Healthcare Company Restructures Operations: NAYA Biosciences Pivots to Pure-Play Fertility Focus, Spins Off Oncology Pipeline as Independent Entity

Strategic Separation Unlocks Value as Market Expands – Company Rebrands to INVO Fertility, Inc. and Shifts Ticker to IVF

The fertility healthcare sector is experiencing renewed momentum, and INVO Fertility, Inc. (formerly NAYA Biosciences) is positioning itself to capitalize on the tailwind. The company announced on April 14, 2025, that it is pursuing a major corporate restructuring that splits its dual-focus business model into two specialized entities, each pursuing distinct market opportunities.

The Split: Fertility Gets the Spotlight, Oncology Goes Private

Under the new structure, the publicly traded arm will operate exclusively as INVO Fertility, Inc., trading under the Nasdaq ticker “IVF” (transitioning from “NAYA”). This shift signals management’s confidence in the reproductive healthcare marketplace and the company’s ability to build a scaled fertility services network.

The oncology division, NAYA Therapeutics, will transition to private ownership. The parent company will retain a minority stake, positioning itself to benefit if the bifunctional antibody pipeline generates meaningful value appreciation down the road. This arrangement gives investors exposure to potential upside while allowing the oncology team to operate with focused, dedicated resources.

Why Now? Market Tailwinds and Strategic Clarity

The decision reflects broader industry dynamics. The U.S. President’s recent executive order on reducing IVF costs and expanding fertility service access has reinforced market expansion potential. Rather than trying to juggle fertility clinics and early-stage oncology programs simultaneously, NAYA Biosciences is betting that two independent, focused entities can move faster and capture more value than a combined structure.

“Moving forward, we will leverage our existing, revenue-generating fertility operations with operating centers in Wisconsin, Alabama, and Georgia, to acquire and build new centers across the U.S.,” noted Steve Shum, CEO of INVO Fertility. The company currently operates two INVO Centers and one IVF clinic, with plans to expand through both acquisition and organic growth.

The Fertility Piece: Device-Enabled Clinics as a Model

INVO Fertility’s core strategy centers on three vectors: operating branded INVO Centers that offer intravaginal culture (IVC) procedures using the FDA-cleared INVOcell device, acquiring and operating traditional IVF clinics, and distributing INVOcell technology to third-party clinic operators.

The INVOcell represents a differentiated approach—it enables fertilization and early embryo development to occur naturally within the patient’s body, offering a lower-cost alternative to conventional laboratory-based IVF while maintaining comparable efficacy. The company projects that this approach can deliver results at a meaningful cost reduction compared to standard IVF treatment and significantly outperforms intrauterine insemination (IUI).

The Oncology Angle: Next-Generation Antibodies in Development

NAYA Therapeutics will continue advancing its bifunctional antibody platform independently. The pipeline includes three clinical-stage programs:

NY-303: A GPC3 x NKp46 bispecific antibody targeting hepatocellular carcinoma (HCC). The drug is designed to address the 70-85% of HCC patients who don’t respond to current immunotherapy standards. A Phase I/IIa monotherapy trial is cleared to enroll patients in the second half of 2025.

NY-500: An AI-optimized PD-1 x VEGF bispecific aiming to be first-to-market in this pairing for HCC. Preclinical and translational data are expected in 2025, with Phase I/II initiation targeted for early 2026.

NY-338: A CD38 x NKp46 antibody for multiple myeloma, designed with a differentiated safety and efficacy profile compared to daratumumab and T-cell engagers. Phase I/II enrollment is planned for early 2026.

What This Means for Shareholders

The separation is designed to allow each business to attract capital and investor attention appropriate to its risk-return profile. A public fertility services company with existing revenue streams and near-term expansion plans appeals to a different investor base than early-stage oncology development. By splitting, NAYA Biosciences is signaling confidence that the market will value each piece more fairly in isolation.

CEO Shum emphasized the retained minority stake in NAYA Therapeutics as a potential value driver: “We remain enthusiastic about NAYA TX’s assets and their significant potential upside, which we hope to monetize in the future through value appreciation in the minority stake we plan to retain.”

Execution Timeline and Approvals

The final separation is contingent on completing definitive transaction documents and satisfying standard closing conditions, including necessary regulatory and shareholder approvals. The company is also completing its 2024 financial statements after filing an extension on its Form 10-K.

The restructuring underscores a broader trend in healthcare: companies with diverse pipelines are increasingly opting for focused, specialized structures. For NAYA Biosciences, the decision reflects confidence that both fertility services and next-generation oncology therapeutics deserve dedicated platforms to maximize their respective potential.