ATLANTA, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of inoffice, accessible, and innovative therapeutic and diagnostic products, announces that the Company will be exhibiting at the American Society of Reproductive Medicine's (ASRM) 2024 Scientific Congress and Expo, being held October 19-23 in Denver, Colorado. The Company will be showcasing its solutions at booth #243. ...

ATLANTA, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of inoffice, accessible, and innovative therapeutic and diagnostic products, announces that the Company has received its second order from its strategic distribution partners after successfully completing its first commercial FemaSeed® procedures in Europe. Members of the Femasys team traveled to Madrid to in-service he ...

ATLANTA, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of inoffice, accessible, and innovative therapeutic and diagnostic products, announces the onboarding of the first infertility medical clinic customers to offer its FemaSeed infertility treatment to patients in California and Florida. "Femasys has begun partnering with infertility centers across the United States, enab ...

Core Insights - Femasys, Inc. has secured strategic distribution partnerships for its CE-marked products, FemaSeed® and FemVue®, in Spain, marking a significant step in its global expansion [1][2] - The distribution partners, Comercial Medico Quirurigca, SA (CMQ) and Durgalab, are committed to purchasing a minimum of $1.3 million of FemaSeed over the next year, indicating strong confidence in expanding access to these products [2] Company Overview - Femasys is a biomedical company focused on addressing unmet needs of women with a portfolio of innovative therapeutic and diagnostic solutions, including FemaSeed® for infertility treatment and FemBloc® for permanent birth control [5] - FemaSeed® is designed to deliver sperm directly where conception occurs and has received regulatory approval in Canada and Europe, while FemBloc® is in late-stage clinical development as a non-surgical birth control method [5] Spanish Infertility Market - Spain has the highest number of in vitro fertilization (IVF) clinics in Europe, with 244 facilities, and ranks second in intrauterine insemination (IUI) cycles using husband sperm, as well as leading in IUI cycles using donor sperm [3]

Core Insights - Femasys Inc. has received FDA clearance for FemChec, a diagnostic device for assessing fallopian tubes, which offers a radiation-free alternative for tubal assessments [1][4] - The FemChec device is integral to the ongoing pivotal trial for FemBloc, a non-surgical permanent birth control solution [2][4] - Femasys has seen a positive stock performance, with shares rising 11.8% year to date, outperforming the industry [10] Regulatory Approvals - Femasys has achieved both U.S. FDA clearance and Canadian regulatory approval for FemChec, which utilizes a saline and air pattern for tubal evaluations [2] - The company also received CE mark certification and Health Canada approval for FemVue MINI, an eco-friendly device for fallopian tube assessment [8] - In June, Femasys obtained EU MDR certification and CE Mark approval for four products, allowing marketing across the European Union [9] Market Potential - The women's healthcare market is projected to grow from $8.22 billion in 2024 to $10.9 billion by 2032, with a CAGR of 3.6% [7] - Growth drivers include increasing chronic health issues, rising contraceptive demand, government initiatives for population control, and a focus on product innovation [7] Product Development - FemChec is designed to work alongside FemBloc, which delivers a biopolymer into fallopian tubes to block them non-invasively [5] - The biopolymer solidifies upon contact with tissue, initiating a wound-healing response that forms scar tissue [5] - Femasys continues to collaborate with the FDA to advance the FemBloc solution through the FINALE pivotal trial [6]

Core Insights - Femasys, Inc. has received 510(k) clearance from the FDA for its innovative diagnostic solution, FemChec, aimed at assessing fallopian tube status [1][2] - FemChec is designed to provide a safer alternative for confirming tubal status using natural contrast and ultrasound, eliminating the need for radiation exposure associated with traditional methods [2][3] - The company is advancing its FemBloc non-surgical permanent birth control solution through ongoing clinical trials, with FemChec being a key component for confirming procedure success [2][3] Company Overview - Femasys is a biomedical company focused on addressing unmet needs in women's healthcare with a range of innovative therapeutic and diagnostic products [4] - The company’s product portfolio includes FDA-cleared solutions such as FemaSeed for infertility treatment and FemBloc for non-surgical permanent birth control, which is positioned as a safer and cost-effective alternative to surgical methods [4] - Femasys has developed complementary diagnostic products, including FemVue and FemCerv, which have received regulatory approvals in multiple regions, including the U.S., Canada, and Europe [4]

ATLANTA, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of inoffice, accessible, and innovative therapeutic and diagnostic products, announces that the Company will be exhibiting at the Canadian Fertility and Andrology Society's (CFAS) 70th Annual Meeting, to be held September 12-14, 2024 at The Westin Bayshore, Vancouver, British Columbia. The Company will be exhibiting at ...

Company Overview - Femasys Inc. (FEMY) is a leading biomedical company focused on addressing unmet needs in women's health through innovative therapeutic and diagnostic solutions [2] - The company has developed a range of products, including FemVue, the first FDA-cleared device for real-time fallopian tube evaluation via ultrasound, and other FDA-cleared products like FemaSeed and FemBloc [2] Recent Developments - Femasys has received CE mark certification and Health Canada approval for its new device, FemVue MINI, which is designed for fallopian tube assessment with a reduced ecological footprint [1] - In June, Femasys obtained EU MDR certification and CE Mark approval for four of its products: FemaSeed, FemVue, FemCerv, and FemCath, allowing them to market these products across the European Union [6] Product Significance - The FemVue MINI represents a significant advancement in women's reproductive health, combining diagnostic technology with sustainability, and aims to improve access to eco-conscious diagnostic tools for women in Europe and Canada [4] Market Prospects - The women's healthcare market is projected to grow from $8.22 billion in 2024 to $10.9 billion by 2032, with a CAGR of 3.58%, driven by factors such as increasing chronic health issues and rising demand for contraceptives [5] Stock Performance - Femasys shares have increased by 20% year to date, outperforming the industry growth of 0.6% and the S&P 500's rise of 18.4% during the same period [7]

Company Overview - Femasys, Inc. is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products [3] - The company has developed products such as FemaSeed® for intratubal insemination and FemBloc® for permanent birth control, which are designed to be safer and more cost-effective alternatives to traditional methods [3] Upcoming Events - Kathy Lee-Sepsick, Founder, President, and CEO of Femasys, will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference from September 9 to 11, 2024 [1] - The presentation will be available on-demand starting at 7:00 AM ET on September 9, 2024, and a replay will be archived for approximately 90 days [2] Product Development - FemaSeed® is FDA-cleared and has received regulatory approval in Canada and Europe, while FemBloc® is in late-stage clinical development [3] - The company has achieved regulatory approvals for its diagnostic products, which include FemVue® and FemCerv®, and these products are ready for commercialization due to in-house manufacturing capabilities [3]

ATLANTA, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of inoffice, accessible and innovative therapeutic and diagnostic products, announces that it has received CE mark certification and product approval from Health Canada, the Public Health Agency of Canada, for its compact, eco-friendly FemVue® MINI for fallopian tube assessment. "Our mission at Femasys has always been to ...