Femasys Inc. announced the peer-reviewed publication of positive data from its pivotal trial of FemaSeed intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading peer-reviewed journal covering gynecology and reproductive medicine. The publication titled, ?FemaSeed directional intratubal artificial insemination for couples with male-factor or unexplained infertility associated with low male sperm count,? includes positive data from the pivotal trial (Clinicaltrials.gov NCT04968847).

The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95% CI: 13.443.1%; n=10/38) and 17.5% per cycle (95% LCB: 7.6%, 95% CI: 5.729.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P=0.041). Safety reports were consistent with IUI. The vast majority of subjects stated they would probably or definitely recommend FemaSeed, and investigator satisfaction was similarly high.

Targeted intratubal insemination of washed spermatozoa using the FemaSeed ITI device is a safe artificial insemination technique that demonstrated high effectiveness for couples with male-factor/unexplained infertility associated with low male sperm count. Delivery of washed spermatozoa directly into the utero-tubal ostium and fallopian tube without catheterization likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility.