MediBeacon expands management team as enrollment in Phase 3 study focused on kidney disease is completed
ST. LOUIS, May 16, 2023 /PRNewswire/ -- MediBeacon Inc., a portfolio company within the Pansend Life Sciences segment of INNOVATE Corp. (NYSE: VATE), today announced the appointment of Dr. Steve Miller as chief medical officer. In this role, Dr. Miller will be focused on driving a range of clinical and strategic initiatives.
Dr. Miller formerly served as executive vice president and chief clinical officer at Cigna, where he led the company's clinical policy, quality, and performance efforts. Dr. Miller was chief medical officer at Express Scripts in advance of Cigna's acquisition of the company. Prior to Express Scripts Dr. Miller was vice president and chief medical officer at Barnes-Jewish Hospital, Washington University School of Medicine in St. Louis. He has been a member of the MediBeacon board of directors since 2015.
"We are thrilled to have Dr. Miller take on a more active role at MediBeacon," said Steve Hanley, chief executive officer, MediBeacon. "Dr. Miller has a strong understanding of the MediBeacon kidney monitoring technology as it applies to a range of unmet medical needs. His intimate knowledge of the company, combined with his business, healthcare policy, medical, clinical and research experience provides unique and valuable perspective."
MediBeacon is a medical technology company focused on advancing fluorescent technology to help improve patient care through the science of tracer agents and transdermal measurement.
"Understanding kidney function remains a significant clinical challenge," said Dr. Miller. "Real-time, accurate renal function measurements have the potential to have meaningful impact in patient management. MediBeacon's goal continues to be to provide technology to aid in both improving health outcomes and reducing costs of kidney disease."
Dr. Miller received his medical degree from the University of Missouri-Kansas City and completed an internal medicine residency at the University of Colorado. He trained as a fellow in pathology and research at the University of Alabama, Birmingham; nephrology at Washington University; and did a cardiology research fellowship at University of California, San Francisco. Dr. Miller earned an MBA at the Washington University Olin Business School.
The MediBeacon® Transdermal GFR Measurement System (TGFR) is designed to measure Glomerular Filtration Rate (GFR), an indicator of kidney function, in real-time without the need for blood sampling or urine collection. The TGFR was designated a Breakthrough Device by the U.S. FDA and an Innovative Medical Device by China NMPA.
MediBeacon TGFR Pivotal Study
MediBeacon TGFR Pivotal Study (NCT05425719) is a Phase 3 open label, multi-center, safety and pharmacokinetic study of Lumitrace® (relmapirazin) and the use of the MediBeacon Transdermal GFR Measurement System (TGFR) in normal and renal compromised subjects for the evaluation of kidney function. The safety and effectiveness of the MediBeacon TGFR for point of care non-invasive transdermal fluorescence detection of Lumitrace is being evaluated in subjects with kidney function from normal to Stage 4 CKD. Patient enrollment covers the entire range of human skin colors spanning fair to black pigmentation. The study's primary outcome measure is the correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Measured GFR (mGFR) obtained from blood samples collected over time.1
About Lumitrace® (relmapirazin)
Lumitrace is an investigational 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 investigational Lumitrace solution for injection has been administered to over 500 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 tGFR by proprietary algorithms.
About MediBeacon Inc.
MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and 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's 47 granted U.S. patents and 170+ granted patents worldwide provide extensive coverage of the MediBeacon TGFR, including Lumitrace, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology including potential applications in nephrology, gastroenterology, ophthalmology and surgery. MediBeacon products are in various stages of clinical development and are NOT yet approved for human use. For more information, please visit: www.medibeacon.com
About INNOVATE Corp.
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 3,900 people across its subsidiaries. For more information, please visit: www.INNOVATECorp.com.
1ClinicalTrials.gov
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