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NEPHROLOGY
Helping physicians to make better decisions sooner.
HOW WE’RE MASTERING RENAL FUNCTION MEASUREMENT**

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MB-102 brand name is Lumitrace™

24-72 HOURS
IS TOO LONG.

Using SCr is like waiting for the quarterly financial report rather than realizing that the market is crashing today.

- Richard J. Solomon, MD, FASN, FACP
Read the Publications >>
Creating a new vital sign.*

Correct determination of GFR as an indicator of kidney function has the potential to bear great importance in the treatment of patients because experts believe that clinical decision-making could be aided by it in many situations.

In October of 2018 the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the Transdermal GFR Measurement System (TGFR). The device is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.

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MediBeacon’s Breakthrough Device is Intended to Measure GFR in Patients with Impaired or Normal Kidney Function

 

ST. LOUIS, October 22, 2018 – MediBeacon Inc., whose largest shareholder is Pansend Life Sciences of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the company’s Transdermal GFR Measurement System (TGFR). The device is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.1

MediBeacon’s TGFR, which is designated by the FDA to be a combination product, includes an optical skin sensor, monitor and MB-102, which is a proprietary fluorescent tracer agent that glows in the presence of light. The TGFR is designed to provide clinicians continuous real-time measurement of GFR at the point of care with no need for blood sampling or urine collection.

The ability to measure GFR is of high clinical interest especially in patients with or at risk of kidney disease. Kidney disease is a hidden epidemic, affecting more than 850 million people worldwide. This is twice the number of people who have diabetes and more than 20 times the number of people with cancer. 2

Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with companies to expedite regulatory review in order to give patients more timely access to diagnostic and therapeutic technologies. According to the FDA, a “Breakthrough Device” like the TGFR is a product that has the potential to be more effective at diagnosing a life-threatening or irreversibly debilitating disease or condition compared to the current standard of care. 3

“We are delighted that the FDA has recognized the Transdermal GFR Measurement System meets the requirements for this designation,” said Steve Hanley, MediBeacon CEO. “We look forward to continued close collaboration with the FDA as we begin our pivotal multicenter clinical study in the United States and Europe.”

“We are extremely excited about MediBeacon’s breakthrough real-time kidney function measurement system,” said Philip Falcone, HC2’s Chairman, Chief Executive Officer and President. “HC2 is committed to continued support of this remarkable innovation which has the potential to help millions of people around the world.”

MediBeacon tracer agents and devices, including the TGFR, are not approved or cleared for human use by any regulatory agency.

1 Data on file. MediBeacon Inc., St. Louis, MO.

2 Joint Press Release, June 27, 2018 “The hidden epidemic: Worldwide, over 850 million people suffer from kidney diseases”, American Society of Nephrology – ASN
(https://www.asn-online.org ), ERA-EDTA (http://web.era-edta.org) and ISN (https://www.theisn.org).

3 Food and Drug Administration. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM581664.pdf

“For decades, physicians have sought more efficient and sensitive tools to detect changes in kidney function, which can guide therapy and potentially prevent kidney impairment or failure.”

- Dr. Joseph V. Bonventre Professor of Medicine Harvard Medical School
The TGFR is poised to begin its global Pivotal Study.

The TGFR is engineered to allow non-invasive detection of the change in patient levels of fluorescent GFR tracer agent (Lumitrace™) over time via a sensor placed on the patient’s skin. The rate of decrease in the emitted fluorescence from Lumitrace™ is automatically calculated and displayed on the monitor yielding a measured GFR or kidney function.*

MediBeacon’s vision of a renal function vital sign is one where real-time measurements are accurate and responsive to changes in actual organ function. There are a vast number of situations in which real-time renal function data could have utility to physicians. Many of the uses for real time kidney function measurements will only be discovered with continued research. Some of the areas where real-time renal function measurements may have value may require repeat injections of MediBeacon’s proprietary dye to enable long-term, or repeat renal function measurements.**

Nephrology consultations that would include measurement of renal function are common in many clinical situations. Some possible uses for accurate real-time renal function measurements are presented below.

Intensive Care
Patients with numerous comorbidities involving the kidney commonly present in the ICU. Real-time, bed side renal function measurements have the potential to yield important information to aid in patient management.
Chronic Kidney Disease (CKD)

Experts believe that proactive and accurate diagnosis and monitoring of kidney function may potentially help delay the onset of End Stage Renal Disease (ESRD). Over 30 million adults are estimated to have CKD. 48% of those with severely reduced kidney function and 96% of those with mildly reduced kidney function are not aware they have CKD.

- Centers for Disease Control and Prevention of the United States (CDC) - National Chronic Kidney Disease Fact Sheet, 2017

Cardiac Catheterization Lab

Experts believe that accurate real-time GFR measurements could aid in the management of patients undergoing Percutaneous Coronary Interventions (PCI) in cases where kidney damage is perceived to be a risk.

Cardiac Surgery

Physicians are exploring ways to mitigate perioperative kidney damage risks. Accurate real-time GFR is anticipated to provide useful information which may contribute to improved management of cardiothoracic surgery patients.

Transplants (kidney, heart and liver transplants)

Monitoring kidney function for organ transplants is critical. Well-identified interventions exist to improve transplantation success rates. Earlier organ function knowledge could help clinicians in their efforts to improve the standard of care.

The TGFR is designed to accurately measure GFR in a clinically practical manner. The TGFR system includes a novel fluorescent tracer agent utilized in combination with a highly engineered transdermal sensor.*

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*MediBeacon products are in various stages of clinical development and are not yet approved for human use.

**The Transdermal GFR Measurement System (TGFR) is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function. References on this website to measured kidney function and measured renal function refer to the measured GFR.

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