Femasys Expands FemSperm™ Product Line with New Insemination Prep Kit to Broaden Gynecology-Based Access to FemaSeed®
Femasys Inc. (NASDAQ: FEMY) has launched its new FemSperm Insemination Prep Kit, completing the sperm preparation component of their FemSperm product line. This development enables gynecologists to perform FemaSeed Intratubal Insemination procedures directly in their offices.
The kit works in conjunction with the FemSperm Setup kit to optimize sperm preparation for FemaSeed procedures. This innovation targets the estimated 10 million U.S. women facing infertility, offering a more accessible fertility treatment option through gynecologist offices, as an alternative to traditional IVF centers which only perform about 200,000 transfer cycles annually.
FemaSeed has demonstrated superior efficacy, achieving more than double the pregnancy rates of intrauterine insemination (IUI) in cases of low male sperm count during its pivotal trial. The treatment is currently authorized in multiple markets including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand.
Femasys Inc. (NASDAQ: FEMY) ha lanciato il nuovo FemSperm Insemination Prep Kit, completando il componente di preparazione dello sperma della linea di prodotti FemSperm. Questo sviluppo consente ai ginecologi di eseguire direttamente nei propri studi le procedure di FemaSeed Intratubal Insemination.
Il kit va utilizzato insieme al FemSperm Setup kit per ottimizzare la preparazione degli spermatozoi nelle procedure FemaSeed. L’innovazione è rivolta alle circa 10 milioni di donne statunitensi che affrontano l’infertilità, offrendo un’opzione di trattamento della fertilità più accessibile tramite gli studi ginecologici, rispetto ai centri tradizionali di IVF che eseguono solo circa 200.000 cicli di trasferimento all’anno.
FemaSeed ha mostrato una efficacia superiore, raggiungendo nel trial fondamentale tassi di gravidanza più che doppi rispetto all’inseminazione intrauterina (IUI) nei casi di conteggio spermatico maschile ridotto. Il trattamento è attualmente autorizzato in diversi mercati, tra cui Stati Uniti, Europa, Regno Unito, Canada, Israele, Australia e Nuova Zelanda.
Femasys Inc. (NASDAQ: FEMY) ha lanzado su nuevo FemSperm Insemination Prep Kit, completando el componente de preparación de esperma de su línea FemSperm. Este avance permite que los ginecólogos realicen procedimientos de FemaSeed Intratubal Insemination directamente en sus consultorios.
El kit se utiliza junto con el FemSperm Setup kit para optimizar la preparación del esperma en los procedimientos FemaSeed. La innovación está dirigida a las aproximadamente 10 millones de mujeres en EE. UU. que enfrentan infertilidad, ofreciendo una opción de tratamiento de fertilidad más accesible a través de los consultorios ginecológicos, frente a los centros tradicionales de FIV que realizan solo unos 200.000 ciclos de transferencia al año.
FemaSeed ha demostrado una eficacia superior, alcanzando en su ensayo pivotal tasas de embarazo más del doble que la inseminación intrauterina (IUI) en casos de bajo recuento de espermatozoides masculinos. El tratamiento está autorizado actualmente en varios mercados, incluidos EE. UU., Europa, Reino Unido, Canadá, Israel, Australia y Nueva Zelanda.
Femasys Inc. (NASDAQ: FEMY)가 새로운 FemSperm Insemination Prep Kit을 출시하여 FemSperm 제품군의 정자 준비 부문을 완성했습니다. 이로써 산부인과 의사들이 진료실에서 직접 FemaSeed Intratubal Insemination 시술을 시행할 수 있게 되었습니다.
이 키트는 FemSperm Setup kit와 함께 사용되어 FemaSeed 시술을 위한 정자 준비를 최적화합니다. 이 혁신은 불임을 겪고 있는 미국 내 약 1,000만 명의 여성을 겨냥해, 연간 약 20만 건의 이식 사이클만 수행하는 기존 IVF 센터 대신 산부인과 진료실에서 보다 접근하기 쉬운 생식 치료 옵션을 제공합니다.
FemaSeed는 주요 임상시험에서 남성 정자 수 감소의 경우 인공수정(IUI)보다 임신율이 두 배 이상 높은 우수한 효능을 입증했습니다. 이 치료법은 현재 미국, 유럽, 영국, 캐나다, 이스라엘, 호주 및 뉴질랜드 등 여러 시장에서 승인되어 있습니다.
Femasys Inc. (NASDAQ: FEMY) a lancé son nouveau FemSperm Insemination Prep Kit, complétant ainsi le volet préparation du sperme de sa gamme FemSperm. Cette avancée permet aux gynécologues de réaliser des procédures de FemaSeed Intratubal Insemination directement en cabinet.
Le kit s'utilise conjointement avec le FemSperm Setup kit pour optimiser la préparation des spermatozoïdes pour les procédures FemaSeed. Cette innovation s'adresse aux
FemaSeed a démontré une efficacité supérieure, obtenant lors de son essai pivot des taux de grossesse plus du double de ceux de l'insémination intra-utérine (IUI) en cas de faible numération de spermatozoïdes chez l'homme. Le traitement est actuellement autorisé sur plusieurs marchés, notamment aux États-Unis, en Europe, au Royaume‑Uni, au Canada, en Israël, en Australie et en Nouvelle‑Zélande.
Femasys Inc. (NASDAQ: FEMY) hat sein neues FemSperm Insemination Prep Kit vorgestellt und damit den Spermienvorbereitungs-Baustein der FemSperm-Produktlinie vervollständigt. Dadurch können Gynäkologen FemaSeed Intratubal Insemination-Verfahren direkt in ihren Praxen durchführen.
Das Kit wird zusammen mit dem FemSperm Setup Kit verwendet, um die Spermienvorbereitung für FemaSeed-Verfahren zu optimieren. Die Neuerung richtet sich an die geschätzten 10 Millionen Frauen in den USA, die mit Unfruchtbarkeit konfrontiert sind, und bietet eine leichter zugängliche Fruchtbarkeitsbehandlungsoption über gynäkologische Praxen als Alternative zu herkömmlichen IVF-Zentren, die nur etwa 200.000 Transferzyklen pro Jahr durchführen.
FemaSeed hat in der Schlüsslestudie eine überlegene Wirksamkeit gezeigt und bei vermindertem männlichen Spermienzählen mehr als doppelt so hohe Schwangerschaftsraten erzielt wie die intrauterine Insemination (IUI). Die Behandlung ist derzeit in mehreren Märkten zugelassen, darunter USA, Europa, Großbritannien, Kanada, Israel, Australien und Neuseeland.
- Clinical trials showed more than double pregnancy rates compared to IUI for low sperm count cases
- Expansion of market reach through tens of thousands of gynecologist offices
- Product addresses large untapped market of 10 million U.S. women facing infertility
- Multi-market authorization including U.S., Europe, UK, Canada, Israel, Australia and New Zealand
- Current IVF market penetration shows limited reach with only 200,000 transfer cycles annually
Insights
Femasys' new FemSperm kit completes their fertility solution ecosystem, substantially expanding addressable market through gynecologist offices.
Femasys has strategically expanded its product portfolio with the FemSperm Insemination Prep Kit, which completes the necessary toolset for gynecologists to perform FemaSeed Intratubal Insemination procedures in-office. This represents a pivotal market expansion strategy that shifts fertility treatment access from specialized fertility centers to standard gynecology practices.
The market opportunity is substantial. The company cites
The clinical advantage appears compelling. Their pivotal trial demonstrated more than double the pregnancy rates of traditional intrauterine insemination (IUI) in cases with low male sperm count. Positioned between basic fertility interventions and expensive IVF treatments, FemaSeed creates a new mid-tier option in the fertility care continuum.
The complete FemSperm system now provides gynecologists with both the Setup Kit and Insemination Prep Kit needed for in-office sperm preparation. This removes a critical workflow barrier that previously limited adoption and required patient referrals to specialized centers. By integrating directly into existing gynecology practices, Femasys is pursuing a streamlined commercialization approach that could accelerate market penetration and reduce patient access friction.
-- Following the Setup Kit, the Insemination Kit completes the sperm preparation portion of FemSperm enabling gynecology call point activation to drive revenue growth --
ATLANTA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced the introduction of its FemSperm Insemination Prep Kit, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination. The kit includes customized components, such as sperm washing for specific use with the FemSperm Setup kit to optimize sperm preparation for FemaSeed procedures.
This offering marks a key milestone in advancing Femasys’ gynecology-focused commercialization strategy for the FemaSeed platform and supports entry into the large, underserved fertility market. By providing a streamlined, in-office solution, the company is creating the foundation for gynecologist-driven adoption of FemaSeed as a first-step fertility treatment, broadening patient access to alternatives ahead of IVF and strengthening its long-term revenue growth strategy.
“The availability of the FemSperm Insemination Prep Kit completes the sperm preparation process required for FemaSeed and enables tens of thousands of gynecologists to offer our first-step fertility solution directly within their practices,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “Until now, most gynecologists have lacked a convenient method for sperm preparation. With an estimated 10 million U.S. women facing infertility and only about 200,000 IVF transfer cycles performed each year, the vast majority never reach a referral infertility center. By removing this barrier, we are making fertility care more accessible where women already receive care, at their gynecologist’s office.”
With the availability of the FemSperm product family, gynecologists can now perform sperm preparation and offer FemaSeed Intratubal Insemination directly within their practices. FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by delivering sperm precisely to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers a safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed achieved more than double the pregnancy rates of 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 www.femaseed.com.
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’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue®, 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® 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, United Kingdom in August 2025, and New Zealand in September 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®, 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.
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
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., Castaño, 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
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,” “suggests,” “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 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.
Contacts:
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com
FAQ
What is the new FemSperm Insemination Prep Kit by Femasys (NASDAQ: FEMY)?
How effective is FemaSeed compared to traditional IUI treatment?
What markets has Femasys received authorization for FemaSeed?
How many women could potentially benefit from Femasys's fertility treatment?
What advantages does FemaSeed offer over traditional fertility treatments?
