{"success":true,"data":{"pressRelease":{"id":"169015","rtpr_id":"nGNX450Hf4-20261014","ticker":"FEMY","exchange":"NASDAQ","all_tickers":["FEMY"],"title":"Femasys Doubles Enrolling Sites in FemBloc FINALE Pivotal Trial for Non-Surgical Permanent Birth Control","author":"Globe Newswire","published_at":"2026-10-14T13:00:00.494Z","article_body":"ATLANTA, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc.\n(https://www.globenewswire.com/Tracker?data=IqeJc7qD7BtPpL5YkHvrOCpEm0Fxduq5xtiUop_kuvnJFxBmdLRfGs9IKpDPDJhoNNg0VMaG9D-JBInNwmoodA==)\n(NASDAQ: FEMY), a leading biomedical innovator developing transformative\nfertility and non-surgical permanent birth control solutions designed to\nimprove the standard of care, expand access, and reduce costs for women\nworldwide, announced today that it has doubled the number of actively\nenrolling sites in its FemBloc(®) FINALE Pivotal Trial to twelve across the\nUnited States. The coast-to-coast network of academic centers and private\nclinical practices now includes Baylor Research Institute and Columbia\nUniversity Medical Center, joining existing academic sites Maimonides Medical\nCenter, Stanford University, University of California Davis and the University\nof Utah. Participation by these prominent centers reflects broad clinical\ninterest in advancing permanent birth control options for women through this\nlandmark study and marks continued progress in Femasys’ U.S. clinical\nprogram.\n\n“Our August 2026 financing has enabled us to meaningfully advance the FINALE\ntrial, and doubling our investigative sites demonstrates important progress in\nexecuting on our U.S. regulatory strategy,” said Kathy Lee-Sepsick, Chief\nExecutive Officer and Founder of Femasys Inc. “FemBloc’s approval in\nEurope marked the beginning of access outside the U.S. and now enables the\ncollection of post-market real-world data. Together with evidence from our\nU.S. pivotal trial, these data will support broader adoption. As we work to\ncomplete the U.S. study and pursue FDA approval, we are building toward\nexpanded access to this revolutionary option for women globally.”\n\nFemBloc is a first-of-its-kind solution for permanent birth control designed\nto be delivered in the OB/GYN office, addressing a significant unmet need in\nwomen’s reproductive health. The technology combines a patented delivery\nsystem with a separately patented blended polymer that is placed into both\nfallopian tubes, safely degrades and forms natural scar tissue for permanent\nocclusion. Unlike surgical sterilization, FemBloc requires no anesthesia,\nincisions or recovery time, offering women a more convenient and affordable\nalternative while avoiding risks associated with surgery. Learn more at\nwww.FemBloc.com.\n\nAbout the FINALE Pivotal Trial\nThe FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion\nfor TranscervicAL PErmanent Birth Control] trial is a prospective,\nmulti-center, open-label, single-arm study evaluating the safety and\neffectiveness of FemBloc, a novel, non-surgical approach to permanent birth\ncontrol for women. Enrollment of an initial roll-in cohort of 50 women was\ncompleted to assess preliminary safety. These data, together with data from\nprior IDE-approved studies, supported U.S. Food and Drug Administration (FDA)\napproval to continue enrolling the remaining study participants. The primary\nendpoint is pregnancy rate, assessed after 401 women have relied on FemBloc\nfor one year, with an interim analysis planned after 300 women complete one\nyear of reliance. Under the FDA-approved protocol, the Company will submit for\nFDA approval based on the one-year data, with annual follow-up continuing for\nfive years. For more information, visit www.FemBloc.com.\n\nAbout Femasys Inc.\nFemasys is a leading biomedical innovator developing transformative fertility\nand non-surgical permanent birth control solutions designed to improve the\nstandard of care, expand access, and reduce costs for women worldwide. The\nCompany is focused on commercializing its fertility portfolio, led by\nFemaSeed(®) Intratubal Insemination, together with complementary diagnostic\nand sperm preparation products, in the U.S. and key international markets.\nFemasys is also advancing FemBloc(®), its non-surgical, in-office permanent\nbirth control solution, toward U.S. FDA approval through the ongoing FINALE\npivotal trial (NCT05977751). FemBloc received regulatory approvals in Europe,\nthe UK and New Zealand in 2025, supporting commercialization through strategic\npartnerships in select international markets. Femasys’ portfolio is\nsupported by broad intellectual property protection and clinical data\ndemonstrating favorable safety, encouraging effectiveness results, and high\npatient and practitioner satisfaction.\nLearn more at www.femasys.com, or follow us on X\n(https://www.globenewswire.com/Tracker?data=LA-tCLnpy2vxftXnfXHLQRHu_i69VUxfK_fOXacSRNI3EHjPFBHIACEq9rUAmRGHcWnr-Nx_FtPGKqkTx90-og==),\nFacebook\n(https://www.globenewswire.com/Tracker?data=YIJxQVTJ_ru1sFIn9zvi8XufIsXy5NfLPAcroTFNsJbCWaAan8qjKHkny4Rm-kQuyO_FYGgVi46jce8P91Tc6ljuVWoWNds7KjNJ4aYUFCA=)\nand LinkedIn\n(https://www.globenewswire.com/Tracker?data=mZx2DfzApOBILUhFOxN3WfMceaJzN17CkYlwSvGNsYT6fIhPwoUQ05EhGFaShRACYW8CV3pHfRTPTcO-2p6_Cbs_mCIru5iFfo63V3ow__d6guzn2QRz2ne40QNKDYJ3).\n\nForward-Looking Statements \nThis press release contains forward-looking statements that are subject to\nsubstantial risks and uncertainties. Forward-looking statements can be\nidentified by terms such as “may,” “will,” “should,” “expect,”\n“plan,” “anticipate,” “could,” “pending,” “intend,”\n“believe,” “suggests,” “potential,” “hope,” or “continue”\nor the negative of these terms or other similar expressions, although not all\nforward-looking statements contain these words. Forward-looking statements are\nbased on our current expectations and are subject to inherent uncertainties,\nrisks and assumptions, many of which are beyond our control, difficult to\npredict and could cause actual results to differ materially from what we\nexpect. Further, certain forward-looking statements are based on assumptions\nas to future events that may not prove to be accurate. Factors that could\ncause actual results to differ include, among others: our ability to obtain\nregulatory approvals for our FemBloc product candidate; develop and advance\nour current FemBloc product candidate and successfully enroll and complete the\nclinical trial; the ability of our clinical trial to demonstrate safety and\neffectiveness of our product candidate and other positive results; estimates\nregarding the total addressable market for our products and product candidate;\nour ability to commercialize our products and product candidate, our ability\nto establish, maintain, grow or increase sales and revenues, or the effect of\ndelays in commercializing our products, including FemaSeed; our business model\nand strategic plans for our products, technologies and business, including our\nimplementation thereof; and those other risks and uncertainties described in\nthe section titled \"Risk Factors\" in our Annual Report on Form 10-K for the\nyear ended December 31, 2025, and other reports as filed with the SEC.\nForward-looking statements contained in this press release are made as of this\ndate, and Femasys undertakes no duty to update such information except as\nrequired under applicable law.\n\nContacts: \nIR@femasys.com\nMedia@femasys.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/c668c3db-ff7f-4eb5-b51a-b8db25e838b4)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX450Hf4-20261014","title":"Femasys Doubles Enrolling Sites in FemBloc FINALE Pivotal Trial for Non-Surgical Permanent Birth Control","author":"Globe Newswire","ticker":"FEMY","created":"2026-10-14T13:00:00.494Z","tickers":["FEMY"],"exchange":"NASDAQ","article_body":"ATLANTA, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc.\n(https://www.globenewswire.com/Tracker?data=IqeJc7qD7BtPpL5YkHvrOCpEm0Fxduq5xtiUop_kuvnJFxBmdLRfGs9IKpDPDJhoNNg0VMaG9D-JBInNwmoodA==)\n(NASDAQ: FEMY), a leading biomedical innovator developing transformative\nfertility and non-surgical permanent birth control solutions designed to\nimprove the standard of care, expand access, and reduce costs for women\nworldwide, announced today that it has doubled the number of actively\nenrolling sites in its FemBloc(®) FINALE Pivotal Trial to twelve across the\nUnited States. The coast-to-coast network of academic centers and private\nclinical practices now includes Baylor Research Institute and Columbia\nUniversity Medical Center, joining existing academic sites Maimonides Medical\nCenter, Stanford University, University of California Davis and the University\nof Utah. Participation by these prominent centers reflects broad clinical\ninterest in advancing permanent birth control options for women through this\nlandmark study and marks continued progress in Femasys’ U.S. clinical\nprogram.\n\n“Our August 2026 financing has enabled us to meaningfully advance the FINALE\ntrial, and doubling our investigative sites demonstrates important progress in\nexecuting on our U.S. regulatory strategy,” said Kathy Lee-Sepsick, Chief\nExecutive Officer and Founder of Femasys Inc. “FemBloc’s approval in\nEurope marked the beginning of access outside the U.S. and now enables the\ncollection of post-market real-world data. Together with evidence from our\nU.S. pivotal trial, these data will support broader adoption. As we work to\ncomplete the U.S. study and pursue FDA approval, we are building toward\nexpanded access to this revolutionary option for women globally.”\n\nFemBloc is a first-of-its-kind solution for permanent birth control designed\nto be delivered in the OB/GYN office, addressing a significant unmet need in\nwomen’s reproductive health. The technology combines a patented delivery\nsystem with a separately patented blended polymer that is placed into both\nfallopian tubes, safely degrades and forms natural scar tissue for permanent\nocclusion. Unlike surgical sterilization, FemBloc requires no anesthesia,\nincisions or recovery time, offering women a more convenient and affordable\nalternative while avoiding risks associated with surgery. Learn more at\nwww.FemBloc.com.\n\nAbout the FINALE Pivotal Trial\nThe FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion\nfor TranscervicAL PErmanent Birth Control] trial is a prospective,\nmulti-center, open-label, single-arm study evaluating the safety and\neffectiveness of FemBloc, a novel, non-surgical approach to permanent birth\ncontrol for women. Enrollment of an initial roll-in cohort of 50 women was\ncompleted to assess preliminary safety. These data, together with data from\nprior IDE-approved studies, supported U.S. Food and Drug Administration (FDA)\napproval to continue enrolling the remaining study participants. The primary\nendpoint is pregnancy rate, assessed after 401 women have relied on FemBloc\nfor one year, with an interim analysis planned after 300 women complete one\nyear of reliance. Under the FDA-approved protocol, the Company will submit for\nFDA approval based on the one-year data, with annual follow-up continuing for\nfive years. For more information, visit www.FemBloc.com.\n\nAbout Femasys Inc.\nFemasys is a leading biomedical innovator developing transformative fertility\nand non-surgical permanent birth control solutions designed to improve the\nstandard of care, expand access, and reduce costs for women worldwide. The\nCompany is focused on commercializing its fertility portfolio, led by\nFemaSeed(®) Intratubal Insemination, together with complementary diagnostic\nand sperm preparation products, in the U.S. and key international markets.\nFemasys is also advancing FemBloc(®), its non-surgical, in-office permanent\nbirth control solution, toward U.S. FDA approval through the ongoing FINALE\npivotal trial (NCT05977751). FemBloc received regulatory approvals in Europe,\nthe UK and New Zealand in 2025, supporting commercialization through strategic\npartnerships in select international markets. Femasys’ portfolio is\nsupported by broad intellectual property protection and clinical data\ndemonstrating favorable safety, encouraging effectiveness results, and high\npatient and practitioner satisfaction.\nLearn more at www.femasys.com, or follow us on X\n(https://www.globenewswire.com/Tracker?data=LA-tCLnpy2vxftXnfXHLQRHu_i69VUxfK_fOXacSRNI3EHjPFBHIACEq9rUAmRGHcWnr-Nx_FtPGKqkTx90-og==),\nFacebook\n(https://www.globenewswire.com/Tracker?data=YIJxQVTJ_ru1sFIn9zvi8XufIsXy5NfLPAcroTFNsJbCWaAan8qjKHkny4Rm-kQuyO_FYGgVi46jce8P91Tc6ljuVWoWNds7KjNJ4aYUFCA=)\nand LinkedIn\n(https://www.globenewswire.com/Tracker?data=mZx2DfzApOBILUhFOxN3WfMceaJzN17CkYlwSvGNsYT6fIhPwoUQ05EhGFaShRACYW8CV3pHfRTPTcO-2p6_Cbs_mCIru5iFfo63V3ow__d6guzn2QRz2ne40QNKDYJ3).\n\nForward-Looking Statements \nThis press release contains forward-looking statements that are subject to\nsubstantial risks and uncertainties. Forward-looking statements can be\nidentified by terms such as “may,” “will,” “should,” “expect,”\n“plan,” “anticipate,” “could,” “pending,” “intend,”\n“believe,” “suggests,” “potential,” “hope,” or “continue”\nor the negative of these terms or other similar expressions, although not all\nforward-looking statements contain these words. Forward-looking statements are\nbased on our current expectations and are subject to inherent uncertainties,\nrisks and assumptions, many of which are beyond our control, difficult to\npredict and could cause actual results to differ materially from what we\nexpect. Further, certain forward-looking statements are based on assumptions\nas to future events that may not prove to be accurate. Factors that could\ncause actual results to differ include, among others: our ability to obtain\nregulatory approvals for our FemBloc product candidate; develop and advance\nour current FemBloc product candidate and successfully enroll and complete the\nclinical trial; the ability of our clinical trial to demonstrate safety and\neffectiveness of our product candidate and other positive results; estimates\nregarding the total addressable market for our products and product candidate;\nour ability to commercialize our products and product candidate, our ability\nto establish, maintain, grow or increase sales and revenues, or the effect of\ndelays in commercializing our products, including FemaSeed; our business model\nand strategic plans for our products, technologies and business, including our\nimplementation thereof; and those other risks and uncertainties described in\nthe section titled \"Risk Factors\" in our Annual Report on Form 10-K for the\nyear ended December 31, 2025, and other reports as filed with the SEC.\nForward-looking statements contained in this press release are made as of this\ndate, and Femasys undertakes no duty to update such information except as\nrequired under applicable law.\n\nContacts: \nIR@femasys.com\nMedia@femasys.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/c668c3db-ff7f-4eb5-b51a-b8db25e838b4)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-14T13:00:00.833828943Z","server_sent_at_ms":1791982800833},"received_at":"2026-10-14T13:00:00.884Z","source_url":null},"analysis":{"id":"157270","press_release_id":"169015","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["trial still enrolling with no interim or primary data yet; FDA approval remains subject to future results"],"eventType":"clinical_trial","narrative":"Femasys doubled the number of actively enrolling sites in its FemBloc FINALE pivotal trial to twelve across the United States.\n\nNew sites include Baylor Research Institute and Columbia University Medical Center, joining existing academic centers such as Stanford and the University of Utah; the CEO attributed the expansion to the company's August 2026 financing.\n\nThe trial's primary endpoint is pregnancy rate assessed after 401 women rely on FemBloc for one year, with an interim analysis after 300 completions; a positive study would support the company's U.S. FDA approval bid for its non-surgical permanent birth control device.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Enrollment-site expansion signals execution progress on FemBloc's U.S. pivotal trial, but no new data until the 300-patient interim analysis."},"keyFigures":{"drugName":"FemBloc","phaseOfTrial":"Pivotal (FINALE)","customDimensions":{"roll_in_cohort_completed":50,"interim_analysis_reliance_n":300,"primary_endpoint_reliance_n":401}},"quotedText":"doubling our investigative sites demonstrates important progress in executing on our U.S. regulatory strategy","namedEntities":{"people":[{"name":"Kathy Lee-Sepsick","role":"CEO and Founder"}],"products":["FemBloc","FemaSeed Intratubal Insemination"],"companies":[{"name":"Femasys Inc.","ticker":"FEMY"},{"name":"Baylor Research Institute","relationship":"trial site"},{"name":"Columbia University Medical Center","relationship":"trial site"},{"name":"Maimonides Medical Center","relationship":"trial site"},{"name":"Stanford University","relationship":"trial site"},{"name":"University of California Davis","relationship":"trial site"},{"name":"University of Utah","relationship":"trial site"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Doubling active enrolling sites to twelve in the FemBloc FINALE pivotal trial is incremental operational progress, not a binary readout or regulatory event. No new clinical data is disclosed."},"tickerRelevance":{"others":[],"primary":"FEMY"},"globalImportance":18,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"incremental trial-enrollment progress, no data readout","sectorWeight":"women's health medtech","retailFavoriteBoost":false}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Femasys doubled the number of actively enrolling sites in its FemBloc FINALE pivotal trial to twelve across the United States.\n\nNew sites include Baylor Research Institute and Columbia University Medical Center, joining existing academic centers such as Stanford and the University of Utah; the CEO attributed the expansion to the company's August 2026 financing.\n\nThe trial's primary endpoint is pregnancy rate assessed after 401 women rely on FemBloc for one year, with an interim analysis after 300 completions; a positive study would support the company's U.S. FDA approval bid for its non-surgical permanent birth control device.","key_figures":{"drugName":"FemBloc","phaseOfTrial":"Pivotal (FINALE)","customDimensions":{"roll_in_cohort_completed":50,"interim_analysis_reliance_n":300,"primary_endpoint_reliance_n":401}},"named_entities":{"people":[{"name":"Kathy Lee-Sepsick","role":"CEO and Founder"}],"products":["FemBloc","FemaSeed Intratubal Insemination"],"companies":[{"name":"Femasys Inc.","ticker":"FEMY"},{"name":"Baylor Research Institute","relationship":"trial site"},{"name":"Columbia University Medical Center","relationship":"trial site"},{"name":"Maimonides Medical Center","relationship":"trial site"},{"name":"Stanford University","relationship":"trial site"},{"name":"University of California Davis","relationship":"trial site"},{"name":"University of Utah","relationship":"trial site"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-14T13:00:13.973Z","global_importance":18,"audience_relevance":15,"importance_components":{"tickerTier":"micro-cap","eventGravity":"incremental trial-enrollment progress, no data readout","sectorWeight":"women's health medtech","retailFavoriteBoost":false}},"durationMs":6938,"modelName":"glm-5.3-flashx"}}