Summary: The iCertainty™ platform technology from RFPi, Inc. simultaneously visualizes and quantifies the dynamic physiology of blood flow distribution – flow in vascular structures and perfusion in tissues. Surgeons will no longer have to guess about the adequacy of blood flow distribution in the tissues being operated upon – they will see it. This medical imaging technology’s differentiating attributes are: 1) non-invasive, 2) non-contact, 3) no risk, 4) non-disruptive to the procedure, and 5) and true real-time imaging data acquisition + analysis (10 sec). The surgeon sees the dynamic blood flow distribution ‘fused’ to the traditional anatomic framework, at the moments where critical technical decisions must be made. More accurate decisions will result in better outcomes and lower healthcare costs. The fidelity of this physiologically accurate data exceeds the competition in this emerging, $2.3B (est) real-time medical imaging space. The patented hardware/software solution – Multi-spectral Physiologic Visualization (MSPV) – has a laser safety rating of Class 1M. The first open surgical product is in the Class II FDA 510k approval process. RFPi, Inc. will bring MPSV to open and endoscopic surgeries (GI, vascular, transplant, plastic/reconstructive, GYN, GU, cardiothoracic), to the clinic (wound healing, diabetic foot care), and to medical monitoring solutions.
Need: Non-invasive, no-risk blood flow imaging in a real-time non-disruptive technology is transformational for surgeons and their procedures. These new data create an unprecedented opportunity for better outcomes, quality improvement, and lower costs. iCertainty enables the surgeon to identify the reparable tissue perfusion abnormalities, fix them, and avoid the resulting complications (anastomotic leak, wound breakdown, transplant hypoperfusion, early graft occlusion, limb salvage failure) – each of which has an incidence of 5-15% and results in prolonged hospitalizations and treatment readmissions. Elimination of these preventable complications is a substantial unmet healthcare Value need.
Value: Most major surgical complications link to an inadequate supply of blood flow/ perfusion in tissues being operated upon. Surgeons can’t identify this vulnerability, because → they can’t see blood flow distribution in visible light → they guess about tissue viability → they can’t avoid the complication. iCertainty eliminates this deficiency by visualizing tissue blood flow and perfusion in real-time. The Patient Value proposition is: 1) intraoperative remedy of perfusion abnormalities → better procedural outcomes; and 2) intraop validation of procedural quality. The Healthcare Value proposition is: 1) sustained standard-of-care improvement; and 2) sustained cost reduction.