RFPi Receives FDA Clearance to Market iCertainty Blood Flow and Perfusion Imaging Medical Device

RFPi Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing for use by surgeons in open surgery its iCertainty blood flow and perfusion imaging medical device. 
 
RFPi’s proprietary product shows real-time blood flow and perfusion in vascular structures and critical tissues during surgeries. iCertainty is the first commercially available imaging device that doesn’t require injections, dyes, radiation, direct patient contact or interrupting a surgical procedure the way other traditional modalities—such as X-ray, ultrasound and magnetic resonance imaging—do. 
 
By allowing surgeons to immediately visualize patient blood flow and perfusion during procedures, iCertainty offers surgeons, hospitals, patients and third-party payers the potential to reduce procedural complications or repeat surgeries, reduce hospital costs, and objectively measure and help to improve clinical outcomes. 
 
“Repeat surgery rates in iCertainty’s target indications run as high as 20 percent—a figure that masks a tremendous amount of patient discomfort, uncertainty and inconvenience, as well as financial loss for hospitals and insurers,” said Jeffery Basham, CEO. “iCertainty offers an entirely new and advanced standard of imaging detail, speed, ease and flexibility that should benefit surgeons, hospitals and third-party payers—and, most importantly, the patients they all care for.” 
 
RFPi, which closed on its Series A round of financing in May 2017, is securing Series B financing now to commercialize iCertainty and market it to surgeons and medical centers. 
 
“iCertainty has the potential to permanently change non-invasive medical imaging,” Basham said. “It’s exciting to bring to market new technology that delivers in terms of safety and patient and surgeon benefits.” 
 
iCertainty has been cleared by the FDA for imaging blood flow and perfusion in tissue up to a depth of 4-5mm. Basham anticipates that initial early applications will involve gastrointestinal and plastic surgeries as well as lower-leg vascular procedures.

Learn more about iCertainty in the video below:

 

But the technology behind iCertainty—called multi-spectral physiologic visualization or MSPV—offers the field of medicine even broader possible uses, Basham said. MSPV uses low-energy lasers, high-speed imaging cameras, and proprietary analysis techniques and flow-calculation algorithms to deliver real-time visualization and quantification of blood flow and perfusion. 
 
Having secured a federal grant to study it further, RFPi researchers are examining whether MSPV can accurately monitor a patient’s basic cardiovascular parameters at the point of care without touching the patient, and then transmit that information to other health-care providers. The implications there are substantial, especially in trauma-care or battlefield situations, Basham said. 
 
RFPi researchers also are developing a mobile device that could prove useful in outpatient settings, particularly in the field of wound care and diabetic clinics, an increasing health-care need in light of the country’s growing diabetic population. 
 
“Multi-spectral physiologic visualization offers multiple applications to achieve different medical goals,” Basham said. “The possibilities are staggering.”  
 
A mid-stage startup company, RFPi has secured three patents that provide significant intellectual property protection for its multi-spectral physiologic visualization technology. 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 working prototypes have been deployed successfully in three-plus years of pre-clinical and clinical studies. Its technology was invented in 2010 at East Carolina University by a team of cardiovascular medicine, optical physics and engineering experts. Development has included bench-top and experimental studies, and clinical proof-of-concept and validation studies.