UK regulatory approval follows FemaSeed, FemVue and FemCerv clearance/approvals within the U.S., Europe, Canada and Israel.
Femasys Inc., (Nasdaq: FEMY), a number one biomedical innovator addressing vital unmet wants in girls’s well being worldwide, with a broad portfolio of disruptive, accessible in-office therapeutic and diagnostic merchandise, pronounces the receipt of the Medicines & Healthcare merchandise Regulatory Company (MHRA) approvals for the FemaSeed® Intratubal Insemination product for feminine infertility therapy and two diagnostic units, FemVue® for tubal analysis and FemCerv® for cervical most cancers detection.
“This is another key milestone as we expand our reach to the UK following successful approval across Europe for our innovative infertility and cancer detection products.” said Kathy Lee-Sepsick, Femasys’ CEO. “We remain committed to advancing much-needed options that are safe, effective and cutting-edge for patients globally.”
About FemaSeed
FemaSeed® is an modern development in synthetic insemination, designed to reinforce fertilization by exactly delivering sperm into the fallopian tube, the pure web site of conception. It affords a protected, accessible and cost-effective first-line therapeutic choice for infertile girls, males and {couples} searching for being pregnant by way of insemination. FemaSeed affords a revolutionary different to IUI, enabling healthcare professionals to develop their follow companies with a simpler method as demonstrated within the pivotal trial (NCT0468847) for low male sperm depend.1 It serves as an inexpensive, much less burdensome and lower-risk first step earlier than IVF. Study extra at www.femaseed.com.
About FemVue
FemVue® is the primary FDA-cleared product that creates pure saline and air distinction for a protected, dependable, real-time analysis of the fallopian tubes utilizing ultrasound. When mixed with a uterine cavity evaluation, it offers a complete examination within the consolation of the gynecologist’s workplace. Since FemaSeed infertility therapy requires a minimum of one open fallopian tube, FemVue is an important companion diagnostic. Study extra at www.femvue.com.
About FemCerv
FemCerv® is the primary and solely FDA-cleared product purposefully designed to gather a complete and uncontaminated pattern in a pain-free workplace process for the detection of cervical most cancers. Study extra at www.femcerv.com.
About Femasys
Femasys, an Atlanta-based main biomedical innovator, develops and commercializes a portfolio of patent-protected, minimally invasive girls’s well being options, all manufactured within the U.S. Our modern therapeutic and diagnostic merchandise have acquired international regulatory approvals and are being commercialized within the U.S. and choose nations. FemaSeed® Intratubal Insemination, a groundbreaking infertility therapy delivering sperm on to the location of conception, is U.S. FDA-cleared and accredited in Europe, UK, Canada and Israel. FemVue®, a companion diagnostic for fallopian tube evaluation by way of ultrasound, is U.S. FDA-cleared with approvals in Europe, UK, Canada, Japan and Israel. FemCerv®, an endocervical tissue sampler for cervical most cancers prognosis, is U.S. FDA-cleared with approvals in Europe, UK, Canada and Israel. FemBloc® everlasting contraception, the Firm’s late-stage product candidate, is the primary and solely non-surgical, in-office, methodology providing vital advantages over the expensive, inconvenient, risk-laden surgical different. The pivotal scientific trial (NCT05977751) is now enrolling contributors for U.S. approval. FemCath® and FemChec®, companion diagnostic merchandise for FemBloc’s ultrasound-based affirmation take a look at, are U.S. FDA-cleared and accredited in Europe and Canada. Study extra at www.femasys.com, or comply with us on X, Fb and LinkedIn.
Reference
1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Okay. Lee-Sepsick (2024). FemaSeed Directional Intratubal Synthetic Insemination for {Couples} with Male-Issue or Unexplained Infertility Related to Low Male Sperm Depend. J Gynecol Reprod Med, 8(2), 01-12.
Ahead-Wanting Statements
This press release comprises forward-looking statements which can be topic to substantial dangers and uncertainties. Ahead-looking statements will be recognized by phrases akin to “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the unfavourable of those phrases or different comparable expressions, though not all forward-looking statements comprise these phrases. Ahead-looking statements are based mostly on our present expectations and are topic to inherent uncertainties, dangers and assumptions, lots of that are past our management, tough to foretell and will trigger precise outcomes to vary materially from what we anticipate. Additional, sure forward-looking statements are based mostly on assumptions as to future occasions that will not show to be correct. Elements that would trigger precise outcomes to vary embrace, amongst others: our capacity to develop and advance our present product candidates and applications into, and efficiently provoke, enroll and full, scientific trials; the power of our scientific trials to reveal security and effectiveness of our product candidates and different optimistic outcomes; estimates concerning the overall addressable marketplace for our merchandise and product candidates; our capacity to commercialize our merchandise and product candidates, our capacity to determine, keep, develop or enhance gross sales and revenues, or the impact of delays in commercializing our merchandise, together with FemaSeed; our enterprise mannequin and strategic plans for our merchandise, applied sciences and enterprise, together with our implementation thereof; and people different dangers and uncertainties described within the part titled “Risk Factors” in our Annual Report on Type 10-Okay for the 12 months ended December 31, 2023, and different stories as filed with the SEC. Ahead-looking statements contained on this press release are made as of this date, and Femasys undertakes no obligation to replace such data besides as required beneath relevant regulation.
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Firm Identify: Femasys Inc.
Contact Particular person: Media Relations
E-mail: Media@femasys.com
Web site: https://www.femasys.com/
State: Atlanta
Nation: United States