Femasys Inc. Obtains Medical Device Establishment License from Health Canada
ATLANTA, Aug. 31, 2023 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with two lead revolutionary product candidates in late-stage clinical development for reproductive health in addition to innovative diagnostic products constituting a broad portfolio of in-office accessible solutions, today announced that it has obtained a Medical Device Establishment License (“MDEL”) from Health Canada (License Number 24825). The MDEL license is issued by Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) to companies for the activities of manufacturing, importing and distributing and selling of medical devices for human use in Canada. This license allows Femasys to directly sell its four products, FemaSeed®, FemVue®, FemCath® and FemCerv®, approved in Canada.
“Obtaining an MDEL license is another milestone achieved and key step to entering the Canadian marketplace,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We are thrilled to provide women in Canada access to Femasys’ medical products for infertility treatment and diagnosis, as well as cervical cancer diagnosis.”
More information on Femasys’ approved products in Canada (FemaSeed, FemVue, FemCath and FemCerv) is below:
About FemaSeed®
FemaSeed is a first-of-its-kind infertility solution in late-stage clinical development in the U.S. for directional intrauterine insemination that delivers sperm to the fallopian tube where conception occurs. It is intended to augment natural fertilization as a first-line infertility treatment option that is less invasive and more affordable than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
About FemVue®
FemVue is the first FDA-cleared product that creates natural contrast to allow for real time evaluation of the fallopian tubes with ultrasound in the GYN’s office that is safer and less costly than the alternative radiology exam.
About FemCath®
FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes by using in conjunction with FemVue. The baseline ultrasound-based diagnostic test is essential prior to any infertility treatment, including our therapeutic solution FemaSeed.
About FemCerv®
FemCerv is the first FDA-cleared product that allows for the capture and protection of a comprehensive endocervical tissue sample in a virtually pain-free procedure for diagnosis of cervical cancer.
About Femasys Inc.
Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide by developing two lead revolutionary product candidates in late-stage clinical development for reproductive health in addition to innovative diagnostic products constituting a broad portfolio of in-office, accessible solutions. Our FemBloc® permanent birth control in pivotal trial is intended to be a safer, less costly option for women by eliminating surgery and implants. Our FemaSeed® localized directional insemination in pivotal trial for infertility (approved in Canada) is intended to offer couples a safer, less costly alternative by eliminating invasive surgical procedures. Complimentary products with approvals to market in the U.S., Canada and other countries outside the U.S, have allowed the Company to optimize its ability to achieve regulatory approvals, and improve operational efficiencies and commercial readiness with its in-house manufacturing capabilities. Learn more at www.femasys.com, and follow us on Twitter, Facebook 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, 2022 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 Contact:
Media@femasys.com
