Femasys Inc. Announces Enrollment Completion for Stage 2 Study of FemBloc for Permanent Birth Control
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®, a first-of-its-kind, nonsurgical, in-office solution in development for permanent birth control.
“Achieving this clinical milestone brings us one step closer to bringing FemBloc to as many women as possible,” said Edward Evantash, M.D., chief medical officer of Femasys. “Efficiently 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’s healthcare.”
Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys, added, “It has been Femasys’ 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. We hope FemBloc can offer women a convenient and reliable alternative method, should they make the decision for permanent birth control.”
The Stage 2 study is a prospective, multi-center, feasibility study () 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.
About Femasys
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® permanent birth control and FemaSeed® localized directional insemination for infertility. The Company’s product for fallopian tube assessment by ultrasound, FemVue®, and FemCerv®, an endocervical tissue sampler are currently being marketed in the United States. Femasys is also advancing FemCath™, an intrauterine catheter for selective evaluation of the fallopian tubes intended to be marketed alongside its other women-specific medical products in the physician’s office setting. To learn more, visit or follow us on and .
Reference:
1Gariepy, A.M., et al. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: a retrospective cohort study. Fertility and Sterility. Vol. 117, Issues 6 (2022). DOI: /10.1016/j.fertnstert.2022.03.001
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LifeSci Communications
Femasys Inc.
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