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Femasys Announces FDA Approval of its IDE for the Pivotal Clinical Trial of FemBloc Permanent Birth Control, a Non-Surgical Alternative for Women
- Pivotal clinical trial to begin in the third quarter of 2023 - ATLANTA, June 26, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company
About this update from Femasys Inc.
[{"type":"text","content":"- Pivotal clinical trial to begin in the third quarter of 2023 - ATLANTA, June 26, 2023 (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, announced today the approval of an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to evaluate the safety and efficacy of FemBloc®, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial (the “FINALE” trial). FemBloc is intended to be a safer option for women by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer women a convenient and reliable option for permanent birth control. FemBloc along with FemaSeed® localized directional insemination for infertility represent the two lead product candidates of the Company and if approved will provide therapeutic solutions to compliment the Company’s existing marketed diagnostic products, FemVue® for fallopian tube assessment by ultrasound which can be used in conjunction with FemCath®, an intrauterine catheter for selective evaluation of the fallopian tubes, and FemCerv®, an endocervical sampler for cervical cancer diagnosis that is the first product of the technology platform for tissue sampling. “We are excited to be one step closer to making FemBloc, an extremely important and novel non-surgical, permanent birth control approach a reality for women seeking a better option,” stated Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “On this one-year anniversary of the overturn of Roe v. Wade, the need for more accessible birth control options for women has never been more important. FemBloc has been designed to be a solution that provides an alternative to surgical tubal ligation (or tying a woman’s tubes), thus reducing the unnecessary risks and substantial cost associated with surgery. In addition, FemBloc could provide an option to women using temporary birth control methods long term that may require implants or hormones. FemBloc is one of several candidates in Femasys’ portfolio of products that showcases our dedication to developing safer and more accessible reproduct...