Adding the physiology of blood flow and tissue perfusion to the anatomy of structures, RFPi, LLC’s iCertainty non-invasive imaging technology provides surgeons and clinicians with new knowledge to make better real-time decisions that improve patient safety and outcomes and lower healthcare costs.
Primary Application Area: Medical Devices
Technology Development Status: Proven Manufacturability
The iCertainty platform will enter the new, $2B (est) medical imaging space between human visible light reflectance/optical cortex processing and ionizing radiation-based imaging with Radiology interpretation. iCertainty uses a newly-patented (US 9,226,673 B2; Application No. 13/819,817, all claims allowed) hardware/software platform technology solution involving laser illumination, light/tissue interaction and scattering, reflectance capture, and proprietary analyses. This technology visualizes and quantifies blood flow in vessels and microvascular perfusion at or near the surface of tissues and organs, non-invasively and in real-time. Documented clinical applications include cardiac surgery, GI surgery, vascular surgery/wound healing, plastic/reconstructive surgery, and medical monitoring solutions being developed in collaboration with the military. Along with this unique technology solution, the attributes of non-invasiveness and real-time analysis visualization distinguish iCertainty from other technologies in this space. The availability of this physiologic quantification of flow and perfusion makes this iCertainty technology solution transformative, because it provides completely new, actionable data at the moment where critical technical and clinical decisions must be made. Importantly, incorporation of imaging-based quantitative analysis of blood flow/perfusion physiology as an objective documentation of technical quality in surgical procedures and clinical evaluations will be equally transformative to our healthcare system.
FIGURES OF MERIT:
Value Proposition: The Value proposition of this iCertainty platform is paradigm-shifting for the Healthcare industry. Currently, surgeons/clinicians make technical decisions mostly based on anatomy, including visible light inspection of the tissues being operated upon. The absence of an iCertainty-like technology forces surgeons/clinicians to make educated guesses about the physiology/pathophysiology of arterial and venous blood flow and microvascular perfusion in these tissues. However, the technical outcomes and clinical complications of most surgical procedures are directly related to these pathophysiologic changes in flow/perfusion at critical anatomic sites – anastomoses, resections, and reconstructions.
This unique technology gives direct, instant, image-based feedback to the surgeon/clinician. Repeated measurement minimally increases procedure duration, and doesn’t increase patient risk; iCertainty incorporation into the operative procedure is non-disruptive. The analyses uniquely combine both anatomy and physiology metadata for unsurpassed visualization clarity. iCertainty is faster, more cost-effective, and more accurate than competitive technologies.
Imaging to document procedural technical quality sets a new standard of care for these procedures. With these new physiologic data, surgeons/clinicians will make better, more accurate real-time decisions. Using iCertainty's data will reduce complications, produce better patient outcomes, and lower care costs.
Organization Type: Mid-stage Startup (A or B)
GOVT/EXTERNAL FUNDING SOURCES
SBIR/STTR Awards: NHLBI Agency Tracking Number 3871371, "Point-of-Care Imaging for Cardiovascular Monitoring: Light Energy-Tissue Interactions," in review.
External Funding to Date: GoldenLEAF Foundation of NC, $100,000; January 2014- January 2016.
Angel funding Rd #1, $400,000
Angel funding Rd #2, $1.1M of total $2.5M