Canadian Regulators Approve FemCerv Endocervical Tissue Sampler

Femasys Inc. has received Health Canada approval for FemCerv, the first endocervical tissue sampler (curette) designed to collect and contain a comprehensive sample to maximize quality and quantity. FemCerv captures a tissue sample in a relatively pain-free manner and has the potential to be an improvement over the existing standard of care to diagnose the presence of cancerous cells in a woman’s cervix.
 
“We are delighted to gain another product approval in Canada, with FemCerv now available to women throughout all of North America as a more advanced alternative for tissue sampling to detect cervical cancer,” Femasys Founder, President, and CEO Kathy Lee-Sepsick said. “The current method for detection relies on antiquated tools that can be painful and result in an inadequate or contaminated sample, which may lead to missed diagnosis and unnecessary invasive procedures. Femasys continues to build out our commercial suite of products to bring much-needed technologies to women.”
 
If a woman’s pap smear is abnormal, she generally needs to undergo a colposcopy, which often includes endocervical curettage or taking a tissue sample from the highly sensitive cervical canal. The tools available to collect this tissue are limited and can cause pain, bleeding and extreme discomfort, as well as result in an inadequate or contaminated sample. Further, should sample contamination occur, this would require subsequent tests and office visits to obtain additional samples. FemCerv can be used in conjunction with colposcopy and is intended to capture and protect a comprehensive 360-degree tissue sample for maximization of the quality and quantity, in a relatively pain-free office visit.
 
FemCerv is the first U.S. Food and Drug Administration-cleared endocervical tissue sampler designed to improve tissue quality and quantity in a pain-free manner that has the potential to be an improvement over the existing standard of care. FemCerv can be used in conjunction with colposcopy and is intended to capture and protect a comprehensive 360-degree tissue sample in a relatively pain-free office visit. FemCerv features an expandable collection chamber that is exposed during sampling and closed during removal for containment of cervical cells and tissue.
 
Femasys Inc. is a biomedical company aiming to meet women’s needs worldwide by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc permanent birth control and FemaSeed localized directional insemination for infertility. The company’s products currently marketed in the United States include FemVue for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath, an intrauterine catheter for selective evaluation of the fallopian tubes, and FemCerv, an endocervical tissue sampler that is the first product of the technology platform for tissue sampling.