GREENVILLE, N.C. — RFPi Inc. has received a grant from the National Institutes of Health to develop a novel, imaging-based medical device that health-care providers could use to test asymptomatic patients at risk for peripheral arterial disease.
A mid-stage startup company, RFPi is pioneering breakthrough medical imaging technologies using its proprietary Multi-Spectral Physiologic Visualization (MSPV). MSPV uses low-energy lasers, high-speed imaging cameras, and analyses and algorithms to deliver real-time visualization and quantification of blood flow distribution — flow and perfusion — without the need for injections, radiation or even direct patient contact.
RFPi anticipates the deployment of new technologies that improve surgical and clinical outcomes, enhance patient care, and reduce health-care costs. Last December, the company received 510(k) clearance from the U.S. Food and Drug Administration to market its iCertainty™ blood flow and perfusion imaging medical device for use by surgeons in open surgery.
This latest $1.48 million grant from the NIH’s National Heart, Lung and Blood Institute will help RFPi scientists develop a prototype device that provides a more efficient way to detect peripheral arterial disease, or PAD.
A subset of vascular disease, PAD affects blood flow to the lower extremities. Although a patient may feel pain while walking, the condition often presents with atypical symptoms or even no symptoms at all.
Patients with PAD are at increased risk for heart attack or stroke; left untreated, the condition can lead to the loss of a leg. As with vascular disease, patients more likely to experience PAD are older, smokers, or overweight, or have high blood pressure or high cholesterol.
Currently, a health-care provider conducts an initial evaluation for PAD by measuring the patient’s blood pressure in the arm, and comparing that to a blood pressure measurement taken at the ankle. Called the Ankle-Brachial Index Test, it detects PAD about 75 percent of the time when performed by a trained health-care provider.
However, in patients who don’t have symptoms, the test becomes significantly less accurate; in diabetic patients, accuracy falls to less than 50 percent.
This is a problem considering the country’s growing population of patients with Type 2 diabetes, a known leading cause of lower-limb amputation, said T. Bruce Ferguson, MD, Chief Medical Officer at RFPi.
“Peripheral arterial disease poses a legitimate and dangerous threat to people at highest risk for the condition — who happen to be the same people for whom the current standard of diagnostic evaluation is less than effective,” he said. “We need a better technology solution for identifying patients with PAD earlier to, hopefully, avoid painful, invasive and life-altering surgeries altogether. Such a solution would benefit patients, their families, their health-care providers and insurance companies alike.”
With this NIH grant, RFPi’s scientists will implement the design of a technology that measures a patient’s blood pressure in both upper and lower extremities simultaneously, using no-risk, non-invasive, no-contact, and non-ionizing imaging that captures data in 10 seconds and displays actual results in real time.
RFPi then will evaluate the prototype in a clinical study conducted with the Division of Vascular Surgery at Brody School of Medicine at East Carolina University, and the Division of Vascular Surgery at the University of Rochester in Rochester, N.Y.
RFPi aspires to become a leader in real-time, non-invasive medical imaging devices that
RFPi’s technology was invented in 2010 at East Carolina University by a team of cardiovascular medicine, optical physics and engineering experts. Videos demonstrating how RFPi’s iCertainty platform works can be seen on the company’s website at www.rfpi-co.com.