FEMASYS INC Stock Price, News & Analysis

Femasys (NASDAQ: FEMY) announced U.S. FDA 510(k) clearance on December 18, 2025 for its next‑generation FemVue Controlled diagnostic device.

The single‑device solution combines the company’s original FemVue and FemChec technologies to provide controlled contrast delivery for fallopian tube evaluation, support multiple clinical uses, and streamline manufacturing and practice workflows. Management said the clearance advances clinician‑focused innovations and aims to strengthen the scalability and efficiency of the product portfolio.

PharmaCyte Biotech (Nasdaq:PMCB) announced it has successfully monetized its stake in Femasys (Nasdaq:FEMY), boosting its liquidity position.

Proceeds lift cash and marketable securities to approximately $20 million in cash (up from $13.3 million on July 31, 2025) and the company reports roughly $25 million in marketable securities as valued in its most recent 10-Q.

The company noted a recent share price of $0.65 with about 6.8 million shares outstanding and reiterated plans to pursue value-accretive investments and disciplined operations to enhance shareholder returns.

Femasys (NASDAQ: FEMY) reported 3Q 2025 results and multiple corporate milestones on Nov 14, 2025. Key operational highlights include FDA IDE approval to advance the final FemBloc pivotal trial, regulatory approvals in the U.K. and New Zealand, initiation of European post-market surveillance, and new distribution partnerships and initial commercial orders in Europe.

Financing actions strengthened liquidity: a $12 million secured convertible notes agreement (with up to $58 million potential if warrants exercised) and an underwritten public offering raising $8 million. Financials: 3Q sales were $729,394 (+31.4% vs. 3Q2024); 9M sales were $1.480M (+41.3% YoY). Cash was approximately $4.6M with a stated cash runway into September 2026.

Femasys (NASDAQ: FEMY) announced an initial commercial order of approximately $500,000 to launch FemBloc Permanent Birth Control in France and the Benelux region through distributor Kebomed, dated Nov 10, 2025. This follows the company’s recent entry into Spain and represents continued European expansion for the non-surgical permanent contraceptive.

FemBloc is described as a first‑of‑its‑kind, non‑surgical permanent contraception that places a proprietary polymer into both fallopian tubes to form permanent occlusion without anesthesia, incisions, or recovery time, positioning the product as a potentially disruptive global offering.

Femasys (NASDAQ: FEMY) received U.S. FDA Investigational Device Exemption (IDE) approval to continue enrollment in Part B of the FINALE pivotal trial for FemBloc, advancing toward potential U.S. Pre-Market Approval (PMA).

The company also closed a $12 million senior secured convertible note financing with accompanying warrants that could produce up to $58 million in total proceeds if all warrants are exercised for cash. Notes bear 8.5% interest, 10-year maturity, and convert into up to 16,378,563 shares at $0.73 per share. Warrants exercisable at $0.81, $0.92, and $1.10 could add up to $46 million if exercised.

Femasys (NASDAQ: FEMY) announced the initiation of a post-market surveillance (PMS) clinical study for its CE-marked FemBloc Permanent Birth Control in Europe on October 22, 2025.

The study is conducted under the EU Medical Device Regulation (EU MDR 2017/745, Annex XIV Part B), has approval from multiple Ethics Committees, and follows ISO 14155:2020 Good Clinical Practice and applicable national rules. FemBloc is described as a non-surgical permanent birth control using a biodegradable polymer delivery to occlude fallopian tubes without anesthesia, incisions, or recovery time, positioned to support physician adoption and reimbursement across Europe.

Femasys (NASDAQ: FEMY) will exhibit at the ASRM 2025 Scientific Congress & Expo in San Antonio, Oct 25–29, 2025, at booth #619. The company will showcase FemaSeed Intratubal Insemination (ITI), described as a next‑generation artificial insemination solution that delivers sperm directly to the fallopian tube.

The release highlights a pivotal trial where FemaSeed achieved >2x pregnancy rates versus IUI in low male sperm count cases, notes authorization for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand, and announces an expanded ITI portfolio (FemSperm Setup Kit, FemSperm Prep Kit, FemSperm Analysis Kit). ASRM 2025 expects over 5,500 reproductive‑medicine professionals.

Femasys Inc. (NASDAQ: FEMY) has announced a strategic partnership with Kebomed to commercialize its FemBloc Permanent Birth Control solution in France and Benelux countries. This partnership follows FemBloc's recent CE mark approval and targets France as the largest European market opportunity.

FemBloc is a revolutionary non-surgical permanent birth control solution that uses a proprietary polymer delivery system to create natural scar tissue in fallopian tubes. The technology eliminates risks associated with surgical sterilization, including anesthesia complications and infection, while offering a more cost-effective and accessible option for women.

Femasys Inc. (NASDAQ: FEMY) has announced a strategic partnership with Medical Electronic Systems LLC (MES) to launch the FemSperm Analysis Kit. This addition completes the FemSperm product family, which includes the Setup Kit and Insemination Prep Kit.

The partnership enables gynecologists to perform complete in-office sperm preparation and analysis for FemaSeed Intratubal Insemination, a first-step infertility treatment. FemaSeed has demonstrated more than double the pregnancy rates of intrauterine insemination (IUI) in cases of low male sperm count in its pivotal trial.

The solution is currently authorized for use in multiple markets including the U.S., Europe, UK, Canada, Israel, Australia and New Zealand, offering a more accessible and cost-effective alternative to traditional fertility treatments.