Femasys details fertility and FemBloc growth plans
Femasys Inc. filed an 8-K to share an updated corporate presentation outlining its women’s reproductive health portfolio and growth strategy.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Femasys Inc. filed an 8-K to share an updated corporate presentation outlining its women’s reproductive health portfolio and growth strategy. The slide deck highlights FDA-cleared and internationally approved products, including FemaSeed for in-office fertility treatment and FemBloc, a non-surgical permanent birth control now in a U.S. pivotal trial.
The company emphasizes a large unmet fertility and contraception market, noting record-low U.S. fertility rates and limited innovation in first-line care. It presents clinical data showing FemaSeed achieved about double the pregnancy rate of intrauterine insemination in a trial, and early FemBloc data showing a 0% pregnancy rate versus historical surgical controls, along with favorable in-office economics for OB/GYN practices.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Issued patents: 200+ patents
CEO experience: 30+ years
CFO experience: 30+ years
+5 more
8 metrics
Issued patents
200+ patents
Clinically validated portfolio with extensive intellectual property
CEO experience
30+ years
Chief Executive Officer & Founder industry experience
CFO experience
30+ years
Chief Financial Officer industry experience
FemaSeed pregnancy rate
26.3%
Women treated for low male sperm count in clinical trial
FemaSeed vs IUI efficacy
2X pregnancy rate
FemaSeed compared with intrauterine insemination per cycle
States with limited fertility coverage
~70% of states
Limited to no fertility insurance coverage
FemBloc profit multiple
>10X profit potential
Estimated profit vs surgical sterilization for physician/practice
FemBloc pivotal trial enrollment
n=523 Part B
Planned enrollment in U.S. FINALE pivotal trial
Key Terms
forward-looking statements, 510(k) pathway, de novo, permanent birth control, +2 more
6 terms
forward-looking statements regulatory
"This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
510(k) pathway regulatory
"Robust clinical data supported 510(k) pathway conversion from de novo"
A 510(k) pathway is a U.S. Food and Drug Administration review process for medical devices that lets makers gain market clearance by showing a new device is similar to one already approved. Think of it as proving your new model is close enough to a proven design so regulators allow sales faster and with lower upfront testing than the more demanding approval route; that matters to investors because it usually shortens time to revenue and reduces regulatory risk and development cost.
de novo regulatory
"Robust clinical data supported 510(k) pathway conversion from de novo"
De novo means “starting from scratch” — creating something new rather than buying, copying, or modifying an existing asset. For investors it signals a fresh venture or a first-time regulatory pathway where there is no operating history or precedent, which can mean higher upside if it succeeds but greater risk and uncertainty because outcomes, costs and approvals are less predictable; think of it as backing a new recipe instead of a well-known restaurant.
permanent birth control medical
"Non-Surgical permanent birth control"
Permanent birth control describes medical procedures or devices intended to stop a person from being able to become pregnant or cause pregnancy on a long-term basis, typically through a one-time surgical or implant intervention (for example, blocking or sealing reproductive pathways). For investors, it matters because demand, regulatory approvals, insurance coverage and technology changes in this area affect manufacturers, health-care providers and the overall contraceptive market much like a single, durable product that replaces ongoing purchases or repeat treatments.
CAT III regulatory
"In covered states CAT III approved for reimbursement (effective Jan 2027)"
Category III (Cat III) designates the highest regulatory risk class for medical devices under many national systems, covering devices that sustain or support life, are implanted, or present a high potential for harm if they fail. It matters to investors because Cat III products face the most stringent testing, longer approval timelines, and higher development costs—like building a bridge rather than a footpath—while also often creating larger market barriers and potential returns if approved.
pivotal trial medical
"Study design: U.S. FINALE pivotal trial for FDA approval"
A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Femasys Inc. (FEMY) disclose in its latest 8-K filing?
Femasys Inc. furnished an updated corporate presentation describing its women’s health product portfolio, clinical data, and growth strategy. The materials cover FemaSeed fertility treatment, FemBloc non-surgical permanent birth control, market size, and practice economics, and will be used in meetings with investors and analysts.
What is Femasys FemaSeed and how is it positioned in the fertility market for FEMY?
FemaSeed is an in-office directional intratubal insemination treatment positioned as a first-line fertility option. The presentation reports approximately double the pregnancy rate versus intrauterine insemination and emphasizes use in OB/GYN offices, leveraging existing workflows and cash-pay economics to expand access before IVF referral.
What is FemBloc and what stage is Femasys (FEMY) at in the U.S. approval process?
FemBloc is a non-surgical, implant-free permanent birth control delivered in-office via a degradable polymer that leads to fallopian tube blockage. It is approved in Europe and select markets and is in the U.S. FINALE pivotal trial, with Part A completed and Part B enrolling hundreds of patients.
How large is the women’s health opportunity Femasys (FEMY) is targeting?
The presentation cites millions of U.S. women with infertility, record-low fertility rates, and about 13 million women who no longer intend children but remain on temporary birth control. It frames fertility and permanent contraception as large, under-served markets with limited non-surgical, in-office options today.
What clinical results does Femasys (FEMY) highlight for FemaSeed in the 8-K materials?
Femasys highlights a prospective clinical trial where FemaSeed showed about a two-times higher pregnancy rate than intrauterine insemination. The data include a 26.3% pregnancy rate for women with low male sperm count, most pregnancies within one or two cycles, and no reported safety concerns in the study.
What economics for OB/GYN practices does Femasys (FEMY) describe in its corporate presentation?
The company describes cash-pay fertility procedures and expected reimbursement as creating new in-office revenue streams. For FemaSeed and related diagnostics, it notes potential net revenue contributions exceeding $1,000 per case and suggests FemBloc could offer more than ten times profit potential versus surgical sterilization for physicians.
What major upcoming milestones does Femasys (FEMY) outline for FemaSeed and FemBloc?
The milestone slide lists FemaSeed launches, OB/GYN partnership expansion, U.S. billing partnerships, and additional post-market data through 2026. For FemBloc, it highlights MDSAP approval, U.S. FINALE trial enrollment progress, more U.S. trial sites, and an international post-market real-world study managed by the Spanish Contraception Society.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Accepted by SEC EDGAR
Learn about SEC filing dates
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 13, 2026
(Exact name of registrant as specified in its charter)
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(Address of principal executive offices)
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(770 ) 500-3910
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instructions A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Exchange Act:
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Name of each
exchange
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
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Item 7.01
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Regulation FD Disclosure Other Events
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On May 13, 2026, Femasys Inc. (the “Company”) posted on its website an updated slide presentation, which is attached as Exhibit 99.1 to this Current Report on Form 8-K
and incorporated by reference herein. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time.
The information furnished in this Item 7.01 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as may be expressly set
forth by specific reference in such filing.
The Company expressly disclaims any obligation to update or revise any of the information contained in the corporate presentation.
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Financial Statements and Exhibits.
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Exhibits.
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Exhibit
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Description
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99.1
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Press Release of Femasys Inc. dated May 13, 2026
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Femasys Inc.
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By:
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/s/ Kathy Lee-Sepsick
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Names: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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Date: May 13, 2026
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Exhibit 99.1
