Femasys

What Femasys does

Femasys Inc. (NASDAQ: FEMY) is a publicly-traded biomedical company founded in 2004 by Kathy Lee-Sepsick and headquartered in Suwanee, Georgia. It develops and commercializes non-surgical, catheter-based medical devices for women's reproductive health across three clinical franchises: infertility treatment (FemaSeed intratubal insemination and FemVue/FemChec/FemVue Controlled/FemHSG diagnostic catheters), permanent non-surgical birth control (FemBloc, which uses a proprietary Blended Polymer to occlude the fallopian tubes), and cervical/endometrial tissue sampling (FemCerv, FemEMB). Founder and CEO Kathy Lee-Sepsick holds more than 200 global patents covering the portfolio, and the company has secured FDA clearances, CE Mark, UK MHRA approval, MDSAP certification (US/Canada/Japan/Australia/Brazil), and country-level approvals in Australia, New Zealand, Canada, and Israel.

Femasys sells primarily to OB/GYNs and fertility specialists through a U.S. direct sales force, supplemented by regional distribution partners — OR Consulting in Switzerland, Kebomed in France and the Benelux region, and AMI Technologies in Israel — covering more than ten countries. Products are sold as single-use hardware on a quote-based, pay-as-you-go basis to healthcare providers, with no public list pricing; an AMA Category III CPT code for FemaSeed becomes effective January 1, 2027 to support reimbursement. The commercial lead, FemaSeed Complete, launched in April 2026, shifts first-line fertility treatment from specialized fertility centers into the OB/GYN office by integrating intratubal insemination with in-office sperm preparation. The company reported Q1 2026 sales of $424,889 (+24.5% YoY) and trailing twelve-month revenue of approximately $2.06 million, with an initial ~$500,000 FemBloc order placed through Kebomed.

Financially, Femasys is in an early commercial ramp: it returned to net income of $846,100 in Q1 2026 (versus a $5.9M loss a year earlier) but carries an accumulated deficit of approximately $145 million and a March 31, 2026 cash balance of $5.4M, which management expects will fund operations only into Q3 2026. The company has raised roughly $34 million across four 2025 financing transactions (May, August, November, and December) plus a $7M PharmaCyte Biotech convertible note in 2023, and regained Nasdaq minimum-bid-price compliance in June 2026. The most material near-term catalysts are U.S. FemBloc approval via the FINALE pivotal trial (enrollment initiated March 2026) and continued international commercialization of FemBloc following EU, UK, and New Zealand approvals.

Name

Femasys

Legal name

Femasys Inc.

Website

https://femasys.com

Company type

Public

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

Femasys Inc. (NASDAQ: FEMY) is a publicly-traded biomedical company that develops non-surgical, catheter-based medical devices for women's reproductive health, including FemaSeed intratubal insemination, FemBloc permanent birth control, and FemVue/FemCerv diagnostics, sold to OB/GYNs and fertility specialists globally.

Ownership category

akta.pro rank

Product category

Women's Health Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Family Planning & Contraception (Including Abortion Care) (HLAKAJAG)

akta.pro secondary industries

Reproductive Endocrinology & Infertility (IVF/Fertility) (HLAKAJAC), Gynecologic Oncology (HLAKAFAF)

Keywords

• Women's reproductive health
• Medical device manufacturing
• Infertility treatment devices
• Permanent birth control
• Fallopian tube evaluation

Headquarters

HQ city

Suwanee

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Product Sales - Fertility Treatments: Revenue from sale of FemaSeed intratubal insemination products, FemVue diagnostic devices, and related fertility care solutions to OB/GYNs and fertility clinics.
2. Product Sales - Birth Control: Revenue from FemBloc permanent birth control system sales following regulatory approvals in Europe, UK, and New Zealand, with U.S. FDA pivotal trial ongoing.
3. Product Sales - Cancer Diagnostics: Revenue from FemCerv endocervical sampler sales for cervical cancer diagnosis, with regulatory approvals in U.S., Europe, UK, Canada, and Israel.
4. Diagnostic Device Sales: Revenue from FemChec tubal occlusion confirmation device and FemCath cornual balloon catheter for fallopian tube evaluation.

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels6 records

Core offering

Femasys is a biomedical company that develops, manufactures, and commercializes proprietary medical devices for women's reproductive health. Its portfolio addresses three under-served areas: infertility treatment (FemaSeed intratubal insemination and FemVue/FemChec/FemCath diagnostics), non-surgical permanent birth control (FemBloc with Blended Polymer adhesive), and cervical cancer diagnostics (FemCerv tissue sampler). Products are sold primarily to OB/GYNs, fertility specialists, and healthcare systems in the U.S. and through international distribution partners.

Differentiator

Problem solved

Functional benefit

Brands

• FemBloc: First-of-its-kind non-surgical permanent birth control system using Blended Polymer technology to occlude fallopian tubes.
• FemaSeed
• FemVue
• FemChec
• FemCath
• FemCerv
• FemEMB
• FemHSG

Products and services

• FemaSeed Intratubal Insemination FDA-cleared device that precisely delivers sperm into the fallopian tube, the site of conception, to enhance natural fertilization. Clinical data show pregnancy rates more than double those of standard intrauterine insemination (26.3% per subject vs. 6.7% historical IUI control). Sold to OB/GYNs and fertility clinics as a first-line infertility treatment.
• FemaSeed Complete Comprehensive first-line fertility solution combining FemaSeed intratubal insemination with FemSperm integrated in-office sperm preparation, enabling OB/GYNs to perform insemination entirely within their own practices. Shifts fertility care from specialized centers to primary women's healthcare providers.
• FemBloc Permanent Birth Control First-of-its-kind non-surgical permanent birth control system using proprietary Blended Polymer synthetic tissue adhesive delivered into both fallopian tubes simultaneously. The polymer fully degrades and produces nonfunctional scar tissue to permanently block the fallopian tubes, eliminating the need for surgical tubal ligation. Demonstrated 0% pregnancy rate vs. 6% historical control and no serious adverse events through five years of follow-up.
• FemVue Fallopian Tube Evaluation First FDA-cleared product that creates natural saline and air contrast enabling safe, reliable, real-time evaluation of fallopian tubes with ultrasound. Enables in-office tubal patency assessment during routine OB/GYN visits.
• FemVue Controlled Diagnostic Device Next-generation diagnostic device integrating features from FemVue and FemChec into a single platform for controlled contrast delivery during ultrasound imaging to evaluate fallopian tube patency.
• FemChec Tubal Occlusion Confirmation Device Diagnostic device used to confirm tubal occlusion following permanent birth control procedures such as FemBloc.
• FemCath Cornual Balloon Catheter FDA-cleared intrauterine catheter for selective fallopian tube evaluation, used in conjunction with the FemVue system for comprehensive ultrasound-based diagnostic assessments.
• FemHSG Catheter CE Mark approved device for in-office fertility evaluation procedures used in conjunction with the FemVue system for comprehensive ultrasound-based diagnostic assessments of uterine cavity and fallopian tubes.
• FemCerv Endocervical Tissue Sampler FDA-cleared endocervical sampler featuring an expandable collection chamber for capture of complete and uncontaminated sample in a relatively pain-free procedure, intended for cervical cancer diagnosis.
• FemEMB Endometrial Tissue Sampler Endometrial tissue sampler product used for in-office endometrial biopsy procedures.

Quantifiable outcome

• FemaSeed achieved 26.3% pregnancy rate by subject and 17.5% by cycle, significantly higher than 6.7% historical control rate for IUI with male factor
• +4 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Six partnerships are on record, tiered core.

• AMI TechnologiescoreChannel Partner/ Reseller/ Distributor · 16 April 2026Partnership with AMI Technologies to commercialize FemaSeed artificial insemination device and FemVue diagnostic tool in Israel. AMI Technologies handles distribution and commercialization through its existing healthcare provider network. FemaSeed has regulatory approvals in multiple markets including US, Europe, and UK.
• OR ConsultingcoreChannel Partner/ Reseller/ Distributor · 4 February 2026Strategic distribution partnership with Switzerland-based OR Consulting to commercialize Femasys' women's health product portfolio in Switzerland, including FemBloc Permanent Birth Control and FemaSeed Intratubal Insemination. Represents continued execution of European expansion following recent market entries in Spain and ongoing commercial launch in France.
• Refuah Health CentercoreStrategic or Co-development Partner · 13 January 2026Partnership with Refuah Health Center to expand access to FemaSeed infertility treatment within community-based fertility care in New York's Hudson Valley. Partnership aims to strengthen commercial footprint by leveraging Refuah's established patient engagement model to accelerate adoption of FemaSeed as first-line treatment option.
• KebomedcoreChannel Partner/ Reseller/ Distributor · 10 November 2025Initial order of approximately $500,000 USD for FemBloc permanent birth control in France and Benelux region through partnership with Kebomed. Marks significant step in expanding FemBloc's presence across key European markets after recent entries into Spain and other countries.
• HRC FertilitycoreStrategic or Co-development Partner · 3 December 2024Partnership with HRC Fertility, a leading provider of fertility services in the Western U.S., to offer FemaSeed intratubal insemination treatment. HRC Fertility is a prominent conglomerate provider of fertility services.
• Boston IVFcoreStrategic or Co-development Partner · 5 November 2024Partnership with Boston IVF to expand access to FemaSeed fertility treatment. Boston IVF is one of the largest fertility networks in the U.S.

Scale indicators14 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• CooperSurgical: A leading women's health medical device and fertility solutions provider (subsidiary of CooperCompanies). Directly comparable to Femasys as a broader incumbent offering fertility, contraception, and OB/GYN diagnostic devices to similar healthcare provider customers.
• Hologic: Major women's health diagnostics company with ThinPrep cervical cancer screening and NovaSure endometrial ablation. Comparable to Femasys as a broad incumbent serving OB/GYNs across diagnostics and procedural categories.
• Boston Scientific: Large diversified medical device company with a women's health/pelvic floor franchise. Broad incumbent serving OB/GYNs with overlapping procedural device categories that could compete with or acquire Femasys technologies.
• Bayer (Women's Health): Global healthcare company that acquired Conceptus (Essure non-surgical permanent birth control) and historically competed directly with FemBloc. Important comparable given prior non-surgical permanent birth control market dynamics and the Essure withdrawal precedent.
• Medtronic: Large diversified medical device company with women's health and gynecologic surgical offerings. Broad incumbent that could enter or acquire in the women's reproductive device space where Femasys operates.
• Stryker: Diversified medical device company with surgical and gynecology-adjacent product lines. Broad incumbent comparable on the basis of overlapping provider customers and procedural device categories.

Direct peers

• Minerva Surgical: Commercial-stage medical device company focused on minimally invasive gynecologic procedures. Direct peer to Femasys given similar target customers (OB/GYNs) and focus on office-based, minimally invasive women's health interventions.
• Caldera Medical: Privately held women's pelvic health medical device company offering surgical mesh and sling products. Direct peer to Femasys as a women's health device specialist targeting OB/GYN and urogynecology procedures.

Emerging players

• Axonics Modulation Technologies: Commercial-stage medical device company focused on sacral neuromodulation and pelvic health. Emerging peer given overlapping women's pelvic health customer base (urogynecologists/OB/GYNs) and similar small-cap commercialization profile.
• Halt Medical: Medical device company focused on minimally invasive treatment of uterine fibroids. Emerging peer given comparable OB/GYN customer base and office-based procedural device business model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/FemasysInc
• Facebookfacebook.com/Femasys
• LinkedInlinkedin.com/company/femasys

Revenue estimate

Valuation estimate

Number of profiles

Profiles19 records

Funding overview

Funding rounds15 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Femasys