US biomedical company launches intrauterine device for tubal evaluation

The US biomedical company Femasys has announced the commercial availability of its new intrauterine catheter for selective tubal evaluation.

Tubal patency is a key element in women who are undergoing assisted reproductive techniques (ART), in order to attempt or exclude intrauterine insemination (IUI) cycles.

The new FemCath is the first FDA-cleared intrauterine catheter that allows for selective evaluation of a fallopian tube with contrast.

The device utilises Femasys’ delivery platform, which involves placement of balloon technology close to the opening of a selected fallopian tube for directed delivery.

The Atlanta-based company company has developed a suite of product candidates such as minimally invasive, in-office technologies for reproductive health currently marketed in the US, including FemVue for fallopian tube assessment by ultrasound and FemCerv, an endocervical tissue sampler.

According to the developers, FemCath can be used in conjunction with the FemVue device for an ultrasound-based diagnostic test as part of an infertility evaluation, which is essential prior to any infertility treatment.

Kathy Lee-Sepsick, founder, president and CEO of Femasys, said: “This is one more important milestone reached this year as we continue to expand much needed options for women with our suite of innovative products.

“We are encouraged to improve the options available for those struggling with infertility and expect if FemaSeed, a product in development for directional intrauterine insemination, is approved to bring a solution to the front-end of care.

“In the meantime, FemCath will provide another measure of incremental revenue for Femasys when used with FemVue for any conditions requiring tubal evaluation.”

Femasys’ other biomedical solutions in development, FemaSeed and FemBloc, utilise the same delivery platform for directed delivery of other materials.

In the case of FemaSeed, sperm is delivered directly to the tube where conception occurs. For FemBloc, a proprietary biopolymer is delivered to both tubes for nonsurgical permanent birth control.