MediBeacon receives regulatory approval to sell the Transdermal GFR System in China
INNOVATE (NYSE: VATE) announced that MediBeacon received NMPA approval for Lumitrace (relmapirazin) injection, the fluorescent agent used with the MediBeacon Transdermal GFR System (TGFR).
The TGFR—comprised of Lumitrace injection, the TGFR Monitor and TGFR Sensor—will be available for sale in China before the end of the year. The company noted prior approvals: the MediBeacon TGFR including Lumitrace received FDA approval in January, and NMPA previously approved the TGFR Monitor and Sensor in February. MediBeacon formed a commercial and clinical partnership with Huadong Medicine in July 2019. The release highlights tGFR as a point-of-care measured GFR alternative to lab-based eGFR and mGFR, and cites China CKD prevalence at 11% of 1.4 billion.
INNOVATE (NYSE: VATE) ha annunciato che MediBeacon ha ottenuto l'approvazione NMPA per Lumitrace (relmapirazin) injection, l'agente fluorescent in uso con il MediBeacon Transdermal GFR System (TGFR).
Il TGFR—composto da Lumitrace injection, il TGFR Monitor e il TGFR Sensor—sarà disponibile per la vendita in Cina entro la fine dell'anno. L'azienda ha indicato approvazioni precedenti: il MediBeacon TGFR inclusa Lumitrace ha ottenuto l'approvazione FDA a gennaio, e la NMPA aveva precedentemente approvato il TGFR Monitor e il Sensor a febbraio. MediBeacon ha formato una partnership commerciale e clinica con Huadong Medicine nel luglio 2019. Il comunicato evidenzia tGFR come alternativa di misurazione GFR sul punto di cura rispetto al lab-based eGFR e mGFR, citando una prevalenza della CKD in Cina pari all'11% di 1,4 miliardi.
INNOVATE (NYSE: VATE) anunció que MediBeacon recibió la aprobación de la NMPA para Lumitrace (relmapirazin) injection, el agente fluorescente utilizado con el MediBeacon Transdermal GFR System (TGFR).
El TGFR—compuesto por la Lumitrace injection, el TGFR Monitor y el TGFR Sensor— estará disponible para su venta en China antes de fin de año. La empresa señaló aprobaciones previas: el MediBeacon TGFR que incluye Lumitrace recibió la aprobación de la FDA en enero, y la NMPA aprobó previamente el TGFR Monitor y el Sensor en febrero. MediBeacon formó una asociación comercial y clínica con Huadong Medicine en julio de 2019. El comunicado destaca tGFR como una alternativa de punto de atención para medir el GFR respecto al eGFR y mGFR basados en laboratorio, y cita la prevalencia de CKD en China en 11% de 1,4 mil millones.
INNOVATE (NYSE: VATE)가 MediBeacon이 Lumitrace (relmapirazin) 주사에 대한 NMPA 승인을 받았다고 발표했습니다. 이는 MediBeacon 경피 GFR 시스템(TGFR)에서 사용되는 형광 제제입니다.
TGFR은 Lumitrace 주사, TGFR 모니터, TGFR 센서로 구성되며 연말까지 중국에서 판매를 시작할 예정입니다. 회사는 이전 승인도 언급했습니다: Lumitrace를 포함한 MediBeacon TGFR은 1월에 FDA 승인을 받았고, NMPA는 2월에 TGFR 모니터와 센서를 승인을 이미 했습니다. MediBeacon은 2019년 7월에 Huadong Medicine과 상업적 및 임상적 파트너십을 맺었습니다. 보도자료는 tGFR을 연구실 기반의 eGFR 및 mGFR에 대한 현장 진단 GFR의 대안으로 강조하고, 중국의 CKD 유병률을 14억 명의 11%로 인용합니다.
INNOVATE (NYSE: VATE) a annoncé que MediBeacon a reçu l'approbation NMPA pour Lumitrace (relmapirazin) injection, l'agent fluorescent utilisé avec le MediBeacon Transdermal GFR System (TGFR).
Le TGFR—composé de Lumitrace injection, du TGFR Monitor et du TGFR Sensor—sera disponible pour la vente en Chine avant la fin de l'année. La société a noté des autorisations antérieures: le MediBeacon TGFR incluant Lumitrace a reçu l'approbation FDA en janvier, et la NMPA avait précédemment approuvé le TGFR Monitor et le Sensor en février. MediBeacon a formé un partenariat commercial et clinique avec Huadong Medicine en juillet 2019. Le communiqué met en avant tGFR comme une alternative de GFR mesurée au point de care par rapport au eGFR et au mGFR basés sur le laboratoire, et cite une prévalence de CKD en Chine à 11% de 1,4 milliard.
INNOVATE (NYSE: VATE) gab bekannt, dass MediBeacon die NMPA-Zulassung für Lumitrace (relmapirazin) Injektion erhalten hat, das fluoreszierende Mittel, das mit dem MediBeacon Transdermal GFR System (TGFR) verwendet wird.
Das TGFR—bestehend aus Lumitrace-Injektion, dem TGFR Monitor und dem TGFR Sensor—wird vor Jahresende in China zum Verkauf erhältlich sein. Das Unternehmen verwies auf frühere Genehmigungen: Das MediBeacon TGFR einschließlich Lumitrace erhielt im Januar die FDA-Zulassung, und die NMPA hatte zuvor den TGFR Monitor und Sensor im Februar genehmigt. MediBeacon hat im Juli 2019 eine kommerzielle und klinische Partnerschaft mit Huadong Medicine gebildet. Die Mitteilung hebt tGFR als Punkt-der-Versorgung gemessene GFR-Alternative zu laborbasiertem eGFR und mGFR hervor und nennt die CKD-Prävalenz in China bei 11% von 1,4 Milliarden.
INNOVATE (NYSE: VATE) أعلنت أن MediBeacon حصلت على موافقة NMPA لـ Lumitrace (relmapirazin) injection، وهو العامل الفلوري المستخدم مع MediBeacon Transdermal GFR System (TGFR).
سيكون TGFR—الذي يتكون من Lumitrace injection، TGFR Monitor و TGFR Sensor—متاحاً للبيع في الصين قبل نهاية هذا العام. أشارت الشركة إلى موافقات سابقة: حصل MediBeacon TGFR بما في ذلك Lumitrace على موافقة FDA في يناير، وسبق لـ NMPA أن وافقت على TGFR Monitor و Sensor في فبراير. شكلت MediBeacon شراكة تجارية و سريرية مع Huadong Medicine في يوليو 2019. يبرز البيان tGFR كبديل يقيس GFR في نقطة الرعاية مقارنة بـ eGFR و mGFR المعتمدة على المختبر، ويذكر انتشار CKD في الصين عند 11% من 1.4 مليار.
INNOVATE（NYSE: VATE）宣布，MediBeacon 获得 NMPA 对 Lumitrace（relmapirazin）注射剂的批准，这是与 MediBeacon 经皮 GFR 系统（TGFR）一起使用的荧光剂。
TGFR—由 Lumitrace 注射剂、TGFR 监控器和 TGFR 传感器组成—将在今年年底前在中国上市。
公司指出既往批准：包括 Lumitrace 的 MediBeacon TGFR 在一月获得 FDA 批准，NMPA 也在二月批准了 TGFR 监控器和传感器。MediBeacon 于 2019 年 7 月与华东药业建立了商业与临床伙伴关系。新闻稿强调 tGFR 作为现场式测量 GFR 的替代方案，相较于基于实验室的 eGFR 和 mGFR，并引用中国 CKD 的患病率为 11%（人口约 14 亿）。
- NMPA approval granted for Lumitrace injection in China
- TGFR to be sold in China before year-end
- FDA approval for MediBeacon TGFR including Lumitrace obtained in January
- Commercial partnership with Huadong Medicine since July 2019
- Lumitrace is categorized as a drug requiring a separate NMPA approval process, adding regulatory complexity
Insights
China NMPA approval for Lumitrace and TGFR enables commercial sales and expands clinical access.
INNOVATE (MediBeacon equity method) gains regulatory clearance in China for Lumitrace injection as part of the Transdermal GFR System on
Clinical utility rests on the device and drug functioning together; prior U.S. FDA approval and earlier Chinese approvals of the monitor and sensor reduce one regulatory hurdle. Key dependencies include manufacturing and distribution readiness with partner Huadong Medicine, clinician adoption in settings that manage kidney disease, and real-world performance versus existing lab methods.
Watch roll-out metrics over the next 6–12 months: commercial launch timing, uptake in clinics treating chronic kidney disease (estimated at
- MediBeacon® 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 TGFR will be available for sale in China before the end of the year
NEW YORK, Oct. 21, 2025 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that MediBeacon Inc., a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, and an equity method investment of INNOVATE, has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent. Lumitrace will be sold as an integral component of the Transdermal GFR System in China.
Lumitrace injection, together with the MediBeacon® TGFR Monitor and MediBeacon® TGFR Sensor, allow 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).
A commercial and clinical development partnership between MediBeacon and Huadong Medicine was formed in July 2019. The TGFR will now be introduced into the clinic where it is designed to be an important tool for physicians who care for patients where kidney health is a concern. Chronic Kidney Disease (CKD) is estimated to affect
In January, the U.S. Food and Drug Administration approved the MediBeacon TGFR including Lumitrace injection for the assessment of kidney function in patients with normal or impaired renal function. In February, the NMPA approved the MediBeacon TGFR Monitor and MediBeacon TGFR Sensor in China where Lumitrace® (relmapirazin) injection is categorized as a drug with a separate approval process.
“Full China approval is a major step forward in our commitment to expanding access to transdermal GFR globally,” said Steven Hanley, CEO and Co-Founder of MediBeacon. “China represents a significant opportunity, and we look forward to providing access to our technology with the goal of improving patient management.”
Estimation of kidney function in clinical practice has broad negative implications for certain patients.2 An estimated Glomerular Filtration Rate (eGFR) is derived from a blood draw or urine sample. The test measures levels of serum creatinine or Cystatin C, which are waste products normally cleared by the kidneys. These values along with a person’s age, weight, height and sex are used to estimate kidney function. These tests can be impacted by muscle mass, diet, hydration status, medication use and other non-renal inputs that may lead to misclassification of kidney function in patients.3
While measured GFR (mGFR) does exist it is not at the point of care. Its use remains limited since serial blood sampling and sophisticated laboratory analysis are required, driving an associated high cost.4 Transdermal GFR (tGFR) has been designed to achieve the benefits of mGFR without the associated challenges of mGFR.
“Kidney function is often assessed reactively after abnormal labs given the limitations with tools today,” said Dr. Richard Solomon, the Patrick Professor of Medicine and Director of the Division of Nephrology and Hypertension at University of Vermont Medical Center. “The benefit of Lumitrace is that it doesn’t interact with medications, is cleared by GFR, and importantly, is agnostic to a patient’s demographic information. Transdermal GFR can fundamentally impact kidney disease management through the assessment of a patient’s GFR at the point of care without the use of estimating equations and has the potential to transform patient care and outcomes.”
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 3,100 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 60 granted U.S. patents and over 245 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.5
About MediBeacon® Transdermal GFR System (TGFR)
The MediBeacon TGFR is comprised of the MediBeacon TGFR Sensor, MediBeacon 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.
FOR IMPORTANT SAFETY INFORMATION FOR TGFR (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 adoption of MediBeacon’s TGFR in China or other markets. 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 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
—————————————
1 International Society of Nephrology – Global Kidney Health Atlas (China page), https://gkha.theisn.org/country/china/
2 Quantifying Individual-Level Inaccuracy in Glomerular Filtration Rate Estimation: A Cross-Sectional Study. Ann Intern Med. 2022;175(8):1073-1082. doi: 10.7326/M22-0610
3 How unmeasured muscle mass affects estimated GFR and diagnostic inaccuracy, EClinicalMedicine, 29-30 (2020), DOI: 10.1016/j.eclinm.2020.100662
4 GFR measurement in patients with CKD: Performance and feasibility of simplified iohexol plasma clearance techniques, PLOS ONE, July 17, 2024, DOI: 10.1371/journal.pone.0306935
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 did INNOVATE (VATE) announce on October 21, 2025 about sales in China?
How does the NMPA approval affect MediBeacon TGFR availability in China (VATE)?
What regulatory approvals does MediBeacon already have for TGFR and Lumitrace (VATE)?
Will the MediBeacon TGFR be sold with Lumitrace in China and who is the commercial partner (VATE)?
What clinical advantage does Lumitrace-based transdermal GFR offer compared to eGFR?
