CivaTech Oncology has secured approval from the US Food and Drug Administration (FDA) for its new skin cancer therapy product called CivaDerm.
CivaDerm is a temporary radiation therapy product developed for intraoperative or surface radiation to treat skin cancer and other lesions.
CivaDerm is a temporary radiation therapy product for skin cancer patients
The new polymer-encapsulated brachytherapy device has been designed to use as a bandage and serve as a low dose rate (LDR) brachytherapy treatment option for skin cancer patients.
CivaDerm is claimed to be the only product of its kind to have an effective gold shielding, which makes only one side of the radiation device active.
A physician will place the active side of the device on the area targeted for treatment and secure it.
CivaDerm, which will be worn by patients over a five-day window, is said to deliver the dose of radiation prescribed by the physician.
The new skin cancer treatment will enable providers to deliver radiation therapy without using expensive specialised capital equipment or shielding.
CivaTech said that it has three FDA-cleared radiation therapy devices and holds the only polymer encapsulated radiation devices that are approved to be implanted in patients or used on the surface.
CivaDerm is provided with the same flexible substrate embedded with radioactive palladium as the CivaSheet, which has a Sealed Source and Device Registry issued by the State of North Carolina Division of Health Service Regulation (DHSR) and the US Nuclear Regulatory Commission.
CivaDerm is a variant of the CivaSheet platform that was developed in collaboration with the NIH, NCI and the NC Biotech Centre.
CivaTech Oncology CEO Suzanne Babcock said: “I am thrilled about the beneficial impacts of this product for the many patients who can utilize this new treatment option.
“Physicians will now have the option to place a bandage on patients for approximately 5 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.”
In 2014, CivaTech Oncology secured FDA approval for its CivaSheet brachytherapy device, which was developed for use either during surgery or with standard, less invasive and implant devices.
