CivaTech Gets FDA OK for Third Cancer Device
CivaTech Oncology, a Research Triangle Park company developing a unique platform of cancer therapy devices, has received marketing approval from the U.S. Food and Drug Administration for its new CivaDerm skin cancer treatment device.
CivaDerm is a variant of the CivaSheet platform that the company developed with funding support from the North Carolina Biotechnology Center and the National Institutes of Health. CivaDerm is a bandage-like device that emits a five-day low dose of radiation to treat certain skin cancers and other lesions.
The company’s products have an overlay of gold shielding, making only one side of the radiation device active. The active side of the device, a flexible substrate embedded with radioactive palladium, is secured by a physician to the area targeted for treatment.
Radiation therapy for common skin cancers is already a popular treatment option, with excellent cosmetic outcomes and treatment success rates. CivaDerm allows providers to offer radiation therapy without the need to purchase expensive specialized equipment or shielding. It also relieves patients from the need to make repeated trips to a facility during treatment.
This is CivaTech’s third FDA-approved radiation therapy device. The others are CivaString, for treating prostate cancer, and CivaSheet, which is implanted for other internal cancers. CivaTech boasts that it now sells the only polymer encapsulated radiation devices that are approved to be implanted in patients or used on the surface.
“I am thrilled about the beneficial impacts of this product for the many patients who can utilize this new treatment option,” said CivaTech Oncology CEO Suzanne Babcock. “Physicians will now have the option to place a bandage on patients for approximately five days to treat non-melanoma skin cancers, keloids and other external surface conditions that respond to radiation. This treatment is intended to be used instead of surgery but it is approved for adjuvant therapy, as well.”