FemaSeed demonstrates potential in treating severe male infertility cases, according to Investing.com

FemaSeed demonstrates potential in treating severe male infertility cases, according to Investing.com

© Reuters.

ATLANTE- Femasys Inc. (NASDAQ:NASDAQ:), a biomedical company, reported encouraging results from a pivotal trial of its FemaSeed product, designed for use in artificial insemination. The trial focused on severe male 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 from the 6.7% pregnancy rate per cycle achieved with intrauterine insemination (IUI) for similar cases.

The majority of successful pregnancies occurred after a single 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 injection of spermatozoa (ICSI).

The pivotal trial, which ended ahead of schedule due to its positive results leading to FDA authorization in September 2023, also confirmed the safety of FemaSeed. Adverse events reported were mild and consistent with those known for IUI, with no new safety concerns noted during the seven-week follow-up.

Femasys has already begun commercial deployment of FemaSeed in the United States, with the first procedure performed in March 2024. Positive early data from the trial supports the company’s goal of providing a cost-effective and accessible option for couples suffering from ‘infertility.

The study’s findings are based on a press release from Femasys Inc., which highlights its commitment to addressing unmet women’s health needs. The Company’s portfolio includes FDA-approved products and those in late-stage development, such as the FemBloc permanent birth control method. Femasys continues to focus on expanding its offering with innovative therapeutic and diagnostic solutions for women around the world.

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