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Femasys Closes $8 Million in Financing to Accelerate Commercialization of Fertility and Birth Control Portfolios
Globenewswire· 2025-09-02 13:00
Core Insights - Femasys Inc. has successfully closed $8 million in financing to enhance its commercialization efforts and address unmet needs in women's reproductive health [1][2] - The company focuses on making fertility treatments and non-surgical permanent birth control more accessible and cost-effective for women globally [3] Company Overview - Femasys is a biomedical innovator with a patent-protected portfolio of therapeutic and diagnostic products aimed at women's health [3] - The company's lead products include FemaSeed, an intratubal insemination treatment, and FemBloc, a non-surgical permanent birth control option [3][4] Recent Milestones - Regulatory approvals for FemBloc were obtained in Europe on June 25, 2025, and in the United Kingdom on August 20, 2025 [6] - FemaSeed received regulatory approval in Australia and New Zealand on July 1, 2025 [6] - The company made its first commercial entry into Europe with a $400,000 order for FemBloc in Spain on August 6, 2025 [6] - A partnership was established with Carolinas Fertility Institute to offer FemaSeed across eight locations [6] Leadership Commentary - CEO Kathy Lee-Sepsick emphasized the importance of the new financing in executing the company's strategy and achieving revenue growth [2] - Jorey Chernett, a major shareholder, highlighted the critical need addressed by FemBloc and expressed confidence in Femasys' mission and products [2]
Femasys Announces Pricing of $8.0 Million Underwritten Public Offering
Globenewswire· 2025-08-26 03:44
Core Viewpoint - Femasys Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $8.0 million to support its commercial expansion and product development efforts [2][4]. Group 1: Offering Details - The public offering consists of 10,434,586 shares of common stock and pre-funded warrants to purchase up to 11,750,000 shares, with a combined offering price of $0.36 per share and accompanying common warrant [1][2]. - The offering is expected to close on or about August 27, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - Femasys plans to utilize the net proceeds from the offering for the expansion of commercial efforts, product development, general corporate purposes, capital expenditures, and working capital [2]. Group 3: Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of in-office therapeutic and diagnostic products [6]. - The company’s fertility portfolio includes FemaSeed, which is over twice as effective as traditional IUI, and FemVue, a diagnostic tool for fallopian tube assessment [6]. - FemBloc, a non-surgical permanent birth control method, received regulatory approval in Europe and the UK in 2025, with commercialization planned through strategic partnerships [7].
Progyny Partners with ŌURA to Empower Women and Their Care Teams with Wearable Tech Data, Further Supporting Outcomes from Preconception to Menopause
Globenewswire· 2025-07-10 13:06
Core Insights - Progyny, Inc. has announced a partnership with ŌURA to enhance women's health and family building solutions through personalized data and insights [1][4] - The collaboration aims to integrate wearable data from ŌURA into Progyny's care team decision-support process, promoting proactive health management from preconception to menopause [2][4] Company Overview - Progyny is recognized as a global leader in women's health and family building solutions, serving leading employers, health plans, and benefit purchasers [5][6] - The company focuses on comprehensive, inclusive, and intentionally designed solutions that benefit employers, patients, and physicians [5] Partnership Details - The partnership will allow Progyny clients, including employers and health plans, to access ŌURA's smart ring and membership starting in early 2026 [4] - The integration of ŌURA's health metrics will help women track key health indicators, optimize conception attempts, and manage health during menopause [3][4] Health Management Approach - The collaboration emphasizes the importance of daily awareness of health patterns as a foundation for reproductive health management [4] - By utilizing data from the Oura Ring, Progyny aims to facilitate smarter care, earlier interventions, and personalized health journeys for women [4]
Femasys Achieves Australian and New Zealand Regulatory Approvals for FemaSeed® for First-Line Infertility Treatment and FemVue Diagnostic
Globenewswire· 2025-07-01 13:00
Core Insights - Femasys, Inc. has achieved regulatory approvals in Australia and New Zealand for its infertility solutions, FemaSeed and FemVue, enhancing global access to innovative treatments for women facing infertility [1][2] Group 1: Product Overview - FemaSeed is a next-generation artificial insemination solution that significantly improves fertilization by delivering sperm directly to the fallopian tube, achieving over double the pregnancy rates compared to intrauterine insemination (IUI) in cases of low male sperm count [3][5] - FemVue is an ultrasound-based diagnostic tool that evaluates fallopian tube patency, providing a safe and reliable assessment within a gynecologist's office, and serves as a companion diagnostic for FemaSeed [4][5] Group 2: Market Expansion - The regulatory approvals in Australia and New Zealand represent a strategic milestone for Femasys, validating the clinical value of its products and creating commercial opportunities to grow revenue and expand its global footprint [2][5] - Femasys is actively commercializing its products in the U.S. and key international markets, with a focus on addressing critical unmet needs in women's health [5] Group 3: Additional Innovations - Femasys has also received regulatory approval for FemBloc, a non-surgical, in-office permanent birth control solution, which will begin commercialization in Spain and subsequently in other European countries [6] - FemChec, a diagnostic product that confirms the success of the FemBloc procedure, has shown compelling effectiveness and high satisfaction rates in initial clinical trials [6]
Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control
GlobeNewswire News Room· 2025-06-25 13:00
Core Points - Femasys Inc. has received CE mark certification for its FemBloc blended polymer component, marking the first global regulatory approval for a non-surgical permanent birth control solution [1][2] - The FemBloc System is now approved for marketing in the European Economic Area, which includes 27 EU member states and 3 EFTA countries [1] - Femasys plans to commercialize FemBloc in select European countries, starting with Spain, and is also pursuing U.S. FDA approval through ongoing clinical trials [2][4] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of in-office therapeutic and diagnostic products [4] - The FemBloc System is a non-surgical solution that places a proprietary blended polymer into the fallopian tubes, creating natural scar tissue to block them permanently [3] - Femasys also has a fertility portfolio that includes FemaSeed for infertility treatment and FemVue for fallopian tube assessment, with FemaSeed showing over twice the effectiveness of traditional IUI [4]
Progyny Adds Pelvic Floor Therapy, Continuing to Close Gaps in Care Across Women's Health
Globenewswire· 2025-06-24 13:10
Core Insights - Progyny, Inc. is expanding its women's health offerings by adding pelvic floor therapy to its services, aiming to improve access and education for women suffering from pelvic floor disorders [1][3] - Approximately one in three women experience pelvic floor issues, with one in five requiring surgery, highlighting the prevalence and impact of these disorders on women's health [2][3] - The company is partnering with Origin and Hinge Health to provide both in-person and virtual pelvic floor therapy, enhancing the accessibility of specialized care [5][6] Summary by Sections Company Initiatives - Progyny is committed to addressing the silent suffering of women by providing expanded care access and educational resources related to pelvic floor disorders [1][3] - The addition of pelvic floor therapy is part of a broader strategy to enhance women's health services from preconception to menopause [1][4] Health Impact - Pelvic floor disorders can lead to significant quality of life issues, including reduced work performance and increased healthcare costs, with urinary incontinence alone costing the healthcare industry $20 billion annually [2][4] - Untreated pelvic health issues are linked to conditions such as endometriosis and infertility, emphasizing the need for timely intervention [2][4] Partnerships and Services - The collaboration with Origin allows Progyny members to access a wide range of pelvic floor physical therapy services, addressing both common and complex pelvic health needs [5][6] - Hinge Health provides digital care plans tailored to individual symptoms, promoting sustainable health habits and symptom relief [6][7] Company Vision and Recognition - Progyny envisions a world where everyone can achieve their family and health goals, supported by a comprehensive network of specialists and innovative solutions [8][9] - The company has received multiple accolades for its leadership and growth in the healthcare sector, including recognition as a TIME100 Most Influential Company and a CNBC Disruptor 50 [10]
Femasys Announces Proposed Public Offering of Common Stock and Concurrent Private Placement
Globenewswire· 2025-05-29 20:23
Core Viewpoint - Femasys Inc. plans to conduct an underwritten public offering of its common stock, with an additional 30-day option for underwriters to purchase up to 15% more shares, alongside a concurrent private placement involving existing institutional stockholders and certain directors and officers [1][2]. Group 1: Offering Details - The public offering and private placement are subject to market conditions, with no assurance on completion timing or terms [2]. - Jones is the sole book-running manager for the public offering and placement agent for the private placement [3]. - The net proceeds from the offerings will be used for commercial expansion, product development, general corporate purposes, capital expenditures, and working capital [3]. Group 2: Regulatory Information - The securities are being offered under a Registration Statement on Form S-3, previously filed and declared effective by the SEC [4]. - The private placement will rely on an exemption from registration under the Securities Act, meaning the securities may not be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - Femasys Inc. focuses on women's health, developing minimally invasive, in-office technologies for reproductive health, including products like FemBloc for permanent birth control and FemaSeed for infertility [6]. - Current marketed products include FemVue for fallopian tube assessment and FemCath, an intrauterine catheter for selective evaluation [6].
ATTENTION NYSE: OGN INVESTORS: Contact Berger Montague About an Organon & Co. Class Action Lawsuit
Prnewswire· 2025-05-29 12:56
Core Viewpoint - A securities class action lawsuit has been filed against Organon & Co. for allegedly misleading investors regarding its capital allocation priorities following the acquisition of Dermavant [1][3]. Company Overview - Organon & Co. is a healthcare company focused on women's health, headquartered in Jersey City, NJ [2]. - In October 2024, Organon acquired Dermavant, a biopharmaceutical company, for $1.2 billion [2]. Lawsuit Details - The lawsuit claims that despite increasing debt from the Dermavant acquisition, Organon assured investors it would maintain its dividend as its "1 capital allocation priority" [3]. - The suit alleges that after the acquisition, Organon shifted its focus to reducing debt rather than maintaining dividend payouts [3]. Stock Price Reaction - On May 1, 2025, Organon announced a significant reduction in its dividend payout from $0.28 per share to $0.02 per share, stating that returning capital to shareholders was a lower priority [4]. - Following this announcement, Organon's stock price fell by $3.48 per share, approximately 27%, from $12.93 on April 30, 2025, to $9.45 on May 1, 2025 [4].
Progyny Appoints Two Renowned Women's Health Experts to Medical Advisory Board
GlobeNewswire News Room· 2025-05-14 13:05
Core Insights - Progyny, Inc. has appointed Dr. Gloria Richard-Davis and Dr. Whitney Booker to its Medical Advisory Board, enhancing its leadership in women's health and family building solutions [2][3] Group 1: Company Developments - The addition of Dr. Richard-Davis and Dr. Booker is aimed at bringing critical insights to Progyny's work in advancing care, health equity, and research in fertility and maternal health [3] - Dr. Richard-Davis is recognized for her leadership in women's health and reproductive medicine, with a focus on health equity and has held significant academic and leadership roles [3][4] - Dr. Booker is noted for her expertise in prenatal fetal diagnosis and high-risk maternal care, contributing her research background in hypertension and cardiovascular disease in pregnancy [4][5] Group 2: Company Vision and Services - Progyny envisions a world where everyone can achieve their family and health goals, providing comprehensive, inclusive, and intentionally designed solutions that benefit employers, patients, and physicians [7] - The company's benefits solution includes concierge support, coaching, education, and access to a network of fertility and women's health specialists, aimed at driving optimal clinical outcomes and reducing healthcare costs [8] Group 3: Recognition and Impact - Progyny has been recognized as a leader in its field, receiving accolades such as TIME100 Most Influential Company and CNBC Disruptor 50, highlighting its growth and impact in women's health [9]
Progyny, Inc. to Present at BofA Securities 2025 Health Care Conference
Globenewswire· 2025-05-12 19:58
Company Overview - Progyny, Inc. is a global leader in women's health and family building solutions, trusted by leading employers, health plans, and benefit purchasers [3][5] - The company aims to create a world where everyone can achieve their family and health aspirations through comprehensive and inclusive solutions [3] Recent Events - Progyny's CEO Pete Anevski and CFO Mark Livingston will participate in a fireside chat at the BofA Securities 2025 Health Care Conference on May 14, 2025, at 3:00 P.M. Pacific Time / 6:00 P.M. Eastern Time [1] Services and Solutions - Progyny offers a benefits solution that includes concierge support, coaching, education, and digital tools, providing access to a premier network of fertility and women's health specialists [4] - The company's approach is designed to drive optimal clinical outcomes while reducing healthcare costs [4] Recognition and Awards - Progyny has received multiple accolades, including being named a TIME100 Most Influential Company, CNBC Disruptor 50, and recognized by Modern Healthcare, Forbes, Financial Times, and Inc. for its leadership and growth [5]