Women's health care startup Femasys Inc. has raised $40 million in a series C round. The Suwanee, Ga.-based company will use the funding to support the further development of Fembloc, a non-surgical, permanent contraception solution. The transaction was arranged by Salem Partners, a Los Angeles-based investment bank, which also participated as a principal investor.

The funding comes at the same time the private company revealed it received FDA approval to launch a prospective, multicenter, trial to evaluate the safety of the Fembloc while preventing pregnancy. Femasys said the study will enroll women who desire permanent birth control by occlusion of the fallopian tubes.

The Fembloc device works by having a biopolymer sent through a catheter-based delivery system to permanently block the fallopian tubes.

"[This] financial investment enables us to conduct and complete the Fembloc clinical plan, which will support our planned PMA," said Kathy Lee-Sepsick, Femasys president and CEO.

Femasys could not be reached for additional comment.

If the company can gain FDA approval for the Fembloc, then it could easily find a position to occupy in the contraceptive market, which is set to expand at a steady 3.10 percent change of growth rate until 2020, according to a Transparency Market Research study. The report, which was released in September of this year, predicts the market will hit $19.6 billion by 2020.

Femasys' competition in the market includes Petah Tikva, Israel-based Teva Pharmaceutical Ltd; St. Paul, Minn.-based Church & Dwight Co. Inc.; Berkeley, Calif.-based Mayer Laboratories Inc.; Slough, U.K.- based Reckitt Benckiser plc.; Trumbull, Conn.-based Coopersurgical Inc. and Chicago-based The Female Health Company.

THE LITTLE START UP THAT'S GROWING

Key hires, partnerships with larger companies in the med-tech space and multiple funding rounds make up the 12-year-old company's track record.

Last year, the company picked up former ZS Pharma Inc. executive Todd Creech as CFO. (See Medical Device Daily, Dec. 15, 2015.) Creech was part of the team responsible for taking the company ZS, completing a successful secondary offering, disseminating key clinical data, and positioning the company for M&A discussions.

In 2013, Femasys made a strategic partnership with London-based, Smith & Nephew plc (S&N). Under the agreement, S&N became the sole U.S. distributor of Femasys' Femvue Saline-Air diagnostic, which is designed to help evaluate a woman's fallopian tubes to determine if she can become pregnant.

The non-radiologic device is designed to aid in the evaluation of a sono-hysterosalpingogram. In that procedure, the device is used to test the flow of saline and air through the fallopian tubes, which is visualized via ultrasound.

Femasys gained FDA approval for the device about five years ago. (See Medical Device Daily, May 4, 2011.) The partnership was a win-win for both companies. The Femvue Saline-Air diagnostic was able to reach a broader market population and was complementary to S&N's device designed to remove polyps or fibroids. Femvue could help detect both growths, which can cause infertility.

Femasys was able to get another product on the market – its Femcerv Endocervical Sampler. The device was launched in 2013 and collects a sample from the cervical canal for histological analysis. It is intended to be a less painful alternative to the current standard-of-care for cervical cancer testing, which is cervical scraping.

The company has also been increasingly aggressive with funding efforts since its formation in 2004. Last year, the firm brought in about $10.2 million in a series B round (See Medical Device Daily, April 30, 2015.) In June 2012, Femasys was able to obtain a $4 million loan from GE Capital's health care financial services arm to help with commercialization efforts.