Femasys Inc. Announces Enrollment is over 25% Complete for FemaSeed® De Novo Trial Following Updated Strategic Study Design

Rhea-AI Summary

Femasys Inc. (NASDAQ: FEMY) has achieved over 25% enrollment in its FemaSeed de novo clinical trial, focusing on male factor infertility. The trial aims to evaluate the safety and effectiveness of FemaSeed, a cost-effective alternative to assisted reproduction methods like IVF. CEO Kathy Lee-Sepsick highlighted the potential impact on the estimated 50% of infertility cases linked to male factors. The trial enrollment is expected to complete in 2023, with results supporting FDA review for FemaSeed.

Positive

• Over 25% of targeted 214 patient fertility cycles enrolled in the FemaSeed trial.
• FemaSeed aims to address male factor infertility, which affects about 40-50% of infertility cases.
• FemaSeed is positioned as a more affordable option compared to IVF.

Negative

• None.

--FemaSeed de novo trial enrollment has accelerated with trial recruitment focus on male factor infertility--

ATLANTA, Nov. 29, 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 announced that it has completed over 25% of its targeted enrollment (214 patient fertility cycles) in its FemaSeed^® de novo trial. FemaSeed is the first and only first-line approach in development designed to deliver sperm directly to where conception occurs. FemaSeed is a localized artificial insemination option that is also designed to be more affordable than assisted reproduction, such as in vitro fertilization (IVF).

“Our strategy to focus on male factor infertility, where we believe FemaSeed could have the greatest impact, is proving to be a sound strategy as we expedite advancement of this clinical program,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “After announcing our updated strategic trial design only a month ago, we are thrilled to have reached over 25% of our targeted 214 FemaSeed cycles. Since it is estimated that 50% of all infertility cases can be attributed to male factor infertility, the Company believes that its FemaSeed product candidate could significantly benefit this population. We are proud to have hit multiple company milestones – both this quarter and last – and maintain continued momentum on all fronts with a strengthened management team as we advance our other programs: preparing for a pivotal study of FemBloc^® for permanent birth control followed by a confirmation test with FemChec^® early next year, and readying FemCath^™ for the commercial marketplace before year end as well.”

About the De Novo Trial for FemaSeed

The FemaSeed LOCAL de novo clinical trial is a prospective multi-center, unblinded study (NCT04968847) being conducted across centers in the United States requiring evaluation of up to 214 women undergoing 214 FemaSeed cycles due to male factor infertility. The primary endpoints of the study are to determine the effectiveness (pregnancy rate) and safety over a period of seven weeks post-FemaSeed procedure. In October, the Company announced an updated study design for this trial, which is now focused on couples experiencing male factor infertility. This update reflects a strategic decision to address this underserved infertility population with a goal of facilitating accelerated enrollment. The Company expects study enrollment to be completed in 2023. Results from the trial will support a future de novo authorization by the FDA for FemaSeed.

About Male Factor Infertility

Of all infertility cases, approximately 40–50% are reportedly due to male factor infertility, which represents a dramatic increase in prevalence over the past 40 years. Sperm counts worldwide have declined by over 50% between 1973 and 2011, with an increasing proportion of men having sperm counts below the threshold to be deemed sub-fertile or infertile. Assisted forms of reproductive treatment such as in-vitro fertilization (“IVF”) or intracytoplasmic sperm injection (“ICSI”) are both effective first-line treatments, but are associated with significant costs (approximately $30,000 USD), are often not covered by health insurance and may pose clinical risks.

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^®, is currently marketed in the United States. Femasys is also advancing FemCath^™, an intrauterine catheter for selective evaluation of the fallopian tubes and FemCerv^®, an endocervical tissue sampler that is the first product of the technology platform for tissue sampling intended to be marketed alongside its other women-specific medical products in the physician’s office setting. 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

+1-917-741-7792

chuck@lifesciadvisors.com 

Femasys Inc.

Investor Contact:

IR@femasys.com

Media

Media Contact:

Media@femasys.com

FAQ

What is Femasys' FemaSeed trial about?

The FemaSeed trial focuses on male factor infertility and aims to evaluate the product's safety and effectiveness.

When is the FemaSeed trial expected to complete enrollment?

Enrollment for the FemaSeed trial is expected to be completed in 2023.

What percentage of infertility cases relate to male factors?

Approximately 40-50% of infertility cases are attributed to male factor infertility.

What does FemaSeed offer in comparison to IVF?

FemaSeed aims to provide a localized artificial insemination option that is more affordable than IVF.

Who is the CEO of Femasys?

Kathy Lee-Sepsick is the founder, president, and CEO of Femasys.