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): September 25, 2023
 
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

On September 27, 2023, 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 8.01
Other Events

On September 25, 2023, Femasys Inc. (the “Company”) announced FDA clearance to market FemaSeed. A copy of the press release is being furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
No.
Description
   
Femasys Inc. Corporate Presentation dated September 27, 2023.
Press Release of Femasys Inc. dated September 25, 2023


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: September 27, 2023
 
 



Exhibit 99.1

 Disrupting Convention in Women’s Health Through Continuous Innovation  September 2023  Corporate Presentation  1 
 

 Forward-Looking Statements  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 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 patient population with the potential to benefit from treatment with any product candidates the Company may develop 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.  2 
 

 Femasys: At-a-Glance  Who We Are  Financial Information  Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including FemaSeed® an FDA-cleared infertility treatment, FemBloc® a lead late-clinical stage product candidate for permanent birth control, and FDA-cleared, innovative diagnostic products.  Headquarters: Suwanee, GA  Nasdaq: FEMY  IPO date: June 2021   Market Cap: $22.3M  (as of 09/26/23)     Cash: $10.7M  (as of 06/30/23)  3 
 

 Investment Highlights  Differentiator  4  Develop disruptive approaches for women’s health   Address multi-billion-dollar global market opportunities in permanent birth control and infertility   Clear reimbursement path with limited competition   Improved patient care and health economics  Intellectual property portfolio with >150 patents globally  Cash runway into Q2 2024  Woman-founded and led, experienced leadership team  Commercial-readiness with in-house CMC and device manufacturing  Global regulatory approvals, including the U.S., Japan, and Canada   Mission  Foundation 
 

 Key Leadership  Experienced biotechnology and medical device professionals  Brian Drumheller  VP, Quality  30+ years of experience  Dan Currie  Chief Operating Officer  30+ years of experience  Jeremy Sipos  VP, Research & Development  20+ years of experience  Christine Thomas  SVP, Regulatory & Clinical  20+ years of experience  Terrell Pruitt  VP, Manufacturing  25+ years of experience  Edward Evantash, MD  Chief Medical Officer  20+ years of experience  Mary An Merchant, JD, PhD  VP Counsel, Intellectual Property  25+ years of experience  Dov Elefant  Chief Financial Officer  25+ years of experience  5  Kathy Lee-Sepsick  President, CEO, Founder  25+ years of experience 
 

 FemBloc®  Product Candidate  Research  Preclinical  Stage ISafety  Stage IIValidation  Stage IIIPivotal  Our Technologies Provide a Continuum of Care  Permanent Birth Control and Ultrasound Occlusion Confirmation  6  In-office, minimally invasive solutions that share delivery platforms.  Commercially Available Products  Commercially Available Products  FemaSeed®  Treatment  Intratubal Insemination  FemVue®  Diagnostic  Contrast-Generating Device  FemCath®  Diagnostic  Selective Delivery Catheter  FemCerv®  Diagnostic  Endocervical Tissue Sampler  Treatment  Clinical Trial 
 

 Femasys Portfolio of Products  7  Initial Focus on Infertility Specialists   + Added Focus   on Gynecologists  ~1,700 (U.S.)  ~40,000 (U.S.)  Product  U.S. Commercial  Ex-US  Commercial  Primary   Detailing Target  Secondary   Detailing Target  FemaSeed  NOW FDA CLEARED  ✔  (Canada)  REI  GYN  FemVue  ✔  ✔  (Japan, Canada, Hong Kong, UAE)  REI  GYN  FemCath  ✔  ✔  (Canada)  REI  GYN  FemCerv  ✔  ✔  (Canada)  GYN  GYN Onc  FemBloc  Est 2027  Est 2027  GYN  — 
 

 Strong Global Intellectual Property Portfolio  Our Patent Estate Encompasses Utility and Design  >150 patents globally  Directional Delivery (dual or single)   to Fallopian Tubes  Biopolymer Composition for Tubal Occlusion  Contrast Generating Ultrasound Visible  Tissue Sampling for Cancer Detection  FemBloc*, FemaSeed, FemCath  FemBloc  FemVue  FemCerv  FemChec  8  *New U.S. patent application for FemBloc allowed with anticipated expiration in 2039 at the earliest. 
 

 FemaSeed®  Intratubal Artificial Insemination  9  Innovative first-line infertility treatment designed to deliver sperm directly where conception occurs  Designed to be more affordable than assisted reproduction   Complementary Diagnostics FemVue® and FemCath®  First in-office ultrasound evaluation of fallopian tubes for infertility diagnosis  Infertility Focused Portfolio  FDA-Cleared in U.S. and Approved in Canada  
 

 Infertility: Unmet Need (U.S. only)   >10M women struggle with infertility1  Birth rate fell 4% in 2020 (largest single year decrease in 50 years)2  Despite advancements, there have been no new affordable options in decades.  10  https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm  Hamilton, et al. (2021) Births: Provisional Data for 2020. U.S. Department of Health and Human Services • Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System. Report No. 12.  https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2022/12/the-long-term-decline-in-fertility-and-what-it-means-for-state-budgets   43 U.S. states have recorded lowest fertility rate in last three decades3 
 

 FemaSeed: Low Cost for Front-End of Infertility Treatment  FemaSeed  $$  Traditional IUI  $  IVF/ ICSI*  $$$$$  Artificial Insemination  ✔  ✔  Intratubal sperm delivery   (into fallopian tube where conception occurs)  ✔  Ovulation stimulation  optional  optional  ✔  No egg retrieval, no egg freezing  ✔  ✔  Minimal training  ✔  ✔  11  There have been limited advancements and continuous demand for less costly options.  *For couples with male infertility, treatment with IVF/ ICSI is advised given the low success rates for IUI; CDC (2016), >90% of couples with male factor infertility use Intracytoplasmic Sperm Injection (ICSI).  
 

 FemaSeed Intratubal Insemination  An innovative treatment for infertility designed to deliver sperm directly to where conception occurs, in a woman’s fallopian tube.  12  Undirected sperm delivery to cavity (IUI) is first-line treatment despite low success rates  Video will open in browser window. 
 

 Summary:  Study Design: prospective, multi-center, unblinded, single arm  Study Population: male factor infertility  Sample Size: up to 214 subjects contributing 214 FemaSeed cycles   Primary Effectiveness Endpoint: Pregnancy Rate      FemaSeed Ongoing Clinical Trial for Male Infertility Factor  SITE RECRUITMENT UNDERWAY  Clinical Trial(IDE Approved October 2022)  13  To Evaluate Safety and Effectiveness  ~ 40-50% of infertility is due to male factor1  Sperm counts worldwide have declined by >50%2  Kumar N, et al. (2015) Trends of male factor infertility, an important cause of infertility: A review of literature. J Hum Reprod Sci. 8(4): 191–196. doi: 10.4103/0974-1208.170370: 10.4103/0974-1208.170370.  Levine H, et al. (2023) Temporal trends in sperm count: a systematic review and meta-regression analysis of samples collected globally in the 20th and 21st centuries. Human Reproduction Update, Vol.29, No.2, pp. 157–176, 2023 
 

 The Unmet Need in Infertility: Compelling Testimonials  14  For more than 20 years, current approaches to infertility treatment have been limited during the initial stage of therapeutic care, but with the advancement of FemaSeed, we believe a next generation intrauterine procedure may have the opportunity to truly change this traditional paradigm.  - Michael Glassner, MD  Founding Partner and Medical Director of Main Line Fertility & Reproductive Medicine  FemaSeed Physician Testimonial  FemVue Patient Testimonials  Being aware that there are many reasons why women have issues conceiving, FemVue is one easy procedure that can assist in finding out why it may have been difficult. As such, I highly recommend any woman who has tried for months or years to conceive to get the FemVue procedure. It is a procedure that will get you immediate results for you and your doctor to discuss the next steps of making your dreams come true.  After a month of completing successful medical procedures including FemVue, my husband and I conceived our first child. 
 

 First In-office, Ultrasound Approach for Fallopian Tube Evaluation  FemVue creates saline-air contrast that travels through the fallopian tube(s) when open  15  First Intrauterine Catheter for Selective Tubal Evaluation  Complimentary Diagnostics: test prior to infertility treatments, including FemaSeed   Approved in U.S., Japan, and Canada  Video will open in browser window. 
 

 Diagnosis  Discussion  Drugs  IUI  IVF  Infertility Addressable Market (U.S. only)  16  Least Costly  Most Costly  seek evaluation & treatment (1.4M IUI)  FemVue/FemCath  FemaSeed  $2B total  4.3M seek evaluation only  Market Expansion for FemaSeed  $800M total  Immediate Addressable  4.8M seek evaluation & treatment (~1M cycles/yr IUI*)  >10M women struggle with infertility  *Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. US Dept of Health and Human Services; 2021. 
 

 Competitive Options: Price Comparison  17  IUI  Intrauterine Insemination  FemaSeed  $500-$4,000  total per cycle including   ultrasound monitoring, and   optional ovulation drugs2  + device  per cycle above IUI cost  Average  Total Cost  1https://www.fertilityiq.com/iui-or-artificial-insemination/the-cost-of-iui  2Parenthood, Planned. “What Is Intrauterine Insemination (IUI)?” Planned Parenthood, https://www.plannedparenthood.org/learn/pregnancy/fertility-treatments/what-iui.  3Ravitsky, et al. The forgotten men: rising rates of male infertility urgently require new approaches for its prevention, diagnosis and treatment. Biology of Reproduction, 2019, 101(5), 872-874.  IVF/ ICSI  In vitro fertilization /   intracytoplasmic sperm injection  $30,000  total per cycle, including   ultrasound monitoring, ovulation drugs,   egg extraction and freezing3  Population  If insurance, covered under IUI codes (service, sperm washing)  Insurance with positive coverage policy typically covers 3-6 cycles  Required prior to IVF/ ICSI in many coverage policies  Infertile Women/ Couples Seeking Treatment  Subset of Infertile (After 1-3 IUI cycles or as indicated)  Intratubal Insemination  Reimbursement  14/20 covered states that have fertility insurance coverage, include IVF 
 

 FemBloc®  Permanent Birth Control  18  First and only non-surgical, in-office, permanent birth control option in late-stage clinical development with the potential to be the safest and most natural approach at substantially less cost than the long-standing surgical alternative  Companion Diagnostics FemChec® and FemCath®  First in-office ultrasound diagnosis of fallopian tubes for confirmation of procedure success  Contraception Focused Portfolio 
 

 Since surgical tubal ligation has been performed since the 1880’s and remains the most common option for women who want permanent birth control.   Permanent Birth Control Alternatives: Unmet Need (U.S. only)  >13M women no longer intend to have children  >12M use non-permanent birth control, long-term  800,000 women choose surgical tubal ligation as a form of permanent birth control every year*  More than 100 years of stagnant innovation for permanent birth control  19  *Frattarelli 2007 
 

 Essure® is a registered trademark of Bayer Healthcare (Conceptus) and, as of December 2018, no longer a marketed solution.  FemBloc: Expected Competitive Advantages over existing or previous birth control options  On-Market Solutions  Off-Market  FemBloc  Surgical Tubal Ligation*  IUD  (Reversible)  Essure®*  Permanent  ✔  ✔  ✔  Office Procedure  ✔  ✔  Some  No Special Capital Equipment   ✔  ✔  No Anesthesia  ✔  ✔  No Permanent Implant (coil/ clip)  ✔  No Surgery (risks/ cost)  ✔  ✔  No Hormones  ✔  ✔  ✔  One-Time Treatment Cost  ✔  ✔  Multiple IUDs  ✔  Worldwide Applicability  ✔  Varies  ✔  20  *6% failure rate for laparoscopic sterilization (tubal ligation) and 5% failure rate for hysteroscopic sterilization (Essure), reported in published study as higher than expected (Fertility and Sterility, 2022) 
 

 No Permanent Implant – Scar Tissue Closes Tubal Lumen  FemBloc Treatments  FemBloc Permanent Birth Control in Development  The first and only non-surgical, in-office approach.  Balloon at tubal opening without cannulation  Biopolymer is designed to be expelled within 3 months  Biopolymer solidifies  21  Video will open in browser window.  Biopolymer degrades 
 

 Companion ultrasound test (FemChec® and FemCath®) exclusive to FemBloc - confirms procedure success  Occlusion Confirmation  FemBloc Permanent Birth Control in Development  3 Months  Blockage  Biopolymer degrades  Saline-air contrast confirms blockage  22  Video will open in browser window. 
 

 Completed Earlier FemBloc Supportive Studies (N=321)  Stage I: Safety  FemBloc Clinical Studies for Pre-Market Approval (PMA)  23  Stage III: Pivotal Clinical Trial (IDE approved June 2023; currently enrolling)  FINALE Trial Design:  Prospective, multi-center, open-label, single-arm study  Roll-in study design to begin with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling remaining subjects.  Primary Endpoint: pregnancy rate at 1-year after FemBloc use for permanent birth control (N=401)  Secondary Endpoints: safety and various in-office assessments  Safety Follow-Up: 2-5 years post-market  Interim analysis planned after 300 women have used FemBloc for permanent birth control for 1-year.  Selection of Confirmation Test for Pivotal  Stage II: Validation  Early Clinical  Long-Term Safety with No Serious AEs Reported   Evaluated Delivery & Biopolymer  Summary:  n=45 subjects being followed for 5 years   Subjects received two confirmation tests (ultrasound and radiology)   Continued safety established; no serious AEs  Continued patient tolerability and physician ease of use established  Summary:  n=183 subjects being followed for 5 years   Patients found procedures highly tolerable   Physicians found procedure to be extremely simple or very simple  99% physicians assessed easier than tubal ligation surgery  Summary:  n=93 subjects received planned hysterectomy   Subset with histopathology demonstrating biopolymer tissue reactions  No serious safety events reported 
 

 61%  8%  16%  3%  0.5%  0.5%  0.8%  5%  4%  FemBloc Treatment  (>90 days)  FemBloc: Majority AEs Occurred at Time of Procedure (N = 228 subjects from Stage I & II)  Patients are being followed for 5 years, with first subjects completed 5-year follow-up  91% AEs related to device/ procedure occurred within 7 days of procedure  No SAEs  24  Investigators rated extremely or very satisfied for 96% of FemBloc procedures 
 

 Bleeding/Spotting (59%)  Pain/Cramps (55%)  40%  13.1%  3.5%  2.6%  34.5%  13.5%  7%  *Long-Acting Contraceptive Comparison (Bayer, Mirena IFU, August 2022) reported most common adverse events (>5%) as:  71% bleeding related  66% reproductive system and breast disorders   23% abdominal/pelvic pain  16% headache/migraine  8 % back pain  7% skin and subcutaneous disorders  6% depression  FemBloc: Most Common Reported AEs (>5%)(N = 228 subjects from Stage I & II)  Mean pain/discomfort score (visual analog scale) out of 10 as reported by patient in-office with no anesthesia:   4.6 for FemBloc Treatment and 3.4 for Confirmation  25 
 

 The Unmet Need for Women: Options for Family Planning  26  Although tubal ligation has been performed for over a century, women will benefit from an in-office approach that avoids the risks and discomforts associated with incisions, general anesthesia and surgery. FemBloc may expand much needed options for women seeking permanent contraception.  - Paul Blumenthal, MD, MPH  Professor Emeritus and Director of the Stanford Program for International Reproductive Education and Services (SPIRES) at Stanford University’s School of Medicine 
 

 Permanent Birth Control Addressable Market (U.S. only)  27  Pills  Condoms  Injectable/Ring/Patch  IUDs  Tubal Ligation  Least Invasive / Least Reliable  Most Invasive / Most Reliable  $20B Total  Includes women using non-permanent options but are candidates (>12M)3  Market Expansion Opportunity  $2B Annual  Near-Term Target Market  Includes women (and partners) choosing permanent birth control annually (~1.3M) 1,2  >13M Reproductive Aged Women NO Longer Intend Children  Frattarelli 2007  Eisenberg ML 2009  Daniels K. NCHS Data Brief, no 388. 2020 
 

 FemBloc: Improved Health Economics  Permanent One-Time Cost Breakdown  Pre-Op   $6,000*  Facility  Anesthesia  Post-Op  Cost of FemBloc System  Anesthesia  Physician / Practice  Est < ½ cost of Tubal Ligation  Physician  In-office procedure expands practice services  Can perform multiple procedures in same room  Quick to perform; ease of room turnover  Patient resumes normal activities  FemBloc Efficiencies  *Planned Parenthood 2019, https://www.plannedparenthood.org/learn/birth-control;Doximity 2019; U.S. Bureau of Labor Statistics, 2019.   28 
 

 In-office procedure  FemBloc Treatments  Category covered (ACA)  Cat III code approved  FemBloc: Clear U.S. Reimbursement Path  Reimbursable Visits  In-office/ TeleVisit(required for permanent birth control)  Counseling/Eligibility  Existing CPT codes  In-office test   (ultrasound)  Cat III code approved  FemBloc Confirmation  29  NO COST TO PATIENT  
 

 30  FemCerv®  Diagnostic for Cervical Cancer   First endocervical biopsy designed for comprehensive tissue sampling with minimal contamination that is virtually pain free  Cancer Diagnostic Portfolio  FDA-Cleared in U.S. and Approved in Canada  
 

 Expanded Collection   Chamber  FemCerv Endocervical Tissue Sampler  1  2  Collected sample  31  Video will open in browser window.  The incidence of stage IV cervical cancer in the U.S. is increasing.*  *Francoeur et. al, International Journal of Gynecologic Cancer (2022).   1 (https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines)  2 Obstet Gynecol. 2017 December ; 130(6): 1218–1225. doi:10.1097/AOG.0000000000002330.  
 

 Femasys is Prepared for Execution  32  Clear Regulatory & Clinical Path to FDA Approval  Clear Reimbursement Pathway  Commercial Expertise  Full manufacture facility with ability to scale and transfer  MFG Ready  Sales Ready  Built infrastructure prior to commercial salesforce with FDA-cleared diagnostic products 
 

 Recently Achieved & Upcoming Anticipated Milestones  Near term expected valuation inflection points creating accretive value for investors  33  2024  Q2  Complete FemaSeed enrollment for male infertility factor trial   Q3  2023  FemBloc pivotal trial enrollment initiated   Q4  Q1  Commercialize infertility portfolio of products in U.S.     FemaSeed FDA 510(k) clearance achieved  Top line data for FemaSeed male infertility factor trial     Achieve CE mark for FemaSeed, FemVue, FemCath and FemCerv  Q3  Complete FemBloc Part A pivotal trial enrollment 
 

 Investment Highlights  Differentiator  34  Develop disruptive approaches for women’s health   Address multi-billion-dollar global market opportunities in permanent birth control and infertility   Clear reimbursement path with limited competition   Improved patient care and health economics  Intellectual property portfolio with >150 patents globally  Cash runway into Q2 2024  Woman-founded and led, experienced leadership team  Commercial-readiness with in-house CMC and device manufacturing  Global regulatory approvals, including the U.S., Japan, and Canada   Mission  Foundation 
 

 Disrupting Convention in Women’s Health Through Continuous Innovation  September 2023  Corporate Presentation  Investors:   IR@femasys.com  Contact:   Media:  Media@femasys.com   35  03333 R07 
 



Exhibit 99.2

Femasys Inc. Receives U.S. FDA Clearance to Market FemaSeed, an Innovative Infertility Treatment Solution

- The 510(k) Clearance from the United States Food and Drug Administration (FDA) allows for the U.S. commercialization of FemaSeed®, an intratubal artificial insemination option designed to augment the natural fertilization process -
 
- FemaSeed® is an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube-
 
ATLANTA, September 25, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced it has received 510(k) Clearance from the United States Food and Drug Administration (FDA) for FemaSeed®, an innovative infertility treatment designed to deliver sperm directly to where conception occurs in a woman’s fallopian tube.
 
In recent decades, infertility has affected an increasing number of women - estimated at 10 million in the United States according to the Center for Disease Control (CDC).  Despite incremental advancements, there have been no recent meaningful affordable options. FemaSeed® Intratubal Insemination is a type of an intrauterine insemination procedure that is less invasive than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), which we expect would reduce the chances of procedural complications.
 
“We are thrilled to receive 510(k) Clearance from FDA for FemaSeed®, an innovative infertility treatment designed to deliver sperm directly to where conception occurs,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “This FDA 510(k) Clearance of FemaSeed demonstrates our successful collaborative efforts with the FDA to bring forward new technology that will address the significant unmet need for less burdensome infertility treatments.”
 
Femasys is creating accessible options for women, as exemplified with FemaSeed®, now an FDA-cleared infertility treatment, and its lead product candidate, FemBloc® in late-stage clinical development for permanent birth control. The Company is commercializing complementary diagnostic products that were internally developed through its in-house manufacturing capabilities, with regulatory approvals in the U.S., Canada and other countries outside the U.S. The FemaSeed procedure works synergistically with FemVue®, Femasys’ FDA-cleared diagnostic device that enables an in-office ultrasound assessment of the fallopian tubes and serves to provide an infertility diagnosis prior to FemaSeed.
 

Ms. Lee-Sepsick continued, “In recent years, there has been a sharp decline in fertility rates with a downward trajectory of sperm counts and record low birth rates.  At this critical time, we are incredibly gratified that women and couples in the United States struggling with infertility will now have access to a new cost-effective infertility treatment option, in addition to the diagnostic solutions we have already made available.”
 
About FemaSeed®
 
FemaSeed is an innovative infertility treatment designed to deliver sperm to the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a first-line treatment option for infertility. FemaSeed is less invasive and more affordable than assisted reproduction procedures, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Femasys is supporting an ongoing pivotal clinical trial specific for male factor infertility.  FemaSeed has achieved U.S. FDA clearance and regulatory approval in Canada.

About Femasys
 
Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary late-clinical stage product candidate and FDA-cleared, innovative therapeutic and diagnostic products.  Femasys’ FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. Femasys’ FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is now FDA-cleared (and also approved in Canada). The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada and other non-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company’s diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosisLearn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
 

Forward-Looking Statements
 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts:
 
Investors
Chuck Padala
LifeSci Advisors, LLC
917-741-7792
chuck@lifesciadvisors.com

Femasys Inc.
Investor Contact:
IR@femasys.com

Media Contact:
Media@femasys.com



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Document and Entity Information
Sep. 25, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Sep. 25, 2023
Entity File Number 001-40492
Entity Registrant Name Femasys Inc.
Entity Central Index Key 0001339005
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 11-3713499
Entity Address, Address Line One 3950 Johns Creek Court
Entity Address, Address Line Two Suite 100
Entity Address, City or Town Suwanee
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30024
City Area Code 770
Local Phone Number 500-3910
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol FEMY
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period true
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false

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