– Funding to support pivotal testing of non-surgical permanent contraception solution FemBloc™ –
– IDE approval granted by FDA for U.S. clinical trial of FemBloc; study to start early 2017 –
ATLANTA, Dec. 15, 2016 (GLOBE NEWSWIRE) — Femasys Inc., a developer of innovative medical devices for the women’s healthcare market, today announced that it has closed $40 million in Series C financing. The transaction was arranged by Salem Partners, a Los Angeles-based investment bank which also participated as a principal investor. The Series C syndicate included multiple institutional investors, family offices and a multibillion-dollar global medical device company. The funding will be used primarily to support the pivotal testing of FemBloc™, the Company’s revolutionary, non-surgical permanent contraception solution. Femasys designed FemBloc to provide women with the first non-surgical permanent contraceptive option delivered exclusively in the physician’s office.
“We are thrilled with the level of enthusiasm in this oversubscribed round of funding and grateful for the backing from our new and existing investors,” said Kathy Lee-Sepsick, Femasys President and CEO. “Their financial investment enables us to conduct and complete the FemBloc clinical plan, which will support our planned premarket approval application (PMA), and ultimately, our vision of improving the lives of women by providing access to an ideal permanent contraception solution that is safe and highly effective for women in the U.S. and worldwide.”
Femasys also announced that it has gained U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to launch a prospective, multi-center, clinical trial to evaluate the safety of the FemBloc permanent contraceptive system while preventing pregnancy. The clinical trial, which will enroll women who desire permanent birth control by occlusion of the fallopian tubes, will be the Company’s first trial to evaluate the complete FemBloc contraceptive system for its intended use.
“FemBloc is designed to fill the unmet need of a safe, permanent contraceptive method that can be easily implemented since it does not require specialized surgical skills or investment in costly surgical equipment,” said Mimi Zieman, M.D., Vice President of Clinical Affairs at Femasys and a board certified Ob/Gyn specializing in Family Planning. “This contrasts with current female sterilization options that have the inconvenience and risks associated with surgery and anesthesia for tubal ligation; and for hysteroscopic procedures – the challenge of placing the devices correctly, and concerns with long-term use.”
Dechert LLP served as legal counsel to Femasys Inc. while Baker Botts LLP served as investor counsel.
Femasys is a privately held corporation committed to transforming women’s healthcare worldwide by expanding options for women with innovative medical devices and next generation advancements providing significant clinical impact. Additional information about Femasys and the Company’s products can be found at www.femasys.com
Femasys has developed a groundbreaking non-surgical female sterilization solution (FemBloc™ Permanent Contraceptive System*) that allows physicians to deliver exclusively in their office a Biopolymer through a catheter-based Delivery System to permanently block the fallopian tubes in a procedure that substantially reduces patient risks and costs by eliminating the use of anesthesia and permanent implants. The company has also expanded options for women with its two commercially available products for diagnosis of infertility (FemVue® Saline-Air device) and cervical cancer (FemCerv® Endocervical Sampler) that present significant advantages for the patient, physician, and healthcare system.
*FemBloc Permanent Contraceptive System is not commercially available for sale.
Femasys, FemBloc, FemVue and FemCerv are registered trademarks of Femasys Inc.
All rights reserved.
Source: Femasys Inc.
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