Business
Femasys Inc. Announces Financial Results for the Third Quarter Ended September 30, 2022 and Provides Corporate Update
--FemaSeed® de novo trial enrollment accelerates with strategic trial design update to focus on male factor infertility-- --Company remains on track to file
About this update from Femasys Inc.
[{"type":"text","content":"--FemaSeed® de novo trial enrollment accelerates with strategic trial design update to focus on male factor infertility-- --Company remains on track to file an Investigational Device Exemption (IDE) for a pivotal trial to support a Pre-Market Authorization (PMA) for FemBloc® in Q1 2023-- --FemCerv® now commercially available with FemCath™ launch expected by year-end-- ATLANTA, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the third quarter and nine months ended September 30, 2022 and provided a corporate update. “We’ve hit multiple company milestones this past quarter, as well as further strengthened our management team in key functional areas,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Most notably, we completed enrollment in our Stage 2 trial of FemBloc® permanent birth control and strategically updated the FemaSeed® de novo trial design, accelerating enrollment for this important program. Approximately 50% of infertility is attributed to male factor and FemaSeed is being studied to offer a cost-effective, efficacious option to existing invasive and expensive treatment alternatives. We also made FemCerv®, designed for comprehensive cervical sampling and minimal contamination for the diagnosis of cervical cancer, available to gynecologists. To support all of these high-value programs, we have sales and marketing as well as regulatory and clinical affairs teams well-positioned to lead us towards the next catalysts for the company at this pivotal time.” Third Quarter and Recent Developments Related to Clinical Programs and Commercial Products FemBloc In July, Femasys hosted a Key Opinion Leader (KOL) event in the wake of the overturn of Roe v. Wade, to discuss FemBloc. The webinar featured a presentation from key opinion leader, Paul D. Blumenthal, M.D., MPH, Professor of Obstetrics and Gynecology of The Stanford University Medical Center and discussion of the unmet need for women seeking permanent birth control options. Following the event, several media outlets reported on the topic, including CNN Business and other industry-focused publications.In Oc...