Femasys Inc. received FDA Investigational Device Exemption approval to continue enrollment in the final phase of its FemBloc pivotal trial, a key step toward U.S. pre‑market approval for the company’s first non‑surgical permanent birth‑control system.
The company also closed a senior secured convertible note financing of $12 million, with an 8.5% annual interest rate and a ten‑year maturity. The notes are convertible into up to 16,378,563 shares at a conversion price of $0.73 per share, representing a 15% premium to the closing price of Femasys’ common stock immediately prior to the agreement.
The transaction includes warrants that could raise an additional $46 million if exercised for cash, bringing total potential proceeds to $58 million. The warrants have exercise prices of $0.81, $0.92, and $1.10.
Proceeds will be used to refinance existing debt and accelerate commercialization of Femasys’ fertility and permanent birth‑control portfolio, including FemBloc, FemaSeed, and FemVue. The company plans to use the funds to support the final phase of the FemBloc trial, expand marketing and distribution in the U.S., and strengthen its balance sheet.
FemBloc is positioned to be the first non‑surgical permanent birth‑control option in the U.S., offering a safer, more accessible alternative to surgical tubal ligation. The company has already obtained CE mark approval for the FemBloc delivery system in Europe and expects to launch in select European markets in 2026.
The FINALE pivotal trial aims to enroll 573 women and will provide critical data for U.S. pre‑market approval. Femasys’ broader product portfolio includes FemaSeed, a fertility treatment that has shown higher pregnancy rates than intrauterine insemination, and FemVue, a fallopian tube assessment device.
The financing follows prior capital raises, including an $8 million financing in September 2025 and a $6.85 million investment in November 2023, underscoring investor confidence in the company’s pipeline.
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