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Femasys CEO and Founder Kathy Lee-Sepsick Meets with Members of Congress to Raise Awareness of the Company and Discuss Women’s Healthcare Initiatives

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Femasys CEO and Founder Kathy Lee-Sepsick meets with Members of Congress to raise awareness of the company and discuss women's healthcare initiatives. The company focuses on addressing unmet needs of women with a portfolio of innovative products. President Biden's executive order for women's health initiatives has spurred interest in Femasys' solutions. The company offers minimally-invasive reproductive products and is developing a permanent birth control solution called FemBloc. Femasys recently announced positive topline data from its FemaSeed pivotal trial, showing a 24% pregnancy rate in women with male factor infertility.
La CEO e fondatrice di Femasys, Kathy Lee-Sepsick, si è incontrata con i membri del Congresso per sensibilizzare riguardo all'azienda e discutere iniziative sulla salute femminile. La compagnia si concentra sul soddisfare le necessità non ancora risolte delle donne con un portafoglio di prodotti innovativi. L'ordine esecutivo del Presidente Biden sulle iniziative per la salute delle donne ha suscitato interesse nelle soluzioni di Femasys. L'azienda offre prodotti riproduttivi minimamente invasivi e sta sviluppando una soluzione di controllo delle nascite permanente chiamata FemBloc. Femasys ha recentemente annunciato dati positivi preliminari dal suo studio pivotale FemaSeed, evidenziando un tasso di gravidanza del 24% in donne con infertilità da fattore maschile.
La CEO y fundadora de Femasys, Kathy Lee-Sepsick, se ha reunido con miembros del Congreso para concienciar sobre la empresa y discutir iniciativas de salud femenina. La compañía se enfoca en abordar las necesidades no cubiertas de las mujeres con una cartera de productos innovadores. La orden ejecutiva del Presidente Biden sobre iniciativas de salud de la mujer ha estimulado el interés en las soluciones de Femasys. La empresa ofrece productos reproductivos mínimamente invasivos y está desarrollando una solución de control de natalidad permanente llamada FemBloc. Femasys anunció recientemente datos positivos de su ensayo pivotal FemaSeed, mostrando una tasa de embarazo del 24% en mujeres con infertilidad por factor masculino.
Femasys의 CEO이자 창립자인 Kathy Lee-Sepsick이 회사에 대한 인식을 높이고 여성 건강 케어 이니셔티브에 대해 논의하기 위해 의회 구성원들과 만났습니다. 이 회사는 혁신적인 제품 포트폴리오로 여성들의 미충족 필요를 해결하는 데 중점을 두고 있습니다. 바이든 대통령의 여성 건강 이니셔티브에 대한 행정 명령은 Femasys의 솔루션에 대한 관심을 촉발시켰습니다. 이 회사는 최소 침습적인 생식 제품을 제공하며 FemBloc이라는 영구적인 출산 통제 솔루션을 개발 중입니다. Femasys는 최근 그들의 FemaSeed 핵심 시험에서 남성 요인 불임을 가진 여성들의 24% 임신율을 보여주는 긍정적인 최상위 데이터를 발표했습니다.
La PDG et fondatrice de Femasys, Kathy Lee-Sepsick, a rencontré des membres du Congrès pour sensibiliser à l'entreprise et discuter des initiatives de santé féminine. L'entreprise se concentre sur la réponse aux besoins non satisfaits des femmes avec un portefeuille de produits innovants. Le décret présidentiel de Biden concernant les initiatives de santé des femmes a suscité un intérêt pour les solutions de Femasys. La société propose des produits de reproduction peu invasifs et développe une solution de contrôle des naissances permanent appelée FemBloc. Femasys a récemment annoncé des données préliminaires positives de son essai pivot FemaSeed, montrant un taux de grossesse de 24 % chez les femmes souffrant d'infertilité due à un facteur masculin.
Die CEO und Gründerin von Femasys, Kathy Lee-Sepsick, hat sich mit Mitgliedern des Kongresses getroffen, um das Bewusstsein für das Unternehmen zu schärfen und über Initiativen im Bereich der Frauengesundheit zu diskutieren. Das Unternehmen konzentriert sich darauf, unerfüllte Bedürfnisse von Frauen mit einem Portfolio innovativer Produkte zu adressieren. Die Exekutivanordnung von Präsident Biden zu Initiativen für die Frauengesundheit hat das Interesse an den Lösungen von Femasys geweckt. Das Unternehmen bietet minimal-invasive reproduktive Produkte an und entwickelt eine dauerhafte Verhütungslösung namens FemBloc. Femasys hat kürzlich positive Topline-Daten aus seiner entscheidenden FemaSeed-Studie bekannt gegeben, die eine Schwangerschaftsrate von 24% bei Frauen mit männlichem Faktor Unfruchtbarkeit zeigen.
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ATLANTA, April 18, 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, today announces its CEO and Founder Kathy Lee-Sepsick has met with several members of Congress to discuss the current women’s healthcare landscape. Further, Lee-Sepsick is raising awareness of Femasys and the status of its reproductive products in light of the recently announced women’s health initiative from the White House. In mid-March President Biden released an executive order, which calls for a $200M investment in research for women’s health and a coordinated approach from more than 20 federal government agencies in addition to the $100M investment announced in November 2023.

“Women’s health remain vastly underserved and underfunded but we are encouraged by the interest our solutions have received during recent meetings with members of Congress,” remarked Lee-Sepsick. “I am proud to be a female-founder and to lead Femasys as we develop revolutionary technologies that provide a continuum of care that are safe, affordable and accessible to women. It is our goal to empower women throughout their reproductive journey by delivering innovative options to meet their needs.”

Femasys provides minimally-invasive solutions that share delivery platforms. It has four commercially available products: FemaSeed® – FDA-cleared, intratubal insemination, FemVue® – contrast-generating device, FemCath® – selective delivery catheter, and FemCerv® – endocervical tissue sampler. And its current lead product candidate in late-stage clinical development is FemBloc® – permanent birth control.

The Company recently announced topline data from its FemaSeed pivotal trial, which investigated FemaSeed in women with a variety of infertility factors with the primary efficacy analysis focused on the male factor infertility. FemaSeed demonstrated 24% of women became pregnant after FemaSeed with male factor (1 million to 20 million total motile sperm count (TMSC)). Although permitted to have multiple FemaSeed attempts, the majority of women who became pregnant did so after the first FemaSeed procedure.

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. For more information visit 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 is Femasys CEO Kathy Lee-Sepsick meeting with Members of Congress for?

Femasys CEO Kathy Lee-Sepsick is meeting with Members of Congress to raise awareness of the company and discuss women's healthcare initiatives.

What is the ticker symbol for Femasys Inc.?

The ticker symbol for Femasys Inc. is FEMY.

What recent executive order has influenced Femasys' discussions with Congress?

President Biden's recent executive order calling for a $200M investment in research for women's health and a coordinated approach from federal government agencies has influenced Femasys' discussions with Congress.

What are some of the products offered by Femasys?

Some of the products offered by Femasys include FemaSeed, FemVue, FemCath, and FemCerv.

What is Femasys' lead product candidate in late-stage clinical development?

Femasys' lead product candidate in late-stage clinical development is FemBloc, a permanent birth control solution.

What was the outcome of Femasys' FemaSeed pivotal trial?

The FemaSeed pivotal trial showed a 24% pregnancy rate in women with male factor infertility, with the majority of pregnancies occurring after the first FemaSeed procedure.

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About FEMY

our experienced management team has over 200 years of collective industry experience with extensive focus in medical devices. the pioneering and collaborative efforts of the management team have created an organization that strives for integrity in all actions, innovation in development activities, excellence in operations, and the highest quality products. the team is complemented by world-class medical advisors. our products have been organically conceived, researched and developed by the company and all manufacturing activities are conducted to ensure compliance with the u.s. food and drug administration (fda) per the requirements of 21 cfr 820, as well as iso 13485. femasys has achieved significant milestones to date, including numerous issued patents and filings, recruitment of a team of experts, clearance of multiple regulatory filings by the u.s. food and drug administration (fda), european union, canada, and japan with other select countries in process. making a difference in t