ATLANTA, March 18, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide, announced today the appointment of Kenneth D. Eichenbaum, M.D., M.S.E., to its Board of Directors. Dr. Eichenbaum is a board-certified anesthesiologist with clinical affiliations at Corewell Health William Beaumont University Hospital and Trinity Health Oakland Hospital, bringing de ...

Core Insights - Femasys Inc. has initiated patient enrollment in the FINALE pivotal trial for FemBloc, a non-surgical permanent birth control solution, following FDA approval based on positive clinical data [1][2] - FemBloc is already being commercialized in Europe and other countries, aiming to provide a safer and more accessible alternative to surgical sterilization [1][2] Company Overview - Femasys is focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a broad portfolio of patented therapeutic and diagnostic products [4] - The company has received regulatory approvals for FemBloc in Europe, the UK, and New Zealand, with plans for strategic partnerships to enhance commercialization [5][6] FINALE Trial Details - The FINALE trial is a prospective, multi-center, open-label study assessing the safety and effectiveness of FemBloc, with an initial roll-in enrollment of 50 women completed [3] - The primary endpoint of the trial is the pregnancy rate after one year of using FemBloc, with an interim analysis planned after 300 participants complete one year [3] Product Features - FemBloc utilizes a patented delivery system to place a proprietary blended polymer into the fallopian tubes, forming natural scar tissue for permanent occlusion [2] - This non-surgical method aims to reduce procedural risks and healthcare costs associated with traditional surgical sterilization [2]

Core Viewpoint - Femasys Inc. has granted stock options to two new non-executive employees as part of their employment inducement strategy, reflecting the company's commitment to expanding its workforce and enhancing its innovative capabilities in the biomedical sector [1][2]. Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally through a broad, patent-protected portfolio of therapeutic and diagnostic products [3]. - The company is actively commercializing its lead product innovations in the U.S. and key international markets, with a focus on enhancing fertility treatment options and permanent birth control solutions [3]. Product Innovations - Femasys' fertility portfolio includes: - FemaSeed Intratubal Insemination (ITI), which has demonstrated more than double the pregnancy rates of traditional IUI with a comparable safety profile [3]. - FemSperm, a sperm preparation and analysis product line [3]. - FemVue, a companion diagnostic for fallopian tube assessment [3]. - FemBloc is the first and only non-surgical, in-office alternative to surgical sterilization, receiving full regulatory approval in Europe, the UK, and New Zealand in 2025 [4]. - The FemChec diagnostic product provides an ultrasound-based test to confirm procedural success, with initial clinical trials showing compelling effectiveness and high satisfaction rates [4]. Stock Options and Employment Strategy - Femasys granted options to purchase 185,000 shares at exercise prices of $0.50 and $0.57, equal to the closing stock price on the employment date [2]. - The stock options will vest 25% on the first anniversary of employment, with the remaining shares vesting 25% each year over the next three years, contingent on continued employment [2].

Core Insights - Femasys Inc. has announced that its FemBloc permanent birth control system has achieved MDSAP certification, which will facilitate regulatory and commercial execution in key global markets [1][2] - The MDSAP certification enhances the company's manufacturing credibility and operational scalability, supporting ongoing commercialization in Europe and enabling market entry in additional high-value regions [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally through a patent-protected portfolio of products [3] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including a fertility portfolio that features FemaSeed, FemSperm, and FemVue [3] Product Details - FemBloc is a non-surgical solution for permanent birth control that addresses the unmet need in women's reproductive health by using a patented delivery system to create natural scar tissue for permanent occlusion [2][4] - The product has received full regulatory approval in Europe, the UK, and New Zealand, and its commercialization will be completed through strategic partnerships in select European countries [4]

Core Insights - Femasys Inc. has received approval from the American Medical Association (AMA) for a new Category III CPT code for its FemaSeed intratubal insemination (ITI) procedure, which is set to take effect on January 1, 2027, enhancing reimbursement strategies and patient access to this infertility treatment [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [3] - The company's fertility portfolio includes FemaSeed ITI, FemSperm, and FemVue, with FemaSeed demonstrating more than double the pregnancy rates of traditional intrauterine insemination (IUI) in clinical trials [3] Product Details - FemaSeed is designed to improve fertilization by delivering sperm directly to the fallopian tube, offering a less invasive and more cost-effective alternative to traditional IUI and in vitro fertilization (IVF) [2] - FemBloc, another product, is the first non-surgical, in-office alternative to surgical sterilization, receiving regulatory approval in Europe, the UK, and New Zealand in 2025 [4] Market Strategy - The approval of the CPT code is expected to support broader clinical adoption and provider utilization of FemaSeed, aiming to reach over 10 million women in the U.S. affected by infertility [2] - Femasys plans to expand its provider footprint and accelerate adoption through the rollout of FemaSeed and the availability of its FemSperm product line [2]

Core Insights - Femasys Inc. has announced a strategic distribution partnership with OR Consulting to launch its product portfolio in Switzerland, which includes FemBloc Permanent Birth Control and FemaSeed Intratubal Insemination, as part of its European expansion strategy [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [3] - The company's fertility portfolio includes FemaSeed, which is over twice as effective as traditional IUI, and FemVue, a companion diagnostic for fallopian tube assessment [3] Product Details - FemBloc is the first non-surgical, in-office alternative to surgical sterilization, receiving full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025 [4] - The FemChec diagnostic product provides an ultrasound-based test to confirm procedural success, demonstrating compelling effectiveness and high satisfaction among patients and practitioners [4] Market Strategy - The partnership with OR Consulting is aimed at strengthening Femasys' European commercial platform and expanding access to its innovative technologies through experienced regional partners [2] - The ongoing launches in Spain and France, along with the entry into Switzerland, reflect the company's disciplined approach to building a multi-country footprint [2]

Regulatory Developments - Atossa Therapeutics, Inc. (ATOS) received Orphan Drug Designation from the U.S. FDA for (Z)-endoxifen to treat Duchenne muscular dystrophy, leading to a 12.98% increase in stock price to $0.69 [1] - ImmunityBio, Inc. (IBRX) reported that enrollment in its QUILT-2.005 trial for bladder cancer exceeded expectations, with over 85% enrollment, anticipating full enrollment by Q2 2026 and FDA submission by year-end 2026, resulting in a 9.43% stock price increase to $6.04 [2] Financing Updates - Foghorn Therapeutics Inc. (FHTX) closed a $50 million registered direct financing at a 30% premium, contributing to a 4.02% increase in stock price to $6.26 [4] - Femasys Inc. (FEMY) received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement, allowing until July 13, 2026, for compliance, leading to a 10.68% increase in stock price to $0.72 [3] Investor Sentiment - Theravance Biopharma, Inc. (TBPH) saw a 5.00% increase in stock price to $21.01 despite no new announcements [5] - Daré Bioscience, Inc. (DARE) experienced a modest gain of 1.04% to $1.95 without any new news [4]

Core Viewpoint - Femasys Inc. has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement of $1.00 per share, now having until July 13, 2026, to meet this requirement [1][2]. Company Compliance Status - The extension does not affect the continued listing status of Femasys' common stock on Nasdaq, and compliance will be confirmed if the stock price remains at or above $1.00 for ten consecutive business days [2]. - Femasys is committed to regaining compliance and plans to monitor its share price closely, taking necessary actions within the extension period [3]. Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4]. - 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 [4]. - FemBloc, a non-surgical permanent birth control method, received regulatory approval in Europe, the UK, and New Zealand in 2025, and is being commercialized through strategic partnerships [5].

Core Insights - Femasys Inc. has announced a partnership with Refuah Health Center to enhance the adoption of FemaSeed, a fertility treatment, within community-based healthcare settings [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company’s lead product, FemaSeed, is a next-generation artificial insemination solution that has shown over double the pregnancy rates compared to traditional intrauterine insemination (IUI) in cases of low male sperm count [3][4] Product Details - FemaSeed is designed to deliver sperm directly to the fallopian tube, providing a safe, accessible, and cost-effective first-line treatment option before in vitro fertilization (IVF) [3] - The product is authorized for use in multiple regions, including the U.S., Europe, UK, Canada, and Israel [3] Partnership Impact - The collaboration with Refuah Health Center aims to expand patient access to FemaSeed, thereby increasing its utilization as a first-line approach in infertility treatment [1][2] - Refuah Health Center, a Federally Qualified Community Health Center, emphasizes providing evidence-based options to streamline the fertility journey for patients [7]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]