STOCK TITAN
  1. Home
  2. Sec-filings
  3. FEMY
  4. [8-K] FEMASYS INC Reports Material Event

Femasys (NASDAQ: FEMY) outlines FemaSeed fertility and FemBloc birth control strategy

Filing Impact
(High)
Filing Sentiment
(Neutral)
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.

Positive

  • None.

Negative

  • None.
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, and exhibit attachments filed with this report.
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
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)"
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.
See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Understanding 8-K Material Events →
 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

Femasys Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-40492
11-3713499
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100
Suwanee, Georgia
  
30024
(Address of principal executive offices)
  
(Zip Code)

(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):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class
  
Trading
Symbol(s)
  
Name of each
exchange
on which registered
Common Stock, par value $0.001 per share
  
FEMY
  
The Nasdaq Stock Market LLC

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. ☒

Item 7.01
Regulation FD Disclosure Other Events

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.
 
Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit
No.
Description
   
99.1
Press Release of Femasys Inc. dated May 13, 2026

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.

 
Femasys Inc.
   
 
By:
/s/ Kathy Lee-Sepsick
 
Names: Kathy Lee-Sepsick
 
Title: Chief Executive Officer
   
Date: May 13, 2026
  

 
Exhibit 99.1

 CONFIDENTAIL | NASDAQ: FEMY  1  CORPORATE PRESENTATION  May 2026  ©️ 2026 Femasys Inc.  Redefining Women’s Reproductive Health at Global Scale  NASDAQ: FEMY 
 
 Forward Looking Statements  NASDAQ: FEMY  2  This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, results of clinical trials and other future conditions. Words such as, but not limited to, "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "potential", "predict", "project", "should", "will", "would" or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes, identify forward-looking statements. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Presentation and are subject to risks and uncertainties. Moreover, the Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company qualifies all of the forward-looking statements in this Presentation by these cautionary statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.  Statements contained herein are made as of the date of this Presentation unless stated otherwise, and neither this Presentation, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that the information will be updated or revisited to reflect information that subsequently becomes available or changes occurring after that date hereof. Certain information contained in this Presentation relates to or is based on statistical and other industry and market data obtained from independent industry publications and research, surveys and studies conducted by independent third parties as well as the Company's own estimates. The market data used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. The Company's estimates of the total addressable market of the patient population with the potential to benefit from treatment with any products and product candidates the Company may develop, our ability to commercialize our products and product candidates, or the effect of delays in commercializing include several key assumptions based on its industry knowledge, industry publications and third-party research, which may be based on a small sample size and may fail to accurately reflect the addressable patient population. While the Company believes that its internal assumptions are reasonable, no independent source has verified such assumptions.  This Presentation contains trademarks, trade names, or service marks belonging to other entities. The Company does not intend the use or display of other parties' trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of, or by these other parties. This Presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Femasys Inc., nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus, meeting the requirements of the Securities Act of 1933, as amended.  
 
 Femasys Overview  NASDAQ: FEMY  3  STRONG INFRASTRUCTURE  Experienced leadership team  U.S. and global regulatory approvals   In-house, scalable U.S. manufacturing  Efficiency over years of optimization  INNOVATIVE PRODUCTS  Near-term revenue inflection with meaningful growth acceleration   Limited competition enabling market creation   Expanding access patient-driven in-office procedures  Compelling economics for physicians and practices  COMMERCIALIZATION & GROWTH  A woman-founded, U.S. based biomedical device company unlocking one of healthcare’s largest untapped markets  Market-first solutions  Purpose-built for safe, in-office delivery   Clinically validated with extensive data  200+ issued patents 
 
 Key Leadership  NASDAQ: FEMY  4  Chief Financial Officer  30+ years of experience  Cellectar Biosciences, Akari Therapeutics, Lev Pharmaceuticals, EpiCept  DovElefant  Chief Executive Officer & Founder  30+ years of experience  Terumo Medical, Novoste, Salumedica  Kathy Lee-Sepsick  Sr. Vice President  Global Marketing  20+ years of experience  Neurolief, Bolton Medical, Medtronic, Intuitive Surgical  Megan  Eckerman  Chief Medical Officer  40+ years of experience  Chair, Dept OB/ GYN Univ Heath System, Chair Dept Reproductive Biology at Case Western, and Division Head Univ of Cincinnati  James   Liu, MD  Chief Operating Officer  25+ years of experience  Terumo Aortic, Bolton Medical, Medtronic Vascular  John   Canning  Chief Technology Officer  20+ years of experience  Theragenics  Jeremy  Sipos  Extensive industry expertise with a proven track record of execution 
 
 NASDAQ: FEMY  5  Commercializing Multi-Asset Women’s Health Portfolio  Unlocking large market opportunities through office-based innovation  FERTILITY   PRODUCT FAMILY  PERMANENT   BIRTH CONTROL  First-line fertility treatment  Non-Surgical permanent birth control  Companion Diagnostic:  FemCerv®  for cervical cancer diagnosis  Additional OB/GYN product:  (enabled by FemSperm® for in-office sperm handling)  FemBloc is approved in Europe and select countries outside the U.S. and is currently in a U.S. trial for FDA approval. All other products have regulatory approval across the U.S., Europe, and select global markets.  
 
 NASDAQ: FEMY  6  From Historical Headwinds to Future Opportunity  Driven by a strong pipeline, expanding patient access and favorable provider economics  MULTI-ASSET WOMEN’S HEALTH PORTFOLIO  BIPARTISAN POLITICS  STRATEGIC TARGET  Diversified portfolio across indications and stages delivers scale and resilience.  Support for women’s health and access drives policy tailwinds.  Aim to create future optionality for large healthcare players with large underserved markets, limited competition.  MACRO TRENDS  Record-low fertility rates and rising post-Roe contraception demand1.  CAPITAL ENVIRONMENT  More focus may equate to favorable conditions for innovation in women’s health and medtech.  Martinez GM. (2024) DOI: https://dx.doi.org/10.15620/cdc/169629  
 
 Fertility in Crisis – Massive Unmet Need  NASDAQ: FEMY  7  Centuries of limited innovation in first-line treatment have limited access for millions   U.S. women with infertility1  (~50% male factor contribution2)  ~10M  Take first step and  undergo infertility testing3  ~100K  Receive IVF  transfer cycle4  https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm  Kumar N, et al. (2015). doi: 10.4103/0974-1208.170370.  Nugent CN, Chandra A. Use of fertility services in women ages 20–49 in the United States: 2022–2023. NCHS Data Brief. 2025 Dec;(542):1–10. DOI: https://dx.doi.org/10.15620/cdc/174628.   Centers for Disease Control and Prevention. 2022 Assisted Reproductive Technology (ART) Fertility Clinic and National Summary Report. US Dept of Health and Human Services; 2024.  Hamilton BE, Osterman MJK, Gregory ECW. Births: Provisional data for 2025. Vital Statistics Rapid Release. 2026 Apr;(43):1–7. DOI: https://dx.doi. org/10.15620/cdc/252434.   2025: U.S. fertility rate dropped to another record low5  ~5M 
 
 Fertility Portfolio with Strong Revenue Potential  NASDAQ: FEMY  8  Scalable growth driven by expanding access and adoption  Estimate  <10%  Early REI Launch  Established foundation, KOL advocacy and REI alignment  Initial OB/GYN Launch  Growth OB/GYN Expansion  Existing patient base, validate seamless integration   Drive growth through broader patient engagement and market expansion  $1B  of infertile women  Choose FemaSeed   first-line treatment  ~1,500 REIs, ~500 centers1  ~20k OB/GYNs, ~13k offices2  Sunderam S, et al. Assisted Reproductive Technology Surveillance - United States, 2018. MMWR Surveill Summ. 2022 Feb 18;71(4):1-19.   https://www.bls.gov/oes/2023/may/oes291218.htm 
 
 Femasys Fertility FastTrack™  NASDAQ: FEMY  9  Connecting diagnosis to treatment in a streamlined pathway in OB/GYN office  FemaSeed®  OB/GYN qualifies patients in-office  Leverages existing workflows (no lab required)  First-line fertility treatment in OB/GYN office  Intratubal Insemination  DIAGNOSE  PREPARE  TREAT  Enhances Natural Fertilization  FemSperm®  Sperm Handling  FemVue®  Diagnosis - HER  SpermVue™  Diagnosis - HIM 
 
 FemaSeed Offers Favorable Competitive Advantages  NASDAQ: FEMY  10  Artificial Insemination  Assisted Reproductive  FemaSeed  IUI  IVF  ICSI  No surgery (risks/cost)  ✓  ✓  —  —  No egg retrieval or storage  ✓  ✓  —  —  No required injections  ✓  —  —  —  Delivery to fallopian tube(s)  (site of conception)  ✓  —  N/A  N/A  Cost-effective  ✓  ✓  $15-30k on avg1  More than IVF  Minimal safety risks  ✓  ✓  —  —  Low male sperm count efficacy  ✓  Rec for IVF/ICSI  ✓  ✓  Single fallopian tube solution  ✓  —  N/A  N/A  Widespread accessibility  ✓  ✓  Varies  Varies  https://bettercare.com/costs/ivf-cost#average-ivf-cost (does not include genetic testing, embryo freezing and storage)  
 
 FemaSeed Transforming the IUI Standard of Care  NASDAQ: FEMY  11  Reducing time lost in repeated, low-efficiency IUI cycles  Artificial insemination has remained largely unchanged since first being performed in 1790.  Why Historic IUI Falls Short…  Sperm Counts worldwide have declined by >50%.1  Levine H. et al. (2023). doi: 10.1093/humupd/dmac035.  Brannigan RE, et al. Updates to male infertility: AUA/ASRM guideline (2024). J Urol. Published online August 15, 2024. doi:10.1097/JU.0000000000004180.   Low sperm count reduces IUI effectiveness and may necessitate IVF/ICSI.2 
 
 Commercial Readiness to Unlock the Fertility Market   NASDAQ: FEMY  12  Proven clinical performance, strong revenue potential and high-intent patients drive adoption  Prospective clinical trial demonstrated superior results against historic IUI1   CLINICAL VALIDATTION  COMPELLING ECONOMICS  ENGAGED PATIENTS  Robust clinical data supported 510(k) pathway conversion from de novo  Cash-pay   procedures are established at OB/GYN practices  Seamless integrationinto existing workflows without adding headcount  Elective procedureswith high patient intent and urgency to act  In-office solution  providing cost-effective access before infertility referral  No additional data required  New services create meaningful revenue  Patients prefer accessible OB/GYN-led care  Liu et al. (2024). doi: 10.33140/JGRM.08.02.08 
 
 FemaSeed Delivering Clinically Superior Care  NASDAQ: FEMY  13  Liu et al. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.   Duran et al. (2002). Intrauterine insemination: a systematic review on determinants of success. Human Reproduction, vol.8, no.4, pp.373-384.   A first-line fertility solution designed to expand access and improve outcomes  2X  Pregnancy rate   with FemaSeed vs IUI1  Key Results  1:4 women became pregnant  26.3% of women became pregnant with FemaSeed for low male sperm count1  Most pregnancies occurred in 1 or 2 cycles  (IUI attempts 3–6+)  No safety concerns  Performed in-office in few minutes  FemaSeed1  IUI2  Pregnancy Rate per Cycle (%) 
 
 Compelling Economics for OB/GYN Practices  NASDAQ: FEMY  14  ~70%   States have Limited to NO fertility coverage1  Femasys fertility portfolio enables a new, high-value in-office revenue stream  Resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state  Cash Pay Opportunity  In covered states  CAT III approved for reimbursement  (effective Jan 2027)  Diagnosis  for HER for   tubal evaluation   FemVue®  FemSperm®  Sperm collection and preparation  Potential >$1,000   net revenue contribution  Treatment  for HIM for   Sperm analysis  SpermVue™  FemaSeed®  Intratubal Insemination  With prepared sperm 
 
 Fertility Portfolio Enables Accelerated FemBloc Adoption  NASDAQ: FEMY  15  Commercial Synergies  Same OB/GYN call point as fertility portfoliowith pre-trained physicians at FemBloc launch  Leverages delivery platform with FemaSeed   for FemBloc treatment  Shares device & procedure with FemVue   for FemBloc confirmation testing  Leveraging shared commercial infrastructure  Then…  First…  Expanding access to in-office fertility care   Advancing in-office permanent birth control 
 
 U.S. women no longer  intend to have children1,2  ~13M  Remain on form oftemporary birth control2,3  Elect surgical sterilization every year2,4  ~1.2M  Permanent Contraception – Critical Gap  NASDAQ: FEMY  16  Centuries of limited innovation have created massive unmet need for millions of women  Jones et. al, Current contraceptive use in the United States, 2006–2010, and changes in patterns of use since 1995. National health statistics reports; no 60. Hyattsville, MD: National Center for Health Statistics. 2012.  Daniels et. al, Current contraceptive status among women aged 15–49: United States, 2017–2019. NCHS Data Brief, no 388. Hyattsville, MD: National Center for Health Statistics. 2020.  National health statistics reports; no 60. Hyattsville, MD: National Center for Health Statistics. 2012.  Martinez GM. Receipt of family planning services in the United States: 2022–2023. NCHS Data Brief, no 520. Hyattsville, MD: National Center for Health Statistics. 2024. DOI: https://dx.doi.org/10.15620/cdc/169629   ~12M  Today: Only surgery remains an option 
 
 FemBloc Potential for Exponential Revenue Expansion  NASDAQ: FEMY  17  Leveraging existing fertility portfolio and physician base to drive outside growth  Estimate  ~30%  Europe Launch  Gather real-world evidence  Initial OB/GYN Launch  Growth OB/GYN Expansion  Broaden access, drive adoption  Scale reach, expand market and accelerate growth  $3B  every year  +  electing surgery  ~5%  on temp birth control   but done having children  Choose non-surgical FemBloc 
 
 Natural with No Implant and No Hormones  FemBloc: Non-Surgical Permanent Birth Control  NASDAQ: FEMY  18  Patient-Centered Market Drivers  High demand for natural & safe optionsthat empower women with choice  Growing concern with hormone-based   birth control options  Patients seek non-implant solutions  due to fear of safety risks  Blended Polymer delivered as liquid through catheters  Balloons positioned at each fallopian tube opening  Blended Polymer solidifies; delivery system removed  Blended Polymer degrades leaving patient’s scar tissue to block tubes  1  2  3  4 
 
 FemBloc Offers Favorable Competitive Advantages  NASDAQ: FEMY  19  Permanent Birth Control  Temporary  FemBloc(non-surgical)  SurgicalSterilization  Essure®(off-market)  IUD  Permanent  ✓  ✓  ✓  —  Office procedure  ✓  —  Some  ✓  No special capital equipment  ✓  —  —  ✓  No anesthesia  ✓  N/A  N/A  ✓  No implant (coil/clip)  ✓  —  —  —  No surgery (risks/cost)  ✓  —  —  ✓  No hormones  ✓  ✓  ✓  —  Reimbursement in-place / expected  ✓  ✓  ✓  ✓  Widespread accessibility  ✓  Varies  N/A  ✓ 
 
 FemBloc Extensive Clinical Data Redefining Birth Control  NASDAQ: FEMY  20  Over 20 years of comprehensive research and successful regulatory review and approvals  Liu et al. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.   Gariepy et al. (2022). Comparative Effectiveness of Hysteroscopic and Laparoscopic Sterilization for Women: A Retrospective Cohort Study. Fertility and Sterility, 117(6):1322-1331. doi: 10.1016/j.fertnstert.2022.03.001.  LOW RISK  In-office  FemBloc1  Sterilization2(control)  Pregnancy Rate (%)  0%  Safety (Risk)  HIGH RISKSurgery with general anesthesia  Adoption Advantages  0% pregnancy rate  statistically lower than historical control; expected to evolve with larger sample size (pivotal trial on-going)  Earlier FemBloc clinical studies (n=228 subjects)1Prospective, multi-center, unblinded  Safe with only Mild AEs reported (spotting/bleeding, cramping); NO Serious AEs  Immediate return to normal activities 
 
 Limited options and strong interest   support efficient enrollment  FemBloc Advancing Toward U.S. Approval  NASDAQ: FEMY  21  De-risked through international regulatory approvals and clinical use  Study design:  U.S. FINALE pivotal trial for FDA approval1Prospective, multi-center, open-label, single-arm with historical control  Part A for safety (n=50) – completed  Part B (n=523) – currently enrolling, initiated Mar 2026  Primary endpoint:  Pregnancy rate, 1-year relying on FemBloc (n=401)  Safety analysis:  2-5 years post-market  Additional analyses:  Interim for sample re-estimation (n=300)  Clinicaltrials.gov: NCT05977751  European Post-Market Real-World StudyProspective, multi-center, with oversight from Spanish Contraception Society (n=200) – initiated Q4 2025 
 
 U.S. Cost Breakdown Compared to Surgical Sterilization  Expansion of In-Office Revenue Opportunities  NASDAQ: FEMY  22  Potential to reduce healthcare system costs while enhancing practice profitability  Changing Economic Paradigm  In-Office Proceduresmaximize physician time and efficiency  Reimbursement Expected  increase patient access through ACA coverage  >10X Profit Potential  for physician/ practice  Planned parenthood (2019). https://www.plannedparenthood.org/learn/birth-control; Doximity 2019; U.S. Bureau of Labor Statistics.  0  1000  2000  3000  4000  5000  6000  Amount in $  Pre-Op  Facility  Anesthesia  Post-Op  FemBloc  Cost  Anesthe  Physician / Practice  FemBloc estimate  < ½ cost of surgery  Physician  Surgical Sterilization1 FemBloc 
 
 Major Value Inflection Points  NASDAQ: FEMY  23  FEMASEED  Additional partnership  Cat III reimbursement  Q1 2026  FEMBLOC  MDSAP approval  Initiate U.S. trial (FINALE) enrollment  ACHIEVED  ACHIEVED  FEMASEED  Launch FemSperm U.S.  OB/GYN partnerships  Q2 2026  FEMBLOC  Additional U.S. trial sites  Expand post-market study  ACHIEVED  IN-PROGRESS  FEMASEED  Expand OB/GYN partnerships  Patient advocacy  Q3 2026   (anticipated)  FEMBLOC  Additional U.S. trial sites  Support post-market study  FEMASEED  Post-market study data U.S.  Billing partnership(s)  Q4 2026  (anticipated)  FEMBLOC  Advance FINALE enrollment  Post-market study data OUS  Strategic execution across the portfolio expected to drive value creation 
 
 Contact Details  Investor RelationsIR@femasys.com   Public Relations   Media@femasys.com   NASDAQ: FEMY 
 

Source: View Original Filing on SEC EDGAR

FAQ

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.

Filing Exhibits & Attachments

4 documents

Press Releases

Other Documents