Femasys Announces Partnership with CNY Fertility, National Conglomerate Network of Fertility Centers, to Offer FemaSeed in its 11 Locations
ATLANTA, March 19, 2025 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces a partnership with CNY Fertility, a national provider of fertility services across the U.S. CNY Fertility will provide the Company's FemaSeed intratubal insemination product as an infertility treatment option to patients throughout its network of 11 locations.
'We are thrilled to partner with CNY Fertility, a prominent infertility group, to continue to expand access of our FemaSeed infertility treatment to those seeking a first-line fertility solution,' said Femasys CEO Kathy Lee-Sepsick. 'By providing FemaSeed to CNY Fertility, we are supporting their commitment to delivering exceptional care and helping patients navigate their fertility journey with confidence.'
Dr. Robert Kiltz, Founder and Director of CNY Fertility stated, 'Our mission at CNY Fertility is to offer comprehensive, affordable, high-quality fertility solutions for our patients. We believe FemaSeed is an innovative technology that expands options for our patients seeking the latest advancements to grow their family.'
About FemaSeed
FemaSeed® is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.1 It serves as an affordable, less burdensome and lower-risk first step before IVF. Learn more at www.femaseed.com.
About Femasys
Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women's health with a broad, patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company, a U.S. manufacturer, has received regulatory approvals for its product portfolio worldwide, and they are currently being commercialized in the U.S. and key international markets. FemaSeed® Intratubal Insemination, a groundbreaking first-line infertility treatment, is FDA-cleared and approved in Europe, UK, Canada and Israel. Clinical trial data, published in peer-reviewed journal, demonstrate safety, effectiveness, and high satisfaction from patients and practitioners.1 FemVue®, a companion diagnostic for fallopian tube assessment, is FDA-cleared and approved in Europe, UK, Canada, Japan and Israel. FemCerv®, a tissue sampler for cervical cancer diagnosis, is FDA-cleared and approved in Europe, UK, Canada and Israel.
FemBloc® permanent birth control, is the first and only non-surgical, in-office approach offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The revolutionary FemBloc delivery system is approved in Europe and the proprietary blended polymer has been recommended for approval, which is expected mid-year 2025. For U.S. FDA approval, the FINALE pivotal clinical trial (NCT05977751) is currently enrolling participants. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.2 FemCath® and FemChec®, diagnostic products for FemBloc's ultrasound-based confirmation test, are FDA-cleared and approved in Europe and Canada. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
About CNY Fertility
CNY Fertility is a leading fertility clinic known for its affordable and accessible fertility treatments. With a commitment to excellence in care and a comprehensive suite of services, CNY Fertility helps individuals and couples achieve their dreams of parenthood. Unique in its affordability, inclusiveness, accessibility, geographic reach, professional expertise, and personal service, CNY Fertility has helped create more than 30,000 lives since its opening in 1997 and is expanding its capability to give this gift to many more people. Learn more at www.cnyfertility.com.
References
1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12.
2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'pending,' 'intend,' 'believe,' 'suggests,' 'potential,' 'hope,' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled 'Risk Factors' in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
Media Contact:
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
14 minutes ago
- Yahoo
India Wind Turbine Industry Report 2025: $4.84 Bn Market Trends, Competitive Landscape, Forecasts & Opportunities 2021-2031 - Growing Government Policies, Rise of Wind-Solar Hybrid Projects
Key market opportunities in India's wind turbine sector include robust government support with favorable policies, the rise of wind-solar hybrid projects enhancing efficiency, and technological advancements boosting reliability. Despite challenges like land acquisition issues, the drive for renewable energy presents substantial growth potential. Indian Wind Turbine Market Dublin, June 06, 2025 (GLOBE NEWSWIRE) -- The "India Wind Turbine Market, By Region, Competition, Forecast & Opportunities, 2021-2031F" report has been added to India Wind Turbine Market was valued at USD 3.18 Billion in 2025, and is expected to reach USD 4.84 Billion by 2031, rising at a CAGR of 7.10% Wind turbines, which transform wind's kinetic energy into electricity through rotor-driven generators, are pivotal to the country's clean energy strategy. Predominantly installed in high-wind regions such as coastal and open plains, they are available in horizontal-axis and vertical-axis configurations, with the former being more widespread. As environmentally friendly power sources, wind turbines produce no direct emissions and are integrated with advanced systems to ensure optimized and safe operations. Despite challenges like intermittency and noise, wind energy offers vital benefits in emission reduction and energy security. Advancements in turbine technology continue to enhance efficiency and reliability, reinforcing wind power's essential role in India's transition to sustainable energy. Key Market Drivers Government Policies and IncentivesA major driver of India's wind turbine market is the robust government support manifested through favorable policies, financial subsidies, and regulatory initiatives. The Ministry of New and Renewable Energy (MNRE) has laid out ambitious plans to reach 140 GW of wind capacity by 2030. To facilitate this goal, the government has introduced measures like Accelerated Depreciation (AD), Generation-Based Incentives (GBI), and concessional financing to reduce project costs and attract private and foreign investments. Competitive bidding for wind energy projects fosters cost efficiency and transparency. Additionally, the rollout of wind-solar hybrid policies and offshore wind guidelines has broadened the market potential, supporting the development of integrated renewable infrastructure across the Market Challenges Land Acquisition and Infrastructure BottlenecksA significant hurdle for the Indian wind turbine sector is the complex and time-consuming process of land acquisition and the insufficient infrastructure in high-potential areas. Although states such as Tamil Nadu, Gujarat, and Maharashtra offer strong wind resources, securing land for projects often involves dealing with bureaucratic delays, unclear land titles, and local resistance. Communities may oppose projects due to fears of displacement, disruption to traditional land use, and perceived inadequate compensation. Furthermore, many optimal wind sites are in remote locations that lack critical infrastructure like roads and power evacuation systems. In several cases, completed wind farms are underutilized due to inadequate transmission connectivity, causing financial setbacks for Market Trends Rise of Wind-Solar Hybrid ProjectsAn emerging trend in India's wind energy landscape is the rise of wind-solar hybrid projects, which combine both energy sources at a shared site or grid point. This setup enhances land and infrastructure use efficiency and delivers a more stable power supply. Recognizing the value of hybrid models, the government launched the National Wind-Solar Hybrid Policy, aimed at improving grid reliability and optimizing energy output. These projects allow for shared infrastructure, resulting in cost savings and operational efficiency. Technological innovations are also supporting this trend, with customized solutions such as hybrid-compatible inverters and control systems. States like Gujarat and Rajasthan, with rich wind and solar potential, are leading hybrid deployments, and key industry players are actively participating in hybrid tenders, signifying growing market traction. Key Attributes: Report Attribute Details No. of Pages 86 Forecast Period 2025 - 2031 Estimated Market Value (USD) in 2025 $3.18 Billion Forecasted Market Value (USD) by 2031 $4.84 Billion Compound Annual Growth Rate 7.1% Regions Covered India Report Scope: Competitive LandscapeCompany Profiles: Detailed analysis of the major companies present in the India Wind Turbine Market. Vestas Wind Systems A/S Siemens Gamesa Renewable Energy, S.A. General Electric Company (GE Renewable Energy) Nordex SE Goldwind Science & Technology Co., Ltd. Envision Energy Suzlon Energy Limited Mingyang Smart Energy Group Co., Ltd. India Wind Turbine Market, By Type: Horizontal-Axis Turbine Vertical-Axis Turbine India Wind Turbine Market, By Installation: Offshore Onshore India Wind Turbine Market, By Component: Foundation Tower Rotor Generator Nacelle Others India Wind Turbine Market, By Application: Industrial Commercial Residential Utilities India Wind Turbine Market, By Rating: < 100KW 100KW to 250KW 250KW to 500KW 500KW to 1MW 1MW to 2MW >2MW India Wind Turbine Market, By Region: South India North India West India East India For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Indian Wind Turbine Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Associated Press
14 minutes ago
- Associated Press
Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer
– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine – – VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer – NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE: PFE), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. 'This milestone comes after an exciting presentation at the American Society of Clinical Oncology's annual meeting,' said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. 'We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.' Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer and was granted fast track designation as a monotherapy by the FDA. Results from the VERITAC-2 study were recently presented in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and were selected for the ASCO press briefing and for Best of ASCO. Detailed results were also simultaneously published in the New England Journal of Medicine. About the VERITAC-2 Clinical Trial The Phase 3 VERITAC-2 clinical trial ( NCT05654623 ) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint. About Vepdegestrant Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER). Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About Arvinas Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit and connect on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option; and vepdegestrant's development as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'target,' 'goal,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'look forward,' 'continue,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; risks related to our expectations regarding the potential clinical benefit of vepdegestrant to patients; uncertainties relating to regulatory applications and related filing and approval timelines, including the New Drug Application seeking FDA approval of vepdegestrant and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of vepdegestrant; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas' ability to protect its intellectual property portfolio; Arvinas' reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the 'Risk Factors' section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release. Contacts Investors: Jeff Boyle +1 (347) 247-5089 [email protected] Media: Kirsten Owens +1 (203) 584-0307 [email protected]
Associated Press
14 minutes ago
- Associated Press
RYVYL Announces Conversion for Remainder of 8% Senior Convertible Note; Successfully Completes Process of Delevering Balance Sheet
SAN DIEGO, CA, June 06, 2025 (GLOBE NEWSWIRE) -- RYVYL Inc. (NASDAQ: RVYL) ('RYVYL' or the 'Company'), a leading innovator of payment transaction solutions leveraging electronic payment technology, announced the securityholder of its remaining 8% Senior Convertible Note ('Note'), has converted the entire outstanding principal balance of $4.0 million and accrued interest of $136,000 into 7.1 million shares of common stock. 'We've pursued an anti-dilutive strategy to restructure our balance sheet, and this final debt to equity conversion successfully completes that process,' said George Oliva, CFO of RYVYL. 'In January 2025, we redeemed our Series B Convertible Preferred Stock with a liquidation value of $53.1 million and $14.3 million of the Note for a payment of $13.0 million, which avoided over 90 million shares of potential dilution and converted over $50 million of additional paid in capital from Preferred Stock to Common shareholders.' About RYVYL RYVYL Inc. (NASDAQ: RVYL) was born from a passion for empowering a new way to conduct business-to-business, consumer-to-business, and peer-to-peer payment transactions around the globe. By leveraging electronic payment technology for diverse international markets, RYVYL is a leading innovator of payment transaction solutions reinventing the future of financial transactions. Since its founding as GreenBox POS in 2017 in San Diego, RYVYL has developed applications enabling an end-to-end suite of turnkey financial products with enhanced security and data privacy, world-class identity theft protection, and rapid speed to settlement. As a result, the platform can log immense volumes of immutable transactional records at the speed of the internet for first-tier partners, merchants, and consumers around the globe. Cautionary Note Regarding Forward-Looking Statements This press release includes information that constitutes 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. These forward-looking statements are based on the Company's current beliefs, assumptions and expectations regarding future events, which in turn are based on information currently available to the Company. Such forward-looking statements include statements that are characterized by future or conditional words such as 'may,' 'will,' 'expect,' 'intend,' 'anticipate,' 'believe,' 'estimate' and 'continue' or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. By their nature, forward-looking statements address matters that are subject to risks and uncertainties. A variety of factors could cause actual events and results to differ materially from those expressed in or contemplated by the forward-looking statements. Risk factors affecting the Company are discussed in detail in the Company's filings with the SEC. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by applicable laws. IR Contact: David Barnard, Alliance Advisors Investor Relations, 415-433-3777, [email protected]
