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Femasys CEO and Founder Kathy Lee-Sepsick Meets with the White House’s Gender Policy Council

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Femasys CEO Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the company's reproductive health products and the future of women's health in the U.S. The meeting supported the President's Executive Order on Advancing Women’s Health Research and Innovation, highlighting funding needs for women’s healthcare initiatives. Femasys, an Atlanta-based biomedical company, offers innovative in-office therapeutic and diagnostic products. The company will display its products, including FemBloc® and FemaSeed®, at the ACOG Annual Meeting in San Francisco from May 17-19, 2024.

Positive
  • CEO Kathy Lee-Sepsick met with the White House’s Gender Policy Council, indicating recognition and validation from a high-level government entity.
  • Femasys’ products align with President’s Executive Order on women’s health research and innovation.
  • Femasys will display its key products at the 2024 ACOG Annual Clinical and Scientific Meeting, enhancing visibility and potential market reach.
  • The company’s lead product candidate, FemBloc®, is in late-stage clinical development, indicating progress towards market readiness.
Negative
  • No specific financial figures or growth metrics were disclosed in the press release.
  • There is an implied need for additional funding to support research and innovation in women’s health, indicating potential financial constraints.
  • The success of the products largely depends on future funding and government support, which may introduce uncertainties.

Lee-Sepsick Discussed Atlanta-Based Biomedical Company’s Women’s Reproductive Health Products

ATLANTA, May 16, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces CEO and Founder Kathy Lee-Sepsick met with the White House’s Gender Policy Council (GPC) staff to discuss the Company’s reproductive health products and the future of women’s health in the United States. According to The White House, “The GPC covers a range of issues including economic security, health, gender-based violence and education, with a focus on gender equity and equality, and particular attention to the barriers faced by women and girls.”

As part of the discussion, Ms. Lee-Sepsick and the GPC staff discussed the crucial need to fund women’s healthcare initiatives. The meeting was held in support of the President’s Executive Order on Advancing Women’s Health Research and Innovation, released in March 2024, which states, “The Director of OMB and the Assistant to the President and Director of the Gender Policy Council (Directors) shall lead an effort, in collaboration with the Initiative, to identify current gaps in Federal funding for women’s health research and shall submit recommendations to the President describing the additional funding and programming necessary to catalyze research on women’s health, including in priority areas within women’s health as identified by the Initiative.”

“It was an honor and a privilege to meet with staff from the Gender Policy Council at The White House, where I had the opportunity to discuss Femasys’ product initiatives, including our permanent birth control, FemBloc® and infertility treatment, FemaSeed®,” stated Ms. Lee-Sepsick. “Given the mutual acknowledgement of the pressing need to fund late-stage women’s health innovations, as well as the gaps in research to address multiple women’s health issues, we believe Femasys can serve to provide historical perspective of the challenges of advancing a company in women’s health and can be instrumental in realizing the mission of closing gender disparities in critical areas. I am proud to have the opportunity to interact with our government and to fuel change as we strive to empower women.”

Femasys is an Atlanta-based company that provides minimally invasive women’s reproductive health solutions, which are manufactured in the U.S. Later this week, the Company will be displaying its four commercially available products: FemaSeed® – FDA-cleared, intratubal insemination; FemVue® – contrast-generating device; FemCath® – selective delivery catheter; FemCerv® – endocervical tissue sampler; and its current lead product candidate in late-stage clinical development FemBloc® – a non-surgical, non-hormonal permanent birth control, at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The event is taking place in San Francisco’s Moscone Center May 17-19, 2024 and Femasys will be exhibiting at Booth #1413.

About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada. 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. 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 ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its 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 diagnosis. Learn 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,” “suggests,” “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 products and product candidates; our ability to commercialize our products and product candidates, or the effect of delays in commercializing our products, including FemaSeed; 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, 2023, 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: 
Gene Mannheimer
IR@femasys.com

Media Contact: 
Kati Waldenburg
Media@femasys.com


FAQ

What did Femasys CEO discuss with the White House’s Gender Policy Council?

Femasys CEO Kathy Lee-Sepsick discussed the company's reproductive health products and the future of women's health in the U.S. with the White House’s Gender Policy Council.

When did Femasys CEO meet with the Gender Policy Council?

The meeting took place in support of the President’s Executive Order on Advancing Women’s Health Research and Innovation, announced in March 2024.

What products did Femasys discuss with the Gender Policy Council?

Femasys discussed its reproductive health products, including FemBloc® for permanent birth control and FemaSeed® for infertility treatment.

Which event will Femasys be attending to display its products?

Femasys will display its products at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting in San Francisco from May 17-19, 2024.

What are some of Femasys' commercially available products?

Femasys' commercially available products include FemaSeed®, FemVue®, FemCath®, and FemCerv®.

What is Femasys' current lead product candidate?

Femasys' current lead product candidate is FemBloc®, a non-surgical, non-hormonal permanent birth control solution.

Why is additional funding important for Femasys' initiatives?

Additional funding is important to support late-stage women’s health innovations and to address gaps in research for multiple women’s health issues.

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