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) signed an agreement with SandsRx Pharmacy to support its FemaSeed fertility portfolio launch to OB/GYN practices.
The partnership provides medication coordination and preferred pricing for practices and their patients, alongside pharmacy expertise and education. It supports a portfolio covering diagnostics for women and men, sperm preparation and in-office fertility treatment. Patients undergoing FemaSeed treatment may be prescribed fertility medications to support ovulation.
Femasys (FEMY) has doubled actively enrolling sites in its FemBloc FINALE pivotal trial to twelve across the United States. Baylor Research Institute and Columbia University Medical Center have joined the network of academic centers and private practices studying non-surgical permanent birth control. Femasys said its August 2026 financing enabled progress in the trial.
The study evaluates safety and effectiveness. Enrollment of an initial 50-woman safety cohort is complete; those data and prior study data supported FDA authorization to continue enrollment. The primary endpoint is pregnancy rate after 401 women have relied on FemBloc for one year, with an interim analysis planned after 300 women reach that milestone. Femasys plans to seek FDA approval using one-year data, with annual follow-up continuing for five years. European approval enables collection of post-market real-world data.
Femasys (FEMY) will exhibit at the American Society for Reproductive Medicine 2026 Scientific Congress & Expo on October 24–28. The event takes place at the Baltimore Convention Center in Baltimore, Maryland. At booth #513, the company will highlight FemaSeed Intratubal Insemination, a fertility treatment option, and FemVue, its complementary diagnostic solution for in-office fallopian tube evaluation.
Femasys (FEMY) announced that Minnesota Women’s Care will adopt its FemVue fertility diagnostic system and FemaSeed Complete first-line fertility treatment across all four OB/GYN practice locations.
The practice plans to use FemVue for fertility diagnostic evaluation and FemaSeed Complete for in-office treatment earlier in patients’ fertility journeys. Femasys’ chief executive said the multi-site implementation reflects early recognition of the portfolio’s value. The company also noted that, following its August financing, it is in the early stages of expanding its commercial team to deepen sales presence and support broader OB/GYN adoption.
Femasys (FEMY) announced a partnership with fertility financing provider CapexMD to offer dedicated patient financing for its FemaSeed-led fertility portfolio. The collaboration is intended to expand access to FemaSeed Complete, an in-office intratubal insemination solution positioned as a first-line fertility treatment, along with the FemVue and SpermVue diagnostic products.
The financing program will be available across OB/GYN practices and fertility centers using these Femasys solutions. The company said the goal is to help patients overcome out-of-pocket costs, including medications and ancillary services, so that earlier, less invasive and lower-cost fertility care becomes a more practical option.
Femasys (NASDAQ:FEMY) announced a partnership with UNC Health to introduce its FemVue female fertility evaluation, SpermVue male fertility diagnostic, and FemaSeed Complete intratubal insemination solution as first-line fertility options across UNC Health OB/GYN practice locations.
According to Femasys, this collaboration aims to bring fertility diagnostics and treatment earlier into the OB/GYN care pathway, enabling women to begin fertility care with their existing physicians and improving access for patients in regions where travel distances to fertility specialists can delay or prevent treatment.
Femasys (NASDAQ:FEMY) announced that the U.S. FDA has approved its modular premarket approval (PMA) submission approach for FemBloc, the company’s investigational non-surgical permanent birth control technology in the United States.
According to Femasys, the modular PMA allows FDA to review key components of the FemBloc submission before final clinical data are available, creating a clearer regulatory framework toward potential U.S. approval. FemBloc is already approved for marketing in Europe and select international markets. In parallel, Femasys is building a U.S. commercial team and expanding distribution of its fertility portfolio from infertility specialists to OB/GYNs, with the intention that this team will ultimately also support FemBloc.
FemBloc is designed as an office-based, first-of-its-kind permanent birth control solution that uses a patented delivery system and polymer placed into both fallopian tubes, which degrades and promotes natural scar tissue for permanent occlusion, without anesthesia, incisions, or recovery time.
Femasys (NASDAQ:FEMY) reported second-quarter and six-month 2026 results and a major financing. The company completed a $30 million private placement with potential proceeds up to $90 million upon full cash exercise of warrants, and subsequently believes it has resources to execute its U.S. commercial and clinical strategy.
For the six months ended June 30, 2026, sales were $756,716, up 0.8% year over year, with net loss $3.6 million versus $10.5 million in 2025, helped by a 25.7% reduction in R&D expenses. For Q2 2026, sales declined 18.9% to $331,827 and net loss was $4.5 million. Cash was $1.4 million at June 30, 2026, before the private placement.
Corporate updates include regaining Nasdaq listing compliance, new U.S. and international patents for FemBloc, CE Mark approval for FemHSG Catheter, initial commercial use and launch of FemaSeed Complete, a commercialization partnership in Israel, and appointment of a new COO.
Femasys (NASDAQ:FEMY) announced new issued patents in the United States and multiple key international markets that protect the blended polymer component of FemBloc, its non-surgical permanent birth control technology. These patents complement existing delivery system patents, broadening and extending FemBloc’s global intellectual property coverage.
The protected blended polymer is delivered into both fallopian tubes, degrades, and induces scar tissue for permanent occlusion. FemBloc is approved for marketing in Europe and select international markets but remains investigational in the United States, where a pivotal clinical trial is ongoing.
Femasys (NASDAQ:FEMY) entered a securities purchase agreement for a $30 million private placement with accredited investors led by Nantahala Capital, joined by Rosalind Advisors and company management. Closing is subject to customary conditions and is expected around August 10, 2026.
The company is selling an aggregate of 9,374,999 common shares and pre-funded warrants, plus accompanying warrants to purchase 18,749,998 common shares. The purchase price is $3.20 per share and $3.1999 per pre-funded warrant, with pre-funded warrants exercisable at $0.0001 per share. Accompanying warrants have a $2.95 exercise price and three-year term. If fully exercised for cash, warrants could provide up to an additional $60 million.
Milestone warrants for 9,374,999 shares become exercisable 12 months after closing and require specified U.S. revenue and share-price milestones plus an effective resale registration statement. According to Femasys, proceeds will support commercialization of its fertility portfolio and advancement of the U.S. FemBloc clinical and regulatory program.