NAYA Biosciences Supports Recent Executive Order Aimed at Improving Access to Fertility Treatment

Rhea-AI Summary

NAYA Biosciences (NASDAQ: NAYA) has expressed support for a recent U.S. presidential executive order aimed at improving access to fertility treatments. The order directs the Domestic Policy Council to develop policy recommendations within 90 days to protect IVF access and reduce out-of-pocket expenses for families dealing with infertility.

As a provider of in vitro fertilization (IVF) and in vivo Intravaginal Culture (IVC) fertility treatments, NAYA believes this initiative could positively impact its operations. The company highlighted that its FDA-cleared INVOcell device and IVC treatment process are "uniquely positioned to offer an efficient, effective, and more affordable treatment solution" aligned with the administration's cost-reduction goals.

NAYA operates fertility centers in Wisconsin, Alabama, and Georgia. CEO Steve Shum emphasized that "no one should have to choose between financial stability and starting a family" and committed to supporting efforts making fertility treatments more accessible and affordable.

Positive

• Executive order could expand market for NAYA's fertility services
• NAYA's INVOcell technology positioned as cost-effective solution aligned with policy goals
• Company operates multiple fertility centers across three states (Wisconsin, Alabama, Georgia)
• FDA-cleared technology gives competitive advantage in potentially expanding market

Negative

• Benefits depend on actual implementation of policy recommendations
• Timeline for potential business impact uncertain with 90-day policy development period
• current insurance coverage (fewer than 20 states) remains a market challenge

NAYA Sees Potential Positive Impact to Its Existing Fertility Operations and FDA-Cleared INVOcell Technology

SARASOTA, Fla. and MIAMI, Feb. 25, 2025 (GLOBE NEWSWIRE) -- NAYA Biosciences, Inc. (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and women’s health, and a leading provider of in vitro fertilization (IVF) and in vivo Intravaginal Culture (“IVC”) fertility treatments, proudly supports the U.S. President’s recent executive order aimed at reducing the cost of IVF and expanding access to fertility services. The order directs the Domestic Policy Council to develop policy recommendations within 90 days to protect IVF access and significantly lower out-of-pocket expenses and health plan costs for families dealing with infertility.

For many individuals and couples struggling with infertility, the high cost of IVF often makes treatment financially out of reach. The lack of comprehensive insurance coverage for fertility services in most states further compounds this challenge, forcing many patients to take on significant debt or forego treatment altogether.

“Infertility is a challenging medical condition, and no one should have to choose between financial stability and starting a family,” said Steve Shum, CEO of NAYA Biosciences. “President Trump’s executive order is a critical step in the right direction, and we stand ready to support efforts that make fertility treatments more accessible and affordable for all. In addition to our existing fertility clinic operations, we also believe our FDA-cleared INVOcell device and the IVC treatment process is uniquely positioned to offer an efficient, effective, and more affordable treatment solution, which is aligned with the administration’s efforts to reduce costs.”

Currently, fewer than 20 states mandate some level of fertility coverage, leaving millions without insurance assistance. By addressing cost concerns, the administration’s action has the potential to bring hope to those who have faced heartbreaking obstacles on their journey to parenthood.

“As a trusted partner in fertility care with centers in Wisconsin, Alabama, and Georgia, NAYA remains committed to providing high-quality, patient-centered treatment and advocating for policies that support individuals and families seeking to conceive. We look forward to working alongside policymakers, medical professionals, and advocacy groups to ensure that every hopeful parent has the opportunity to experience the joy of building a family,” Shum concluded.

About NAYA Women’s Health
NAYA Women’s Health is currently focused within the fertility marketplace. Our commercial strategy includes operating fertility-focused clinics providing treatment to patients via INVO Centers, LLC, our wholly owned subsidiary. We currently have two operational INVO Centers in the United States along with a conventional IVF clinic.

Naya Women’s Health also includes the INVOcell medical device. The INVOcell is the first in vivo Intravaginal Culture (“IVC”) system granted FDA clearance in the United States. We believe this novel device and procedure provides a more natural, safe, effective and economical fertility treatment for patients. Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women’s vagina as an incubator to support a more natural fertilization and embryo development environment, and infertility treatment. We currently sell and distribute INVOcell into existing independently owned and operated fertility clinics as well as within our own INVO Center clinics.

About NAYA Biosciences
NAYA Biosciences (NASDAQ: NAYA) is a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and women’s health. Our proven hub & spoke model harnesses the shared resources of a parent company and agility of lean strategic franchises, enabling efficient acquisition, development, and partnering of assets and allowing for optimized return on investment by combining scalable, profitable commercial revenues with the upside of innovative clinical-stage therapeutics.

NAYA’s expanding portfolio of assets currently includes NY-303, a GPC3 x NKp46 bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) with a unique mode of action targeting non-responders to the current immunotherapy standard of care (approximately 70% of the current treatable market) cleared to enroll patients in a Phase 1/2a monotherapy trial in 2025, NY-338, a CD38 x NKp46 bifunctional antibody for the treatment of multiple myeloma and autoimmune diseases with a differentiated safety and efficacy profile, NY-500, a PD-1 x VEGF bifunctional antibody for the treatment of HCC and other solid tumors, and NY-600 a PSMA x NKp46 bifunctional antibody for the treatment of metastatic Castration Resistant Prostate Cancer (mCRPC).

Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.

NAYA Investor & Media Contact
Anna Baran-Djokovic
SVP, Investor Relations
+1-305-615-9162
anna@nayabiosciences.com

FAQ

How might the recent executive order on fertility treatments affect NAYA Biosciences (NAYA) stock?

The executive order could positively impact NAYA Biosciences' stock by potentially expanding their customer base through increased accessibility to fertility treatments. As a provider of IVF and IVC treatments with their FDA-cleared INVOcell technology, NAYA is positioned to benefit from policy changes that reduce costs and increase insurance coverage for fertility services.

What is NAYA Biosciences' INVOcell technology and how does it relate to the executive order on fertility treatments?

INVOcell is NAYA Biosciences' FDA-cleared device for in vivo Intravaginal Culture (IVC) fertility treatments. It's positioned as an efficient, effective, and more affordable treatment solution compared to traditional IVF, aligning with the executive order's goal of reducing fertility treatment costs and expanding access.

Where does NAYA Biosciences currently operate fertility centers as mentioned in the February 2025 announcement?

According to the announcement, NAYA Biosciences operates fertility centers in three states: Wisconsin, Alabama, and Georgia.

What specific timeline did the executive order set for developing fertility treatment policy recommendations according to NAYA's press release?

The executive order directs the Domestic Policy Council to develop policy recommendations within 90 days to protect IVF access and significantly lower out-of-pocket expenses and health plan costs for families dealing with infertility.

How many states currently mandate fertility coverage according to NAYA Biosciences' February 2025 press release?

According to NAYA Biosciences' press release, fewer than 20 states currently mandate some level of fertility coverage, leaving millions of Americans without insurance assistance for fertility treatments.