INVO Fertility Receives Notice of Allowance for Modified INVOcell Device Patent
INVO Fertility (Nasdaq: IVF) has received a notice of allowance for a new patent extending protection of its modified INVOcell device through 2040. The patent (Application No. 16/949,960) covers a simplified design based on embryologist feedback, removing the separate microchamber in favor of a singular main chamber.
INVOcell is the world's first FDA-cleared intravaginal culture (IVC) system that enables fertilization and embryo development within a woman's body. The device, which delivers comparable pregnancy rates to traditional IVF, was first FDA-cleared in 2015 and received additional clearance in 2023 for an extended 5-day incubation period.
INVO Fertility (Nasdaq: IVF) ha ricevuto un avviso di concessione per un nuovo brevetto che estende la protezione del suo dispositivo modificato INVOcell fino al 2040. Il brevetto (Domanda n. 16/949,960) riguarda un design semplificato basato sul feedback degli embriologi, eliminando la microcamera separata a favore di una camera principale unica.
INVOcell è il primo sistema di coltura intravaginale (IVC) autorizzato dalla FDA al mondo, che consente la fertilizzazione e lo sviluppo dell'embrione all'interno del corpo della donna. Il dispositivo, che offre tassi di gravidanza comparabili alla fecondazione in vitro tradizionale, è stato approvato per la prima volta dalla FDA nel 2015 e ha ricevuto un'ulteriore approvazione nel 2023 per un periodo di incubazione esteso a 5 giorni.
INVO Fertility (Nasdaq: IVF) ha recibido una notificación de concesión para una nueva patente que extiende la protección de su dispositivo modificado INVOcell hasta 2040. La patente (Solicitud No. 16/949,960) cubre un diseño simplificado basado en comentarios de embriólogos, eliminando la microcámara separada en favor de una cámara principal única.
INVOcell es el primer sistema de cultivo intravaginal (IVC) aprobado por la FDA en el mundo, que permite la fertilización y el desarrollo del embrión dentro del cuerpo de la mujer. El dispositivo, que ofrece tasas de embarazo comparables a la FIV tradicional, fue aprobado por primera vez por la FDA en 2015 y recibió una aprobación adicional en 2023 para un período extendido de incubación de 5 días.
INVO Fertility (나스닥: IVF)는 수정된 INVOcell 장치의 보호 기간을 2040년까지 연장하는 새로운 특허 허가 통지를 받았습니다. 이 특허(출원 번호 16/949,960)는 배아학자의 피드백을 반영하여 별도의 마이크로 챔버를 제거하고 단일 메인 챔버로 단순화된 설계를 포함합니다.
INVOcell은 여성의 몸 안에서 수정과 배아 발달을 가능하게 하는 세계 최초의 FDA 승인 인트라바지널 배양(IVC) 시스템입니다. 이 장치는 전통적인 체외수정(IVF)과 유사한 임신율을 제공하며, 2015년에 처음 FDA 승인을 받았고 2023년에는 5일간의 연장된 배양 기간에 대한 추가 승인을 받았습니다.
INVO Fertility (Nasdaq : IVF) a reçu un avis d'acceptation pour un nouveau brevet prolongeant la protection de son dispositif modifié INVOcell jusqu'en 2040. Le brevet (numéro de demande 16/949,960) couvre un design simplifié basé sur les retours des embryologistes, supprimant la microchambre séparée au profit d'une chambre principale unique.
INVOcell est le premier système de culture intravaginale (IVC) approuvé par la FDA au monde, permettant la fécondation et le développement embryonnaire à l'intérieur du corps de la femme. Le dispositif, qui offre des taux de grossesse comparables à ceux de la FIV traditionnelle, a été approuvé pour la première fois par la FDA en 2015 et a reçu une autorisation supplémentaire en 2023 pour une période d'incubation prolongée de 5 jours.
INVO Fertility (Nasdaq: IVF) hat eine Zulassungsmitteilung für ein neues Patent erhalten, das den Schutz seines modifizierten INVOcell-Geräts bis 2040 verlängert. Das Patent (Antragsnummer 16/949.960) umfasst ein vereinfachtes Design basierend auf dem Feedback von Embryologen, bei dem die separate Mikrokammer zugunsten einer einzigen Hauptkammer entfernt wurde.
INVOcell ist das weltweit erste von der FDA zugelassene intravaginale Kultursystem (IVC), das Befruchtung und Embryonalentwicklung im Körper der Frau ermöglicht. Das Gerät, das vergleichbare Schwangerschaftsraten wie die herkömmliche IVF bietet, wurde erstmals 2015 von der FDA zugelassen und erhielt 2023 eine zusätzliche Zulassung für eine verlängerte Inkubationszeit von 5 Tagen.
- New patent extends intellectual property protection through 2040
- Device modification simplifies usage based on professional feedback
- Comparable pregnancy rates to traditional IVF
- FDA clearance for extended 5-day incubation period received in 2023
- None.
Insights
INVO's patent allowance extends INVOcell protection to 2040 with design improvements addressing clinician feedback, strengthening their market position.
The patent allowance for INVO Fertility's modified INVOcell device represents a significant intellectual property milestone that extends protection through 2040. The modification—simplifying the device to a singular main chamber without a separate microchamber—directly addresses feedback from embryologists who use the device clinically, potentially improving usability and adoption rates.
This patent builds upon INVO's existing regulatory achievements, including the original 2015 FDA clearance and the 2023 labeling update that extended the incubation period from 3 to 5 days. The extended incubation period is particularly noteworthy as it allows for blastocyst-stage embryo development, which typically yields higher success rates in fertility treatments.
From a competitive standpoint, this patent strengthens INVO's position in the fertility market by protecting their unique intravaginal culture approach. The company's claim of comparable pregnancy rates to traditional IVF (backed by FDA-reviewed data) combined with extended patent protection creates a sustainable competitive advantage in a growing market.
The simplified device design addresses a critical adoption barrier—ease of use for clinical embryologists—which could accelerate market penetration. While not explicitly stated, such design improvements typically reduce complexity in clinical workflows, potentially lowering the training burden for new clinics adopting the technology.
This patent allowance effectively secures INVO's core technology against competitive replication for nearly 15 more years, providing a substantial runway for market development and potential licensing opportunities in both domestic and international markets.
SARASOTA, Fla., June 25, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare company focused on the fertility sector, today announced it has received a notice of allowance on a new patent for a modified version of the Company’s proprietary INVOcell device. The new patent extends intellectual property protection on the Company’s INVOcell device through 2040 based on a modified design which reflects feedback from leading embryologists to simplify use of the device.
The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 16/949,960, titled "Intravaginal Culture Incubation Container and Method." The Notice of Allowance, dated June 17, 2025, indicates that the USPTO has completed its examination and found the claims patentable. Once the issue fee is paid, the patent will be granted and published, providing protection to the claimed invention for 20 years from the filing date.
INVOcell is the world’s first FDA-cleared intravaginal culture (IVC) system, a patented medical device that enables fertilization and early embryo development to occur within a woman’s body, offering a more natural and intimate alternative to traditional in vitro fertilization (IVF). During the INVOcell procedure, eggs and sperm are placed in the thumb-sized device, which is then inserted into the vaginal cavity, typically, for a 5-day incubation period, utilizing the body’s natural environment as an incubator. After incubation, embryos are transferred to the uterus, with any remaining embryos available for freezing. This innovative approach delivers comparable pregnancy rates to IVF—as reflected in the Company’s 510k submission that was cleared by the FDA in 2023.
INVOcell was originally granted FDA clearance in 2015 and, in 2023, received clearance from the FDA for a change in labeling that increased the incubation period from 3 days to 5 days. The original INVOcell device included both a main chamber and microchamber. As real-world use cases of INVOcell have occurred over the past number of years, feedback from embryologists highlighted a preference for a singular main chamber without a separate microchamber. The Company redesigned the INVOcell device to reflect the feedback and subsequently submitted a modified device design for patent.
“The INVOcell device has represented a unique and alternative fertility treatment option, offering a more patient-centered approach that empowers couples by allowing fertilization and early embryo development to occur within the woman’s body,” commented Steve Shum, CEO of INVO Fertility. “The receipt of a new patent for our simplified device expands our intellectual property protection to this innovative approach, which delivers success rates comparable to traditional IVF, helping to make parenthood more accessible and inclusive for those facing infertility challenges worldwide.”
About INVO Fertility
We are a healthcare fertility company dedicated to expanding assisted reproductive technology (”ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. The INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more natural, intimate, and affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination (“IUI”). For more information, please visit www.invofertility.com.
Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events, or otherwise.
For more information, please contact:
INVO Fertility, Inc.
Steve Shum, CEO
978-878-9505
sshum@invobio.com
Investor Contact
Lytham Partners, LLC
Robert Blum
602-889-9700
INVO@lythampartners.com
FAQ
What is the new patent allowance for INVO Fertility's (IVF) INVOcell device?
How does the INVO Fertility (IVF) INVOcell device work?
What are the success rates of INVO Fertility's (IVF) INVOcell compared to traditional IVF?
What modifications were made to INVO Fertility's (IVF) INVOcell device?
When did INVO Fertility (IVF) receive FDA clearance for INVOcell?
