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Femasys’ FemaSeed Localized Directional Insemination for Infertility Receives Product Approval in Canada
- FemaSeed® is the first-ever, first-line approach designed to deliver sperm directly where contraception occurs - ATLANTA, April 18, 2023 (GLOBE NEWSWIRE) --
About this update from Femasys Inc.
[{"type":"text","content":"- FemaSeed® is the first-ever, first-line approach designed to deliver sperm directly where contraception occurs - ATLANTA, April 18, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women's needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced the Health Canada, the Public Health Agency of Canada, has granted product approval of FemaSeed®, the first-ever infertility solution designed to deliver sperm directly to where contraception occurs. FemaSeed is Femasys’ localized artificial insemination option that is designed to be less invasive and more affordable than assisted reproduction, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). “We are thrilled to gain approval of FemaSeed in Canada, now being able to offer a safe, novel and affordable option for treating infertility,” stated Kathy Lee-Sepsick, Femasys’ founder, president, chief executive officer. “Our advanced approach delivers sperm directly to the area where conception occurs in the fallopian tube. Prior to FemaSeed, Femasys’ first-of-its-kind in-office ultrasound diagnostic product FemVue®, which is also approved in Canada, can be used to assess that the fallopian tube is patent. Both of these proprietary solutions will offer women and couples in Canada cutting-edge options that are affordable and safe.” Assisted forms of reproductive treatment such as in-vitro fertilization (“IVF”) or intracytoplasmic sperm injection (“ICSI”) are both effective first-line treatments for infertility but are associated with significant costs and risks. Ms. Lee-Sepsick, continued, “In terms of FemaSeed’s availability in the rest of North America, we are progressing after receiving IDE approval from the United States Food and Drug Administration (FDA) in the fourth quarter of last year. We are on track to complete enrollment of our de novo clinical trial of FemaSeed this year, with a potential commercial launch of FemaSeed in the U.S. projected in 2024, if cleared by the FDA.” About FemaSeedFemaSeed features intrauterine directional delivery that deposits sperm locally and directly to the fallopian tube where conception occurs. As the first and only approach presenting significant advantages over existing artifici...