ATLANTA, Nov. 01, 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 in-office, accessible, and innovative therapeutic and diagnostic products, announces that the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 12,12796 covering FemBloc® permanent birth control. This further strengthens Femasys’ intellectual property position and coverage for FemBloc, the Comp ...

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 ...

ATLANTA, Sept. 11, 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 secured strategic distribution partnerships for its CE-marked products, including FemaSeed® and FemVue® in Spain. Comercial Medico Quirurigca, SA (CMQ) will distribute the products in northern Spain and Durgalab ...

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 ...

Femasys Inc. (FEMY) has announced that it has received the CE mark certification and Health Canada approval for its latest innovation, the FemVue MINI. This compact and environmentally conscious device is designed for fallopian tube assessment, offering the same high efficacy as its predecessor with a reduced ecological footprint. This milestone marks a significant step forward in Femasys' mission to provide accessible and sustainable healthcare solutions for women. FEMY is a leading biomedical company comm ...

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]