Welcome to our dedicated page for FEMASYS news (Ticker: FEMY), a resource for investors and traders seeking the latest updates and insights on FEMASYS stock.
Femasys Inc. develops biomedical products for women’s reproductive health, with news centered on fertility treatment, fallopian tube assessment, and non-surgical permanent birth control. Its portfolio includes FemaSeed intratubal insemination, FemaSeed Complete for in-office fertility care, FemVue for ultrasound-based fallopian tube evaluation, FemBloc permanent birth control, and related diagnostic products such as FemChec.
Recurring updates cover product commercialization in OB/GYN settings, international distribution and market access, regulatory approvals outside the United States, U.S. clinical and regulatory development for FemBloc, reimbursement-related developments, financing, operating results, and governance changes.
Femasys (NASDAQ: FEMY) reported 2025 results and corporate progress on March 31, 2026. Sales rose 40.8% to $2,293,313, driven by FemBloc, while net loss was $18,627,887 (−$0.47 per share). Cash and cash equivalents were approximately $9.3 million, expected to fund operations into Q3 2026.
Key operational milestones include initiation of patient enrollment in the FINALE pivotal trial for FemBloc, FDA 510(k) clearance for FemVue, MDSAP certification for FemBloc, AMA Category III CPT code for FemaSeed, a $12 million financing, and a Switzerland distribution partnership.
Femasys (NASDAQ: FEMY) appointed Dr. Kenneth D. Eichenbaum to its board on March 18, 2026. Dr. Eichenbaum is a board-certified anesthesiologist with over 20 years evaluating biotech and medical device companies, and holds degrees from Icahn School of Medicine, University of Pennsylvania, and Wharton.
The company thanked Joshua Silverman for his board service and highlighted Dr. Eichenbaum’s clinical, engineering, and finance expertise as strategic support for Femasys’ growth in women’s reproductive health.
Femasys (NASDAQ: FEMY) has begun patient enrollment in the FDA-authorized FINALE pivotal trial of FemBloc, a first-of-its-kind non-surgical permanent birth control. The move follows an FDA Investigational Device Exemption approval and positive earlier clinical data. FemBloc is already approved and commercialized in Europe and select countries outside the U.S., and completion of FINALE is expected to support a future U.S. regulatory submission.
Femasys (NASDAQ: FEMY) announced that its FemBloc permanent birth control system achieved MDSAP certification on Feb. 26, 2026, enabling accelerated regulatory and commercial execution across the United States, Canada, Japan, Australia, and Brazil. The certification supports pivotal trial readiness toward a future PMA submission and strengthens manufacturing credibility for global expansion.
Femasys (NASDAQ: FEMY) received AMA CPT Editorial Panel approval for a new, unique Category III CPT code covering FemaSeed intratubal insemination (ITI). The code is expected to be issued publicly with an effective date of January 1, 2027.
This coding approval advances the company’s U.S. reimbursement strategy to support broader clinical adoption, provider rollout with the FemSperm product line, and expanded patient access; FemaSeed’s pivotal trial (NCT0468847) showed >2x pregnancy rates versus IUI. FemaSeed is authorized for use in the U.S., Europe, UK, Canada, and Israel.
Femasys (NASDAQ: FEMY) expanded its European commercial footprint by signing a distribution agreement with OR Consulting to launch FemBloc permanent birth control, FemaSeed intratubal insemination, and other fertility and women’s diagnostic products in Switzerland. This follows recent market entry in Spain and ongoing launches in France as part of the company’s Europe expansion strategy.
Femasys (NASDAQ: FEMY) said Nasdaq granted a 180-calendar day extension on January 13, 2026 to regain compliance with the minimum $1.00 bid price requirement.
The company has until July 13, 2026 to achieve a closing bid of $1.00 or higher for at least ten consecutive business days to regain compliance. Nasdaq noted Femasys meets the market value of publicly held shares and other initial listing requirements, except the bid price rule. Femasys said it may effect a reverse stock split, if necessary, and will monitor its share price and take actions within the prescribed period to regain compliance.
Femasys (NASDAQ: FEMY) announced a partnership with Refuah Health Center on Jan 13, 2026 to offer FemaSeed as a first-line step in infertility treatment within community-based care.
The agreement aims to expand patient access, strengthen Femasys' commercial footprint in community fertility care, and accelerate adoption by leveraging Refuah's patient engagement and care model.
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.