MediBeacon’s fluorescent pharmaceuticals enable physiological function monitoring at the point of care. The company’s transdermal kidney-function measurement system received FDA Breakthrough Designation and addresses a multi-billion-dollar unmet medical need. Use of MediBeacon technology in gastrointestinal health has been supported by the Bill & Melinda Gates Foundation.
MediBeacon, in a management buyout in 2012, acquired technology from Covidien. Since then, the company has conducted numerous clinical studies focused on the transdermal detection of proprietary fluorescent agents as a means to measure physiological function.
The company’s intellectual property has expanded substantially over the past 7 years and now includes over 30 granted US patents, which cover composition of matter of the company’s pharmaceuticals, as well as algorithms and methods related to the transdermal detection of these patented fluorescent agents.
In 2015, Pansend Life Sciences of HC2 Holdings, Inc. (NYSE MKT: HCHC) became the largest equity investor in MediBeacon. In 2019, MediBeacon entered into a $30 million investment and exclusive commercialization partnership in Greater China with Huadong Medicine Co., Ltd. Huadong is a leading Chinese-based pharmaceutical company listed on the Shenzhen Stock Exchange.
MediBeacon’s fluorescent agent platform for use in physiological function monitoring has important applications in kidney health, gastrointestinal health, and beyond.
Current methods to evaluate kidney function are indirect estimates that are inaccurate and not real-time. In the acute hospital setting, these estimates lag actual declines in kidney function by 24-48 hours. In the case of Chronic Kidney Disease (CKD), impaired function may only be detected after up to half of a person’s kidney function is lost. In addition, unrelated factors such as age, hydration status, muscle mass, and diet may further confound the estimates.
No clinically practical method exists to measure kidney function in realtime at the point of care. MediBeacon’s Transdermal GFR Measurement System (TGFR) includes a patented pharmaceutical, Lumitrace™, that is entirely eliminated by the kidneys. Lumitrace fluorescence is detected by a sensor placed on the skin, analogous to pulse oximetry for oxygen saturation SpO2.
The TGFR received the US Food and Drug Administration (FDA) Breakthrough Designation in 2018. 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.
Kidney disease is a “hidden epidemic” affecting more than 850 million people worldwide.² The ability to measure GFR is of high clinical interest, especially in patients with or at risk of kidney disease. TGFR use has the potential to improve healthcare outcomes for ICU patients, cancer patients, transplant donors and recipients, and for individuals with or at risk of CKD.
Grants from the Bill & Melinda Gates Foundation have supported MediBeacon transdermal GI permeability research. Clinical interest in the field has increased exponentially over the past several decades. An initial clinical study of the use of the company’s technology to measure gastrointestinal permeability in Crohn’s patients is anticipated to begin in 2019. Increased gut permeability can be viewed as a “leading indicator” of gut inflammation, and control of inflammation is the cornerstone of all modern treatment of Inflammatory Bowel Disease.
MediBeacon technology is used by leading medical schools, academic centers, research institutes, contract research organizations, and pharmaceutical companies worldwide to enhance preclinical assessment of kidney therapeutics, evaluate nephrotoxicity, and gain a fundamental understanding of kidney function in animals.
Research using the MediBeacon preclinical product has been featured at scientific meetings worldwide. There are over 150 peer reviewed publications and conference abstracts in which this transdermal mGFR technique has been used.
The TGFR product is poised to begin its pivotal clinical trial in the U.S. and Europe, and as such, MediBeacon’s preclinical customers are increasingly interested in the future use of the TGFR in human health.
MediBeacon tracer agents and devices are not approved for human use.
