GREENVILLE, N.C. — RFPi Inc. has secured a federal Small Business Innovation Research (SBIR) grant to create a simple, effective, patient-friendly and non-invasive cardiac monitoring and communication device to promote healthy independent living in elderly patients.
The grant totaling $224,841 will pay for RFPi to incorporate its proprietary Multi-Spectral Physiologic Visualization (MSPV) technology into a novel new medical device design. Without touching the patient, the device would capture data about a patient’s hemodynamics (blood pressure and heart rate), peripheral tissue oxygen saturation (SpO2), and hemoglobin concentration (Hgb), and then transmit that information to the patient’s health-care provider.
Elderly patients who are discharged from the hospital after they’ve undergone surgical procedures requiring anesthesia are at high risk for cardiopulmonary complications; the first signs of complications can be changes in hemodynamics and oxygenation in tissues. The time interval between hospital discharge and the first post-operative visit is when these patients are most vulnerable.
Point-of-care cardiopulmonary parameter trend monitoring could signal the early onset of abnormal parameters and alert the patient’s health-care providers.
“The technology would provide reliable clinical information to the physician in an efficient manner, yet also be simple and easy enough to use by patients who may be managing limitations in visual, cognitive or mechanical adeptness,” said T. Bruce Ferguson, MD, Chief Medical Officer at RFPi.
Or, if everything is normal, the device’s feedback could reassure patients and their families. In this way, the device could promote healthy independent living among elderly patients.
“As a physician, I know my older patients value autonomy,” Ferguson said. “A device that could help them live as independently as possible — while also efficiently and non-invasively supporting their health and well-being — would benefit patients, families, health-care providers and insurance companies alike.”
The proposed device in development builds on RFPi’s pioneering imaging technology known as 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.
All RFPi technologies seek to improve surgical and clinical outcomes, enhance patient care, and reduce health-care costs.
A mid-stage startup company, RFPi also was awarded $1.48 million recently from the National Institute of Health’s National Heart, Lung and Blood Institute to develop a prototype device that detects peripheral arterial disease.
The company has 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 SBIR grant covers two phases of research and development — the first to leverage published scientific data to develop optimal protocols for SpO2 and Hgb, and the second to design a commercial prototype of the home cardiac monitoring and communication device.
The mission of the SBIR program is to support scientific excellence and technological innovation that has potential to increase private-sector commercialization.
RFPi aspires to become a leader in real-time, non-invasive medical imaging devices that seek to:
- Improve clinical outcomes for patients, lessening discomfort and stress.
- Benefit surgeons by integrating views of physiologic circumstances in real time without disrupting procedures or requiring patient contact.
- Reduce costs for hospitals by reducing readmission and repeat surgery rates for post-surgical complications.
- Objectively measure outcomes, providing hospitals and third-party payers with quantifiable performance data.
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.