FEMASYS Stock Price, News & Analysis

Femasys Inc. (NASDAQ: FEMY) is a biomedical company in the surgical and medical instrument manufacturing industry that focuses on women’s reproductive health. According to company disclosures, Femasys is a U.S. manufacturer with global regulatory approvals and is centered on making fertility treatment and non-surgical permanent birth control more accessible and cost-effective for women worldwide. The company develops and commercializes a patent-protected portfolio of in-office therapeutic and diagnostic products designed for use by clinicians in gynecology and reproductive medicine.

Business focus and product portfolio

Femasys describes itself as a biomedical innovator dedicated to fertility and permanent birth control. Its fertility portfolio includes FemaSeed Intratubal Insemination, characterized in company materials as a groundbreaking first-step infertility treatment, and FemVue, a companion diagnostic used for fallopian tube assessment via ultrasound. Published clinical trial data cited by the company indicate that FemaSeed has achieved pregnancy rates more than twice those of traditional intrauterine insemination (IUI) in cases involving low male sperm count, with a comparable safety profile and high patient and practitioner satisfaction.

In addition to fertility solutions, Femasys is advancing FemBloc permanent birth control, which it describes as the first and only non-surgical, in-office alternative to traditional surgical sterilization. Company announcements state that FemBloc received full regulatory approval in Europe in June 2025, in the United Kingdom in August 2025, and in New Zealand in September 2025. FemBloc uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which then safely degrades and leads to natural scar tissue formation for permanent occlusion. Femasys positions FemBloc as a safer, more convenient and cost-effective option compared with surgical sterilization, noting that it does not require anesthesia, incisions or recovery time.

Alongside FemBloc, the company has developed FemChec, an ultrasound-based diagnostic product used to confirm the success of the FemBloc procedure. Femasys reports that initial clinical trials of FemBloc and FemChec have demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction. For the U.S. market, FemBloc remains a product candidate, with enrollment in the FINALE pivotal trial (NCT05977751) described as ongoing in company communications.

Diagnostic innovation and FemVue Controlled

Femasys also focuses on diagnostic devices that support fertility care. The company announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for FemVue Controlled, described as a next-generation diagnostic device designed for controlled delivery of a consistent alternating pattern of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status. FemVue Controlled integrates features of the original FemVue and FemChec technologies into a single FDA-cleared platform, enabling multiple clinical uses within one solution, including confirmation of tubal patency prior to use with FemaSeed. This integration is intended to streamline manufacturing and practice workflows by combining related diagnostic functions in one device.

Commercialization and geographic reach

According to repeated company descriptions, Femasys is actively commercializing its lead product innovations in the United States and key international markets. FemaSeed is authorized for use in the U.S., Europe, the UK, Canada and Israel, and in some disclosures also in Australia and New Zealand. The company has highlighted partnerships to broaden access to its products, such as a collaboration with Refuah Health Center to offer FemaSeed as a first step in the infertility treatment process within a community-based care setting. Femasys has also entered into distribution partnerships in Europe, including agreements with Kebomed to commercialize FemBloc permanent birth control in France and the Benelux region, and has reported initial commercial orders in Spain and France.

For FemBloc, Femasys has emphasized a European commercialization strategy supported by strategic partnerships in select countries. The company has also initiated a post-market surveillance clinical study for FemBloc in Europe under the European Union Medical Device Regulation (EU MDR 2017/745). This study is described as being conducted in accordance with ISO 14155:2020 for Good Clinical Practice and applicable national regulations, with the goal of monitoring safety and performance in real-world use and supporting broader physician adoption and reimbursement.

Regulatory and clinical development

Femasys’ disclosures highlight a regulatory and clinical pathway that combines commercial products and late-stage development candidates. FemaSeed and FemVue are described as commercially available fertility solutions with supporting clinical trial data. FemBloc is already approved in certain non-U.S. markets, while in the United States it remains under clinical investigation. The U.S. FDA granted Investigational Device Exemption (IDE) approval allowing Femasys to continue enrollment in the final phase (Part B) of the FINALE pivotal trial for FemBloc, following successful completion of Part A. The company characterizes this IDE approval as a critical step toward potential U.S. Pre-Market Approval (PMA) for FemBloc.

Femasys also notes that it operates under a broad, patent-protected portfolio, indicating a focus on intellectual property protection around its therapeutic and diagnostic technologies. Its regulatory filings describe the company as an emerging growth company and a smaller reporting company under U.S. securities regulations.

Capital markets and listing status

Femasys Inc. is incorporated in Delaware and its common stock, with a par value of $0.001 per share, is listed on The Nasdaq Capital Market under the trading symbol FEMY. The company has filed registration statements on Form S-1 and amendments related to offerings of common stock, pre-funded warrants and common warrants, as well as Form 8-K reports describing private placements of senior secured convertible notes and associated warrants. These financings are described as intended to refinance existing debt, support commercialization of the fertility and permanent birth control portfolio, and provide working capital.

Nasdaq has notified Femasys at various times regarding continued listing requirements. Company disclosures state that Femasys received a notice related to the Market Value of Listed Securities and other quantitative standards, and later reported that, on a pro forma basis after an underwritten offering and warrant exercises, it believed it met the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. In a separate notice, Femasys reported that Nasdaq granted the company an additional 180-calendar day extension to regain compliance with the minimum closing bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2). During this extension period, the company’s common stock continues to trade on The Nasdaq Capital Market under the symbol FEMY, and Femasys has indicated that it may effect a reverse stock split, if necessary, to cure the deficiency.

Financial reporting and SEC filings

Femasys files periodic reports with the U.S. Securities and Exchange Commission (SEC), including Forms 10-Q and 10-K, as well as current reports on Form 8-K describing material events. In its Form 10-Q for the quarter ended September 30, 2025, summarized in an accompanying press release, the company reported sales growth compared with the prior-year period, attributing the increase primarily to sales of FemBloc and FemVue. The same report outlined research and development, sales and marketing, and general and administrative expenses, as well as net loss figures and information on cash, cash equivalents, inventory and other balance sheet items. Femasys has characterized itself as focused on advancing its women’s health portfolio while managing its capital position through financings and cost controls.

Industry context and positioning

Within the surgical and medical instrument manufacturing industry, Femasys concentrates on gynecologic and reproductive health technologies. Its products are designed for in-office use by clinicians, with an emphasis on minimally invasive approaches. Company communications consistently describe a mission to transform women’s healthcare by providing practical, clinician-focused innovations that can be delivered in office-based settings, with potential implications for patient access and health economics. By combining fertility treatments like FemaSeed with diagnostics such as FemVue and FemVue Controlled, and a non-surgical permanent birth control option in FemBloc, Femasys presents an integrated set of tools aimed at key decision points in reproductive care.

FAQs about Femasys Inc. (FEMY)

• What does Femasys Inc. do?
  

  Femasys Inc. develops and manufactures biomedical products focused on women’s reproductive health, including in-office fertility treatments, diagnostic devices for fallopian tube assessment, and a non-surgical permanent birth control system. The company describes its portfolio as patent-protected and designed to make fertility care and permanent contraception more accessible and cost-effective.

• What are Femasys’ main products?
  

  According to company disclosures, Femasys’ fertility portfolio includes FemaSeed Intratubal Insemination, a first-step infertility treatment, and FemVue, a companion diagnostic for fallopian tube assessment. The company is also advancing FemBloc permanent birth control, a non-surgical, in-office alternative to surgical sterilization, and offers FemChec as a diagnostic product to confirm FemBloc procedural success. Femasys has additionally received FDA 510(k) clearance for FemVue Controlled, a diagnostic device for controlled contrast delivery during ultrasound imaging of the fallopian tubes.

• How does FemaSeed differ from traditional intrauterine insemination (IUI)?
  

  Company materials describe FemaSeed as a next-generation artificial insemination solution that delivers sperm directly to the fallopian tube, the natural site of conception. In a pivotal clinical trial cited by Femasys, FemaSeed achieved more than double the pregnancy rates of traditional IUI in cases of low male sperm count, while maintaining a comparable safety profile and high patient and practitioner satisfaction.

• What is FemBloc permanent birth control?
  

  FemBloc is described by Femasys as a first-of-its-kind, non-surgical solution for permanent birth control. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which then safely degrades and leads to natural scar tissue formation that permanently occludes the tubes. The procedure is performed in an office setting without anesthesia, incisions or recovery time, and is positioned as an alternative to surgical sterilization.

• Where is FemBloc approved and how is it being commercialized?
  

  Femasys reports that FemBloc permanent birth control has received full regulatory approval in Europe, the UK and New Zealand. The company is commercializing FemBloc in select European countries through strategic distribution partnerships, including agreements with Kebomed for France and the Benelux region and initial commercial activity in Spain. In Europe, Femasys has also initiated a post-market surveillance study under EU MDR requirements.

• What is FemVue Controlled?
  

  FemVue Controlled is an FDA-cleared diagnostic device developed by Femasys for controlled delivery of a consistent alternating pattern of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status. It integrates features of the company’s original FemVue and FemChec technologies into a single platform, enabling multiple clinical uses and supporting workflow efficiency, including confirmation of tubal patency before FemaSeed procedures.

• Is FemBloc available in the United States?
  

  In company communications, FemBloc is described as a U.S. product candidate. The U.S. FDA granted Investigational Device Exemption approval for Femasys to continue enrollment in the final phase of the FINALE pivotal trial for FemBloc. This trial is part of the pathway toward potential U.S. Pre-Market Approval, but FemBloc has not been described as approved for U.S. commercial use.

• On which exchange does Femasys trade and under what symbol?
  

  Femasys Inc.’s common stock is listed on The Nasdaq Capital Market under the symbol FEMY. The company’s SEC filings identify it as an emerging growth company and a smaller reporting company, and its common stock has a par value of $0.001 per share.

• Has Femasys received any Nasdaq compliance notices?
  

  Yes. Femasys has reported receiving a Nasdaq notice regarding the Market Value of Listed Securities and related quantitative listing standards, and a separate notice regarding non-compliance with the minimum $1.00 bid price requirement. The company later disclosed that Nasdaq granted an additional 180-day extension to regain compliance with the bid price rule, during which its stock continues to trade on The Nasdaq Capital Market under the FEMY symbol.

• How does Femasys describe its overall mission?
  

  In repeated public statements, Femasys describes its mission as making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide. It emphasizes in-office, clinician-focused products that are intended to provide practical options for patients and support improved care delivery and health economics.