NAYA Biosciences Supports Recent Executive Order Aimed at Improving Access to Fertility Treatment
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 HealthNAYA 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 BiosciencesNAYA 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 StatementThis 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 ContactAnna Baran-DjokovicSVP, Investor Relations+1-305-615-9162anna@nayabiosciences.comSign in to access your portfolio
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Understanding these variations is essential for developing targeted interventions and improving patient regions include: The United States Germany France Italy Spain The United Kingdom Japan India These regions exhibit distinct epidemiological trends, reflecting the unique challenges and opportunities within their healthcare epidemiology of congestive heart failure differs across countries due to varying prevalence of risk factors such as obesity, tobacco use, and diabetes. In The United States, the U.S. Centers for Disease Control and Prevention reports that around 6.7 million adults aged 20 and above are currently affected by heart failure. Furthermore, in 2022, heart failure was mentioned on 457,212 death certificates, representing 13.9% of all recorded deaths in the country, reflecting its considerable impact on public Questions Answered What are the primary demographic factors influencing the prevalence of congestive heart failure across different regions? How do lifestyle-related risk factors such as diet, physical inactivity, and smoking contribute to variations in congestive heart failure incidence globally? What is the impact of comorbidities like diabetes, hypertension, and obesity on the progression and outcomes of congestive heart failure? How do socioeconomic status and healthcare access affect the diagnosis and treatment rates of congestive heart failure in low-income versus high-income countries? What regional trends have been observed in the mortality rates associated with congestive heart failure over the past decade? How do age and gender disparities influence the epidemiological patterns of congestive heart failure? What are the projected trends for congestive heart failure prevalence over the next decade, and which regions are expected to see the most significant changes? How effective have national public health campaigns been in reducing risk factors associated with congestive heart failure? What are the differences in hospitalisation and readmission rates for congestive heart failure among urban and rural populations? How does genetic predisposition play a role in the development of congestive heart failure across different ethnic groups? Scope of the Report The report covers a detailed analysis of signs and symptoms, causes, risk factors, pathophysiology, diagnosis, treatment options, and classification/types of congestive heart failure (CHF) based on several factors. The congestive heart failure (CHF) epidemiology forecast report covers data for the eight major markets (the US, France, Germany, Italy, Spain, the UK, Japan, and India) The report helps to identify the patient population, the unmet needs of congestive heart failure (CHF) are highlighted along with an assessment of the disease's risk and burden. Key Topics Covered1 Preface1.1 Introduction1.2 Objectives of the Study1.3 Research Methodology and Assumptions2 Executive Summary3 Congestive Heart Failure (CHF) Market Overview - 8 MM3.1 Congestive Heart Failure (CHF) Market Historical Value (2018-2024)3.2 Congestive Heart Failure (CHF) Market Forecast Value (2025-2034)4 Congestive Heart Failure (CHF) Epidemiology Overview - 8 MM4.1 Congestive Heart Failure (CHF) Epidemiology Scenario (2018-2024)4.2 Congestive Heart Failure (CHF) Epidemiology Forecast (2025-2034)5 Disease Overview5.1 Signs and Symptoms5.2 Causes5.3 Risk Factors5.4 Guidelines and Stages5.5 Pathophysiology5.6 Screening and Diagnosis5.7 Types of Congestive Heart Failure (CHF)6 Patient Profile6.1 Patient Profile Overview6.2 Patient Psychology and Emotional Impact Factors7 Epidemiology Scenario and Forecast - 8 MM (218-2034)7.1 Key Findings7.2 Assumptions and Rationale7.3 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF)7.4 Type-Specific Cases of Congestive Heart Failure (CHF)7.5 Gender-Specific Cases of Congestive Heart Failure (CHF)7.6 Age-Specific Cases of Congestive Heart Failure (CHF)8 Epidemiology Scenario and Forecast: United States (218-2034)8.1 Assumptions and Rationale in the US8.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in the US8.3 Type-Specific Cases of Congestive Heart Failure (CHF) in the US8.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in the US8.5 Age-Specific Cases of Congestive Heart Failure (CHF) in the US9 Epidemiology Scenario and Forecast: United Kingdom (218-2034)9.1 Assumptions and Rationale in United Kingdom9.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in United Kingdom9.3 Type-Specific Cases of Congestive Heart Failure (CHF) in United Kingdom9.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in United Kingdom9.5 Age-Specific Cases of Congestive Heart Failure (CHF) in United Kingdom10 Epidemiology Scenario and Forecast: Germany (218-2034)10.1 Assumptions and Rationale in Germany10.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in Germany10.3 Type-Specific Cases of Congestive Heart Failure (CHF) in Germany10.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in Germany10.5 Age-Specific Cases of Congestive Heart Failure (CHF) in Germany11 Epidemiology Scenario and Forecast: France (218-2034)11.1 Assumptions and Rationale in France11.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in France11.3 Type-Specific Cases of Congestive Heart Failure (CHF) in France11.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in France11.5 Age-Specific Cases of Congestive Heart Failure (CHF) in France12 Epidemiology Scenario and Forecast: Italy (218-2034)12.1 Assumptions and Rationale in Italy12.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in Italy12.3 Type-Specific Cases of Congestive Heart Failure (CHF) in Italy12.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in Italy12.5 Age-Specific Cases of Congestive Heart Failure (CHF) in Italy13 Epidemiology Scenario and Forecast: Spain (218-2034)13.1 Assumptions and Rationale in Spain13.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in Spain13.3 Type-Specific Cases of Congestive Heart Failure (CHF) in Spain13.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in Spain13.5 Age-Specific Cases of Congestive Heart Failure (CHF) in Spain14 Epidemiology Scenario and Forecast: Japan (218-2034)14.1 Assumptions and Rationale in Japan14.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in Japan14.3 Type-Specific Cases of Congestive Heart Failure (CHF) in Japan14.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in Japan14.5 Age-Specific Cases of Congestive Heart Failure (CHF) in Japan15 Epidemiology Scenario and Forecast: India (218-2034)15.1 Assumptions and Rationale in India15.2 Diagnosed Prevalent Cases of Congestive Heart Failure (CHF) in India15.3 Type-Specific Cases of Congestive Heart Failure (CHF) in India15.4 Gender-Specific Cases of Congestive Heart Failure (CHF) in India15.5 Age-Specific Cases of Congestive Heart Failure (CHF) in India16 Patient Journey17 Treatment Challenges and Unmet Needs18 Key Opinion Leaders (KOL) InsightsFor more information about this report visit About is the world's leading source for international market research reports and market data. 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