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 approval on this component of the MediBeacon pipeline 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 trials 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 Covidien
- First Quarter 2012, US patent is issued for APC-2
The path to commercialization
- MediBeacon will submit Investigational Device Exemption (IDE) documents to FDA for approval. The FDA validated the regulatory and clinical pathway for the Optical Renal Function Monitor as part of development that preceded MediBeacon’s acquisition of the optical diagnostics platform.
- First-in-man clinical studies will begin at a world-class academic hospital.
- MediBeacon’s focus on real-time monitoring of GFR is aligned with the National Institute of Diabetes and Digestive and Kidney Diseases strategic direction.
- After initial FDA approval and launch MediBeacon anticipates potential follow-on applications, which among others include improving outcomes for kidney donors and transplant patients.