Femasys Inc. (NASDAQ: FEMY) is a medical device company focused on non-surgical women's reproductive health products. Revenue comes from product sales of its commercial-stage devices, which totaled $2,293,313 in FY2025, up 40.8% from $1,629,108 in FY2024 (per the 10-K filed 2026-03-31). The company remains pre-profitability, posting a net loss of $18,627,887 in FY2025, funded in part through convertible notes and equity financings. Its lead pipeline product, FemBloc, is a non-surgical permanent contraception system for fallopian tube occlusion that received CE mark certification under EU MDR as of early 2025, representing the first regulatory approval for the FemBloc delivery system globally. The companion product FemChec is used as a confirmation test following FemBloc placement. Femasys sells into the women's healthcare channel, targeting hospitals and healthcare practitioners, and operates under a direct transactional product-sales model.

Revenue model

Transactional product sales of medical devices. FY2025 sales were $2,293,313 against cost of sales of $872,400, yielding gross profit before depreciation. The company carries a large operating cost base, with R&D of $7,577,704, sales and marketing of $4,443,807, and G&A of $6,646,037 in FY2025, resulting in an operating loss of $17,588,669.

Products and services

FemBloc: non-surgical permanent contraception device for fallopian tube occlusion, delivered transcervically. FemChec: confirmation test used to verify bilateral occlusion three months post-FemBloc procedure. FemBloc received CE mark certification under EU MDR in March 2025.

Customers and end markets

Hospitals and healthcare practitioners in the women's reproductive health market. End market is female permanent contraception and gynecological device procedures.

Value-chain role

Medical device developer and commercial-stage seller. Sells directly to healthcare providers including hospitals and practitioners. Subject to anti-kickback statutes, false claims laws, HIPAA, and FDA/EU MDR regulatory oversight.

Geographic exposure

CE mark certification under EU MDR obtained in March 2025, indicating regulatory presence in the European Union. U.S. operations ongoing. No further geographic revenue breakdown supported by the filing excerpts.

Source: SEC 10-K, filed 2026-03-31

Industry: Surgical & Medical Instruments & Apparatus Peers: Abbott Laboratories Aethlon Medical Inc NANOMIX Corp Bluejay Diagnostics Inc INVO Fertility Inc Guided Therapeutics Inc ENvue Medical Inc Tenon Medical Inc Valion Bio Inc