相关临床试验
6
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
2
33.3%
已完成
2
33.3%
招募中
1
16.7%
撤回
1
16.7%
暂无批准数据
- The U.S. FDA has approved Femasys' modular premarket approval application (PMA) pathway for FemBloc, its investigational non-surgical permanent birth control technology. - The modular approach allows key submission components to be reviewed by the FDA in advance of final clinical data, enabling meaningful regulatory progress. - FemBloc is a first-of-its-kind, in-office solution requiring no anesthesia, incisions, or recovery time, addressing a significant unmet need in women's reproductive health. - Femasys is building a U.S. commercial team to support FemBloc while FemBloc advances through the ongoing FINALE pivotal trial (NCT05977751).
- Femasys Inc. achieved CE mark certification for its complete FemBloc System, marking the first global regulatory approval for non-surgical permanent female birth control. - The FemBloc System uses a proprietary blended polymer delivered through fallopian tubes to create permanent sterilization without surgery, anesthesia, or recovery downtime. - Commercial launch will begin in Spain through existing partnerships, with the company continuing FDA pivotal trials for U.S. market approval. - Published clinical data demonstrate compelling effectiveness, five-year safety profile, and high patient satisfaction compared to traditional surgical sterilization methods.
- Femasys Inc. announced a partnership with Carolinas Fertility Institute to offer FemaSeed intratubal insemination across CFI's network of more than 8 locations in North Carolina. - FemaSeed achieved over double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count according to pivotal clinical trial data. - The partnership expands access to FemaSeed as a less invasive and cost-effective first-line fertility treatment option before patients consider IVF. - Carolinas Fertility Institute serves patients across North Carolina and the Southeast with locations in Winston-Salem, Greensboro, and Charlotte.
- Femasys Inc. completed a $4.5 million financing through public offering and private placement to fund expansion of its women's health product portfolio. - The biomedical company is developing FemBloc permanent birth control and FemaSeed infertility treatment as lead product candidates for minimally invasive reproductive health. - Proceeds will support commercial expansion, product development, and clinical trials for the company's in-office therapeutic and diagnostic technologies.
- Clinical trials of FemBloc, a novel non-surgical permanent birth control method, demonstrated 0% pregnancy rate among eligible participants, significantly outperforming the 6% benchmark for surgical sterilization. - The innovative procedure, utilizing synthetic tissue adhesive for fallopian tube occlusion, reported no serious adverse events across 229 participants during five years of follow-up. - Patient and practitioner satisfaction rates were notably high, positioning FemBloc as a promising alternative to traditional surgical sterilization methods.
- Femasys Inc. has received FDA 510(k) clearance for FemChec, a diagnostic solution designed for checking the fallopian tubes using controlled contrast delivery. - FemChec is intended for use with an intrauterine catheter, delivering a consistent stream of saline and air for ultrasound evaluation of the fallopian tubes. - The device is a key component of Femasys' FemBloc non-surgical permanent birth control solution, confirming procedure success with natural contrast and ultrasound. - FemChec offers a safer alternative to traditional methods, reducing the need for radiology referrals, X-ray dye, and radiation exposure for women.
