Femasys, a company developing a biopolymer for permanent birth control in women, has received US Food and Drug Administration (FDA) clearance for a related diagnostic device used to test fallopian tube occlusion.
The 510(k) clearance is for FemCheck, Femasys' diagnostic device that delivers a controlled amount of contrast to fallopian tubes for examination of tubal status during ultrasound procedures.
Used with an intrauterine catheter, the system utilises an alternating pattern of saline and air in a continuous stream of contrast media.
While indicated for evaluation of fallopian tubes with or without the uterine cavity, the device’s main use will likely be in conjunction with Femasys’ birth control product, FemBloc.
FemBloc is an implant delivered in-office as a biopolymer via balloon catheters. Once the biopolymer touches the tissue within the tubes, it solidifies, triggering wound healing and eventual scar tissue formation. The resulting scar tissue blocks the tubes while the biopolymer degrades and is expelled.
Currently, women seeking permanent birth control only have surgery as an option. The procedure is called tubal ligation, which involves the surgical tying, cutting, or blocking of fallopian tubes.
The product is being investigated as part of the ongoing FINALE pivotal trial (NCT05977751), in which FemChec is being employed to confirm success in participants.
According to Femasys CEO Kathy-Lee Sepsick, FemChec and its ultrasound use offers the advantage of not exposing women to radiation, which occurs in traditional methods with X-ray dyes.
Sepsick said: “FemChec is an essential part of our suite of women’s health products, as it fortifies our position to provide safe and technologically advanced diagnostic and therapeutic solutions addressing women’s healthcare needs.”
Femasys has developed a successful portfolio of sexual health products. In September 2023, the FDA cleared one of the company’s lead products FemaSeed – a flexible catheter that delivers sperm into the ovulating fallopian tube to help fertilisation.
In June 2024, the company received CE marking for four of its products, namely FemaSeed; FemVue; FemCerv; and FemCath, all in compliance with new EU legislation.
In November 2023, Femasys secured nearly $7m in funding from PharmaCyte. Financial backing in women’s health has grown significantly in the past few years, despite the overall lull in early-stage investment. In January, the UK Government announced women’s health priorities for this year, which included £50m ($63.8m) for research to tackle maternity disparities.
The global reproductive health device market will reach $3.3bn by 2030, according to analysis by GlobalData.
