Femasys Announces $40 Million in Series C Financing to Complete Development of FemBloc(TM)
(Thomson Reuters ONE) -
- Funding to support pivotal testing of non-surgical permanent contraception
solution FemBloc(TM) -
- 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(TM), 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.
About Femasys
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(TM) 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.
Media:
Jerry Fink
770.500.3910
jfink(at)femasys.com
Corporate Development:
Steven Damon
770.598.6446
sdamon(at)femasys.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Femasys Inc. via GlobeNewswire
Datum: 15.12.2016 - 23:23 Uhr
Sprache: Deutsch
News-ID 513336
Anzahl Zeichen: 5168
contact information:
Town:
Suwanee
Kategorie:
Business News
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