MediBeacon was formed in 2012 specifically to acquire the optical diagnostic program from Mallinckrodt, the Pharmaceuticals business of Covidien. MediBeacon’s mission is to commercialize biocompatible optical diagnostic agents for physiological monitoring, surgical guidance, and imaging of pathological disease in the human population. Several product concepts in these arenas are contained in the MediBeacon Intellectual Property (IP) portfolio.
The product pipeline includes real-time kidney function monitoring, a huge leap forward in the world of nephrology. The clinical history and road to FDA and European approvals on this component of the MediBeacon pipeline as well as other developments related to the platform of fluorescent agents and their potential clinical application is described below.
- Scientists explore the idea of using a fluorescent exogenous agent as a real-time GFR tracer agent.
- The FDA is consulted to identify the most efficient regulatory path to approval.
- An ideal small molecule fluorophore platform is identified and patent protected. A lead compound candidate is selected for commercialization.
- Laboratory-based instrumentation is assembled to enable noninvasive detection of fluorescence signal in vivo. Prototype instruments for clinical studies are constructed.
- In vivo safety and toxicology tests required prior to first-in-man use are completed
- MediBeacon acquires outright all technology, market research, patent estate, and other related assets from Mallinckrodt.
- First Quarter 2012, US patent is issued for MB-102.
- MediBeacon began human clinical studies at the University of Maryland at the end of 2013.
- By 2014, the MediBeacon Patent Estate grew to 36 granted patents worldwide with 17 in the USA and 49 additional patents pending.
- Initial human clinical studies were completed at the University of Maryland.
- The MediBeacon Patent Estate grew to 53 granted patents worldwide of which 21 are in the USA.
- In collaboration with Washington University School of Medicine, MediBeacon begins pursuing the use of its core fluorophore technology in Gastroenterology. The work is funded by a grant from the Bill & Melinda Gates Foundation.
- A peer-reviewed article on the novel fluorescent tracer agent is published (MB-102).
- MediBeacon moves forward with next steps in the kidney function clinical program.
- MediBeacon invests in patented fluorescent tracer agents for use in numerous potential medical applications.
- MediBeacon closes on a $22.4 million staged financing with Pansend LLC.
- Results of initial clinical studies presented at American Society of Nephrology (ASN) Kidney Week
- MediBeacon Inc. Acquires Mannheim Pharma & Diagnostics
- MediBeacon Inc. Obtains ISO 13485:2003 and EN ISO 13485:2012 Certifications
- NIH Award to study fluorescent technology for Optical Angiography
- MediBeacon continues gastroenterology collaboration with Washington University School of Medicine funded by a follow on grant from the Bill & Melinda Gates Foundation.
- Clinical studies demonstrating GFR Monitor completed on patients with impaired kidney function
- FDA Grants Breakthrough Device Status for MediBeacon’s Transdermal GFR Measurement System
- MediBeacon Inc. Obtains ISO 13485:2016 Recertification
- MediBeacon Enters into $30 Million Investment and Exclusive Commercialization Partnership in Greater China with Huadong Medicine