iCertainty™ is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact
GREENVILLE, N.C. — RFPi Inc. has received 510(k) clearance from the U.S. Food and Drug Administration 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 MRI — 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.
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. The initial design work on this form factor is supported by a loan from North Carolina Biotechnology Center.
“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.
Videos that demonstrate how RFPi’s iCertainty™ platform works can be seen on the company’s website at www.rfpi-co.com.