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Femasys Inc. Reports Encouraging Promotional Launch of FemCerv at AAGL Based on Positive Reception by Gynecologic Physicians and Surgeons

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Femasys Inc. (NASDAQ: FEMY) successfully launched its FemCerv® endocervical tissue sampler at the AAGL conference, receiving positive feedback from over 2,000 gynecologic specialists. This innovative product aims to enhance tissue quality and reduce discomfort during cervical cancer detection. Additionally, FemVue®, the first FDA-cleared device for fallopian tube evaluation, also garnered attention. Femasys plans to expand its product portfolio further with the upcoming launch of FemCath™ and continuously advance clinical programs including FemaSeed® and FemBloc®.

Positive
  • FemCerv® received strong interest at the AAGL conference, indicating potential market acceptance.
  • FemVue® is recognized as the first FDA-cleared product for fallopian tube evaluation, enhancing Femasys's portfolio.
  • The company plans to launch FemCath™, adding to its three available products by year-end, which may drive incremental revenue.
Negative
  • None.

--FemCerv®, the first endocervical tissue sampler of its kind in the detection of cervical cancer, was well-received after being presented at the AAGL conference attended by over 2,000 leading gynecologic specialists--

ATLANTA, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today reported that it held a promotional launch of its diagnostic product, FemCerv®, the first endocervical tissue sampler designed to improve tissue quality and quantity at the annual meeting of AAGL (formerly known as the meeting of the American Association for Gynecologic Laparoscopists), where the product was very well received by gynecologic physicians and surgeons. The annual AAGL meeting gathers laparoscopic surgeons worldwide dedicated to the research and advancement of minimally invasive gynecologic procedures.

“During our recent market launch and presentation of FemCerv at AAGL, a major medical meeting of gynecologic surgeons and other related specialists, we were extremely encouraged by the interest expressed related to the product,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Gynecologic specialists acknowledged the novelty of FemCerv, an endocervical curette that obtains a virtually pain free comprehensive tissue sample when evaluating for cervical cancer. The current process relies on antiquated tools that can be painful and result in an inadequate or contaminated sample, which may lead to unnecessary invasive procedures.”

Ms. Lee-Sepsick continued, “We were also extremely pleased to hear positive feedback from gynecologic specialists about FemVue®, our first of its kind commercially available diagnostic product for infertility that enables ultrasound evaluation of the fallopian tubes. FemVue works in conjunction with our other approved product, FemCath, a selective catheter, which is expected to be commercially available later this month. By the end of this year, we will offer three commercially available products in our portfolio in addition to our leading clinical development programs, FemaSeed® and FemBloc®. Our goal is to elevate care and expand options for women with our suite of innovative products like FemVue, FemCerv, and FemCath that may provide meaningful additional incremental revenue in the near-term, while we complete the clinical development programs for FemaSeed and FemBloc.”

About AAGL

Founded in 1971, this professional organization for gynecologic laparoscopic surgeons (formerly known as the American Association of Gynecologic Laparoscopists) is dedicated to the research and advancement of minimally invasive gynecologic procedures. The organization has over 7,500 members in over 110 countries. More recently, the name was switched to just the acronym to reflect its international scope.

About FemCerv

FemCerv is the first FDA-cleared product designed to capture a complete and uncontaminated endocervical tissue sample in a relatively pain-free procedure. FemCerv features an expandable collection chamber that is exposed during sampling and closed during removal for containment of cervical cells and tissue.

About FemVue

FemVue is the first FDA-cleared product that creates natural saline and air contrast and enables safe, reliable, and real time evaluation of the fallopian tubes with ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the GYN’s office.

About FemCath

FemCath is the first FDA-cleared intrauterine catheter that allows for selective evaluation of a fallopian tube with contrast. FemCath features our proprietary delivery platform, which places balloon technology close to the opening of a selected fallopian tube for directed delivery.

About FemaSeed

FemaSeed is a first-of-its-kind infertility solution in development for directional intrauterine insemination that delivers sperm to the fallopian tube where conception occurs. It is intended to augment natural fertilization and provide a first-line treatment option for infertility.

About FemBloc

FemBloc is a first-of-its-kind, nonsurgical, in-office solution in development for permanent birth control. It is intended to be a safer option for women by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer women a convenient and reliable alternative method of permanent birth control.

About Femasys

Femasys Inc. is a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc® permanent birth control and FemaSeed® localized directional insemination for infertility. The Company’s product for fallopian tube assessment by ultrasound, FemVue®, and FemCerv®, an endocervical tissue sampler that is the first product of the technology platform for tissue sampling are currently marketed in the United States. Femasys is also advancing FemCath, an intrauterine catheter for selective evaluation of the fallopian tubes. To learn more, visit www.femasys.com or follow us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “potential,” ”hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2021 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts:

Investors
Chuck Padala
LifeSci Advisors, LLC
917-741-7792
chuck@lifesciadvisors.com

Femasys Inc.
Investor Contact:
IR@femasys.com

Media
Media Contact:
Media@femasys.com


FAQ

What is FemCerv® and why is it significant?

FemCerv® is the first endocervical tissue sampler designed to improve the quality and quantity of cervical cancer detection samples and aims to offer a pain-free procedure.

What feedback did Femasys receive at the AAGL conference?

Femasys received positive feedback regarding FemCerv® and FemVue® from gynecologic specialists, highlighting the novelty and effectiveness of their products.

What products does Femasys plan to launch by year-end?

Femasys plans to launch FemCath™ along with FemCerv® and FemVue®, expanding its product offerings in women's health.

How does FemVue® benefit infertility diagnostics?

FemVue® enables ultrasound evaluation of fallopian tubes, providing comprehensive assessments in an office setting, making it a significant tool for infertility diagnostics.

What is the stock symbol for Femasys?

Femasys is traded under the stock symbol FEMY on NASDAQ.

Femasys Inc.

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