INNOVATE unit MediBeacon gains EU CE Mark for TGFR
INNOVATE Corp. reports that its equity method investment MediBeacon has received European Union CE Mark certification under the EU Medical Device Regulation 2017/745 for its TGFR Monitor and TGFR Reusable Sensor.
Rhea-AI Filing Summary
INNOVATE Corp. reports that its equity method investment MediBeacon has received European Union CE Mark certification under the EU Medical Device Regulation 2017/745 for its TGFR Monitor and TGFR Reusable Sensor. This confirms the devices meet EU safety, quality, and performance standards.
The TGFR System combines the Monitor, Reusable Sensor, Disposable Ring, and Lumitrace (relmapirazin) injection to assess kidney function by measuring fluorescent tracer clearance through the skin, providing a transdermal measure of glomerular filtration rate. Lumitrace injection is approved in the U.S. and China, with an EU submission pending, and the system is already approved for human use by the U.S. FDA and China NMPA.
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Insights
EU MDR CE Mark broadens MediBeacon’s regulatory footprint but financial impact for INNOVATE is not quantified.
MediBeacon, an equity method investment of INNOVATE, obtained EU MDR CE Mark certification for its TGFR Monitor and TGFR Reusable Sensor. This validates compliance with stringent European requirements and may support use of the system in clinical trials that include European sites, alongside ongoing clinical entry in the U.S. and China.
The TGFR System offers point-of-care transdermal kidney function assessment using Lumitrace injection and a wearable sensor, and it already has approvals from the U.S. FDA and China NMPA. However, the disclosure does not provide revenue, adoption, or market size metrics, so the direct economic effect for INNOVATE remains unclear based on this information alone.
The press release highlights forward-looking risks including growth management, product misuse, and protection of intellectual property, referencing broader risk factors in INNOVATE’s annual and quarterly reports. Future company filings may clarify how EU activities, additional regulatory submissions, and clinical research translate into commercialization and earnings contributions.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
EU regulation: EU MDR 2017/745
Device classification: Two Class IIa devices
Employees: Approximately 3,700 people
+5 more
8 metrics
EU regulation
EU MDR 2017/745
Regulation under which TGFR devices received CE Mark
Device classification
Two Class IIa devices
TGFR Monitor and TGFR Reusable Sensor
Employees
Approximately 3,700 people
INNOVATE employment across subsidiaries
US patents
Over 55 granted U.S. patents
MediBeacon intellectual property portfolio
Global patents
Over 250 granted patents worldwide
Coverage for TGFR System and pyrazine platform
Sensor sampling rate
2.5 readings per second
TGFR Reusable Sensor fluorescence recording rate
Kidney International article date
October 2024
Peer-reviewed validation of relmapirazin tracer
Commission file number
001-35210
INNOVATE SEC registration reference
Key Terms
CE Mark, EU Medical Device Regulation, Glomerular Filtration Rate, equity method investment, +2 more
6 terms
CE Mark regulatory
"MediBeacon® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under European Medical Device Regulation"
A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.
EU Medical Device Regulation regulatory
"receive CE Mark Under European Medical Device Regulation"
EU Medical Device Regulation is the rulebook the European Union uses to approve, monitor and track medical devices sold across its member countries, covering safety tests, documentation and post‑market checks. It matters to investors because it shapes how quickly a device can reach patients, how much companies must spend to comply, and the legal risk of recalls or sales limits—like a tougher safety inspection for cars that can delay launches or force costly redesigns, affecting revenue and valuation.
Glomerular Filtration Rate medical
"The result is a transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR)."
Glomerular filtration rate (GFR) measures how well the kidneys filter waste from blood, expressed as the volume of blood cleared per minute; think of it like the flow rate through a coffee filter that tells you how quickly liquid is being cleaned. Investors care because GFR is a key clinical metric used to gauge patient health, determine drug dosing, qualify participants for trials, and influence regulatory decisions and market size for treatments related to kidney function.
equity method investment financial
"and an equity method investment of INNOVATE, announced receipt of European Union (EU) CE Mark"
An equity method investment is an accounting way to report ownership in another company when an investor has significant influence (commonly around 20–50% of voting rights). Instead of listing the other company’s full assets and debts, the investor records its share of that company’s profits or losses on its own income statement—like keeping track of your share of a neighborhood bakery’s monthly earnings. Investors care because those shared profits, losses and changes in the investee’s value directly affect the investor’s reported earnings and balance sheet, so this method can materially change a company’s financial picture and valuation.
forward-looking statements regulatory
"Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Class IIa devices medical
"MediBeacon received certification across two Class IIa devices, the TGFR Monitor and TGFR Reusable Sensor."
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did INNOVATE Corp. (VATE) announce about MediBeacon’s TGFR System?
INNOVATE Corp. announced that MediBeacon, its equity method investment, received EU MDR CE Mark certification for the TGFR Monitor and TGFR Reusable Sensor. These devices are part of a system that enables transdermal assessment of kidney function using a fluorescent tracer injection and sensor.
What is the MediBeacon TGFR System mentioned by INNOVATE Corp. (VATE)?
The MediBeacon TGFR System includes the TGFR Reusable Sensor, TGFR Monitor, TGFR Disposable Ring, and Lumitrace (relmapirazin) injection. Together, they measure the clearance rate of a fluorescent agent through the skin to provide a transdermal glomerular filtration rate reading, indicating kidney function at the point of care.
What does the EU MDR CE Mark mean for MediBeacon’s kidney monitoring devices?
The EU MDR CE Mark certifies that MediBeacon’s TGFR Monitor and TGFR Reusable Sensor meet European Union safety, quality, and performance standards under Regulation 2017/745. It allows potential use of the transdermal technology in clinical trials that include European sites, supporting broader international clinical deployment.
Where is Lumitrace (relmapirazin) injection currently approved according to INNOVATE (VATE)?
Lumitrace (relmapirazin) injection is approved for human use in the United States and China as part of the TGFR System. Submission of Lumitrace to European Union regulatory authorities is pending, while the TGFR Monitor and Reusable Sensor have already received EU MDR CE Mark certification.
How does MediBeacon’s TGFR technology assess kidney function?
MediBeacon’s TGFR technology uses Lumitrace injection, a fluorescent tracer, and a skin-mounted sensor to record fluorescence intensity over time. The system converts these data via proprietary algorithms into a transdermal glomerular filtration rate, providing an assessment of kidney function at the point of care without traditional blood draws.
What risks and uncertainties does INNOVATE Corp. highlight regarding MediBeacon?
INNOVATE notes risks related to managing growth as operations scale, potential misuse of MediBeacon’s products by customers or clinicians, and protecting intellectual property. It also references broader risk factors in its Form 10-K and Form 10-Q filings, emphasizing that forward-looking statements are subject to change.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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| Item 8.01 | Other Events. | ||||
On March 31, 2026, the Company issued a press release titled "MediBeacon® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under European Medical Device Regulation”. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act, except as shall be expressly set forth by specific reference in a filing.
| Item 9.01 | Financial Statements and Exhibits. | ||||
(d) Exhibits
Exhibit No. | Description | ||||
| 99.1 | Press Release dated March 31, 2026, titled “MediBeacon® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under European Medical Device Regulation” | ||||
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document). | ||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 31, 2026
INNOVATE Corp. (Registrant) | |||||||||||||||||
| By: | /s/ Michael J. Sena | ||||||||||||||||
| Name: Michael J. Sena | |||||||||||||||||
| Title: Chief Financial Officer | |||||||||||||||||
 | Exhibit 99.1 | ||||
MediBeacon® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under European Medical Device Regulation
NEW YORK, NY, March 31, 2026 (GLOBE NEWSWIRE) – INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that MediBeacon Inc. (“MediBeacon”), a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, and an equity method investment of INNOVATE, announced receipt of European Union (EU) CE Mark certification under the EU Medical Device Regulation (MDR) for its TGFR™ Monitor and TGFR™ Reusable Sensor. The certification confirms that the Monitor and Sensor have met the robust safety, quality, and performance standards required under the EU MDR 2017/745.
“Obtaining the EU CE Mark is a significant milestone for MediBeacon,” said Steven Hanley, CEO and Co-Founder of MediBeacon. “As the TGFR™ System enters the clinic in the U.S. and China, the CE Mark allows for the potential use of the transdermal technology in clinical trials that include European sites. The achievement also underscores our commitment to meeting the highest quality and safety standards.”
MediBeacon received certification across two Class IIa devices, the TGFR Monitor and TGFR Reusable Sensor. The two, coupled with the Lumitrace® (relmapirazin) injection and the CE marked TGFR™ Disposable Ring, comprise the TGFR System, which enables the assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The result is a transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR). Lumitrace (relmapirazin) injection is approved in the U.S. and China. Submission of Lumitrace (relmapirazin) injection to the EU regulatory authorities is pending.
“An accurate, clinically practical, point of care method to assess kidney function could be revolutionary in the development and implementation of future strategies designed to help patients who are at risk of renal complications,” said Dr. Lui Forni, a lead intensive care medicine physician at the Royal Surrey County Hospital NHS Foundation Trust and a global leader in critical care nephrology. “I look forward to including transdermal GFR in my clinical research in Europe later this year.”
About INNOVATE
INNOVATE is a portfolio of best-in-class assets in three key areas of the new economy – Infrastructure, Life Sciences and Spectrum. Dedicated to stakeholder capitalism, INNOVATE employs approximately 3,700 people across its subsidiaries. For more information, please visit: www.INNOVATECorp.com.
About MediBeacon Inc.
MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and
over 250 granted patents worldwide that provide extensive coverage of the MediBeacon® TGFR™ System, including Lumitrace® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR System including Lumitrace is approved for human use by the U.S. FDA and the China NMPA. In addition, the TGFR Monitor and TGFR Reusable Sensor have received the EU MDR CE Mark. Potential technology applications in gastroenterology, ophthalmology, and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: www.medibeacon.com.
About Lumitrace® (relmapirazin) injection
Relmapirazin is a non-radioactive, non-iodinated, pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study, mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al.1
About MediBeacon® TGFR™ System
The MediBeacon® TGFR™ System is comprised of the TGFR™ Reusable Sensor, TGFR™ Monitor, TGFR™ Disposable Ring, and Lumitrace® (relmapirazin) injection, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Reusable Sensor records 2.5 fluorescent readings per second and the TGFR Monitor displays the average session tGFR reading at the point of care.
FOR IMPORTANT SAFETY INFORMATION FOR THE TGFR SYSTEM (U.S. FDA) see ifu.medibeacon.com.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements generally relate to future events, including, but not limited to, statements regarding the market for the TGFR™. You are cautioned that such statements are not guarantees of future performance and that INNOVATE’s actual results may differ materially from those set forth in the forward-looking statements. All of these forward-looking statements are subject to risks and uncertainties that may change at any time. Factors that could cause INNOVATE’s actual expectations to differ materially from these forward-looking statements include risks associated with managing growth related to increased operational size, the misuse by customers, physicians and technicians of MediBeacon’s products, and the ability of MediBeacon to effectively protect its intellectual property and the impact of a failure to do so and the other factors under the
1 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012
heading “Risk Factors” set forth in INNOVATE’s Annual Report on Form 10-K, as supplemented by INNOVATE’s quarterly reports on Form 10-Q. Such filings are available on our website or at www.sec.gov. You should not place undue reliance on these forward-looking statements, which are made only as of the date of this press release. INNOVATE undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent developments, events, or circumstances, except as may be required under applicable securities laws.
Investor Contact:
Solebury Strategic Communications Anthony Rozmus
(212) 235-2691
Email: ir@innovatecorp.com