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.”
The company currently employs 16 people, says Babcock, and it's raising funds to scale its manufacturing facility and to increase its sales force. It's also looking for dermatologists throughout the area to participate in its clinical studies.
She said the CivaTech platform offers significant advantages to people with skin cancers who want to avoid surgery, and to older people and diabetics who don't heal well. Dermatologists welcome the chance to provide people this alternative to surgery, she said, especially when it involves conspicuous areas such as the scalp or around the face, including the nose and around the eyes.