MediBeacon® Transdermal GFR System receives device approval in China
INNOVATE Corp. (NYSE: VATE) announced that MediBeacon's Transdermal GFR System received approval from China's NMPA for kidney function assessment. The system consists of the TGFR Monitor and TGFR Sensor, while Lumitrace® (relmapirazin) injection is expected to be approved in late 2025.
The technology received the TGFR Innovative Medical Device Designation in 2021, granted to only 10% of applications. Recent studies published in the Clinical Kidney Journal revealed that current eGFR methods misclassified 35% of patients' CKD stages. Additionally, research published in JASN demonstrated the system's exceptional correlation (r² = 0.90) with plasma mGFR across all skin types.
The TGFR system, including Lumitrace, recently received FDA approval on January 17th. MediBeacon is developing next-generation TGFR products with updated software and algorithms.
INNOVATE Corp. (NYSE: VATE) ha annunciato che il Sistema GFR Transdermico di MediBeacon ha ricevuto l'approvazione dalla NMPA cinese per la valutazione della funzione renale. Il sistema è composto dal Monitor TGFR e dal Sensore TGFR, mentre l'iniezione di Lumitrace® (relmapirazin) è prevista per l'approvazione entro la fine del 2025.
Questa tecnologia ha ricevuto la Designazione di Dispositivo Medico Innovativo TGFR nel 2021, concessa solo al 10% delle domande. Studi recenti pubblicati nel Clinical Kidney Journal hanno rivelato che i metodi attuali di eGFR hanno classificato in modo errato il 35% delle fasi di CKD dei pazienti. Inoltre, la ricerca pubblicata nel JASN ha dimostrato l'eccezionale correlazione del sistema (r² = 0,90) con il mGFR plasmatico attraverso tutti i tipi di pelle.
Il sistema TGFR, incluso Lumitrace, ha recentemente ricevuto l'approvazione della FDA il 17 gennaio. MediBeacon sta sviluppando prodotti TGFR di nuova generazione con software e algoritmi aggiornati.
INNOVATE Corp. (NYSE: VATE) anunció que el Sistema GFR Transdérmico de MediBeacon recibió la aprobación de la NMPA de China para la evaluación de la función renal. El sistema consta del Monitor TGFR y del Sensor TGFR, mientras que se espera que la inyección de Lumitrace® (relmapirazin) sea aprobada a finales de 2025.
La tecnología recibió la Designación de Dispositivo Médico Innovador TGFR en 2021, otorgada solo al 10% de las solicitudes. Estudios recientes publicados en el Clinical Kidney Journal revelaron que los métodos actuales de eGFR clasificaron erróneamente el 35% de las etapas de CKD de los pacientes. Además, la investigación publicada en JASN demostró la excepcional correlación del sistema (r² = 0.90) con el mGFR plasmático en todos los tipos de piel.
El sistema TGFR, incluido Lumitrace, recibió recientemente la aprobación de la FDA el 17 de enero. MediBeacon está desarrollando productos TGFR de próxima generación con software y algoritmos actualizados.
INNOVATE Corp. (NYSE: VATE)는 MediBeacon의 경피적 GFR 시스템이 중국 NMPA로부터 신장 기능 평가에 대한 승인을 받았다고 발표했습니다. 이 시스템은 TGFR 모니터와 TGFR 센서로 구성되어 있으며, Lumitrace® (relmapirazin) 주사는 2025년 말에 승인될 것으로 예상됩니다.
이 기술은 2021년에 TGFR 혁신 의료 기기 지정 승인을 받았으며, 이는 신청서의 10%만이 해당됩니다. Clinical Kidney Journal에 발표된 최근 연구에 따르면 현재의 eGFR 방법이 환자의 CKD 단계의 35%를 잘못 분류했습니다. 또한 JASN에 발표된 연구는 모든 피부 유형에서 시스템의 탁월한 상관관계(r² = 0.90)를 입증했습니다.
TGFR 시스템은 Lumitrace를 포함하여 1월 17일에 FDA 승인을 받았습니다. MediBeacon은 업데이트된 소프트웨어와 알고리즘을 갖춘 차세대 TGFR 제품을 개발하고 있습니다.
INNOVATE Corp. (NYSE: VATE) a annoncé que le Système GFR Transdermique de MediBeacon a reçu l'approbation de la NMPA en Chine pour l'évaluation de la fonction rénale. Le système se compose du Moniteur TGFR et du Capteur TGFR, tandis que l'injection de Lumitrace® (relmapirazin) devrait être approuvée fin 2025.
Cette technologie a reçu la désignation de Dispositif Médical Innovant TGFR en 2021, accordée uniquement à 10 % des demandes. Des études récentes publiées dans le Clinical Kidney Journal ont révélé que les méthodes actuelles d'eGFR ont mal classé 35 % des stades de CKD des patients. De plus, des recherches publiées dans le JASN ont démontré l'exceptionnelle corrélation du système (r² = 0,90) avec le mGFR plasmatique à travers tous les types de peau.
Le système TGFR, y compris Lumitrace, a récemment reçu l'approbation de la FDA le 17 janvier. MediBeacon développe des produits TGFR de nouvelle génération avec des logiciels et des algorithmes mis à jour.
INNOVATE Corp. (NYSE: VATE) hat angekündigt, dass das transdermale GFR-System von MediBeacon die Genehmigung der NMPA in China für die Beurteilung der Nierenfunktion erhalten hat. Das System besteht aus dem TGFR-Monitor und dem TGFR-Sensor, während die Injektion von Lumitrace® (relmapirazin) voraussichtlich Ende 2025 genehmigt wird.
Die Technologie erhielt 2021 die Auszeichnung als innovatives Medizinprodukt TGFR, die nur 10% der Anträge erhalten. Jüngste Studien, die im Clinical Kidney Journal veröffentlicht wurden, zeigten, dass die aktuellen eGFR-Methoden 35% der CKD-Stadien der Patienten falsch klassifizierten. Darüber hinaus zeigte eine Forschung, die im JASN veröffentlicht wurde, die außergewöhnliche Korrelation des Systems (r² = 0,90) mit dem plasma mGFR über alle Hauttypen hinweg.
Das TGFR-System, einschließlich Lumitrace, erhielt am 17. Januar kürzlich die FDA-Zulassung. MediBeacon entwickelt Produkte der nächsten Generation für TGFR mit aktualisierter Software und Algorithmen.
- FDA approval received for complete TGFR system
- NMPA approval obtained for TGFR Monitor and Sensor in China
- Strong clinical validation with 90% correlation to plasma mGFR
- Elite Innovative Medical Device Designation status in China (top 10%)
- Next-generation product development in progress
- Lumitrace approval in China still pending until late 2025
Insights
INNOVATE Corp's (NYSE: VATE) announcement of Chinese regulatory approval for MediBeacon's Transdermal GFR System represents a significant milestone in the company's expansion into the world's largest healthcare market. This first-in-kind kidney function assessment technology has now secured approvals in both the US (January 2025) and China, with the latter granting the coveted Innovative Medical Device Designation - a status awarded to only 10% of applications.
The approval covers the hardware components (TGFR Monitor and Sensor), while the companion Lumitrace (relmapirazin) injection is expected to receive approval later in 2025. This phased regulatory approach allows for early marketing activities in China, potentially accelerating market penetration once the full system becomes available.
The timing of this approval coincides with two high-profile publications that strengthen the clinical case for adoption. The Clinical Kidney Journal study revealed that 35% of patients are misclassified by at least one CKD stage using current methods - a staggering error rate in a disease affecting over 850 million people globally. Meanwhile, the Journal of the American Society of Nephrology publication demonstrated exceptional correlation (r² = 0.90) with gold standard measurements across all skin types, addressing a critical equity issue in kidney diagnostics.
For VATE investors, this represents a potential inflection point for the MediBeacon subsidiary. The global kidney function testing market is projected to reach $2.2 billion by 2027, with China representing approximately 20% of this opportunity. The partnership with Huadong Medicine provides a commercialization pathway in this complex market, leveraging local expertise while maintaining MediBeacon's technological leadership.
The non-invasive, point-of-care nature of this technology addresses significant unmet needs in nephrology. Current methods require blood draws, laboratory processing, and suffer from well-documented inaccuracies. MediBeacon's approach could potentially become the new standard of care, particularly for monitoring progression in the estimated 120 million Chinese citizens with chronic kidney disease.
While revenue impact will be minimal in 2025 as commercialization ramps up, this technology platform could become a significant growth driver for VATE in 2026 and beyond. The mention of next-generation products already in development suggests a sustainable innovation pipeline that could maintain competitive advantages over time.
Peer-reviewed articles on MediBeacon technology published
- Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function.
- The Clinical Kidney Journal in February published MediBeacon study results on measured GFR (mGFR) using relmapirazin versus estimated GFR (eGFR) for the purpose of classifying patient Chronic Kidney Disease (CKD) stages.
- MediBeacon TGFR study results have been posted online in the February ahead of print section in the Journal of the American Society of Nephrology (JASN).
NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today the National Medical Products Administration (NMPA) in China has approved the MediBeacon® TGFR Monitor and TGFR Sensor for the assessment of kidney function in patients with normal or impaired renal function. Lumitrace® (relmapirazin) injection, categorized as a drug in China, is under review and is targeted for approval in late 2025. The transdermal GFR technology includes Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together with the TGFR Monitor and TGFR Sensor allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body.
In 2021, the NMPA granted the TGFR Innovative Medical Device Designation. Only
In February, the Clinical Kidney Journal published MediBeacon data in an article on Chronic Kidney Disease (CKD) stage misclassification via estimated GFR (eGFR) compared to measured GFR (mGFR) using relmapirazin. In a stable CKD population, more than one-third of the subjects had an actual mGFR (relmapirazin) that differed by at least one CKD stage from their estimated GFR (eGFR).1 Relmapirazin is indicated for use with the TGFR.
“The Clinical Kidney Journal study raises serious concerns about how chronic kidney disease is diagnosed today,” said Dr. Ira Kurtz, Chief of the Division of Nephrology at UCLA Medical Center. “Researchers found that current eGFR methods misclassified
In the February ahead of print section in the Journal of the American Society of Nephrology (JASN), MediBeacon clinical study data from the use of transdermal detection of relmapirazin in patients with normal to impaired kidney function across a range of skin color types was posted online.2 JASN publishes high-impact research to advance the understanding and treatment of kidney diseases.3
In addition to his leadership role at UCLA Medical Center, Dr. Kurtz is active in the development of an artificial kidney and artificial intelligence in the training and practice of nephrology.
Dr. Kurtz commented that: “The study in the Journal of the American Society of Nephrology introduces a wearable, transdermal device that assesses GFR without the need for blood samples. The fluorescence-based test, developed by MediBeacon, demonstrated an exceptional correlation (r² = 0.90) with plasma mGFR across all skin types, paving the way for more equitable and accurate kidney function assessment. These two new studies have reshaped the landscape of kidney disease diagnostics, offering both a cutting-edge innovation and a stark warning about current practices. The findings underscore the urgent need for improved kidney function assessment tools, with non-invasive, point of care GFR measurement emerging as a game-changing solution.”
“Awareness of kidney disease is relatively low despite the fact that it is the 7th leading risk factor for mortality worldwide.4 MediBeacon is pleased to have the opportunity to aid in the assessment of kidney function in China,” said Steve Hanley CEO of MediBeacon. “NMPA approval is the culmination of a rigorous device application process that required close collaboration of the MediBeacon and Huadong Medicine teams. We look forward to the next phase of our partnership with Huadong Medicine and eagerly anticipate Lumitrace approval in China later this year.”
The TGFR, which includes Lumitrace (relmapirazin), was approved on January 17th by the U.S. Food and Drug Administration (FDA). MediBeacon continues development of future TGFR products including a next-generation TGFR Sensor with updated software and algorithms.
About INNOVATE
INNOVATE Corp. 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 4,000 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 215 granted patents worldwide that provide extensive coverage of the MediBeacon® TGFR, including Lumitrace® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. 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.6
About MediBeacon® Transdermal GFR System (TGFR)
The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin), 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 Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient’s bedside or in the outpatient setting.
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. 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 INNOVATE’s ability to continue to comply with applicable listing standards of the NYSE and the other factors under the 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
ir@innovatecorp.com
(212) 235-2691
IMPORTANT SAFETY INFORMATION FOR TGFR (U.S. FDA)
Indication for Use:
The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function.
The MediBeacon® TGFR is not approved for use in patients with GFR <15ml/min/1.73m2, GFR >120ml/min/1.73m2, patients on dialysis or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI).
The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR.
The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor.
Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment.
Contraindications:
There are no known contraindications.
Warnings and Precautions:
- See ifu.medibeacon.com for full instructions, warnings, and cautions.
- In clinical studies no serious or severe adverse events have been observed.
- Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace.
- Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around
20% in limited testing. - Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established.
- During a TGFR session, the patient should be as still as possible, especially during the “Establishing Baseline” stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage.
1 CKD stage misclassification between estimated GFR and measured GFR in a clinical study of chronic kidney patients, Clinical Kidney Journal, Dorshow, Richard B. et al., 2025 Jan 9;18(2):sfaf006. DOI: 10.1093/ckj/sfaf006
2 Glomerular Filtration Rate Measurement Utilizing Transdermal Detection Methodology, Journal of the American Society of Nephrology (JASN), Dorshow, Richard B. et al., February 7, 2025, DOI: 10.1681/ASN.0000000639
3 https://www.asn-online.org/publications/
4 Chronic kidney disease and the global public health agenda: an international consensus, Nature Reviews Nephrology, 20, 473-485 (2024), doi.org/10.1038/s41581-024-00820-6
5 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
FAQ
What regulatory approvals has MediBeacon's TGFR system received for VATE shareholders?
When is Lumitrace (relmapirazin) expected to receive NMPA approval in China?
What advantages did the TGFR system demonstrate in recent clinical studies?
What special designation did NMPA grant to the TGFR system in 2021?
