Technology | September 16, 2014

CivaTech Oncology Receives FDA Approval for CivaSheet Brachytherapy Device

September 16, 2014 — CivaTech Oncology announced it has received U.S. Food and Drug Administration (FDA) clearance on its bioabsorbable planar radiation device. The implantable CivaSheet low-dose-rate (LDR) Palladium source is the only membrane-like brachytherapy device that is truly customizable to a specific patient’s condition and offers a unidirectional option to shield healthy tissue. The product was designed for use either during surgery or with standard, less invasive, implant devices.

Brian J. Moran, M.D., medical director of Chicago Prostate Center, believes the CivaSheet “potential could be huge. It may offer advantages due to its size and directional radiation emissions.” The ability to customize directionality in a planar configuration will help radiation oncologists treat a variety of cancers such as soft tissue sarcoma, early-stage non-small-cell lung cancer, head and neck cancer, colorectal cancer, ocular melanoma and skin cancer.

“We are very excited about the beneficial impact this can have for all of the patients whom are candidates for this new treatment option,” said CivaTech Oncology executive chairman and CEO Suzanne Babcock. “For the first time, radiation oncologists will have a configurable planar LDR array that is truly customizable to a specific patient’s condition, allowing clinicians to specify a tailor-made dose distribution that can be unidirectional or bidirectional.

CivaSheet will be the first commercially available polymer encapsulated bioabsorbable brachytherapy device that has integrated radiation shielding, allowing broader applications where previously risk of harming healthy tissue was problematic. CivaSheet development was partially supported with funding from the National Institutes of Health (NIH), National Cancer Institute (NCI) and the North Carolina Biotech Center.

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