INVO Fertility Announces Patent Issuance for Modified INVOcell® Device

Rhea-AI Summary

INVO Fertility (Nasdaq: IVF) announced issuance of U.S. Patent No. 12,544,204 B2 effective February 10, 2026, covering a modified INVOcell device design. The patent extends intellectual property protection for the INVOcell intravaginal culture system through 2040. The device has prior FDA clearances in 2015 and a 2023 labeling update.

Positive

• U.S. Patent No. 12,544,204 B2 issued on Feb 10, 2026
• Intellectual property protection extended for INVOcell through 2040
• INVOcell retains prior FDA clearances (2015) and a 2023 labeling update

Negative

• Patent term runs only through 2040 (14 years from issuance)

Market Reaction

+10.81% $1.23

15m delay 11 alerts

+10.81% Since News

$1.23 Last Price

$1.13 $1.25 Day Range

+$835K Valuation Impact

$9M Market Cap

0.0x Rel. Volume

Following this news, IVF has gained 10.81%, reflecting a significant positive market reaction. Our momentum scanner has triggered 11 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $1.23. This price movement has added approximately $835K to the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Patent number: U.S. Patent No. 12,544,204 B2 Patent protection through: 2040 Patent effective date: February 10, 2026 +4 more

7 metrics

Patent number U.S. Patent No. 12,544,204 B2 Modified INVOcell device patent

Patent protection through 2040 Intellectual property term for INVOcell device

Patent effective date February 10, 2026 U.S. patent for modified INVOcell device

Initial FDA clearance 2015 First FDA clearance for INVOcell device

Labeling update year 2023 Additional FDA clearance for incubation period labeling

Original incubation period 3 days Initial recommended INVOcell incubation period

Updated incubation period 5 days Extended recommended INVOcell incubation period after 2023 clearance

Market Reality Check

Price: $1.11 Vol: Volume 579,863 is low ver...

low vol

$1.11 Last Close

Volume Volume 579,863 is low versus 20-day average 20,777,591 (relative volume 0.03). low

Technical Shares trade well below the 200-day MA of $14.13, at a pre-news price of $1.11.

Peers on Argus

IVF showed a small pre-news gain of 0.45%, while key medical device peers like V...

IVF showed a small pre-news gain of 0.45%, while key medical device peers like VERO (-29.75%), NAOV (-1.95%), and NUWE (-1.53%) were down, suggesting stock-specific dynamics rather than a sector-wide move.

Historical Context

5 past events · Latest: Feb 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 04	Shareholder letter	Positive	-7.8%	CEO outlined strengthened balance sheet and dual organic/clinic acquisition strategy.
Jan 29	Warrant inducement	Negative	-13.0%	Lowered warrant exercise price and issued new warrants for $7.5M gross proceeds.
Jan 13	Conference participation	Neutral	-4.8%	Announcement of participation in Lytham Partners 2026 Investor Healthcare Summit.
Dec 30	Leadership changes	Positive	+10.0%	Executive realignment to support clinic-acquisition growth via INVO Centers LLC.
Dec 17	Clinic acquisition	Positive	-9.8%	Definitive deal to acquire Indiana fertility clinic Family Beginnings for $750,000.

Pattern Detected

Positive strategic and financing updates often saw mixed or negative next-day reactions, while a leadership realignment was followed by a notable gain.

Recent Company History

Over recent months, INVO reported clinic acquisition activity, leadership realignment, financing transactions, and strategic updates. The acquisition of the Family Beginnings clinic and a shareholder letter highlighting a stronger fundamental position both carried constructive strategic messages but saw negative price reactions. A warrant inducement financing also preceded a decline. In contrast, the executive leadership alignment on Dec 30, 2025 coincided with a near 10% rise. Today’s patent issuance further builds on the INVOcell platform focus seen throughout these updates.

Market Pulse Summary

The stock is surging +10.8% following this news. A strong positive reaction aligns with the clearly ...

Analysis

The stock is surging +10.8% following this news. A strong positive reaction aligns with the clearly favorable nature of this patent issuance, which extends IP protection on INVOcell through 2040. Historically, INVO’s positive strategic updates have produced mixed price responses, so an outsized move could reflect repositioning from a deeply depressed level versus the 52-week high of $76.80. Investors would need to monitor how quickly the company leverages this protection via clinic growth and device adoption.

Key Terms

intravaginal culture, in vitro fertilization, FDA-cleared

3 terms

intravaginal culture medical

"INVOcell is the world’s first FDA-cleared intravaginal culture (IVC) system"

A fertility technique in which eggs and sperm are placed together inside a small, sealed device that is inserted into the woman’s vagina so fertilization and initial embryo development occur using body heat instead of a full laboratory incubator. For investors, it matters because it can lower clinic costs, broaden access to assisted reproduction, and shift demand toward smaller medical devices and different regulatory and reimbursement pathways—similar to moving part of a factory process back into the customer's hands.

in vitro fertilization medical

"alternative to traditional in vitro fertilization (IVF). INVOcell was initially"

In vitro fertilization (IVF) is a medical procedure that fertilizes an egg with sperm outside the body in a laboratory dish, then transfers the resulting embryo to a uterus to achieve pregnancy. Investors care because IVF drives demand for specialized clinics, medical devices, drugs, and insurance coverage—similar to how a new product line creates sales and service needs—so changes in treatment success rates, regulation, or patient demand can affect revenues and costs across healthcare and biotech companies.

FDA-cleared regulatory

"INVOcell is the world’s first FDA-cleared intravaginal culture (IVC) system"

FDA-cleared means a medical product—typically a device or diagnostic—has passed a U.S. regulator’s review showing it is substantially similar to an existing approved product and is safe and effective for its intended use. For investors, clearance acts like an official safety stamp that lowers regulatory risk and can speed market access, comparable to getting a trusted roadworthy certificate before selling cars, which can make sales and adoption happen faster.

AI-generated analysis. Not financial advice.

New patent extends intellectual property protection on the Company’s INVOcell device through 2040

SARASOTA, Fla., Feb. 11, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO” or the “Company”), a healthcare fertility company focused on the establishment, acquisition, and operation of fertility clinics and related businesses and technologies, today announced the final issuance of a U.S. patent covering a modified version of its proprietary INVOcell^® device. The patent (U.S. Patent No. 12,544,204 B2) became effective on February 10, 2026, providing intellectual property protection on the INVOcell device through 2040.

INVOcell is the world’s first FDA-cleared intravaginal culture (IVC) system—a patented medical device for assisted reproductive care that allows fertilization and early embryo development to take place within a woman’s body, offering a more natural and patient-centered alternative to traditional in vitro fertilization (IVF).

INVOcell was initially granted FDA clearance in 2015 and, in 2023, received additional FDA clearance for a labeling update that extended the recommended incubation period from three days to five days. The original INVOcell device design incorporated both a main chamber and a microchamber. Through years of real-world clinical use and feedback from practitioners, a simplified design featuring a single main chamber without a separate microchamber was designed. The Company subsequently submitted the modified design for patent protection which has now been granted.

“We are pleased to see our previously announced patent allowance conclude with this official issuance, which marks an important milestone for INVO Fertility as we continue to strengthen the intellectual property foundation around the INVOcell platform,” said Steve Shum, CEO of INVO Fertility. “INVOcell provides an additional treatment method in the fertility market, enabling fertilization and early embryo development to occur within the patient’s body rather than a traditional laboratory incubator. This expanded IP coverage supports our growth strategy and our mission to deliver high-quality fertility care through ongoing innovation.”

About INVO Fertility

We are a healthcare services fertility company dedicated to expanding access to 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 INVOcell to third-party owned and operated fertility clinics. 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 connected, 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. For more information, please visit 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 the Company’s ability to satisfy closing conditions for the offering, 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@invofertility.com

Investor Contact
Lytham Partners, LLC
Robert Blum
602-889-9700
INVO@lythampartners.com

FAQ

What patent did INVO Fertility (IVF) receive on February 10, 2026?

INVO Fertility received U.S. Patent No. 12,544,204 B2 effective February 10, 2026. According to the company, the patent covers a modified INVOcell device design and extends IP protection for the product through 2040.

How does the new patent affect INVOcell's intellectual property protection timeline for IVF?

The patent extends INVOcell intellectual property protection through 2040. According to the company, the issuance secures rights for the modified single-chamber design and supports its IP foundation for future commercialization and clinic operations.

What design change is covered by the INVO Fertility patent for INVOcell (IVF)?

The patent covers a simplified INVOcell featuring a single main chamber without a separate microchamber. According to the company, the modified design resulted from clinical use and practitioner feedback and was submitted for patent protection.

Does the INVOcell device have FDA clearance alongside the 2026 patent for IVF?

Yes. INVOcell holds initial FDA clearance from 2015 and a 2023 labeling update extending incubation from three to five days. According to the company, these clearances remain part of the device's regulatory profile.

What is the potential investor significance of the INVO Fertility (IVF) patent issuance?

The patent issuance strengthens INVOcell intellectual property through 2040, which may support competitive positioning. According to the company, the expanded IP coverage aligns with its growth strategy and continued innovation in fertility clinic technologies.