthcare services\ncompany and immediately added scale and a significant source of positive cash flow to our operations. The acquisition of profitable fertility\nclinics complements our efforts to build new INVO Centers, and we expect to continue this strategy to accelerate overall growth.\n\n \n\nOn\nMarch 10 and June 28, 2021, we established joint ventures to open INVO Centers in Birmingham, Alabama, and Atlanta, Georgia,\nrespectively. We established these clinics to increase use of the INVOcell, to accelerate the growth and awareness of the IVC\nprocedure and to expand the availability of statistical and clinical data supporting its use. These clinics also represent our\ninitial entry into clinic-based fertility operations and enabled us to expand our revenue per fertility cycle from hundreds of\ndollars (from the sale of each INVOcell device) to thousands of dollars, and to significantly advance our path to\nbuilding greater scale in our overall operations and to reaching profitability.\n\n \n\n4\n\n \n\n \n\n*INVOcell\nDevice*\n\n \n\nOur proprietary INVOcell® device enables\nfertilization and early embryo development to occur in vivo within the woman’s body - the world’s first intravaginal\nculture (“IVC”) technique of its kind. Unlike IVF, which relies on expensive laboratory incubators, the INVOcell allows\nfertilization and early embryo development to take place in the woman’s body and has demonstrated equivalent pregnancy success\nand live birth rates as IVF.\n\n \n\nWhile INVOcell remains part of our efforts, our strategy\nhas expanded to focus more broadly on providing ART services through clinic operations.\n\n \n\n**Recent\nDevelopments**\n\n \n\n*JAG\nAmendment*\n\n* *\n\nOn\nMay 27, 2026, we entered into a letter agreement (the “JAG May 2026 Letter”) with JAG Multi Investments LLC (“JAG”)\npursuant to which (i) the maturity date of certain previously issued convertible notes with a principal balance of $660,000 (the “JAG\nNotes”) was extended until December 31, 2026, (ii) we agreed to repay the JAG Notes in monthly installments of $50,000 starting\nin April 2026 with a balloon payment at the end of December 2026, (iii) confirmation that if we raise more than $3,000,000 after the\ndate of the JAG May 2026 Letter, we shall pay ten percent (10%) of any proceeds in excess of $3,000,000 to accelerate repayment of the\nJAG Notes, (iv) the conversion price of the JAG Notes was reset to $1.60, (v) we agreed to issue to JAG a new warrant (the “JAG\nMay 2026 Warrant”) to purchase up to 150,000 shares of our common stock at an exercise price of $1.60 per share, exercisable for\nfive years from the date of issuance, and (vi) we agreed to the reset of the conversion and exercise prices of the JAG Notes and JAG\nMay 2026 Warrant, respectively, to equal the price of any future financing based on a share price that is lower than the conversion and\nexercise prices then in effect.\n\n \n\n*Nasdaq*\n\n \n\nOn April 23, 2026, we received a letter (the “10-K\nLetter”) from the Listing Qualifications staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating\nthat we failed to file our Annual Report on Form 10-K for the year ended December 31, 2025 (the “10- K Filing”), on a timely\nbasis and, as such, no longer satisfies Nasdaq Listing Rule 5250(c)(1) (the “Timely Filing Rule”)\n\n \n\nOn May 27, 2026 we receive an additional letter (the\n“10-Q Letter”) from the Staff indicating that we failed to file our Quarterly Report on Form 10-Q for the period ended March\n31, 2026 (the “10-Q Filing”), on a timely basis.\n\n \n\nNeither letter had an immediate effect on the listing\nof our common stock.\n\n \n\nBoth letters also stated that, in accordance with Nasdaq rules, we have 60 calendar days from the date of the 10-K\nLetter to submit a plan to regain compliance with the Timely Filing Rule. Should the Staff accept such plan, it could grant an exception\nof up to 180 calendar days from the 10-K Filing’s due date, or until October 13, 2026, to regain compliance.\n\n \n\n*Reverse Stock Split (March 2026)*\n\n \n\nOn March 25, 2026, we filed a certificate of change\nwith the Secretary of State of Nevada to effectuate a reverse split of our common stock at a ratio of 1-for-5, and our authorized common\nstock was proportionately reduced to 50,000,000 shares from 250,000,000 shares. The reverse stock split took effect on March 27, 2026.\nAll share information included in this Form 10-K has been reflected as if the reverse stock split occurred as of the earliest period presented\n\n \n\n*Closing\nof Family Beginnings Acquisition*\n\n \n\nOn\nFebruary 18, 2026, we completed the acquisition of Family Beginnings P.C., a fertility clinic located in Indianapolis, Indiana. The\ntransaction was executed through our wholly owned subsidiary Wood Violet Fertility, LLC (“Wood Violet”). The total\npurchase price was approximately $760,000, consisting of $360,000 in cash, of which $210,000 was paid at closing, and $400,000 in Series D Preferred\nStock.\n\n \n\nAs\npart of the acquisition structure, we acquired the clinic’s non-medical business assets through Wood Violet, while\nthe clinic’s medical assets were acquired by Fertility, P.A., which entered into a long-term Management Services Agreement with\nWood Violet. Under this agreement, Wood Violet will provide management, administrative, laboratory, and operational support services\nto the clinic for an initial 10-year term, renewable for additional five-year periods. Fertility, P.A. agreed to reimburse Wood Violet for costs incurred in providing such services plus twenty percent\n(20%).\n\n \n\nIn\nconnection with the acquisition, we also entered into a lease for approximately 4,387 square feet of clinic and office space in Indianapolis,\neffective March 1, 2026, with an initial term through July 31, 2033.\n\n \n\nFounded\nmore than a decade ago, Family Beginnings has built a strong reputation for delivering comprehensive fertility services with a highly\npersonalized, patient-first approach. The clinic offers a full suite of reproductive services, including in vitro fertilization, intravaginal\nculture (as an early adopter of our INVOcell solution), ovulation induction, intrauterine insemination, fertility preservation, and diagnostic\ntesting, supported by an experienced clinical and embryology team. The acquisition expands INVO’s clinical footprint and is expected\nto support continued growth of our fertility services platform.\n\n \n\n*Warrant\nInducement (January 2026)*\n\n \n\nOn January 28, 2026, we entered into an inducement\nletter agreement (the “January 2026 Inducement Letter Agreement”) with an institutional investor and existing holder (the\n“Holder”) of the Common Warrants (as defined below).\n\n \n\nThe issuance of the shares of common stock upon exercise\nof such the Common Warrants was registered pursuant to a registration statement on Form S-1 (File No. 333-292206), which was declared\neffective by the SEC on December 29, 2025.\n\n \n\nPursuant to the January 2026 Inducement Letter Agreement,\nthe Holder agreed to exercise the Common Warrants for cash at the exercise price of $7.95 per share in consideration for our agreement\nto issue new unregistered warrants to purchase up to an aggregate of 1,893,492 shares of common stock at an exercise price of $7.95 per\nshare. Such new warrants will become exercisable upon receipt of such approval as may be required by the applicable rules and regulations\nof the Nasdaq Capital Market (or any successor entity) from the stockholders of INVO with respect to issuance of all of such new warrants\nand the shares of common stock upon the exercise thereof and have a term of five and one-half years from the date stockholder approval\nis obtained.\n\n \n\nWe registered the resale of the shares underlying such new warrants pursuant to a registration statement on Form\nS-1 (File No. 333-293135), which was declared effective by the SEC on February 12, 2026, and we agreed to observe customary limitations on\nadditional issuances of common stock and variable-rate financing arrangements for a limited period following the warrant inducement\ntransaction.\n\n \n\nThe aggregate gross proceeds to us from the exercise\nof such existing warrants was approximately $7.5 million, before deducting offering expenses payable by us.\n\n \n\nMaxim\nGroup LLC (“Maxim”) acted as our financial advisor in connection with the inducement transaction.\n\n \n\n5\n\n \n\n \n\n*Increase\nin Authorized Common Stock (Jan 2026)*\n\n \n\nOn\nJanuary 22, 2026, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase our number\nof authorized shares of common stock from 6,250,000 to 250,000,000 and we filed a Certificate of Amendment to our Articles of Incorporation\nto increase our authorized shares of common stock for the same.\n\n \n\n*Private\nPlacement (December 2025)*\n\n \n\nOn\nDecember 2, 2025, we entered into a securities purchase agreement with an institutional investor for a private placement of approximately\n$4.0 million in securities, comprised of 47,000 shares of Common Stock, pre-funded warrants to purchase 426,373 shares of Common Stock\n(the “Pre-Funded Warrants”), and common warrants to purchase 946,746 shares of Common Stock (the “Common Warrants”).\nThe Common Warrants became exercisable on January 22, 2026 upon receipt of approval from the stockholders of INVO to increase the number of authorized shares of common stock available for issuance\nthereunder and as required by the applicable rules and regulations\nof the Nasdaq Capital Market (or any successor entity) with respect to issuance of all of such new warrants\nand the shares of common stock upon the exercise thereof, expired five years thereafter, and carried an exercise price of $8.45 per share.\nThe Pre-Funded Warrants were immediately exercisable at $0.0005 per share until exercised in full.\n\n \n\nIn\nconnection with the foregoing private placement, we entered into a placement agency agreement with Maxim on a reasonable best efforts\nbasis, pursuant to which we agreed to pay the Placement Agent a fee equal to 8.0% of gross proceeds, warrants to purchase 23,669 shares\nof Common Stock at $10.5625 per share, and reimbursement of expenses up to $50,000.\n\n \n\nNet\nproceeds from the private placement are being used to support our growth and liquidity needs, including funding a portion of the Family\nBeginnings P.C. acquisition, paying certain outstanding debt obligations, and providing additional working capital.\n\n \n\n*Reverse\nStock Split (Nov 2025)*\n\n \n\nOn\nNovember 26, 2025, we filed a certificate of change with the Secretary of State of Nevada to effectuate a reverse split of our common\nstock at a ratio of 1-for-8, and our authorized common stock was proportionately reduced to 6,250,000 shares from 50,000,000 shares.\nThe reverse stock split took effect on November 28, 2025. All share information included in this Form 10-K has been reflected as if the\nreverse stock split occurred as of the earliest period presented.\n\n \n\n*Pritts\nLitigation and Binding Settlement Term Sheet*\n\n \n\nOn\nMay 7, 2025, Dr. Elizabeth Pritts (“Dr. Pritts”) and the Elizabeth Pritts Revocable Living Trust (the “Pritts Trust”)\nfiled a complaint in the Circuit Court of the State of Wisconsin, Dane County, against us and our subsidiaries INVO CTR, Wisconsin Fertility\nand Reproductive Surgery Associates, S.C., and Wood Violet Fertility LLC (“Wood Violet”). Dr. Pritts and the Pritts Trust\nhave asserted causes of action arising out of the WFI acquisition documents (the “WFI Documents”) for breach of contract,\nbreach of the implied covenant of good faith and fair dealing, tortious interference with contract (or, in the alternative, veil piercing),\nand unjust enrichment.\n\n \n\n6\n\n \n\n \n\nOn\nMay 14, 2025, INVO, Dr. Pritts, the Pritts Trust, and certain of their respective affiliates entered into binding term sheet (the “Term\nSheet”) to settle all disputes between the parties pursuant to the terms set forth in the Term Sheet (the “Terms”).\nThe parties agreed to cooperate in good faith to prepare and enter into a final settlement agreement (the “Settlement Agreement”)\nbased on the terms set forth in the Term Sheet; provided, however, that unless and until the Settlement Agreement is executed, the Terms\nare binding on the parties. Under the Terms, Wood Violet agreed to pay Dr. Pritts $6,000,000 in full and final settlement and satisfaction\nof all obligations to Dr. Pritts and her affiliates under the WFI Documents, of which $525,000 was paid concurrently with the execution\nof the Term Sheet, and the remainder of which is payable as follows: $475,000 due June 30, 2025, $750,000 due September 30, 2025, $750,000\ndue December 31, 2025, $1,000,000 due March 31, 2026, $2,000,000 due June 30, 2026, and $500,000 due December 31, 2026. INVO shall provide\nWood Violet with use of 25% of all gross funding proceeds above $2,000,000 raised within any six-month period to accelerate the payment\nof scheduled settlement payments in chronological order. The parties will enter into a consent judgment to resolve the complaint that\nwould come into effect upon any breach of the Settlement Agreement. The parties agreed to settle all disputes, including those related\nto employment, acquisition, tax, and related matters, the termination of all employment, consulting, and similar agreements with Dr Pritts,\nand other customary terms, including, without limitation, indemnification and release of claims. On September 30, 2025 we executed the\nSettlement Agreement.\n\n \n\n*FNL\nFinancing Transactions*\n\n* *\n\nOn\nOctober 11, 2024, we issued a 7.0% Senior Secured Convertible Debenture in the principal amount of $3,934,146, due December 11, 2025\n(the “Debenture”), to Five Narrow Lane LP (“FNL”). We became a party to that certain Securities Purchase Agreement,\ndated as of January 3, 2024, between FNL and NAYA Therapeutics Inc. (formerly known as NAYA Biosciences, Inc.) (the “Securities\nPurchase Agreement”), pursuant to a joinder agreement (the “Joinder Agreement”) on October 11, 2024. FNL was entitled\nto convert any portion of the outstanding principal and accrued interest into shares of our common stock at a conversion price of $1,339.992\nper share, subject to adjustment, following stockholder approval, provided that conversion could not result in FNL beneficially owning\nmore than 4.99% of our outstanding common stock. Commencing March 14, 2025, we were required to redeem $437,127.24 of principal, plus\naccrued interest, on the 14th of each month until maturity.\n\n \n\nEffective\nMay 23, 2025, we entered into an agreement with FNL (the “May 2025 Amendment and Exchange Agreement”), pursuant to which\nthe parties agreed to (a) exchange outstanding shares of our Series C-1 Convertible Preferred Stock (the “Series C-1 Preferred”)\nheld by FNL for shares of our Series C-2 Convertible Preferred Stock (the “Series C-2 Preferred”), (b) amend the Series C-2\nCertificate of Designation pursuant to a certificate of amendment (the “Certificate of Amendment to the Series C-2 Certificate\nof Designation”), (c) exchange the Debenture for an Amended and Restated Senior Secured Convertible Debenture due February 11,\n2026 (the “Amended and Restated Debenture”), and (d) amend the Securities Purchase Agreement to grant FNL the right (the\n“Additional Investment Right”), exercisable at any time and from time to time beginning on or after May 23, 2025, to purchase\nup to $10,000,000 of aggregate stated value of additional shares of Series C-2 Preferred (the “AIR Preferred Shares”), exercisable\nin minimum amounts of $500,000. The AIR Preferred Shares carry the same terms as the Series C-2 Preferred then outstanding, except that\nthe conversion price upon issuance is deemed to be the lowest of (i) the conversion price then in effect, and (ii) the greater of (x)\nthe Floor Price (as defined in the Certificate of Amendment to the Series C-2 Certificate of Designation) and (y) 85% of the arithmetic\naverage of the three lowest VWAPs during the ten trading days prior to exercise. In consideration of the foregoing, we issued 1,029 additional\nshares of Series C-2 Preferred to FNL.\n\n \n\nOn\nJune 30, 2025, we entered into an Amendment to the Securities Purchase Agreement (the “June 2025 Amendment”) with FNL to\npermit FNL to elect, when exercising its Additional Investment Right, to either purchase AIR Preferred Shares for cash (an “AIR\nPurchase”) or exchange them for all or a portion of the Amended and Restated Debenture, with the aggregate stated value of AIR Preferred\nShares received in such exchange equal to the principal amount so exchanged plus accrued and unpaid interest thereon (an “AIR Exchange”).\nThe Amendment also reduced the minimum exercise amount to $200,000. On the same date, we entered into an inducement letter agreement\nwith FNL (the “AIR Exercise and Reload Agreement”), pursuant to which FNL exercised its Additional Investment Right to acquire\n1,800 shares of Series C-2 Preferred with an aggregate stated value of $1,800,000 in exchange for $1,800,000 of principal, plus accrued\nand unpaid interest, under the Amended and Restated Debenture. In consideration thereof, we issued 630 additional shares of Series C-2\nPreferred to FNL.\n\n \n\n7\n\n \n\n \n\nEffective\nAugust 21, 2025, we entered into an agreement with FNL (the “August 2025 Amendment and Exchange Agreement”), pursuant to\nwhich the parties exchanged the Amended and Restated Debenture for a Second Amended and Restated Senior Secured Convertible Debenture\ndue February 11, 2026 (the “Second Amended and Restated Debenture”) with an outstanding principal amount reduced to $1,751,344,\nand removed the monthly redemption provisions. In connection therewith, the parties agreed to reduce the outstanding principal by $1,300,000\nin exchange for AIR Preferred Shares with an aggregate stated value of $1,300,000, and we issued 325 additional shares of Series C-2\nPreferred to FNL.\n\n \n\nEffective\nSeptember 29, 2025, we entered into an agreement with FNL (the “September 2025 Exchange Agreement”), pursuant to which FNL\nexchanged the Second Amended and Restated Debenture for 467 shares of Series C-2 Preferred with an aggregate stated value of $1,334,000.\nAs a result, the Second Amended and Restated Debenture was paid in full and fully extinguished.\n\n \n\nIn\naddition to the exchanges of outstanding debenture principal, during 2025, FNL exercised the AIR for $2,850,000 in aggregate cash consideration,\nfor which we issued 2,850 shares of Series C-2 Preferred. As January 31, 2026, all outstanding shares of Series C-2 Preferred have been\nconverted into shares of our common stock, and all dividends owed under the Series C-2 Preferred have been settled in full.\n\n \n\n*Decathlon\nAmendment*\n\n* *\n\nOn\nSeptember 29, 2023, we, our CEO, Steven Shum as a Key Person (as defined in the Loan Agreement defined below), and the our wholly-owned\nsubsidiaries Bio X Cell, Inc, INVO Centers LLC, Wood Violet, Fertility Labs of Wisconsin LLC and Orange Blossom Fertility LLC as guarantors\n(the “Guarantors”), entered into a Revenue Loan and Security Agreement (the “Loan Agreement”) with Decathlon\nAlpha V LP (the “Lender”) under which the Lender advanced a gross amount of $1,500,000 to us.\n\n \n\nOn\nSeptember 24, 2024, we, the Lender, Steven Shum and the Guarantors entered into an amendment to the Loan Agreement (the “First\nAmendment to the Loan Agreement”), pursuant to which (i) the Lender approved that certain Standard Merchant Cash Advance Agreement,\ndated September 25, 2024 between us and Cedar Advance LLC, and (ii) we agreed to increase the “Minimum Interest” (as defined\nin the Loan Agreement) multiples set forth therein by 0.15 effective as of December 1, 2024, if we did not receive equity investment\nof at least $1,000,000 by November 30, 2024.\n\n \n\nOn\nOctober 11, 2024, we, the Lender, Steven Shum and the Guarantors entered into a second amendment to the Loan Agreement (the “Second\nAmendment to the Loan Agreement”), pursuant to which we agreed, among other things, to pay down its loan by at least $500,000 and\nincrease its monthly payments by up to $30,000 if we close a private offering of its securities. We also agreed to retain an investment\nbanker to pursue a financing or a sale if it fails to meet certain liquidity covenants.\n\n \n\nOn\nAugust 13, 2025, we, the Lender, Steven Shum and the Guarantors entered into a third amendment to the Loan Agreement (the “Third\nAmendment to the Loan Agreement”), pursuant to which (a) the Lender consented to the change of our name to INVO Fertility, Inc.,\n(b) the Lender waived the event of default that would result from the entry of judgment pursuant to the Term Sheet with Dr. Pritts and\nthe Pritts Trust, (c) the parties agreed to an adjusted repayment schedule whereby the monthly payment under the Loan Agreement increased\nby $20,000, and (d) we agreed to reimburse the Lender for approximately $17,500 in fees and expenses incurred in connection with the\nThird Amendment to the Loan Agreement.\n\n \n\n8\n\n \n\n \n\nOn\nSeptember 22, 2025, we, the Lender, Steven Shum, and the Guarantors entered into a restated third amendment to the Loan Agreement (the\n“Restated Third Amendment to the Loan Agreement”), pursuant to which and in addition to amendments set forth in the Third\nAmendment, since we did not raise the above stated $1 million by November 30, 2024 as required under the Loan Agreement, the Loan Agreement\nwas amended to reflect an increase of 0.15 to the Minimum Interest multiples set forth in the Loan Agreement.\n\n \n\n*Increase\nin Authorized Common Stock (July 2025)*\n\n* *\n\nOn\nJuly 23, 2025, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase our number of\nauthorized shares of common stock from 1,388,888 to 50,000,000 and we filed a Certificate of Amendment to our Articles of Incorporation\nto increase our authorized shares of common stock for the same.\n\n* *\n\n*Reverse\nStock Split (July 2025)*\n\n \n\nOn July 18, 2025, we filed a certificate of change\nwith the Secretary of State of Nevada to effectuate a reverse split of our common stock at a ratio of 1-for-3, and our authorized common\nstock was proportionately reduced to 1,388,888 shares from 4,166,667 shares. The reverse stock split took effect on July 21, 2025. All\nshare information included in this Form 10-K has been reflected as if the reverse stock split occurred as of the earliest period presented.\n\n* *\n\n*Series\nC-2 Preferred Amendments*\n\n \n\nOn May 23, 2025, the Company filed a Certificate of\nAmendment that, among other changes, allows holders of Series C-2 Preferred to receive dividends payable in additional shares of Series\nC-2 Preferred, subject to specified equity-related conditions. The amendment also updated the mechanics for adjusting the conversion price\nof the Series C-2 Preferred in connection with any future issuances of AIR Preferred Shares.\n\n \n\nOn\nJune 27, 2025, the Company filed a second amendment to the Series C-2 Certificate of Designation, which restated the rights and preferences\nof the Series C-2 Preferred and authorized 20,000 shares with a stated value of $1,000 per share. This amendment also removed certain\nredemption features, including the “Bankruptcy Triggering Event” and “Change of Control” redemption rights, as defined therein.\n\n* *\n\n**\n\n*NTI\nDivesture*\n\n* *\n\nOn October 11, 2024, we acquired NAYA Therapeutics,\nInc. with the intent to expand beyond fertility into a broader healthcare portfolio combining our commercial-stage fertility business\nwith a clinical-stage oncology and autoimmune technology business. Following insufficient stockholder support for key elements of the\ntransaction at a March 2025 stockholder meeting, and upon advice of counsel, our proxy solicitation firm, and general stakeholder feedback,\nwe elected to re-focus exclusively on our fertility business.\n\n \n\nEffective June 2, 2025, we divested a majority stake in NAYA Therapeutics, Inc. by redeeming all outstanding shares\nof Series C-1 Preferred at a redemption price of 113.8558 shares of NAYA Therapeutics Class A Common Stock per share of Series C-1 Preferred\nredeemed. We retained 6,300 shares of Series A Preferred Stock of NAYA Therapeutics, representing 19.9% of outstanding common stock on\nan as-converted basis, and hold a secured convertible promissory note issued by NAYA Therapeutics on May 28, 2025 in the principal amount\nof $4,803,175.\n\n* *\n\n*Series\nC-1 Preferred Amendment*\n\n \n\nOn\nMay 28, 2025, we filed with the Nevada Secretary of State a certificate of amendment to the Series C-1 Certificate of Designation pursuant\nto which, we are entitled to redeem at our option at any time or from time to time upon not less than 2 calendar days written notice\nto the holders prior to the date fixed for redemption thereof, at a redemption price of 113.8558 shares of Class A Common Stock\nof NTI for each share of Series C-1 Preferred being redeemed.\n\n* *\n\n**\n\n9\n\n \n\n* *\n\n*Warrant Inducement (April 2025)*\n\n \n\nOn April 30, 2025, we entered into an inducement letter\nagreement (the “April 2025 Inducement Letter Agreement”) with FNL as the existing holder of certain existing warrants to purchase\nup to 3,882 shares of our common stock. Such existing warrants were originally issued on January 14, 2025, with an exercise price of $1,008.00\nper share.\n\n \n\nThe issuance of the shares of common stock upon exercise\nof such existing warrants was registered pursuant to a registration statement on Form S-3 (File No. 333-283872), which was declared effective\nby the SEC on January 14, 2025.\n\n \n\nPursuant to the April 2025 Inducement Letter Agreement,\nFNL agreed to exercise such existing warrants for cash at the exercise price of $193.20 per share in consideration for our agreement to\nissue new unregistered warrants to purchase up to an aggregate of 5,823 shares of common stock at an exercise price of $193.20 per share.\nSuch new warrants would become exercisable upon receipt of such approval as may be required by the applicable rules and regulations of\nthe Nasdaq Capital Market (or any successor entity) from the stockholders of INVO with respect to issuance of all of such new warrants\nand the shares of common stock upon the exercise thereof and have a term of five years from the date stockholder approval would be obtained.\nWe received stockholder approval for the issuance of shares of common stock upon exercise of such new warrants on July 23, 2025.\n\n \n\nThe aggregate gross proceeds to us from the exercise\nof such existing warrants was approximately $750,000, before deducting offering expenses payable by us.\n\n \n\n*Name\nChange*\n\n \n\nOn\nApril 14, 2025, we changed our corporate name to INVO Fertility, Inc., pursuant to an Amendment to Articles of Incorporation filed with\nthe Nevada Secretary of State on April 14, 2025 (the “Name Change”). Pursuant to Nevada law, a stockholder vote was not necessary\nto effectuate the Name Change.\n\n \n\nOn\nApril 28, 2025, our common stock ceased trading under the ticker symbol “NAYA” and began trading under our new ticker symbol,\n“IVF”, on the Nasdaq Capital Market.\n\n \n\n10\n\n \n\n \n\n*Reverse Stock Split (March 2025)*\n\n \n\nOn February 24, 2025, we filed a certificate of change\nwith the Secretary of State of Nevada to effectuate a reverse split of our common stock at a ratio of 1-for-12, and our authorized common\nstock was proportionately reduced to 4,166,667 shares from 50,000,000 shares. The reverse stock split took effect on March 18, 2025. All\nshare information included in this Form 10-K has been reflected as if the reverse stock split occurred as of the earliest period presented.\n\n \n\n*Public Offering*\n\n \n\nOn January 14, 2025, we consummated a public offering\n(the “January 2025 Offering”) of 9,455 units (“Units”), each consisting of either one share of common stock, or\none pre-funded warrant to purchase one share of common stock (the “January 2025 PFWs”) in lieu thereof, and one warrant to\npurchase one share of common stock at an offering price of $1,008.00 per Unit (the “January 2025 Warrants”). The January 2025\nWarrants are exercisable from and after the date of their issuance and expire on the five-year anniversary of such date, at an exercise\nprice of $1,008.00 per share of common stock. Each January 2025 PFW is immediately exercisable at an exercise price of $0.144 per share\nand may be exercised at any time until all of the January 2025 PFWs are exercised in full. In connection with the January 2025 Offering,\nwe entered into a securities purchase agreement (the “January 2025 SPA”) with certain institutional investors who purchased\nUnits in this January 2025 Offering.\n\n \n\nThe securities issued in the January 2025 Offering\nwere offered pursuant to our registration statement on Form S-1, as amended (File No. 333-283872) (the “January 2025 S-1”),\ninitially filed by us with the SEC under the Securities Act of 1933, as amended (the “Securities Act”), on December 17, 2024\nand declared effective on January 13, 2025.\n\n \n\nWe closed the January 2025 Offering on January 14,\n2025, raising gross proceeds of approximately $9.5 million before deducting placement agent fees and other offering expenses payable.\n\n \n\nAlso in connection with the January 2025 Offering,\non January 13, 2025, we entered into a placement agency agreement (the “January 2025 PAA”) with Maxim, pursuant to which (i)\nMaxim agreed to act as lead placement agent on a “best efforts” basis in connection with the January 2025 Offering, and (ii)\nwe agreed to pay Maxim an aggregate fee equal to 6.5% of the gross proceeds raised in the January 2025 Offering (or 5.0% in the case of\ncertain investors) and warrants to purchase up to 1,555 shares of Common Stock at an exercise price of $420.00 per share (the “Maxim\nJanuary 2025 Warrants”). The Maxim January 2025 Warrants are exercisable at any time after the six-month anniversary of the closing\ndate, from time to time, in whole or in part, until five (5) years from the commencement of sales of the securities in the January 2025\nOffering. Additionally, we reimbursed Maxim for certain expenses and legal fees up to $90,000.\n\n \n\nIn\nconnection with the January 2025 Offering, on January 13, 2025, we entered into a Class C-2 Preferred Stock Redemption Agreement with FNL, pursuant to which we agreed to purchase and acquire from FNL 4,000 shares of our C-2 Preferred\nStock for $4,000,000. Accrued dividends, plus any other accrued payments under the Certificate of Designations for the C-2 Preferred\nStock, remained outstanding.\n\n \n\n**Operations**\n\n \n\nOur\ncritical management and leadership functions are carried out by our management team. In the Fertility Clinic segment, each clinic is\nseparately staffed with employees necessary to manage daily activities, while most administrative tasks are centralized and handled by\nthe INVO corporate staff. With respect to the INVOcell Device segment, we have contracted out the manufacturing, assembly, packaging,\nand labeling to a medical manufacturing company, sterilization of the device to a sterilization specialist, and storage and shipping\nto a third party logistics company.\n\n \n\n11\n\n \n\n \n\n*Wisconsin Fertility Institute*\n\n \n\nAs an established and profitable clinic, WFI has a\nfull staff, including a reproductive and endocrinology and infertility medical doctor (“REI”), an OBGYN trained to provide\nfertility treatment and full complement of medical, laboratory and administration staff. The day to day clinical operations are handled\nby the on site staff. Our corporate staff manages finance, accounting, human resources and other overhead responsibilities.\n\n \n\n*Alabama JV*\n\n \n\nWe established a joint venture partnership in Birmingham,\nAlabama (the “Alabama JV”) with HRCFG, LLC (“HRCFG”). The responsibilities of HRCFG’s principals include\nproviding clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management\nof the Alabama JV. Our responsibilities include providing funding to the Alabama JV and being the exclusive provider of the INVOcell.\n\n \n\n*Georgia JV*\n\n \n\nWe formed a joint venture with Bloom\nFertility, LLC (“Bloom”) to establish an INVO Center in Atlanta, Georgia (the “Georgia JV”). The responsibilities\nof Bloom include providing all medical services required for the operation of the Georgia JV. Our responsibilities include providing\nfunding to the Georgia JV, lab services, quality management, and being the exclusive provider of the INVOcell.\n\n \n\n*INVOcell*\n\n \n\nTo\ndate, we have completed a series of important steps in the successful development and manufacturing of the INVOcell:\n\n \n\n●\nManufacturing:\nWe are ISO 13485:2016 certified and manage all aspects of production and manufacturing with qualified suppliers. Our key suppliers,\nwhich include NextPhase Medical Devices, R.E.C. Manufacturing Corporation, and Casco Bay Molding, have been steadfast partners since\nour company first began and can provide us with virtually an unlimited capability to support our growth objectives, with all manufacturing\nperformed in the New England region of the U.S.\n\n \n \n\n●\nRaw\nMaterials: All raw materials utilized for the INVOcell are medical grade and commonly used in medical devices (e.g., medical\ngrade silicone, medical grade plastic). Our principal molded component suppliers, Casco Bay Molding and R.E.C. Manufacturing Corporation,\nare well-established companies in the molding industry and are either ISO 13485 or ISO 9001 certified. The molded components are\nsupplied to our contract manufacturer for assembly and packaging of the INVOcell system. The contract manufacturer is ISO 13485 certified,\nand U.S. Food & Drug Administration (“FDA”) registered.\n\n \n \n\n●\nUS\nMarketing Clearance: The safety and efficacy of the INVOcell has been demonstrated and cleared for marketing and use by the FDA\nin November 2015.\n\n \n \n\n●\nAdditional\nClinical Clearance: In June 2023, we received FDA 510(k) clearance to expand the labeling on the INVOcell device and its\nindication for use to provide for a 5-day incubation period. The data supporting the expanded 5-day incubation clearance demonstrated\nimproved patient outcomes.\n\n \n\n12\n\n \n\n \n\n**Employees**\n\n \n\nAs\nof December 31, 2025, INVO employed 14 full time employees. The clinics employed an additional 26 full time and 2 part time employees.\nWe also engage consultants to further support our operations.\n\n \n\n**Market\nOpportunity**\n\n \n\n*Fertility\nClinics and INVOcell Device*\n\n \n\nThe\nglobal ART marketplace is a large and growing, multi-billion-dollar industry across the world as increased infertility rates,\ngreater patient awareness and improving financial incentives, such as insurance and governmental assistance, continue to drive\ngrowth and demand. According to the European Society for Human Reproduction’s 2024 ART Fact Sheet, one in six couples\nworldwide experience fertility challenges. Additionally, the worldwide market remains vastly underserved as a high percentage of\npatients in need of care continue to go untreated each year for many reasons, but key among them are capacity constraints and cost\nbarriers. There have been large increases in the use of IVF, with current estimates of approximately 4 million ART cycles performed\nglobally each year, producing around 1 million babies. Regrettably, this only amounts to less than 5% of the infertile couples\nworldwide being treated and less than 2% of such couples having a child though IVF. The industry remains capacity constrained which\ncreates challenges in providing access to care at an affordable price for the volume of patients in need. A survey by\n“Resolve: The National Infertility Association,” indicates the two main reasons couples do not use IVF is cost and\ngeographical availability (and/or capacity).\n\n \n\nIn\nthe United States, infertility affects an estimated 10%-15% of the couples of childbearing-age, according to the American Society of\nReproductive Medicine (2017). According to the Centers for Disease Control (“CDC”), there are approximately 6.7 million women\nwith impaired fertility. Based on 2022 data from the CDC’s National ART Surveillance System, approximately 435,000 IVF cycles were\nperformed across ~500 IVF centers, leaving the U.S. with a large, underserved patient population, similar to most markets around the\nworld.\n\n \n\nOur corporate development strategy, which includes\nacquiring established existing practices, building new clinics, and expanding our INVOcell device, is designed to take advantage of the\nattractive fertility market dynamics of supply and demand.\n\n \n\n**Competitive\nAdvantages**\n\n \n\n*INVOcell\nDevice and Fertility Clinics*\n\n \n\nOver\nthe past several years, the principal focus of our commercial efforts has shifted from the distribution of our INVOcell device to the\nprovision of fertility services through our network of clinics. For the most part, our clinical activities have been focused on secondary\nmarkets where there is a greater imbalance between the need for ART treatment and the number of cycles available. Combined with our ability\nto offer a wider range of advanced fertility care, including IVC, IVF and IUI, at multiple price points, our clinics have the opportunity\nfor differentiation from our competitors. As with our INVOcell technology, we continuously look for new solutions that can create greater\nefficiency and effectiveness in the provision of fertility cycles and support our efforts to democratize fertility care.\n\n \n\nWhile\na much smaller part of our current business, we continue to believe that our INVOcell device, and the IVC procedure it enables, can\nplay a key role in making advanced fertility care more affordable and accessible. We continue to engage with sympathetic third-party\nclinics that share our same vision and that use our one-of-a-kind INVOcell device.\n\n \n\nUnlike\nIVF, where the oocytes and sperm develop into embryos in a laboratory incubator, the INVOcell allows fertilization and early embryo development\nto take place in the woman’s body. We believe that the IVC procedure can provide the following benefits:\n\n \n\n \n●\nMay\nreduce lab procedures, helping clinics and doctors to increase patient capacity, lower costs and offer a more affordable advanced\nfertility treatment option;\n\n \n \n \n\n \n●\nA\nnatural and stable incubation environment;\n\n \n \n \n\n \n●\nA\nmore personal, intimate experience in creating a baby; and\n\n \n \n \n\n \n●\nA\nreduced risk of errors and wrong embryo transfers.\n\n \n\n13\n\n \n\n \n\nIn\nboth current utilization of the INVOcell, and in clinical studies, the IVC procedure has demonstrated equivalent pregnancy success and\nlive birth rates as IVF and generally may be offered at a significant discount to IVF cycles.\n\n \n\n**Sales\nand Marketing**\n\n \n\n*Fertility\nClinics*\n\n \n\nOur\nfour fertility clinics employ various strategies to build awareness for their services and/or to maintain and grow patient flow and\nfertility cycle volume. The principal source of patient flow comes through social media marketing, OBGYN referrals, and patient word\nof mouth. Our clinical staff build and maintain relationships with the local OBGYN community, regularly following up with patient OBGYNs to build additional referral flow.\nWe also conduct regular social and other media campaigns to attract new patients and to build awareness.\n\n \n\nAt\nthe corporate level, we seek to build general awareness for our clinical activities and IVC procedure results with a view to drive patients\nto our centers and to grow demand for our INVOcell device. These efforts also support our ongoing work to acquire additional IVF clinics in the near term and open new INVO\nCenters longer term.\n\n \n\nThe\nacquisition of existing fertility clinics requires less sales and marketing effort compared to opening and establishing new INVO\nCenters, as they have established patient flows that can be built upon. When entering a new market with an INVO Center, we leverage\nthe experience developed in establishing our Alabama and Georgia joint ventures. We employ strategies to secure patient\nflow levels that can enable new INVO Centers to become profitable and contribute economically to our overall business as soon as\npossible. Primarily, our INVO Centers seek to employ local, reputable physicians with strong ties to the OBGYN community.\n\n \n\n*INVOcell\nDevice*\n\n \n\nHistorically,\nour approach to marketing INVOcell was focused on identifying partners within targeted geographic regions that we believe could best\nsupport our efforts to expand access to advanced fertility treatment using the INVOcell and IVC procedure for the large number of underserved\ninfertile people around the world. Those efforts resulted in the execution of a series of distribution agreements with partners across\nthe globe. More recently, as we shifted our focus to acquiring and establishing fertility clinics, which activities have been centered\nin the US, and as a result of the limited traction experienced in international markets, proactive marketing efforts for the INVOcell\nhave been limited to the United States. In our domestic market, we distribute the INVOcell directly to a number of third-party IVF clinics\nand we remain open to pursuing foreign markets that present a realistic opportunity for incremental revenue on a profitable basis.\n\n \n\n**Competition**\n\n \n\n*Fertility\nClinics and INVOcell Device*\n\n \n\nOur\nfertility clinics, within their own local markets, compete with other local fertility clinics largely on the basis of reputation,\nquality of patient care, and general pricing. Our fertility clinics have at least 1 or more competing fertility clinics within a\n25-mile radius. We believe each of our existing centers compete effectively on price and quality of care in their respective\nmarkets.\n\n \n\nThe\nfertility treatment regimens with whom the INVOcell and IVC procedure compete when infertile people, in conjunction with their physician,\nare choosing the treatment method include drug-only stimulation, IUI, and conventional IVF. The fertility industry is highly competitive\nand characterized by long-standing well-entrenched procedures. Our INVOcell device enables the first new advanced treatment incubation\nalternative in over forty years. We face competition from all ART practitioners and device manufacturers. To date, most advancements\nin the ART market have been limited to incremental improvements to the various products designed to simply support conventional IVF.\n\n \n\nThe only ART medical device competitors for INVOcell\nthat we are aware of are intrauterine devices called AneVivo™, developed by Anecova, and UteroPod™, developed by invoLab SA,\nboth Swiss life sciences companies. The principal difference between the INVOcell and these devices is the latter’s placement inside\nthe woman’s uterus for early embryo development. We believe that placing the device in the uterus is more invasive and thus may\nincrease the risk to patients compared to the INVOcell, which is placed in the vaginal cavity. It appears that Anecova is no longer active.\n\n \n\nFor\nadditional information about competition, see Risk Factors in Item 1A of this Annual Report on Form 10-K.\n\n \n\n**Government\nRegulation**\n\n \n\nWith\nrespect to our Clinic Segment, all our clinics are subject to standard governmental and oversight regulations and must meet certain standards\nto be certified and operational.\n\n \n\nWith\nrespect to our INVOcell segment, in November 2015, the FDA granted our petition for de novo classification of the INVOcell. Special controls\ninclude clinical and non-clinical performance testing, biocompatibility, sterility and shelf-life testing, and labeling. These special\ncontrols also apply to competing products that seek 510(k) clearance under the classification regulation for IVC systems, including our\nown 510(k) effort to expand the labeling on INVOcell from a 3-day incubation period to up to a 5-day incubation period. In June 2023,\nwe received FDA 510(k) clearance to expand the labeling on the INVOcell device and its indication for use to provide for a 5-day incubation\nperiod.\n\n \n\n14\n\n \n\n \n\nWe\nare not actively targeting international markets for INVOcell, although we are willing to engage with potential foreign partners that\nseek us out and demonstrate a commitment to apply sufficient resources to develop their specific market. Every country has its own, often\ndifferent regulatory and registration requirements for medical devices, and our decision to support a potential partner will also be\nbased on those requirements.\n\n \n\nIn\ngeneral, we may be subject to healthcare fraud, waste, and abuse regulation and enforcement by the federal government and the governments\nin the states and foreign countries in which we might conduct our business. The federal laws and many state laws generally apply only\nto entities or individuals that provide items or services for which payment may be made under a government healthcare program. These\ninclude laws that prohibit the following:\n\n \n\n●\nthe\npayment or receipt of anything of value in exchange for referrals of business (*e.g.*Anti-Kickback Statute (42 U.S.C. §\n1320a-7b) (the “AKS”); Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a) (the “CMPL”); Ala. Code §\n22-1-11(c));\n\n●\nthe\npresenting of a false or fraudulent claim for payment by a government healthcare program, such as Medicare or Medicaid (*e.g.*False\nClaims Act (31 U.S.C. §§ 3729 – 3733); Georgia State False Medicaid Claims Act (Ga. Code Ann. §§ 49-4-168\n– 49-4-168.6)); and\n\n●\nthe\nreferral by certain ordering licensed healthcare providers of certain healthcare items and services that are payable by a government\nhealthcare program to an entity in which the healthcare provider or his or her immediate family member has an investment or other\nfinancial relationship (*e.g.* Section 1877 of the Social Security Act (42 U.S.C. § 1395nn), commonly referred to as the\n“Stark Law”; Georgia Patient Self-Referral Act of 1993 (Ga. Code Ann. §§ 43-1B-1 – 43-1B-8)).\n\n \n\nThese\nlaws are subject to extensive and increasing enforcement by numerous federal, state, and local government agencies including the Office\nof Inspector General, the Department of Justice, the Centers for Medicare & Medicaid Services, and various state authorities. At\npresent, our products and services are not reimbursable under any government healthcare program. If, however, that changes in the future\nand it were determined that we were not in compliance with these federal fraud, waste, and abuse laws, we would be subject to liability.\n\n \n\nWe\nare subject to the requirements of the Health Insurance Portability and Accountability Act of 1996, the Health Information\nTechnology for Economic and Clinical Health Act of 2009 (“HITECH Act”), and related implementing regulations (together,\n“HIPAA”). Under HIPAA, we must have in place administrative, physical, and technical standards to guard against the\nmisuse of individually identifiable health information. In the ordinary course of our business with our fertility clinics as Covered Entities as well as with INVO as a Business Associate, we may use, collect, and store sensitive data, including protected\nhealth information (“PHI”). We face risks relative to protecting this critical information, including loss of access\nrisk, inappropriate disclosure risk, inappropriate modification risk, and the risk of being unable to adequately monitor our\ncontrols. Our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to\nemployee error, malfeasance, or other disruptions. Failure to comply with HIPAA, including through a breach of PHI, could result in\npenalties and sanctions, and materially harm our business.\n\n \n\nFor\nadditional information about government regulation applicable to our business, see Risk Factors in Item 1A.\n\n \n\n**Intellectual\nProperty**\n\n \n\n*Fertility\nClinics and INVOcell*\n\n \n\nWe\nrely on a combination of copyright and trademark laws in the United States and other countries to obtain and maintain our intellectual\nproperty. In the past, we protected our intellectual property by, among other methods, filing patent applications with the U.S. Patent\nand Trademark Office (the “USPTO”) and its foreign counterparts on inventions related to the development of our business.\nOn February 10, 2026, we were notified that our patent application for a redesign of the INVOcell device, aimed at process improvements\non the IVC procedure, was granted and issued by the USPTO’s (Patent No. 12,544,204).\n\n \n\nOur portfolio of U.S. registered trademarks includes\nthe following:\n\n \n\n●\nRegistration Nos. 6146631 and 3757982 for INVOCELL\n\n●\nRegistration No. 4009827 for INVO\n\n●\nRegistration No. 4009828 for INVO BIOSCIENCE\n\n●\nRegistration No. 7516572 for LIFE BEGINS WITHIN\n\n \n\nFor\nadditional information about our intellectual property, see Risk Factors in Item 1A of this Annual Report on Form 10-K.\n\n \n\n**Available\nInformation**\n\n \n\nOur\nprimary corporate website is www.invofertility.com. We make available, free of charge through our website, our annual report on Form\n10-K, current reports on Form 8-K, quarterly reports on Form 10-Q and each amendment to these reports. Each such report is posted on\nour website as soon as reasonably practicable after such report is filed with the SEC via the EDGAR system.\n\n \n\nThe\ninformation on our websites is not incorporated by reference into this Annual Report on Form 10-K and should not be considered a part\nof this Annual Report. Our website address is included in this Annual Report as an inactive textual reference only.\n\n \n\n15"}