FDA approves CivaTech’s oncology therapy product CivaDerm

1 October 2019 (Last Updated October 1st, 2019 12:16)

The US Food and Drug Administration (FDA) has approved medical technology company CivaTech Oncology’s temporary radiation therapy product CivaDerm.

The US Food and Drug Administration (FDA) has approved medical technology company CivaTech Oncology’s temporary radiation therapy product CivaDerm.

CivaDerm has been designed for intra-operative or surface radiation to treat skin cancer and other lesions.

The polymer-encapsulated brachytherapy device can be applied like a bandage to provide a low dose rate (LDR) brachytherapy treatment option for patients with skin cancer.

CivaDerm is designed with gold shielding, enabling only one side of the radiation device to be active.

A physician places the active side of the device on the targeted area. Patients wear the bandage over a five-day window. CivaDerm will fully deliver the physician’s prescribed dose of radiation, as part of the treatment.

CivaTech Oncology CEO Suzanne Babcock said: “I am thrilled about the beneficial impacts of this product for the many patients who can utilise the treatment option.

“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.”

CivaDerm allows healthcare providers to offer radiation therapy for less cost without the need for purchasing expensive equipment. It also enables patients to reduce the number of visits to a facility during treatment.

The device features the same flexible substrate embedded with radioactive palladium as that of 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.

NIH, NCI and the NC Biotech Center helped to develop CivaSheet.

CivaTech Oncology has support from current and past National Institute of Health (NIH) and the National Cancer Institute research and development (R&D) contracts and Fast Track Grants.