Femasys’ pivotal FINALE trial for its permanent birth control device is well under way, and the women’s health company has just activated another recruitment site.
The latest enrolment green light for the FemBloc device is at the University of Utah Hospital in Utah, US. The site joins medical centres and other universities across four other US states.
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According to the trial’s ClinicalTrials.gov entry (NCT05977751), the trial is being conducted across six sites – all of which are now in the recruiting stage.
The trial kicked off in August 2023, with the most recent enrolment activation at California’s Stanford Medicine coming in December 2023.
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 within three months.
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.
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By GlobalDataThe non-surgical permanent birth control market has had a tricky past. Previously, women were able to receive Bayer’s Essure device – a US Food and Drug Administration (FDA)-cleared implanted coil device that used scar tissue formation for permanent birth control. However, in 2019, Bayer pulled the device from the market due to severe safety issues including device-related deaths. Bayer was subsequently subject to thousands of lawsuits.
US-based Femasys aims to put a non-surgical option back on the market that is safer and cheaper than surgery.
Dr Lori Gawron of the University of Utah Hospital said: “An in-office option like FemBloc has the opportunity to change how we deliver care to women when they no longer wish to be at risk of pregnancy but no longer want exposure to hormones or implants or surgery.”
Final focus
The FINALE trial aims to enrol 573 women aged 21–50 years who seek permanent birth control. The trial’s endpoint is the number of subjects who become pregnant through one year. The analysis will be conducted once 401 participants have used the device, although the company will also perform an earlier readout at a 50-participant checkpoint for safety data. An interim analysis will also be carried out once 300 women have used FemBloc for a year.
Femasys has developed a successful portfolio of sexual health products. In September 2023, the FDA cleared the company’s other lead product FemaSeed – a flexible catheter that delivers sperm into the ovulating fallopian tube to help fertilisation. The company also has several FDA-cleared diagnostic products that help with assessment of the fallopian tubes and cervical canal.
In November 2023, Femasys secured nearly $7m in funding from PharmaCyte. Despite the recent lull in life science investment, financial backing in women’s health has grown significantly in the past few years. Earlier in January, the UK Government announced women’s health priorities for 2024, which included £50m ($63.8m) for research to tackle maternity disparities.
A report by GlobalData estimates the global reproductive health device market will reach $3.3bn by 2030.
