INVO Fertility’s Transformation into a Healthcare Services Company

Overview

INVO Fertility, Inc. (formerly NAYA Bioscience, Inc. and INVO Bioscience, Inc.) is a healthcare services company focused on the fertility market. The company’s main strategy is to build, acquire, and operate fertility clinics, including “INVO Centers” that specialize in the intravaginal culture (IVC) procedure using the company’s INVOcell device. INVO also continues to sell and distribute the INVOcell technology to third-party fertility clinics.

In October 2024, INVO acquired a clinical-stage oncology and autoimmune company called NAYA Therapeutics. However, in 2025 the company decided to separate from this subsidiary and return to an exclusive focus on the fertility business. INVO will retain a minority stake in NAYA Therapeutics while divesting the majority interest.

Fertility Clinics

A major development for INVO was the 2023 acquisition of an existing in-vitro fertilization (IVF) clinic called the Wisconsin Fertility Institute (WFI). This established and profitable clinic more than tripled INVO’s annual revenue and became a significant part of the company’s operations.

INVO has also established two joint venture INVO Centers in Birmingham, Alabama and Atlanta, Georgia to increase use of the INVOcell device and expand the IVC procedure. These clinics allow INVO to generate more revenue per fertility cycle compared to just selling the INVOcell device.

The company plans to continue this strategy of acquiring profitable IVF clinics and opening additional wholly-owned INVO Centers, as it believes these clinics require less investment than traditional IVF clinics and can be more operationally efficient.

INVOcell Device

INVO’s proprietary INVOcell device allows fertilization and early embryo development to take place inside the woman’s body, rather than in a laboratory incubator like traditional IVF. This IVC procedure can provide benefits like reducing lab procedures, offering a more natural and intimate experience, and lowering costs compared to IVF.

Clinical studies have shown the IVC procedure can achieve pregnancy and live birth rates comparable to IVF. While the INVOcell remains part of INVO’s efforts, the company’s strategy has expanded to focus more broadly on providing assisted reproductive technology (ART) services through its fertility clinics.

NAYA Therapeutics

INVO’s acquisition of NAYA Therapeutics in 2024 was intended to diversify the company beyond fertility and create a healthcare portfolio. NAYA Therapeutics is a clinical-stage oncology and autoimmune technology company developing a portfolio of bifunctional antibody treatments.

However, in 2025 INVO decided to re-focus exclusively on its fertility business after failing to gain sufficient shareholder support for key elements of the NAYA Therapeutics transaction. INVO will now divest a majority stake in NAYA Therapeutics while retaining a minority interest.

Operations

INVO’s fertility clinics are separately staffed to handle daily activities, while most administrative tasks are centralized. The manufacturing, assembly, packaging, and shipping of the INVOcell device are outsourced to third-party providers. NAYA Therapeutics has its own dedicated staff for the development of its intellectual property.

The Wisconsin Fertility Institute, INVO’s first IVF clinic acquisition, has a full staff including a reproductive endocrinologist, OBGYN, and other medical and administrative personnel. INVO’s corporate staff took on finance, HR, and other overhead responsibilities after the acquisition.

INVO’s two joint venture INVO Centers in Alabama and Georgia have divided responsibilities, with the local partners providing clinical expertise and day-to-day management, while INVO provides funding, lab services, compliance, and being the exclusive INVOcell supplier.

Market Opportunity

The global ART market is a large and growing multi-billion-dollar industry driven by factors like increased infertility rates, greater patient awareness, and improving financial incentives. However, the market remains vastly underserved, with only a small percentage of infertile couples receiving treatment each year.

In the US, infertility affects an estimated 10-15% of couples of childbearing age, but there are only around 435,000 IVF cycles performed annually across 500 clinics. This leaves a large unmet patient population that INVO aims to address through its clinic expansion strategy.

The bifunctional antibody market that NAYA Therapeutics is targeting is also projected to see rapid growth, reaching over $80 billion globally by 2030. This is driven by the potential benefits of these next-generation cancer and autoimmune treatments compared to legacy monoclonal antibodies.

Competitive Advantages

INVO’s focus on building a network of INVO Centers and acquiring profitable IVF clinics provides opportunities for differentiation in the fertility market. The company’s clinics can offer a range of advanced fertility services, including IVC, IVF, and intrauterine insemination (IUI), at multiple price points.

While a smaller part of the business, INVO continues to believe the INVOcell device and IVC procedure can play a key role in making fertility care more affordable and accessible. The company engages with third-party clinics that share this vision.

For NAYA Therapeutics, the company believes its bifunctional antibody candidates, particularly the first-in-class GPC3 x NKp46 and CD38 x NKp46 antibodies, can differentiate themselves from competitors in the rapidly growing market.

Sales and Marketing

INVO’s fertility clinics employ strategies like OBGYN referrals, patient word-of-mouth, and media campaigns to build awareness and maintain patient flow. Acquiring existing IVF clinics requires less sales and marketing effort compared to opening new INVO Centers from scratch.

For the INVOcell device, INVO has historically focused on identifying distribution partners in targeted geographic regions. More recently, as the company has shifted its focus to its own clinic network in the US, proactive marketing efforts for the device have been limited domestically.

Given the early stage of NAYA Therapeutics’ technologies, the focus is entirely on clinical development. The strategy is to partner with large pharmaceutical companies for the commercialization of any FDA-approved solutions.

Recent Developments

In 2025, INVO changed its corporate name to INVO Fertility, Inc. and announced plans to cease trading under the “NAYA” ticker symbol and begin trading as “IVF”. The company also completed a 1-for-12 reverse stock split.

INVO held its 2024 annual shareholder meeting in 2025 after postponing it from 2024. While standard proposals were approved, several special proposals related to the NAYA Therapeutics transaction did not receive sufficient votes. This led INVO to decide to re-focus on the fertility business.

In January 2025, INVO completed a $9.5 million public offering, with the proceeds intended for purposes like funding the second WFI acquisition payment, redeeming preferred stock, and repaying debt.

Financial Performance

In fiscal 2024, INVO focused on improving operations in its fertility business while working to close the NAYA Therapeutics acquisition. The company made significant progress in expanding revenue and reducing costs, leading to strong improvement in adjusted EBITDA.

This was largely driven by the performance of the acquired Wisconsin Fertility Institute, which more than tripled INVO’s top-line revenue. The company plans to use this as a foundation to pursue additional IVF clinic acquisitions going forward.

While INVO expects its clinic operations to dominate its commercial efforts, it will continue working to expand distribution of the INVOcell device to third-party fertility clinics. The company believes the overall ART market will continue growing due to factors like the large underserved patient population and improving insurance coverage.

INVO incurred net losses of $9.1 million in 2024 and $8.0 million in 2023, with approximately $4.3 million and $2.8 million, respectively, related to non-cash expenses. The company has been dependent on raising capital through debt and equity financing to fund its operations and investing activities.

As of December 2024, INVO had negative working capital of $16.6 million and stockholders’ equity of $12.7 million. The company’s auditor expressed substantial doubt about its ability to continue as a going concern, based on the financial statements. INVO will need to raise additional funding over the next 12 months to execute its business strategy and meet liquidity needs.

In summary, INVO Fertility is in the midst of a transformation from a medical device company to a healthcare services provider focused on the fertility market. The company’s acquisition of the Wisconsin Fertility Institute and plans for further clinic expansion are key drivers of its strategy, complemented by ongoing efforts to promote the INVOcell device. However, INVO faces financial challenges that will require additional capital to overcome in the near-term.