Femasys Announces Notice of Allowance for New U.S. Patent Application Covering Use of FemaSeed® for Female Infertility Treatment
Femasys (NASDAQ: FEMY) has received a Notice of Allowance from the USPTO for U.S. Patent Application 18/443,798, strengthening its intellectual property position for FemaSeed® Intratubal Insemination, a therapeutic product for female infertility treatment. The new patent, expected to expire no earlier than 2044, adds to Femasys' portfolio of over 180 patents globally.
The company plans to pursue additional patent applications to enhance protection for FemaSeed® and other products, including FemBloc® permanent birth control and diagnostic products FemVue®, FemCath®, and FemCerv®. FemaSeed is currently being marketed in the United States and Spain as a solution for women and couples seeking pregnancy assistance.
Femasys (NASDAQ: FEMY) ha ricevuto una Notifica di Concessione dall'USPTO per la domanda di brevetto statunitense 18/443,798, rafforzando la sua posizione di proprietà intellettuale per FemaSeed® Inseminazione Intratubale, un prodotto terapeutico per il trattamento dell'infertilità femminile. Il nuovo brevetto, previsto per scadere non prima del 2044, si aggiunge al portafoglio di oltre 180 brevetti globali di Femasys.
L'azienda prevede di perseguire ulteriori domande di brevetto per migliorare la protezione di FemaSeed® e di altri prodotti, inclusi FemBloc® per la contraccezione permanente e i prodotti diagnostici FemVue®, FemCath®, e FemCerv®. FemaSeed è attualmente commercializzato negli Stati Uniti e in Spagna come soluzione per donne e coppie in cerca di assistenza per la gravidanza.
Femasys (NASDAQ: FEMY) ha recibido un Aviso de Concesión de la USPTO para la Solicitud de Patente de EE. UU. 18/443,798, fortaleciendo su posición de propiedad intelectual para FemaSeed® Inseminación Intratubal, un producto terapéutico para el tratamiento de la infertilidad femenina. La nueva patente, que se espera que expire no antes de 2044, se suma al portafolio global de más de 180 patentes de Femasys.
La empresa planea presentar solicitudes de patentes adicionales para mejorar la protección de FemaSeed® y otros productos, incluidos FemBloc® para el control natal permanente y los productos de diagnóstico FemVue®, FemCath®, y FemCerv®. FemaSeed se está comercializando actualmente en los Estados Unidos y España como una solución para mujeres y parejas que buscan asistencia para la concepción.
Femasys (NASDAQ: FEMY)는 미국 특허 상표청(USPTO)으로부터 미국 특허 출원 18/443,798의 허가 통지를 받았으며, 이는 FemaSeed® 자궁내 수정에 대한 지적 재산권을 강화하는 것입니다. 새로운 특허는 2044년 이전에는 만료되지 않을 예정이며, Femasys의 전 세계 180개 이상의 특허 포트폴리오에 추가됩니다.
회사는 FemaSeed®와 FemBloc® 영구적 출산 조절 제품 및 FemVue®, FemCath®, FemCerv® 진단 제품에 대한 보호를 강화하기 위해 추가 특허 출원도 추진할 계획입니다. FemaSeed는 현재 미국과 스페인에서 임신 지원을 원하는 여성과 커플을 위한 해결책으로 판매되고 있습니다.
Femasys (NASDAQ: FEMY) a reçu un Avis de Concession de l'USPTO pour la Demande de Brevet américaine 18/443,798, renforçant sa position de propriété intellectuelle pour FemaSeed® Insemination Intratubale, un produit thérapeutique destiné au traitement de l'infertilité féminine. Le nouveau brevet, prévu pour expirer au plus tôt en 2044, s'ajoute au portefeuille de plus de 180 brevets mondiaux de Femasys.
L'entreprise envisage de poursuivre d'autres demandes de brevet pour améliorer la protection de FemaSeed® et d'autres produits, y compris FemBloc® pour la contraception permanente et les produits diagnostiques FemVue®, FemCath®, et FemCerv®. FemaSeed est actuellement commercialisé aux États-Unis et en Espagne comme une solution pour les femmes et les couples recherchant une aide à la procréation.
Femasys (NASDAQ: FEMY) hat eine Zulassungsbenachrichtigung vom USPTO für die US-Patentanmeldung 18/443,798 erhalten, was die Position des Unternehmens im Bereich des geistigen Eigentums für FemaSeed® Intratubale Insemination, ein therapeutisches Produkt zur Behandlung von weiblicher Unfruchtbarkeit, stärkt. Das neue Patent, das voraussichtlich nicht vor 2044 abläuft, erweitert das Portfolio von Femasys, das über 180 Patente weltweit umfasst.
Das Unternehmen plant, weitere Patentanmeldungen zu verfolgen, um den Schutz von FemaSeed® und anderen Produkten, einschließlich FemBloc® als permanente Verhütungsmethode und den Diagnoseprodukten FemVue®, FemCath®, und FemCerv®, zu verbessern. FemaSeed wird derzeit in den USA und Spanien als Lösung für Frauen und Paare vermarktet, die Unterstützung bei der Schwangerschaft suchen.
- Patent protection for FemaSeed® extended until at least 2044
- Product already commercialized in US and Spain markets
- Strong IP portfolio with over 180 global patents
- None.
Insights
This patent allowance significantly strengthens FEMY's intellectual property position for FemaSeed®, extending protection until at least 2044. The expanded coverage is particularly valuable for a commercialized product already being marketed in the US and Spain. The company's robust IP portfolio of over 180 global patents creates substantial barriers to entry for competitors in the female infertility treatment space.
The strategic timing of this patent application suggests careful IP portfolio management, as it provides extended market exclusivity for FemaSeed® well beyond the typical 20-year patent term of earlier filings. This layered patent strategy, known as 'patent thickets', effectively protects both the technology and its commercial applications, potentially deterring competitors from developing similar solutions.
The FemaSeed® intratubal insemination system represents a significant advancement in fertility treatment accessibility. Traditional fertility treatments often require complex clinical settings and substantial financial investment. This in-office solution potentially offers a more cost-effective and accessible alternative in the $15 billion global fertility treatment market.
The expanded patent protection strengthens FEMY's position in both current markets (US and Spain) and provides leverage for potential expansion into other territories. With the company's diverse portfolio including FemBloc®, FemVue®, FemCath® and FemCerv®, this patent allowance reinforces their comprehensive approach to women's health solutions. In simple terms - imagine having exclusive rights to sell a unique product that helps women become pregnant more easily and affordably - that's essentially what this patent provides FEMY until 2044.
FemaSeed® patent application provides additional coverage for Femasys’ therapeutic option for women seeking infertility solution
ATLANTA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces the United States Patent and Trademark Office (“USPTO”) issued a Notice of Allowance for U.S. Patent Application 18/443,798 further strengthening Femasys’ intellectual property position and coverage for the Company’s infertility therapeutic product FemaSeed® Intratubal Insemination.
Femasys expects the resulting patent, when issued, will have an anticipated expiration in 2044 at the earliest. Femasys intends to continue to prosecute additional patent applications to further enhance its existing patent portfolio protecting FemaSeed® along with FemBloc® permanent birth control, the Company’s late-stage product candidate, in addition to the Company’s other existing available diagnostic products, FemVue®, FemCath®, and FemCerv®.
“The allowance of claims for the FemaSeed infertility treatment is another important milestone in extending protection for this revolutionary infertility solution for women and couples seeking assistance in becoming pregnant, which is currently being marketed in the U.S. and Spain,” stated Kathy Lee-Sepsick, Femasys’ CEO. “Expansion of our patent portfolio, which consists of over 180 patents globally, demonstrates our strong commitment to protecting the innovation and commercial opportunity of FemaSeed, as well as our entire suite of products for women seeking better, lower cost, and more accessible options.”
About FemaSeed
FemaSeed® is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It is intended to be a first-line therapeutic choice for infertile women, men, and couples seeking pregnancy through insemination, offering a safe, accessible, and cost-effective approach. FemaSeed® is a revolutionary device that allows for the expansion of practice services by enabling healthcare professionals with a more affordable and safer alternative to assisted reproductive methods, such as in vitro fertilization (IVF). FemaSeed received U.S. FDA clearance (September 2023), regulatory approval in Canada (April 2023) and CE mark for Europe (June 2024). At the end of 2023, Femasys concluded a prospective, multi-center, pivotal clinical trial (NCT0468847) for those seeking intratubal insemination with FemaSeed. Positive data was published demonstrating FemaSeed as a safe and effective treatment option, with significantly higher efficacy as compared to historic intrauterine insemination for couples with male-factor/ unexplained infertility and low male sperm count.1 Learn more at www.femaseed.com.
About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® and FemVue® MINI for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
Reference
1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, K. Lee-Sepsick (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.
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 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 products and product candidates; our ability to commercialize our products and product candidates, 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, 2023, 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:
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FAQ
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