ATLANTA - Femasys Inc. (NASDAQ: NASDAQ:FEMY), a biomedical company, has reported encouraging results from a pivotal trial of its FemaSeed product, designed for use in artificial insemination. The trial focused on severe male factor infertility, where the total motile sperm count (TMSC) ranges from 1 million to 20 million.
The data revealed that 24% of women became pregnant after using FemaSeed, a significant increase compared to the 6.7% pregnancy rate per cycle achieved with intrauterine insemination (IUI) for similar cases.
The majority of successful pregnancies occurred after just one FemaSeed procedure, suggesting its potential as an effective first-line treatment. FemaSeed aims to deliver sperm directly into the fallopian tube, the natural site of conception, which could offer a less invasive and more affordable alternative to assisted reproductive technologies like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
The pivotal trial, which concluded earlier than planned due to its successful outcomes leading to FDA clearance in September 2023, also confirmed the safety of FemaSeed. The adverse events reported were mild and consistent with those known for IUI, with no new safety concerns noted through the seven-week follow-up.
Femasys has already begun the commercial rollout of FemaSeed in the U.S., with the first procedure performed in March 2024. The trial's positive topline data support the company's goal to provide a cost-effective and accessible option for couples experiencing infertility.
The study's findings are based on a press release statement from Femasys Inc., which emphasizes their commitment to addressing unmet needs in women's health. The company's portfolio includes FDA-cleared products and those in late-stage development, such as the FemBloc permanent birth control method. Femasys continues to focus on expanding its offerings with innovative therapeutic and diagnostic solutions for women worldwide.
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