Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at Stanford Medicine

- Stanford Medicine, a center with a long tradition of leadership in pioneering gynecological research and innovation, is the second academic center to participate in the FemBloc pivotal trial since enrollment began last quarter -

- Faculty of the Stanford Medicine Obstetrics and Gynecology (OB/GYN) Department, Paul Blumenthal, M.D. and Erica Cahill, M.D., participated in Femasys’ earlier FemBloc studies -

- FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clearly defined U.S. regulatory pathway -

ATLANTA, Dec. 15, 2023 (GLOBE NEWSWIRE) -- 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 therapeutic and diagnostic products, today announced that it has activated enrollment for its pivotal FemBloc^® trial at Stanford Medicine (“Stanford”) in Palo Alto, California. The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The FDA-approved, multi-center trial is designed to address the high unmet need that exists for women seeking permanent birth control, for whom elective surgery currently remains the only option.

Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc, in late-stage clinical development for permanent birth control, and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed^®, for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue^®, FemCath^® and FemCerv^®, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories.

“We are thrilled to include Stanford amongst the clinical trial sites participating in this initial phase of the FINALE trial, as we have partnered with Doctors Blumenthal and Cahill in earlier FemBloc studies,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Dr. Blumenthal, a leader in the field of gynecology, has dedicated his career to advancing research and bringing women’s health technologies to those in need around the globe. We greatly appreciate his long-standing support of FemBloc and the selection of Dr. Cahill as the principal investigator in the FINALE trial, as we continue to work together to progress this much needed non-surgical permanent birth control option for women."

“This trial could have significant implications to the health of women and all people who can become pregnant, and we are ready to commit Stanford’s resources and capabilities in research to continue to support the advancement of this important non-surgical option”, said Dr. Erica Cahill, M.D. “This continues to be an unprecedented time in women’s health and accessibility and preservation of options is crucial. An in-office birth control option has the opportunity to become an important solution healthcare providers can offer to their patients for their reproductive health needs on a non-surgical basis that also allows for broad accessibility”, said Dr. Paul Blumenthal, M.D.

About Stanford Medicine | Obstetrics & Gynecology

Stanford Medicine’s mission is to improve women's health through innovative and compassionate care, education, advocacy and discovery. The Stanford Medicine faculty is committed to the highest level of basic and clinical research in Obstetric and Gynecologic science, with a focus on innovative translational medicine; bringing scientific results from the bench to the bedside. Stanford Medicine faculty members practice medicine in a world-class hospital; and are internationally recognized for the medical, surgical and reproductive Obstetric and Gynecologic care they provide to their patients. Their visions are to be local and global leaders, advancing and transforming women's health across the lifespan.

About FemBloc

FemBloc^® is a first-of-its-kind, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a convenient, accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for FemBloc in the U.S. alone. For more information, visit www.FemBloc.com.

About the FINALE Pivotal Clinical Trial

Femasys ‘FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] trial (NCT05977751) is designed as a prospective, multi-center, open-label, single-arm study to evaluate the safety and efficacy of FemBloc^®, a novel, non-surgical female permanent birth control approach. The primary endpoint is pregnancy rate, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. The trial is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for one year. Follow-up will continue annually for five years post-market. For more information, visit www.FemBloc.com.

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 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 has received regulatory approval 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 ex-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 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,” “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 ability to commercialize our product candidates, or the effect of delays in commercializing; 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