FemaSeed has displayed positive topline results for the treatment of infertility in a pivotal trial, according to Femasys Inc, a leading biomedical company targeting unmet needs of women worldwide.
Takeaways
- FemaSeed, developed by Femasys Inc, has shown promising results in treating infertility, offering a safe and accessible option for patients seeking pregnancy through insemination.
- In a pivotal clinical trial, FemaSeed demonstrated a significant pregnancy rate of 24% among women with severe male factor infertility, surpassing conventional intrauterine insemination (IUI) rates of 6.7%.
- The device's precise administration of sperm into the fallopian tube, the natural site of conception, yielded high pregnancy rates, with most women achieving pregnancy during their first attempt.
- Safety outcomes of FemaSeed were comparable to those of IUI, with mild adverse events and no new safety concerns observed during the 7-week follow-up period.
- These compelling results support the ongoing commercial launch of FemaSeed, offering hope for couples facing infertility challenges worldwide.
FemaSeed is an artificial insemination device, providing fertility to patients through precise administration of sperm into the fallopian tube, which is the natural site of conception. It is designed to be a safe, accessible, cost-effective approach for patients seeking pregnancy through insemination to use as a first-line therapeutic option.
In September 2023, the FDA granted clearance to FemaSeed. Following this clearance, Femasys conducted a prospective, multi-center, unblinded pivotal clinical trial to evaluate FemaSeed among patients wanting intratubal insemination.
Participants included women with male factor, unexplained, or tubal factor infertility. The pregnancy rate among these patients following use of FemaSeed was evaluated as a primary outcome of the analysis, analyzed alongside the safety of FemaSeed.
Outcomes were evaluated across a 6-week period, and women could receive up to 6 FemaSeed procedures. Severe male factor infertility was given focus in the primary efficacy analysis.
Pregnancy after FemaSeed with severe male factor was reported in 24% of women, with a 1 million to 20 million total motile sperm count. Most women with pregnancy achieved pregnant status during the first attempt with FemaSeed.
In comparison, literature for intrauterine insemination (IUI) with male factor indicated a 6.7% pregnancy rate. Poor IUI rates often require in vitro fertilization, intracytoplasmic sperm injection, or other assisted reproductive options.
Adverse events from use of FemaSeed matched with those from IUI use, and most were mild. New safety concerns were not observed during the 7-week follow-up.
These results indicated safety and efficacy from FemaSeed in patients with infertility. This data supports the on-going commercial launch of FemaSeed.
Reference
Femasys announces positive topline data from pivotal trial for its FDA-cleared FemaSeed for the treatment of infertility. BioSpace. March 20, 2024. Accessed March 20, 2024. https://www.biospace.com/article/releases/femasys-announces-positive-topline-data-from-pivotal-trial-for-its-fda-cleared-femaseed-for-the-treatment-of-infertility/
