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
FemBloc is being developed as a first-of-its-kind, non-surgical permanent birth control with a clearly defined U.S. regulatory pathway. (Credit: freestocks on Unsplash)
Femasys, 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 in Palo Alto, California.
The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control 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.
Source: Company Press Release