RFPi’s proprietary and patented iCertainty™ medical device offers non-invasive, cost-effective and real-time visualization of blood flow and tissue perfusion, enabled by low-energy lasers, high-speed imaging cameras and proprietary analysis techniques and flow-calculation algorithms.

Having secured Class II 510(k) clearance from the FDA in December 2018 to market iCertainty for use by surgeons in open surgery, RFPi is pursuing full commercialization. The medical device is the product of working prototypes deployed successfully in clinical studies for proof of concept and in more than 100 pre-clinical experimental studies.

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:

2018

  • Received Class II 510(k) approval from the FDA for iCertainty in December
  • Selected as a 2018 MedTech Innovator from among 700 presenting. 25 Midstage companies were selected.

2017

  • Signed license, development and investment agreement with Nipro Corporation for iCertainty in Japan
  • RFPi converts from LLC to C Corp
  • Received federal grant to study new clinical applications of iCertainty
  • Received research loan to develop outpatient prototype of imaging system

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 began at selected clinical sites
  • Secured $4 million in angel investor financing in September 2016

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

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 forms LLC in May
  • Raised initial angel funding

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

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

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

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
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