{"id":692891,"date":"2022-10-06T08:34:34","date_gmt":"2022-10-06T12:34:34","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-announces-enrollment-completion-for-stage-2-study-of-fembloc-for-permanent-birth-control\/"},"modified":"2022-10-06T08:34:34","modified_gmt":"2022-10-06T12:34:34","slug":"femasys-inc-announces-enrollment-completion-for-stage-2-study-of-fembloc-for-permanent-birth-control","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/femasys-inc-announces-enrollment-completion-for-stage-2-study-of-fembloc-for-permanent-birth-control\/","title":{"rendered":"Femasys Inc. Announces Enrollment Completion for Stage 2 Study of FemBloc for Permanent Birth Control"},"content":{"rendered":"

\nCompany remains on track to file an investigational device exemption (IDE) for a pivotal trial to support a pre-market authorization (PMA) in the first quarter of 2023
\n<\/h2>\n
\n

ATLANTA, Oct. 06, 2022 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today announced enrollment completion for its Stage 2 study of FemBloc\u00ae<\/sup>, a first-of-its-kind, nonsurgical, in-office solution in development for permanent birth control.<\/p>\n

\u201cAchieving this clinical milestone brings us one step closer to bringing FemBloc to as many women as possible,\u201d said Edward Evantash, M.D., chief medical officer of Femasys. \u201cEfficiently advancing FemBloc remains a priority for us to provide a safe and effective permanent contraceptive option to women in need. Continuing the advancement of this program and the additional product candidates in our portfolio exemplifies our long-lasting dedication to meaningfully disruptive technologies for women\u2019s healthcare.\u201d<\/p>\n

Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys, added, \u201cIt has been Femasys\u2019 mission from day one to bring an option to women that is non-surgical that eliminates the need for anesthesia, incisions, and permanent implants. FemBloc has been studied extensively for safety and we look forward to the pivotal trial to establish effectiveness. It has just recently been reported in the largest study to date that tubal ligation, a surgical approach that has been around for over 100 years, typically comes with the risk of at least a 6% chance of pregnancy1<\/sup>. We hope FemBloc can offer women a convenient and reliable alternative method, should they make the decision for permanent birth control.\u201d<\/p>\n

The Stage 2 study is a prospective, multi-center, feasibility study (NCT04273594<\/a>) validating the confirmation test required after FemBloc to determine procedure success by comparing an ultrasound approach to the traditional radiology approach. Femasys intends to continue follow-up to monitor the safety of the subjects for a total duration of approximately 68 months after the FemBloc procedure.<\/p>\n

\n About Femasys<\/strong>
\n
Femasys Inc. is a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc\u00ae\u00a0<\/sup>permanent birth control and FemaSeed\u00ae\u00a0<\/sup>localized directional insemination for infertility. The Company\u2019s product for fallopian tube assessment by ultrasound, FemVue\u00ae<\/sup>, and FemCerv\u00ae<\/sup>, an endocervical tissue sampler are currently being marketed in the United States. Femasys is also advancing FemCath\u2122<\/sup>, an intrauterine catheter for selective evaluation of the fallopian tubes intended to be marketed alongside its other women-specific medical products in the physician\u2019s office\u00a0setting. To learn more, visit www.femasys.com<\/a> or follow us on Twitter<\/a> and LinkedIn<\/a>.<\/p>\n

Reference:
1<\/sup>Gariepy, A.M., et al<\/em>. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study. Fertility and Sterility<\/em>. Vol. 117, Issues 6 (2022). DOI: https:\/\/doi.org\/10.1016\/j.fertnstert.2022.03.001<\/p>\n

\n Forward-Looking Statements
<\/strong>
\n 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 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 “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 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.<\/em>\n <\/p>\n

\n Contacts:<\/strong>\n <\/p>\n

\n Investors<\/strong>
\n
Chuck Padala
LifeSci Advisors, LLC
+1-917-741-7792
chuck@lifesciadvisors.com<\/a><\/p>\n

\n Media<\/strong>
\n
Karissa Cross, Ph.D.
LifeSci Communications
kcross@lifescicomms.com<\/a><\/p>\n

\n Femasys Inc.<\/strong>
\n
Investor Contact:
IR@femasys.com<\/a><\/u><\/p>\n

Media Contact:
Media@femasys.com<\/a><\/p>\n

\n
\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Company remains on track to file an investigational device exemption (IDE) for a pivotal trial to support a pre-market authorization (PMA) in the first quarter of 2023 ATLANTA, Oct. 06, 2022 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today announced enrollment completion for its Stage 2 study of FemBloc\u00ae, a first-of-its-kind, nonsurgical, in-office solution in development for permanent birth control. \u201cAchieving this clinical milestone brings us one step closer to bringing FemBloc to as many women as possible,\u201d said Edward Evantash, M.D., chief medical officer of Femasys. \u201cEfficiently advancing FemBloc remains a priority for us … <\/p>\n

Continue reading “Femasys Inc. Announces Enrollment Completion for Stage 2 Study of FemBloc for Permanent Birth Control”<\/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-692891","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nFemasys Inc. 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