FDA says OK to Sicel Technologies' updated radiation-measurement device for cancer tumors

The U.S. Food and Drug Administration has given the green light for Sicel Technologies to begin selling an updated version of a sensor that measures radiation doses delivered to cancer tumors, the Morrisville-based medical device maker announced Monday.

The implantable sensor, 2 millimeters in diameter and 18 millimeters long, sits at the site of a tumor in a cancer patient and helps doctors ensure that the radiation actually hits cancerous cells, CEO Mike Riddle says. The sensor uses radio frequency identification technology to send information about radiation levels to a reader. The sensor is approved for use in breast and prostate cancers.

The sensor is the next generation of the company’s dose verification technology, which the FDA approved in 2006, and the device is specifically calibrated for hypo-fractionated therapy, a treatment that gives patients higher doses of radiation over a shorter period of time compared to conventional radiation therapy.

Riddle says accuracy in delivering radiation therapy is important because missing the tumor can lead to a reoccurrence of cancer and can also damage healthy tissue. The margin for error is small. The prostate gland is about the size of a walnut.

“You better make sure if you give a big dose, you hit it,” Riddle said.

Riddle says the company plans to study use of its device in lung cancer. The company has also applied for a CE Mark, which would clear the device for use in European Union countries.

For now, Sicel is still trying to close a $20 million series G , or seventh, funding round. Riddle says the money would be used to ramp up its sales and marketing efforts. He declined to comment Sicel has raised in the current round or what the company’s revenue is.

Sicel’s total venture haul through six rounds stands at $30 million, collected from high-net worth individuals and European institutions. The company employs 48 people, including five salespeople in the field.

Sicel was founded in 2009. The company’s technology was developed by company founders Dr. Charles Scarantino, a radiation oncologist at Rex Hospital, and Troy Nagle, a professor of electrical and computer engineering at North Carolina State University.