CivaDerm™ - CivaTech Oncology’s New Skin Cancer Therapy Product Receives FDA Clearance

CivaTech Oncologys new device, CivaDerm has received FDA clearance.

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Business Wire, Inc.
Retrieved on: 
Monday, September 30, 2019
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Biotechnology, Surgery, Oncology, FDA, Health, Medical devices, Medicine, Radiation therapy, Health, Medical physics, Clinical medicine, Brachytherapy, Therapy, Skin cancer, Management of prostate cancer, Intraoperative radiation therapy
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United States, North Carolina
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Summary
Key Points: 
  • CivaTech Oncologys new device, CivaDerm has received FDA clearance.
  • CivaDerm is a temporary radiation therapy product designed for intraoperative or surface radiation to treat skin cancer and other lesions.
  • The product can be applied like a bandage to provide a low dose rate (LDR) brachytherapy treatment option for skin cancer patients.
  • Radiation therapy for common skin cancers is already a popular treatment option, with excellent cosmetic outcomes and treatment success rates.


CivaTech Oncology’s new device, CivaDerm™ has received FDA clearance. CivaDerm™ is a temporary radiation therapy product designed for intraoperative or surface radiation to treat skin cancer and other lesions.

FDA clearance for CivaTech’s polymer-encapsulated brachytherapy device is an exciting milestone. The product can be applied like a bandage to provide a low dose rate (LDR) brachytherapy treatment option for skin cancer patients. It is the only product of its type designed with highly effective gold shielding, making only one side of the radiation device active. The active side of the device is placed by a physician on the area targeted for treatment and secured. Patients will wear the bandage and over a five-day window, CivaDerm™ will fully deliver the physician’s prescribed dose of radiation.

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 having to purchase expensive specialized capital equipment or shielding and patients will no longer have to make repeated trips to a facility during treatment.

The Company has three FDA cleared radiation therapy devices. CivaTech has 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 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.”

CivaDerm™ features the same flexible substrate embedded with radioactive palladium as the CivaSheet® that has a Sealed Source and Device Registry issued by the State of North Carolina Division of Health Service Regulation (DHSR) and the U.S. Nuclear Regulatory Commission.

The Company has support from current and past National Institute of Health and the National Cancer Institute R&D contracts and Fast Track Grants. CivaDerm™ is a variant of the same CivaSheet® platform that was developed with support from NIH, NCI and the NC Biotech Center.

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