{"id":786435,"date":"2023-09-27T09:43:45","date_gmt":"2023-09-27T13:43:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/"},"modified":"2023-09-27T09:43:45","modified_gmt":"2023-09-27T13:43:45","slug":"femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/","title":{"rendered":"Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"text-align:center\">\n          <em>The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys\u2019 earlier FemBloc studies &#8211;<\/em><br \/>\n          \n        <\/li>\n<li style=\"margin-bottom:5pt;text-align:center\">\n          <em>FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway &#8211;<\/em><br \/>\n          \n        <\/li>\n<\/ul>\n<p>ATLANTA, Sept.  27, 2023  (GLOBE NEWSWIRE) &#8212; Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The <strong>F<\/strong>emBloc <strong>IN<\/strong>tratubal Occlusion for Transcervic<strong>AL<\/strong> P<b>E<\/b>rmanent Birth Control (the \u201cFINALE\u201d trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc<sup>\u00ae<\/sup>. The FDA approved multi-center pivotal trial is designed to address the high unmet need that exists for women seeking permanent birth control for whom elective surgery remains the only option.<\/p>\n<p>Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc<sup>\u00ae<\/sup> in late-stage clinical development for permanent birth control and its now-United States Food and Drug Administration (FDA)-cleared product, FemaSeed<sup><em>\u00ae<\/em><\/sup> for infertility treatment. The Company is commercializing complementary diagnostic products that were internally developed through its in-house manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.<\/p>\n<p>\u201cAfter just announcing the start of the FINALE trial in August, we are delighted to announce the first academic site is activated to enroll in FemBloc\u2019s FINALE pivotal trial, led by a thought leader in the field of gynecology,\u201d said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. \u201cWe appreciate the long-standing support for the FemBloc technology evidenced by the prominent investigators who are electing to participate in the FINALE trial, as we work to bring this much needed option to women.&#8221;<\/p>\n<p>\n        <strong>About the FINALE Pivotal Clinical Trial<\/strong>\n      <\/p>\n<p>Femasys \u2018FINALE [Prospective Multi-Center Trial for <strong>F<\/strong>emBloc <strong>IN<\/strong>tratubal Occlusion for Transcervic<strong>AL<\/strong> P<strong>E<\/strong>rmanent Birth Control] trial (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xQ84aeJKDluIxXZMe1szl5ODZklUC5yDcDN0mlEDqPABPvD4pqfPzVeYZ79-LPssV_8RO4garGKYLjRd2OfNqY6Xk7XWlc2bgq7N9pF7SNNvw_AMiO3PJHZRCp0cVHnUBikZKIh4lJLoiTC7NSS0lpWVPG_lDwmtl0CBxr6luUs=\" rel=\"nofollow noopener\" target=\"_blank\">NCT05977751<\/a>) is designed as a prospective, multi-center, open-label, single-arm study to evaluate the safety and efficacy of FemBloc, a novel, non-surgical female permanent birth control approach. The primary endpoint is pregnancy rate, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. The trial is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for one year. Follow-up will continue annually for five years post-market. For more information, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=E5D9sFUprBiQOci4y2T9qXXI8G6jf56fZeFHv3vFbu51pNfC1yUWDcmin6ldGfc3KtQU9lBcsS9JAGR9ynt0Gw==\" rel=\"nofollow noopener\" target=\"_blank\">www.FemBloc.com<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>About FemBloc<\/strong><br \/>\n        <sup><br \/>\n          <strong>\u00ae<\/strong><br \/>\n        <\/sup>\n      <\/p>\n<p>FemBloc<sup>\u00ae<\/sup> is a first-of-its-kind, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a convenient, accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for FemBloc in the U.S. alone. For more information, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=E5D9sFUprBiQOci4y2T9qZHigrX8V8StBQYdn1udl4FitC2ILK7CYw_HM9sCa-3x4itmqfDpE-aAVX0mDPWJ7Q==\" rel=\"nofollow noopener\" target=\"_blank\">www.FemBloc.com<\/a>.<\/p>\n<p>\n        <strong>About Femasys <\/strong>\n      <\/p>\n<p>Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary late-clinical stage product candidate and FDA-cleared, innovative therapeutic and diagnostic products. Femasys\u2019 FemBloc<sup>\u00ae<\/sup>\u00a0permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. Femasys\u2019 FemaSeed<sup>\u00ae<\/sup>\u00a0Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is now FDA-cleared (and also approved in Canada). The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada and other non-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company\u2019s diagnostic products include FemVue<sup>\u00ae<\/sup>\u00a0for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath<sup>\u00ae<\/sup>, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv<sup>\u00ae<\/sup>, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7dWvnjS95XX4DOJUtMHwOrkVIr6hOHKgD-1OQ3xvPOjsH0nf24-JsUYHbCQiTVgpGMbHodIJkoIzoAFoEsXqrA==\" rel=\"nofollow noopener\" target=\"_blank\">www.femasys.com<\/a>, or follow us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=yuximjKNr_HKsoc34rB3kBWK7uUyGty7T3r58fk62W5NOKJW1R0_RNSkiOJAcXmNBpVYPZNe1ocR5_-KE0b4Ow==\" rel=\"nofollow noopener\" target=\"_blank\">X<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=mE-AvMuuZFIYwbPwewnwJc1YFmHAQtiM1lIoGif6hMyxXTAIAisUGdcgSJ3GgktqTpLrcL3qUM4FDpVxzZ_72tkVXPR7ieJyJG6thuAEEmM=\" rel=\"nofollow noopener\" target=\"_blank\">Facebook<\/a> and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=pS3HWLZoXh_5Kv1b9BGKaxZgNfXmer8IaT6xT9Bpm_1jZ79XBeHdW8g1ewkXYLK8Ugvr1TtnH6ON7TDbpHCGY7Ytjva1_sA2-LIR-Nui0Oo=\" rel=\"nofollow noopener\" target=\"_blank\">LinkedIn<\/a>.<\/p>\n<p>\n        <strong>Forward-Looking Statements\u00a0<\/strong>\n      <\/p>\n<p>\n        <em>This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cplan,\u201d \u201canticipate,\u201d \u201ccould,\u201d \u201cpending,\u201d \u201cintend,\u201d \u201cbelieve,\u201d \u201cpotential,\u201d \u201chope,\u201d or \u201ccontinue\u201d or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate.\u00a0Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled &#8220;Risk Factors&#8221; in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.\u00a0<\/em>\n      <\/p>\n<p>\n        <strong>Contacts:\u00a0<\/strong>\n      <\/p>\n<p>\n        <strong>Investors\u00a0<\/strong><br \/>\n        <br \/>Chuck Padala\u00a0<br \/>LifeSci Advisors, LLC\u00a0<br \/>917-741-7792\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=hp40ZfATiORd7DMWh4JggxDxRuT_rIu1xIc75QDBeSPRxmko7PMIdM4YnEYHU516K34y2hdF0RdUTi6kq0YzUgJfy0_GHveXeR3LFNvD_TJRS0vH5pOX-vwcsy4UwIVq\" rel=\"nofollow noopener\" target=\"_blank\">chuck@lifesciadvisors.com<\/a><\/p>\n<p>\n        <strong>Femasys Inc.\u00a0<\/strong><br \/>\n        <br \/>Investor Contact:\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=A6q-bIh5HKpeTp-3AeOYpkcq_HMvbT7J89yGrj4kqDozM5hseKNjNR0g3LC8MOHOmJVm7i6zoK4Uq0SBH_JXvg==\" rel=\"nofollow noopener\" target=\"_blank\">IR@femasys.com<\/a><\/p>\n<p>Media Contact:\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=JTEurqVSsLzT1dvu7sfvMllJpITG-5ovM06Q04G_TM13ZjtDJFm_dHrYoct0ej8ymYQDHNeyILV-l5iQsLlqLKMTWBEb2ghFHDbbnR2pQzI=\" rel=\"nofollow noopener\" target=\"_blank\">Media@femasys.com<\/a><\/p>\n<p \/>\n      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODkyOTE5MCM1ODM0NDg3IzIwMjg4MTM=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/ZDNkODFkNjAtMDliZS00N2M5LWFhMzMtZGIxZGUyZGQzYzJmLTEwNDAzODQ=\/tiny\/Femasys-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys\u2019 earlier FemBloc studies &#8211; FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway &#8211; ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) &#8212; Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the \u201cFINALE\u201d trial) is being conducted to investigate the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-786435","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys\u2019 earlier FemBloc studies &#8211; FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway &#8211; ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) &#8212; Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the \u201cFINALE\u201d trial) is being conducted to investigate the &hellip; Continue reading &quot;Femasys Inc. 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Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate - Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/","og_locale":"en_US","og_type":"article","og_title":"Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate - Market Newsdesk","og_description":"The first academic center activated to enroll, led by an instrumental investigator who participated in Femasys\u2019 earlier FemBloc studies &#8211; FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clear U.S. regulatory pathway &#8211; ATLANTA, Sept. 27, 2023 (GLOBE NEWSWIRE) &#8212; Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc trial at its first academic site located in Brooklyn, New York. The FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the \u201cFINALE\u201d trial) is being conducted to investigate the &hellip; Continue reading \"Femasys Inc. Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/","og_site_name":"Market Newsdesk","article_published_time":"2023-09-27T13:43:45+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODkyOTE5MCM1ODM0NDg3IzIwMjg4MTM=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-expands-fembloc-pivotal-trial-enrollment-securing-first-academic-site-to-participate\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Femasys Inc. 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