Femasys Announces First 100 Women Treated in Pivotal Clinical Trial with FemBloc® Permanent Contraceptive System
ATLANTA, Jan. 04, 2019 (GLOBE NEWSWIRE) -- Femasys, Inc., a medical technology company developing a platform of innovative in-office solutions for women’s healthcare today announced that the first 100 woman in the BLOC pivotal clinical trial received the FemBloc® permanent contraceptive treatment.
FemBloc is a first-in-class non-surgical, permanent female contraception solution performed in a medical office setting without anesthesia or implants. FemBloc consists of a temporary biopolymer that initiates a wound healing response in the fallopian tubes to form a permanent closure with the patient’s own scar tissue. The biopolymer completely exits the uterine cavity and fallopian tubes naturally over time. FemBloc is designed to be the safest and most convenient permanent contraceptive solution for patients and physicians. A positive safety profile was demonstrated in the BLOC pilot study (n=49) with no reported serious or unanticipated adverse events.
The open-label, multi-center landmark BLOC pivotal trial will require treatment of 500 patients with FemBloc to establish efficacy and safety with the following primary endpoints for the study: pregnancy rate at one year (n=436) and successful confirmation at three months post treatment (n=500). Secondary endpoints are safety, satisfaction and comfort with a comparison to surgical tubal ligation (control arm, n=300) at the same time points, including long-term follow up annually for two to five years post market.
“FemBloc represents a revolutionary approach to permanent female contraception, providing an important alternative for those considering surgery or those who rely on other methods of birth control such as “the pill,” condoms or IUDs but desire a permanent option,” said Kathy Lee-Sepsick, Chief Executive Officer and President of Femasys. “This trial marks an important milestone for women’s healthcare as Femasys continues to build on its portfolio of innovative in-office gynecological solutions for women at every stage of their reproductive life in our efforts to challenge decades-old practices and standards of care to meet the needs and choices of today’s patients.”
Of the 38 million women in the U.S. currently using contraceptives, approximately 13 million do not intend to have any or more children,1 yet the sole option for permanent contraception (surgical tubal ligation) is outdated with a notable risk profile. Roughly 700,000 women per year1 in the U.S. elect to undergo surgery requiring admittance to the hospital, anesthesia and incisional risks, and surgical recovery time.
About Femasys Femasys is a privately held medical technology company transforming women’s healthcare worldwide by developing a platform of innovative in-office gynecological solutions. Femasys’ flagship product, FemBloc® Permanent Contraceptive System, is based on the Company’s groundbreaking non-surgical technology that utilizes a temporary biopolymer to permanently close the fallopian tubes. FemBloc is designed to reduce risk and cost to patients and the healthcare system at large. Femasys’ reproductive health portfolio includes FemVue®, a product approved for sale worldwide for the diagnosis of infertility, along with a pipeline of solutions designed to improve the standard of women’s healthcare in an office setting. The FemBloc Permanent Contraceptive System is not commercially available for sale. Femasys, FemBloc and FemVue are registered trademarks for Femasys Inc. All rights reserved.
For more information, please visit: www.Femasys.com.
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____________________1 Jones J, Mosher W, Daniels K. Current contraceptive use in the United States, 2006-2010, and changes in patterns of use since 1995. National health statistics reports; no 60. Hyattsville, MD: National Center for Health Statistics. 2012.