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Femasys Announces UK Regulatory Approvals for FemaSeed® for Female Infertility Treatment and Two Diagnostic Devices

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UK regulatory approval follows FemaSeed, FemVue and FemCerv clearance/approvals in the U.S., Europe, Canada and Israel.

Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible in-office therapeutic and diagnostic products, announces the receipt of the Medicines & Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.

“This is another key milestone as we expand our reach to the UK following successful approval across Europe for our innovative infertility and cancer detection products.” stated Kathy Lee-Sepsick, Femasys’ CEO. “We remain committed to advancing much-needed options that are safe, effective and cutting-edge for patients globally.”

About FemaSeed
FemaSeed® is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.1 It serves as an affordable, less burdensome and lower-risk first step before IVF. Learn more at www.femaseed.com.

About FemVue
FemVue® is the first FDA-cleared product that creates natural saline and air contrast for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound. When combined with a uterine cavity assessment, it provides a comprehensive exam in the comfort of the gynecologist’s office. Since FemaSeed infertility treatment requires at least one open fallopian tube, FemVue is an essential companion diagnostic. Learn more at www.femvue.com.

About FemCerv
FemCerv® is the first and only FDA-cleared product purposefully designed to collect a comprehensive and uncontaminated sample in a pain-free office procedure for the detection of cervical cancer. Learn more at www.femcerv.com.

About Femasys
Femasys, an Atlanta-based leading biomedical innovator, develops and commercializes a portfolio of patent-protected, minimally invasive women’s health solutions, all manufactured in the U.S. Our innovative therapeutic and diagnostic products have received global regulatory approvals and are being commercialized in the U.S. and select countries. FemaSeed® Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, UK, Canada and Israel. FemVue®, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared with approvals in Europe, UK, Canada, Japan and Israel. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, UK, Canada and Israel. FemBloc® permanent birth control, the Company’s late-stage product candidate, is the first and only non-surgical, in-office, method offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The pivotal clinical trial (NCT05977751) is now enrolling participants for U.S. approval. FemCath® and FemChec®, companion diagnostic products for FemBloc’s ultrasound-based confirmation test, are U.S. FDA-cleared and approved in Europe and Canada. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

Reference
1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, K. Lee-Sepsick (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.

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, our ability to establish, maintain, grow or increase sales and revenues, 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:
IR@femasys.com

Media Contact:
Media@femasys.com


Media Contact

Company Name: Femasys Inc.

Contact Person: Media Relations

Email: Media@femasys.com

Website: https://www.femasys.com/

State: Atlanta

Country: United States

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DuoKey to Unveil Encrypted Financial Intelligence Use Case at GISEC Global 2025: A Breakthrough in Fraud Detection Powered by Fully Homomorphic Encryption and MPC-based KMS

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Dubai, UAE, 2nd May 2025, ZEX PR WIRECloud security leader DuoKey will unveil its groundbreaking use case for encrypted financial intelligence at GISEC Global in Dubai next week. Designed to address the challenges of fraud detection and regulatory compliance, this approach, which combines Fully Homomorphic Encryption (FHE) and Multi-Party Computation (MPC)-based Key Management (KMS), allows financial institutions to analyse encrypted transactions in real time without ever decrypting sensitive data.

In a global financial landscape where illicit transactions exceed $2 trillion annually and compliance fines topped $10.4 billion on a yearly basis according to the United Nations Office on Drugs and Crimes, DuoKey confidential AI use case for the financial sector demonstrates how financial institutions can securely process high-risk transaction patterns, perform watchlist screening and assess customer risk profile, while preserving end-to-end encryption and maintaining jurisdictional data control.

“Traditional approaches expose data during analysis, creating systemic security gaps,” said Nagib Aouini, CEO of DuoKey. “Our use case shows how FHE and MPC-based KMS together allow financial institutions to detect fraud, meet AML obligations and collaborate securely without any compromise on data confidentiality or sovereignty.”

DuoKey financial intelligence solution enables secure collaboration between banks, regulators, and fintech providers by allowing cross-border investigation and compliance workflows without revealing underlying customer data. This addresses a longstanding roadblock to industry-wide fraud detection while complying with privacy and regulatory standards such as GDPR, FATF, and PCI DSS.

Visitors to GISEC Global will get the opportunity to explore the live use case at the DuoKey booth (D-120, Hall 6) starting on May 6 until May 8. Schedule your personalised demo at GISEC Global to see how DuoKey financial intelligence enhances fraud detection and compliance. Demonstrations include real-time transaction scoring, encrypted rule-based screening and dynamic anti money laundering (AML) analytics all with performance benchmarks that rival traditional unencrypted systems.

About DuoKey

DuoKey is an enterprise cloud security leader specialised in key management and encryption, helping businesses leverage cloud and AI capabilities with true confidence using advanced encryption technologies.

Learn more: https://duokey.com

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Construction Leader Charles Wholey Partakes in A New Online Interview: “From Foundation to Finish”

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Nevada, US, 2nd May 2025, ZEX PR WIRE, Charles Wholey, a highly respected construction superintendent with deep roots in Nevada’s building industry, is the subject of a newly released feature interview titled “From Foundation to Finish: Inside the Mind of Builder Charles Wholey.” The in-depth conversation offers a compelling look into Wholey’s professional journey, leadership philosophy, and the principles that have shaped his approach to modern construction.

Known for his work on complex residential and commercial builds throughout Reno and Carson City, Wholey brings years of hands-on experience and academic achievement to his role as Construction Superintendent at LT Builders. The interview explores everything from his views on decision-making under pressure to the evolving future of sustainable construction.

“I want people to understand that construction isn’t just about the physical outcome—it’s about the people behind the project, the lessons learned, and the standards we uphold every day,” said Wholey. “This interview was a chance to talk about the values that drive me, both on and off the job site.”

The conversation touches on Charles’s background—growing up working for his father’s company, Wholey Construction—as well as his dedication to mentorship, quality control, and continuous improvement. Readers will also learn about his vision for future projects, including his dream of building sustainable, off-grid communities.

This interview positions Charles Wholey as not only a seasoned construction professional, but a thoughtful leader committed to elevating the industry.

About Charles Wholey

Charles Wholey is a construction superintendent based in Reno and Carson City, Nevada. He holds a Bachelor of Applied Science in Construction Management from Western Nevada College, graduating summa cum laude, and has served in key roles ranging from safety officer to project manager. Outside of work, he is active in his community and a passionate supporter of environmental and youth initiatives.

To read the full interview, visit the website here

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Mentorship Over Metrics: Marjorie Jeffrey on Redefining Leadership for Women in Marketing

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Michigan, US, 2nd May 2025, ZEX PR WIRE, As marketing departments race to keep pace with AI, automation, and changing consumer expectations, senior marketing strategist Marjorie Jeffrey says the most significant transformation isn’t happening in the tools marketers use; it’s in how future leaders are developed.

According to Marjorie Jeffrey, mentorship is no longer optional. “If we want more women in leadership, we need to stop treating mentorship as a bonus and start recognizing it as core to how strong, ethical, and inclusive teams are built,” she says.

Jeffrey, who has guided dozens of companies through brand transformations and campaign strategy over the past 15 years, now dedicates a significant portion of her time to mentoring early-career marketers, especially women. She believes that creating the next generation of leadership requires intentional relationship-building, open dialogue, and systems that reward collaboration over competition.

“Marketing has evolved, but the leadership models in many organizations haven’t,” Jeffrey explains. “We’re still valuing output and volume over strategic insight and emotional intelligence. Mentorship is one of the few ways to shift that culture from the inside out.”

While women make up the majority of entry-level marketing roles, Jeffrey points out that they remain underrepresented at the top. “There’s a persistent gap between who’s doing the work and who’s getting the recognition, and that gap only widens without meaningful support structures like mentorship,” she says.

According to Jeffrey, mentorship is especially critical for women navigating industries like tech, finance, or B2B services, where leadership still skews heavily male. She believes the most effective mentors offer more than tactical advice; they provide context, validation, and space for vulnerable conversations about imposter syndrome, negotiation, and self-advocacy.

“People assume mentorship is just about sharing expertise, but often it’s about reminding someone they belong in the room,” says Jeffrey. “I’ve had mentees who were brilliant marketers but struggled to see themselves as leaders. Mentorship helps close that gap between capability and confidence.”

Jeffrey encourages companies to treat mentorship as part of their strategic planning, not a side initiative. She advocates for formal mentorship programs, cross-level collaboration, and reverse mentorship structures where junior employees can share emerging insights with senior leaders.

“If mentorship only happens casually, it stays limited to people with the right networks or personalities to ask for help,” Jeffrey explains. “We need to institutionalize it, especially if we want to foster diversity in leadership. That means giving people the time, training, and tools to mentor well.”

Jeffrey works with organizations in her consulting practice to embed mentorship into their brand cultures, tying it directly to employee retention, leadership pipelines, and internal communications. She often conducts messaging audits and internal workshops to make mentorship more actionable and accessible across teams.

“Mentorship has measurable impact,” she says. “It improves job satisfaction, accelerates career progression, and helps companies retain talent, especially during times of rapid change. Why wouldn’t we prioritize that?”

Jeffrey also emphasizes the importance of storytelling in mentorship. As someone who builds audience-first marketing strategies, she sees narrative as a powerful leadership tool. “When women in leadership share their real stories, the wins and the mistakes, it humanizes success,” she notes. “That vulnerability builds trust and makes leadership seem possible for more people.”

Outside of her client work, Jeffrey frequently speaks on inclusive messaging and brand ethics at industry conferences. She’s building a mentorship circle specifically for mid-career women marketers navigating transitions into management, entrepreneurship, or specialized strategic roles.

“There’s so much support for entry-level talent, but mid-career is where many women drop off the leadership path,” says Jeffrey. “We need to intervene there, with mentorship that’s practical, flexible, and grounded in real experiences.”

For Jeffrey, mentorship is not just a leadership responsibility. It’s a way of investing in the industry’s future. She believes that as marketing becomes more human-centric and purpose-driven, the role of mentors will become even more essential.

“The real legacy of a marketing leader isn’t just in the campaigns they run, it’s in the people they shape,” she says. “If I can help even one person lead with more clarity, confidence, and compassion, that’s the kind of impact that lasts.”

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