Femasys Announces FemSperm鈩� Kit to Activate Gynecologists and Advance FemaSeed庐 Fertility Platform
Femasys (NASDAQ: FEMY) has introduced the FemSperm Setup Kit, the first product in a planned series designed to enable gynecologists to perform FemaSeed Intratubal Insemination in their offices. The kit includes specialized components like a pre-configured centrifuge for optimizing sperm preparation.
FemaSeed is a next-generation artificial insemination solution that delivers sperm directly to the fallopian tube. In pivotal trials, it demonstrated more than double the pregnancy rates compared to IUI in cases of low male sperm count. The treatment is currently authorized in multiple markets including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand.
Femasys (NASDAQ: FEMY) ha lanciato il FemSperm Setup Kit, il primo prodotto di una serie progettata per permettere ai ginecologi di eseguire in ambulatorio la FemaSeed Intratubal Insemination. Il kit contiene componenti specifici, tra cui una centrifuga preconfigurata per ottimizzare la preparazione dello sperma.
FemaSeed 猫 una soluzione di inseminazione artificiale di nuova generazione che deposita lo sperma direttamente nelle tube di Falloppio. Nei trial fondamentali ha mostrato tassi di gravidanza pi霉 che doppi rispetto alla IUI nei casi di bassa conta spermatozoaria maschile. Il trattamento 猫 attualmente autorizzato in diversi mercati, tra cui USA, Europa, Regno Unito, Canada, Israele, Australia e Nuova Zelanda.
Femasys (NASDAQ: FEMY) ha presentado el FemSperm Setup Kit, el primer producto de una serie destinada a permitir que los ginec贸logos realicen en consulta la FemaSeed Intratubal Insemination. El kit incluye componentes especializados, como una centrifugadora preconfigurada para optimizar la preparaci贸n del esperma.
FemaSeed es una soluci贸n de inseminaci贸n artificial de nueva generaci贸n que entrega los espermatozoides directamente en la trompa de Falopio. En ensayos clave demostr贸 tasas de embarazo m谩s del doble que la IUI en casos de baja concentraci贸n esperm谩tica masculina. El tratamiento est谩 autorizado actualmente en varios mercados, incluidos EE. UU., Europa, Reino Unido, Canad谩, Israel, Australia y Nueva Zelanda.
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FemaSeed電� 鞝曥瀽毳� 雮滉磤鞙茧 歆侅爲 鞝勲嫭頃橂姅 彀劯雽� 鞚戈车靾橃爼 靻旊（靺橃瀰雼堧嫟. 欤检殧 鞛勳儊鞁滍棙鞐愳劀 雮劚 鞝曥瀽 靾橁皜 雮潃 瓴届毎 IUI鞐� 牍勴暣 鞛勳嫚鞙澊 霊� 氚� 鞚挫儊 雴掙矊 雮橅儉雮姷雼堧嫟. 鞚� 旃橂氩曥潃 順勳灛 氙戈淡, 鞙犽熃, 鞓侁淡, 旌愲倶雼�, 鞚挫姢霛检棙, 順胳＜ 氚� 雺挫霝滊摐 霌� 鞐煬 鞁滌灔鞐愳劀 項堦皜毳� 氚涭晿鞀惦媹雼�.
Femasys (NASDAQ: FEMY) a lanc茅 le FemSperm Setup Kit, le premier produit d'une s茅rie con莽ue pour permettre aux gyn茅cologues de r茅aliser en cabinet l'Insemination Intratubaire FemaSeed. Le kit comprend des 茅l茅ments sp茅cialis茅s, notamment une centrifugeuse pr茅configur茅e pour optimiser la pr茅paration du sperme.
FemaSeed est une solution d'ins茅mination artificielle de nouvelle g茅n茅ration qui d茅pose les spermatozo茂des directement dans la trompe de Fallope. Lors des essais pivots, elle a montr茅 des taux de grossesse plus du double de ceux de l'IUI en cas de faible num茅ration spermatique masculine. Le traitement est actuellement autoris茅 sur plusieurs march茅s, dont les 脡tats-Unis, l'Europe, le Royaume-Uni, le Canada, Isra毛l, l'Australie et la Nouvelle-Z茅lande.
Femasys (NASDAQ: FEMY) hat das FemSperm Setup Kit eingef眉hrt, das erste Produkt einer geplanten Reihe, die Gyn盲kologen bef盲higen soll, die FemaSeed Intratubal Insemination in ihrer Praxis durchzuf眉hren. Das Kit enth盲lt spezialisierte Komponenten, darunter eine vorkonfigurierte Zentrifuge zur Optimierung der Spermienaufbereitung.
FemaSeed ist eine n盲chste Generation der k眉nstlichen Insemination, die Spermien direkt in die Eileiter liefert. In entscheidenden Studien zeigte sie bei niedriger Spermienzahl des Mannes mehr als doppelt so hohe Schwangerschaftsraten im Vergleich zur IUI. Die Behandlung ist derzeit in mehreren M盲rkten zugelassen, darunter USA, Europa, Gro脽britannien, Kanada, Israel, Australien und Neuseeland.
- FemaSeed showed double pregnancy rates vs IUI in low sperm count cases
- Product already authorized in major markets including US, Europe, UK, Canada
- Strategic expansion into gynecologist offices expands market accessibility
- Positions company for scalable revenue growth through wider distribution
- Product still requires gynecologist adoption and training
- Faces competition from established fertility treatments like IUI and IVF
Insights
Femasys' new FemSperm Setup Kit strategically expands their fertility platform by enabling gynecologists to offer FemaSeed treatments directly, potentially accelerating revenue growth.
Femasys (NASDAQ: FEMY) has launched the FemSperm Setup Kit, a strategic product designed to enable gynecologists to perform FemaSeed Intratubal Insemination procedures in-office. This represents a significant commercial expansion for their fertility platform by moving treatment access upstream in the patient journey.
The kit includes specialized equipment like a pre-configured centrifuge for sperm preparation, effectively removing a technical barrier that previously limited FemaSeed adoption among gynecologists. This is noteworthy because gynecologists typically serve as women's first point of contact for fertility concerns, well before patients reach reproductive endocrinologists or IVF specialists.
From a market positioning perspective, Femasys is attempting to establish FemaSeed as a first-line fertility treatment that precedes more invasive and expensive options like IVF. Their clinical data claiming pregnancy rates more than double those of traditional intrauterine insemination (IUI) for low sperm count cases provides a compelling value proposition if reproducible in real-world settings.
The commercial strategy appears focused on creating an ecosystem of products around the core FemaSeed platform, with this Setup Kit described as the "first in a planned family of products." This suggests a razor-and-blade business model that could drive recurring revenue if successfully implemented.
While the announcement doesn't provide specific revenue projections or pricing details, the company's expansion of FemaSeed into gynecology practices significantly increases their potential market penetration by targeting the much larger number of gynecologists versus reproductive specialists.
-- First in the FemSperm family, the Setup Kit enables gynecologists to offer FemaSeed directly, expanding access ahead of IVF and driving revenue growth --
ATLANTA, Aug. 21, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, today announced the introduction of its FemSperm Setup Kit, the first in a planned family of products designed to fully enable gynecologists for FemaSeed Intratubal Insemination. The setup kit includes customized components, such as a pre-configured centrifuge to optimize sperm preparation for use with FemaSeed. By providing a streamlined, in-office solution, Femasys is establishing the foundation for gynecologist-driven adoption of FemaSeed as a first-step fertility treatment, expanding patient access to alternatives ahead of IVF and advancing the Company鈥檚 commercialization strategy.
鈥淥ur FemSperm Setup Kit represents the beginning of a broader family of products designed to fully activate gynecologists to adopt and expand FemaSeed use,鈥� said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. 鈥淭his strategic step strengthens our commercialization pathway by bringing FemaSeed into the hands of the physicians who see patients first, opening new access points for women seeking fertility care and positioning Femasys for scalable revenue growth.鈥�
"With decades of experience in reproductive medicine and as an investigator in the completed FemaSeed trial, I performed the procedure firsthand and know it is ideally suited for gynecologists to perform," said Dr. James Liu, Chief Medical Officer of Femasys and Former Chairman, Department of Obstetrics and Gynecology, University Hospital System, Former Chair, Department of Reproductive Biology, Case Western Reserve University and Former Division Director of Reproductive Endocrinology and Infertility, University of Cincinnati. "Introducing sperm preparation into the gynecology office is a necessary step to enable this pathway. With FemaSeed, fertility care can begin in the gynecologist鈥檚 practice, the primary setting for family planning, making treatment more accessible and affordable for women earlier in their fertility journey."
FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by precisely delivering sperm to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed established more than double the pregnancy rates compared to IUI in cases of low male sperm count.1 As an affordable, less invasive, lower-risk option before IVF, FemaSeed is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand. Learn more at .
About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys鈥� fertility portfolio includes FemaSeed庐 Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue庐, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1
FemBloc庐 permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025 followed by UK in August 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec庐, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.
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References
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.
2Liu, J. H., Blumenthal, P. D., Casta帽o, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.
Forward-Looking Statements听
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 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渁nticipate,鈥� 鈥渃ould,鈥� 鈥減ending,鈥� 鈥渋ntend,鈥� 鈥渂elieve,鈥� 鈥渟uggests,鈥� 鈥減otential,鈥� 鈥渉ope,鈥� or 鈥渃ontinue鈥� 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.听Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; 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, 2024, 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.
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FAQ
What is the FemSperm Setup Kit announced by Femasys (NASDAQ: FEMY)?
How effective is FemaSeed compared to traditional IUI treatment?
Where is Femasys's FemaSeed treatment currently authorized?
What advantages does FemaSeed offer over traditional fertility treatments?
How does the FemSperm Kit advance Femasys's business strategy?
