INVO Fertility, Inc.

INVO Fertility, Inc.

Overview

INVO Fertility, Inc. is a healthcare services and technology company focused on the fertility market. The company’s primary strategy is to acquire, establish, and operate fertility clinics and related technologies, with an emphasis on profitable U.S.-based clinics. INVO offers IVF and intravaginal culture (IVC) services enabled by its INVOcell device and markets and distributes INVOcell to third-party clinics. The company also plans to license or acquire fertility-focused technologies for use in its clinics.

Clinic footprint and operations

• As of December 31, 2025, INVO operated four fertility clinics in the United States.
• Wisconsin Fertility Institute (WFI) is an established, profitable clinic staffed with an REI physician, OB/GYN, embryology and laboratory personnel, and administrative support.
• Joint ventures established in 2021 in Birmingham, AL (Alabama JV) and Atlanta, GA (Georgia JV) were created to open INVO Centers and expand use of INVOcell/IVC.
• Family Beginnings in Indianapolis, IN was acquired on February 18, 2026 for approximately $760,000. The transaction included cash at closing, Series D Preferred Stock, and a long-term management services arrangement.

INVOcell device and manufacturing

• INVOcell enables fertilization and early embryo development in vivo within the woman’s body as an alternative to conventional IVF.
• The device is manufactured under ISO 13485:2016 certification. Key suppliers include NextPhase Medical Devices and Casco Bay Molding; the contract manufacturer is ISO 13485 certified and FDA-registered.
• In the U.S., INVOcell was cleared through de novo classification, with 510(k) clearance expanded in 2023 to support a 5-day incubation period and enhanced labeling and indications for use. This labeling supports both the device and the IVC workflow.
• Marketing and distribution have emphasized U.S. markets, with consideration of foreign markets through potential partnerships.

People

• Total employees as of December 31, 2025:
  • Corporate: 14 full-time
  • Clinics: 26 full-time and 2 part-time (across the four clinics)
• Total personnel engaged in operations: 42 (14 corporate full-time plus 28 clinic staff).

Financial snapshot

• Accumulated net loss of $91.4 million since inception through December 31, 2025.
• The 2023 WFI acquisition tripled annual revenue and added cash flow to operations.
• The company conducted multiple equity and debt financings and restructurings, including private placements, warrant arrangements, conversions and resets of convertible instruments, reverse stock splits, and a corporate name change in 2025–2026.
• INVO has relied on external capital to fund operations and growth, including notable financing activity in 2025–2026.

Recent developments and capital actions

• Public and private financings
  • January 14, 2025: Public offering of units raising gross proceeds of approximately $9.5 million.
  • December 2025: Private placement raising approximately $4.0 million (common stock, pre-funded warrants, and common warrants); net proceeds allocated to growth, part of the Family Beginnings acquisition, debt repayment, and working capital.
• Warrant and equity arrangements
  • January 2026: Inducement arrangements triggered issuance of new warrants to an existing warrant holder.
• Capital structure and authorized shares
  • March 2025: Reverse stock split 1-for-12.
  • July 2025: Reverse stock split 1-for-3.
  • November 2025: Reverse stock split 1-for-8 (authorized shares reduced from 50,000,000 to 6,250,000).
  • January 22, 2026: Stockholders approved an increase in authorized common shares from 1,388,888 to 50,000,000 (certificate filed February 2026).
• Corporate identity and listing
  • April 14, 2025: Corporate name changed to INVO Fertility, Inc.
  • April 28, 2025: Ticker symbol changed to IVF (trading on Nasdaq).
• Family Beginnings acquisition
  • February 18, 2026: Acquisition completed for approximately $760,000, with a long-term management services arrangement and a lease for clinic space.
• Nasdaq compliance
  • April 23, 2026 and May 27, 2026: Nasdaq staff letters regarding failure to timely file 10-K and 10-Q, with deadlines for regaining compliance and a plan submission process.
• Financing and restructurings with Five Narrow Lane (FNL)
  • 2024–2025 events included convertible debt and exchanges with FNL, conversions/exchanges of preferred stock, and multiple amendments to related loan and securities agreements.
• JAG amendment (May 2026)
  • Letter agreement with JAG in May 2026 included extension and restructuring of a convertible note, issuance of new warrants, price reset mechanics, and revised repayment terms.

Market positioning and strategy

• INVO follows a dual strategy: operate a network of fertility clinics offering IVF, IVC, and related services, and commercialize INVOcell both as a standalone device and as part of clinic workflows.
• Competitive positioning focuses on offering a broader suite of fertility services and using INVOcell/IVC to provide cost-effective alternatives to standard IVF, particularly in secondary markets with access or capacity constraints.
• Growth is targeted through acquisitions of profitable U.S. clinics and expanded INVOCenter presence, with INVOcell maintained as a strategic asset.

Notes and date context

• Information is presented as of December 31, 2025 unless otherwise indicated. Subsequent events referenced include the February 2026 Family Beginnings closing and capital-structure actions through 2026.