Diagnostics & Imaging Week

WINSTON-SALEM, North Carolina — One of the more frustrating aspects of innovation is, sometimes, waiting for the "system" to catch up. That was the case for Sicel Technologies (Raleigh, North Carolina), which reported in 2006 that it had received FDA 510(k) clearance for its Dose Verification System (DVS), a wireless implantable radiation sensor and reader designed to help radiation oncologists know if the radiation they're administering has hit its target.

"We had this great product on the market for more than a year but no reimbursement," said President/CEO Michael Riddle. "We spent a year developing the market. Now we finally have coverage in the majority of 2,000 [cancer] centers in the U.S."

Sicel was one of several presenting med-tech companies at the Council for Economic Development's (Durham, North Carolina) 17th annual Biotech 2008 Conference, co-sponsored by the North Carolina Biotechnology Center and the North Carolina Biosciences Organization (both Research Triangle Park).

The Centers for Medicare & Medicaid Services (CMS) has finally established a new code for implantable radiation dosimeters, providing a mechanism for providers to report the cost for the DVS, the first implantable dosimeter of its kind.

Separate codes are available to cover the cost associated with implanting the device.

DVS is now cleared for use in treatment of breast and prostate cancers. "We chose those indications, from a commercial standpoint, because there are 400,000 patients in the U.S. who suffer from these diseases," Riddle said.

The tube-like structure helps clinicians target the tumor site and minimize damage to the tissue around it. "We'll be expanding into lung and rectal cancer indications," he said. "We're in the process of generating revenues to do that."

Radiation is typically delivered over a six-week period. With some of the newer therapies, those dosages can be condensed into four shots. "If you get that high of a dose, we make sure they're hitting what's aimed at," Riddle said. "While we use this as a radiation sensor, we could potentially also measure temperature, oxygen and pressure. That means we could break into cardiology and orthopedics.

"The idea is to minimize the awful side effects of radiation," he said. "If we know what's happening at the tumor level, treatment can be individualized."

DVS is 20 mm long by 2 mm in diameter and is filled with medical-grade epoxy. It has a bidirectional antenna coil that provides it with power, similar to RFID tags in car keys.

Sicel is exploring the use of thin film batteries that would extend the current read range.

Implant of the sensor is relatively simple; it can be dropped in at the time of lumpectomy or added later in an office procedure under local anesthesia.

"We're proud to have a solution to avoid radiation overdoses, which can injure and kill patients," Riddle said.

"Many radiation oncologists have anxiously awaited the establishment of this new HCPCS code to begin ordering and reporting the use of DVS routinely for cancer patients," he said. "By easing the health insurance claim process using the new code, we anticipate this will enable more radiation therapy centers to offer DVS to patients who will benefit from this technology."