Femasys doubles FINALE trial sites to twelve for FemBloc device

Femasys has expanded its US pivotal trial network to twelve sites, adding Baylor and Columbia, as it pursues FDA approval for its non-surgical birth

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Curved metal rods and threaded posts for surgical implants rest on a blue sterile drape in a brightly lit operating room.

Femasys Inc. has doubled the number of actively enrolling clinical sites in its FINALE pivotal trial, bringing the total to twelve centres across the United States as the NASDAQ-listed company pushes its FemBloc device toward FDA approval for non-surgical permanent birth control.

The expanded network now includes Baylor Research Institute and Columbia University Medical Center, joining previously active academic sites at Maimonides Medical Center, Stanford University, the University of California Davis, and the University of Utah. Private clinical practices also form part of the coast-to-coast footprint. The company said growth in site numbers was enabled by its August 2026 financing round, the terms of which have not been separately disclosed in this release.

How FemBloc works

FemBloc is designed for in-office delivery without general anaesthesia, incisions, or a recovery period. A patented delivery system places a blended polymer into both fallopian tubes; the material degrades gradually and forms scar tissue that permanently occludes the tubes. The approach contrasts with laparoscopic sterilisation procedures, which carry surgical risks and typically require theatre time and post-operative recovery.

The FINALE trial (NCT05977751) is a prospective, multi-centre, single-arm study with a primary endpoint of pregnancy rate. The protocol requires 401 women to have relied on FemBloc for one year, with an interim analysis planned once 300 women reach that threshold. An initial roll-in cohort of 50 participants has already completed enrolment, and the FDA approved continuation of the main enrolment phase following a review of those preliminary safety data. Under the agreed protocol, Femasys will submit for FDA approval on the basis of one-year data, with five years of annual follow-up continuing thereafter.

Kathy Lee-Sepsick, chief executive and founder of Femasys, said the expanded site count "demonstrates important progress in executing on our U.S. regulatory strategy" and that post-market real-world data from Europe would sit alongside the pivotal trial evidence to support broader adoption. The company softened references to the device as a "revolutionary option" have been rendered in neutral terms here, as the FDA has not yet approved the product for the US market.

Market context and competitive landscape

FemBloc holds regulatory approvals in Europe, the UK, and New Zealand, obtained in 2025, and is being commercialised in select international markets through strategic partnerships. The US approval pathway via the FDA's premarket approval process for class III devices is the principal remaining regulatory hurdle for Femasys.

The non-surgical permanent contraception segment has seen limited competition in recent years. Bayer's Essure hysteroscopic coil, once the only non-surgical alternative to tubal ligation in the US, was withdrawn from the market in 2018 following a wave of adverse-event reports and regulatory scrutiny. That withdrawal left a gap in the non-surgical sterilisation category that Femasys is explicitly targeting. Analysts and clinicians will look closely at FemBloc's one-year pregnancy rate and long-term safety profile, given the history of the predecessor product, before drawing conclusions about the device's commercial prospects. The interim data readout, expected once 300 participants complete their first year of reliance, will be the next material milestone for investors to monitor.

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