FDA OKs Greenville firm to produce surgical device

A Greenville company has received clearance from the U.S. Food and Drug Administration to begin marketing a hi-tech medical imaging device it says has the potential to reduce surgical complications, the company announced this week.

RFPi, which started with financial assistance from the N.C. Biotechnology Center, received FDA approval for its iCertainty blood flow and perfusion imaging system, a company news release said. The clearance allows RFPi sell iCertainty to surgeons for use in open surgery procedures.

iCertainty is based on technology developed at and licensed from East Carolina University. It shows real-time blood flow and perfusion in vascular structures and critical tissues during surgeries.

It is the first commercially available imaging device that doesn’t require injections, dyes, radiation, direct patient contact, or interrupting a surgical procedure for X-ray, ultrasound or MRI. The news release said it has the potential to reduce complications, repeat surgeries and costs, and to improve clinical outcomes.

NCBiotech awarded a $250,000 Small Business Research Loan to RFPi in 2017 to help the company develop a prototype device. RFPi videos on the company website show how the iCertainty works.

“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 RFPi CEO Jeffery Basham said in the news release. “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 is securing 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.”

Basham anticipates that early applications will involve gastrointestinal and plastic surgeries as well as lower-leg vascular procedures.

The technology behind iCertainty — called multi-spectral physiologic visualization or MSPV — offers the field of medicine even broader possible uses, he 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.

“This is really gratifying to watch this amazing locally developed technology find its way into the world of clinical medicine,” said Mark Phillips, NCBiotech vice president of statewide operations and executive director of the Eastern Region Office. “This region’s global life science stature has been transformed by pharmaceutical manufacturing, and we’re delighted that we’re adding breakthroughs in advanced medical and agricultural technologies to that mix.”

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.”