US-based medical device company Femasys has initiated enrolment in a pivotal clinical trial investigating the use of its biopolymer that helps permanently close the fallopian tubes to prevent pregnancy.
The company will use the prospective, multi-centre FINALE trial to evaluate pregnancy rates in women who have used the device for one year. The analysis will be conducted once 401 participants have used the device, though the company will also perform an earlier readout at a 50-participant checkpoint for safety data.
The non-surgical, non-implant is delivered in-office as a biopolymer into each fallopian tube 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 tube while the biopolymer degrades and is expelled within three months.
Though Femasys has not openly published results from the research, founder, president and CEO Kathy Lee-Sepsick said the earlier studies “demonstrated the safety and tolerability profile of FemBloc”. The company will use the previous trials and FINALE for a premarket application (PMA) to the US Food and Drug Administration (FDA) to allow the product to be marketed.
Currently, tubal ligation – which involves the surgical tying, cutting, or blocking of fallopian tubes –is the only available form of permanent birth control.
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On the opposite side of the spectrum is the company’s other lead product FemaSeed – a flexible catheter that delivers sperm into the ovulating fallopian tube to help fertilisation.
Lee-Sepsick stated: “We are very pleased to have quickly initiated the pivotal clinical trial phase for FemBloc, which is an important milestone for Femasys.
“As this landmark pivotal trial progresses, we look forward to providing enrolment updates and preliminary data results.”
“Femasys is striving to provide a safe and accessible permanent birth control alternative for women who today must choose between elective surgery and its associated risks or remain on temporary contraception, which can carry the risk of implants or hormones.”