Canadian Regulators Approve FemCath Intrauterine Catheter

Femasys Inc. has received Health Canada approval of FemCath, the first intrauterine catheter that allows for selective evaluation of a fallopian tube with contrast.

FemCath is used in conjunction with Femasys’ FemVue device for an ultrasound-based diagnostic test as part of an infertility evaluation. Femasys’ diagnostic products are to be used prior to performing any infertility treatment, such as artificial insemination with Femasys’ FemaSeed product, which was approved by Health Canada in April this year.
 
“Our momentum in the North American market continues with approval of another Femasys product in Canada, allowing for expanded commercial opportunities,” Femasys Founder, President, and CEO Kathy Lee-Sepsick said. “Given blocked fallopian tubes are a silent infertility factor affecting one out of three infertile women, it is critical to assess the viability of each fallopian tube, which can be achieved utilizing FemCath with our FemVue product. This essential diagnostic evaluation is required prior to performing the FemaSeed procedure, where sperm is delivered directly to one or both of the viable fallopian tubes where conception occurs. With our additional programs advancing this year, Femasys will continue its mission to bring technologies to women’s healthcare and build our suite of products.”
 
FemCath uses Femasys’ proprietary delivery platform, which involves placement of balloon technology close to the opening of a selected fallopian tube for directed contrast delivery. Femasys’ other biomedical solutions in development, FemaSeed and FemBloc, use the same delivery platform for directed delivery of other materials. FemaSeed and FemBloc are not yet approved in the United States, but FemaSeed is already approved in Canada. In the case of FemaSeed, sperm is delivered directly to the tube where conception occurs and for FemBloc, a proprietary degradable biopolymer is delivered to both tubes for nonsurgical permanent birth control.
 
FemCath is the first U.S. Food and Drug Administration (FDA)-cleared product that allows for selective evaluation of the fallopian tubes in conjunction with the FemVue device. The ultrasound-based diagnostic test is part of an infertility evaluation, which is essential prior to any infertility treatment, including with the firm’s other biomedical solution, FemaSeed, approved in Canada and in development in the United States.
 
FemVue is the first FDA-cleared product that creates natural saline and air contrast and enables safe, reliable, and real-time evaluation of the fallopian tubes with ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the GYN’s office.
 
FemaSeed is an infertility solution approved in Canada and in development in the United States for directional intrauterine insemination. FemaSeed delivers sperm to the fallopian tube where conception occurs. It is intended to augment natural fertilization and provide a first-line treatment option for infertility.
 
FemBloc is a first-of-its-kind, nonsurgical, in-office solution in development for permanent birth control. It is intended to be a safer option for women by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer women a convenient and reliable alternative method of permanent birth control.
 
Femasys Inc. is a biomedical company developing products that include minimally invasive, in-office technologies for reproductive health.