RFPi’s proprietary and patented iCertainty™ technology offers non-invasive, cost-effective and real-time visualization of blood flow and tissue perfusion, generated from real-time imaging data capture and instant analyses.

RFPi is moving toward full commercialization, after utilizing working prototypes successfully in clinical studies for proof of concept and in more than 100 pre-clinical experimental studies. The company anticipates its regulatory approval path to be straightforward, with a Class II 510k application to be filed in 2016.

RFPi’s technology represents multiple years’ worth of development, experience and advancement on the part of our entrepreneurial team. Here’s a look at our company’s highlights:

2010

  • Investigated the feasibility of Laser Speckle Imaging (“LSI”) for a cardiac application, in a beating heart
  • Designed laboratory experiments to quantify flow measurement
  • Conducted optics benchtop testing of flow measurement of intra-lipid solution

2011

  • Refine optics benchtop testing of flow measurement of intra-lipid solution and human blood, incorporating cardiovascular pulsatile flow and cardiac cycle movement into the model
  • Conducted initial flow dynamic model testing

2012

  • Built the pre-Alpha-version prototype to successfully document proof of concept in the coronary artery bypass surgery setting, with IRB approval
  • Designed and tested EKG acquisition and synchronization
  • Investigated the feasibility of LSI in other clinical applications, with initial testing with the pre-Alpha-version prototype
  • Successfully documented proof of concept in the coronary artery bypass surgery setting, with IRB approval

2013

  • Continued image collection in coronary artery bypass surgery using the pre-Alpha version prototype, evaluating prototype sub-components
  • Continued image collection in other applications using improved pre-Alpha version prototype
  • Began to derive important additional information beyond flow and perfusion from the visualization image metadata

2014

  • Substantially improved the image visualization algorithms, the hardware design of the system, and the image analysis algorithms
  • Tested high-speed image acquisition and analysis in a beating heart, using an improved pre-Alpha-version prototype
  • Conducted optics benchtop testing improved visualization and analysis algorithms on optics phantoms with microfluidic capacities
  • Built fully functional pre-Alpha-Plus prototype for experimental studies
  • Conducted experimental in vivo studies in collaboration with the ECU Department of Comparative Studies, with IACUC approval
  • Conducted human skin blood flow and perfusion studies
  • RFPi Incorporated in May
  • Raised initial angel funding

2015

  • Conducted additional experimental in vivo studies in collaboration with the ECU Department of Comparative Studies, with IACUC approval
  • Expanded potential clinical application areas with proof-proof-of-concept studies in these experimental studies
  • Conducted additional human skin blood flow and perfusion studies for image metadata analyses

2016

  • Final Beta prototype design and build, with OEM suppliers and GMP
  • Build of Pre-FDA Clinical Devices for first two clinical application areas; testing to begin Q3, 2016 at selected clinical sites
  • Currently engaged in Series A round with a target of raising $2.5m
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