MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function
INNOVATE Corp. (NYSE: VATE) announced FDA approval of the MediBeacon® Transdermal GFR System (TGFR) for assessing kidney function. This first-in-kind system comprises the TGFR Sensor, Monitor, and Lumitrace® injection, enabling non-invasive kidney function assessment without blood draws or urine analysis.
The system measures kidney function by tracking a fluorescent tracer agent's clearance rate through a skin sensor, providing real-time readings at the point of care. Clinical trials demonstrated strong efficacy with a P30 value of 94%, meeting FDA requirements. The technology works effectively across the adult population regardless of age, weight, sex, gender, race, or ethnicity.
This innovation addresses a significant healthcare need, as over 800 million people worldwide suffer from Chronic Kidney Disease (CKD), with associated deaths increasing over recent decades. No serious or severe adverse events were observed in clinical studies.
INNOVATE Corp. (NYSE: VATE) ha annunciato l'approvazione della FDA per il sistema MediBeacon® Transdermal GFR (TGFR) per la valutazione della funzione renale. Questo sistema innovativo è composto dal sensore TGFR, dal monitor e dall'iniezione Lumitrace®, che consentono una valutazione non invasiva della funzione renale senza prelievi di sangue o analisi delle urine.
Il sistema misura la funzione renale tracciando il tasso di eliminazione di un agente tracciante fluorescente attraverso un sensore cutaneo, fornendo letture in tempo reale al punto di cura. Gli studi clinici hanno dimostrato un'elevata efficacia con un valore P30 del 94%, soddisfacendo i requisiti della FDA. La tecnologia funziona efficacemente nella popolazione adulta, indipendentemente da età, peso, sesso, genere, razza o etnia.
Questa innovazione risponde a una significativa esigenza sanitaria, poiché oltre 800 milioni di persone nel mondo soffrono di Malattia Renale Cronica (CKD), con un aumento delle morti associate negli ultimi decenni. Non sono stati osservati eventi avversi gravi o severi negli studi clinici.
INNOVATE Corp. (NYSE: VATE) anunció la aprobación de la FDA para el sistema MediBeacon® Transdermal GFR (TGFR) para evaluar la función renal. Este sistema pionero consta del sensor TGFR, un monitor y la inyección Lumitrace®, lo que permite una evaluación no invasiva de la función renal sin necesidad de extracciones de sangre ni análisis de orina.
El sistema mide la función renal rastreando la tasa de aclaramiento de un agente trazador fluorescente a través de un sensor en la piel, proporcionando lecturas en tiempo real en el punto de atención. Los ensayos clínicos demostraron una fuerte eficacia con un valor P30 del 94%, cumpliendo con los requisitos de la FDA. La tecnología funciona eficazmente en la población adulta, sin importar edad, peso, sexo, género, raza o etnia.
Esta innovación aborda una necesidad significativa en el ámbito de la salud, ya que más de 800 millones de personas en todo el mundo padecen Enfermedad Renal Crónica (ERC), con un aumento de las muertes asociadas en las últimas décadas. No se observaron eventos adversos graves o severos en los estudios clínicos.
INNOVATE Corp. (NYSE: VATE)는 신장 기능 평가를 위한 MediBeacon® Transdermal GFR 시스템(TGFR)의 FDA 승인 소식을 발표했습니다. 이 최초의 시스템은 TGFR 센서, 모니터 및 Lumitrace® 주사제로 구성되어 있으며, 혈액 샘플 채취나 소변 분석 없이 비침습적으로 신장 기능을 평가할 수 있게 해줍니다.
시스템은 피부 센서를 통해 형광 추적제가 배출되는 속도를 추적하여 신장 기능을 측정하며, 즉각적인 결과를 제공하여 현장에서 바로 읽을 수 있습니다. 임상 시험에서 P30 값이 94%로 높은 효능을 입증하였으며, FDA 요구 사항을 충족합니다. 이 기술은 성별, 연령, 체중, 인종에 관계없이 성인 인구에서 효과적으로 작동합니다.
이 혁신은 전 세계적으로 8억 명 이상의 사람들이 만성 신장 질환(CKD)으로 고통받고 있으며, 최근 수십 년 동안 관련 사망자가 증가하고 있는 점을 감안할 때, 중요한 의료 요구를 충족시킵니다. 임상 연구에서는 심각하거나 심한 부작용이 관찰되지 않았습니다.
INNOVATE Corp. (NYSE: VATE) a annoncé l'approbation par la FDA du système MediBeacon® Transdermal GFR (TGFR) pour l'évaluation de la fonction rénale. Ce système de pointe comprend le capteur TGFR, un moniteur et l'injection Lumitrace®, permettant une évaluation non invasive de la fonction rénale sans prélèvements sanguins ni analyses d'urine.
Le système mesure la fonction rénale en suivant le taux d’élimination d’un agent traceur fluorescent à travers un capteur cutané, fournissant des lectures en temps réel sur le lieu de soin. Les essais cliniques ont montré une forte efficacité avec une valeur P30 de 94%, répondant aux exigences de la FDA. La technologie fonctionne efficacement dans la population adulte, quel que soit l'âge, le poids, le sexe, le genre, la race ou l'origine ethnique.
Cette innovation répond à un besoin de santé publique significatif, car plus de 800 millions de personnes dans le monde souffrent de maladies rénales chroniques (MRC), les décès associés augmentant au cours des dernières décennies. Aucun événement indésirable grave ou sévère n’a été observé dans les études cliniques.
INNOVATE Corp. (NYSE: VATE) gab die FDA-Zulassung des MediBeacon® Transdermal GFR-Systems (TGFR) zur Beurteilung der Nierenfunktion bekannt. Dieses erstmalig entwickelte System besteht aus dem TGFR-Sensor, einem Monitor und der Lumitrace®-Injektion, die eine nicht-invasive Beurteilung der Nierenfunktion ohne Blutentnahmen oder Urinanalysen ermöglicht.
Das System misst die Nierenfunktion, indem es die Ausscheidungsrate eines fluoreszierenden Markerstoffs über einen Hautsensor verfolgt und Echtzeitwerte direkt am Ort der Versorgung bereitstellt. Klinische Studien zeigten eine hohe Wirksamkeit mit einem P30-Wert von 94 %, der die Anforderungen der FDA erfüllt. Die Technologie funktioniert effektiv in der Erwachsenenpopulation, unabhängig von Alter, Gewicht, Geschlecht, Geschlechtsidentität, Rasse oder ethnischer Herkunft.
Diese Innovation trifft einen bedeutenden Bedarf im Gesundheitswesen, da weltweit mehr als 800 Millionen Menschen an chronischer Nierenerkrankung (CKD) leiden und die damit verbundenen Todesfälle in den letzten Jahrzehnten zugenommen haben. In klinischen Studien wurden keine schwerwiegenden oder schweren unerwünschten Ereignisse beobachtet.
- First-in-kind FDA approval for non-invasive kidney function assessment
- High efficacy demonstrated with 94% P30 value in clinical trials
- Eliminates need for blood draws and urine analysis
- Addresses large market with 800M+ CKD patients globally
- No serious adverse events reported in clinical trials
- None.
Insights
The FDA approval of MediBeacon's Transdermal GFR System represents a groundbreaking advancement in kidney function assessment. The system's 94% P30 value demonstrates exceptional accuracy compared to traditional methods. The technology eliminates the need for blood draws and urine samples, significantly improving patient experience and potentially reducing healthcare costs.
The system's ability to provide real-time GFR measurements at point-of-care settings could revolutionize CKD management. Current methods requiring laboratory analysis create delays in treatment decisions. This innovation enables immediate assessment across diverse patient populations without demographic adjustments, addressing a critical gap in kidney diagnostics.
The timing of approval coincides with increasing global CKD prevalence, affecting over 800 million people. The market potential is substantial, considering the rising mortality rates from kidney disease and the need for more efficient monitoring solutions.
This FDA approval positions INNOVATE (VATE) for significant market opportunity in the $13 billion global kidney function monitoring market. The TGFR system's unique capabilities and first-mover advantage could drive substantial revenue growth. With CKD being more lethal than breast or prostate cancer, healthcare providers are likely to adopt this superior monitoring solution.
For a company with a market cap of just
Key revenue drivers include device sales, recurring revenue from Lumitrace injections and potential licensing opportunities. The system's validation across diverse patient populations enhances its commercial viability and reimbursement prospects.
- 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 transdermal GFR (tGFR) methodology has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity
- More than 800 million people have Chronic Kidney Disease (CKD), one of the world’s leading causes of mortality worldwide, with associated deaths increasing over the past two decades1
NEW YORK, Jan. 17, 2025 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney function in patients with normal or impaired renal function.
The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, 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.
The TGFR is validated for use in the assessment of Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care. The TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring multiple blood draws or urine samples. In addition, current clinical practice measured GFR (mGFR) assessment requires sophisticated clinical laboratory analysis away from the patient’s point of care.
“The development of a system such as the TGFR that assesses a patient’s kidney function without the need to use estimating equations is an important milestone for the nephrology community,” said Dr. Mitchell Rosner, chair of the Department of Medicine at University of Virginia and a highly regarded expert who has authored numerous articles on the challenges of assessing kidney function. “We are excited to explore applications of the transdermal GFR methodology in patients where current clinical practice is understood to be suboptimal.”
Dr. Pierre Galichon, an active kidney researcher at the Sorbonne Université and an attending physician in kidney transplantation at Pitié-Salpêtrière Hospital in Paris, said: “It has long been a challenge to understand kidney function in the context of its interaction with other vital organs, such as the heart and lungs. My experience with MediBeacon products in preclinical use, as relayed in Scientific Reports,2 has been exciting, and I look forward to evaluating how transdermal GFR can be applied in clinical practice.”
“The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function,” said Steve Hanley, CEO of MediBeacon. “According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is the under-recognized public health crisis.3 The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings.”
The timing of FDA approval aligns well with the Q4 2024 publication by MediBeacon’s Chief Scientific Officer, Dr. Richard Dorshow, et al. in Kidney International with data that supports the utility of MediBeacon’s patented agent Lumitrace®.
The TGFR met its primary efficacy endpoint as per agreement with the FDA by demonstrating a P30 value of
| P30 Value | Upper | Lower | |||
In clinical studies no serious or severe adverse events have been observed. For more information, including the FDA Summary of Safety and Effectiveness Data, please refer to www.fda.gov.
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. Lumitrace injection has been administered to over 850 subjects under Investigational Device Exemptions (IDEs). 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. As noted above, 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 International4 by Dorshow et al.
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, such as the expected timing of the reverse stock split, the impact of the reverse stock split on the Company’s share price, and the Company’s ability to meet the minimum per share bid price requirement for continued listing on the NYSE. 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
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. The MediBeacon TGFR consists of a monitor and a sensor, which are to be used with the Lumitrace® tracer only. 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).
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 Epidemiology of chronic kidney disease: an update 2022, Kidney International Supplement, 2022 Apr;12(1):7-11.
doi: 10.1016/j.kisu.2021.11.003., Csaba P Kovesdy
2 Pulmonary hypertension without heart failure causes cardiorenal syndrome in a porcine model, Scientific Reports (2023) 13:9130, Orieux et al, doi.org/10.1038/s41598-023-36124-1
3 National Kidney Foundation, Fast Facts (2024 Update), Updated as of 8/6/2024
4 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
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