CivaTech Oncology® Receives FDA Approval for CivaSheet™ Brachytherapy Device

RESEARCH TRIANGLE PARK, N.C.-- CivaTech Oncology, a medical device company dedicated to developing innovations in radiation therapy, announced today it has received FDA clearance on its groundbreaking 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 uni-directional option to shield healthy tissue. The product was designed for use either during surgery or with standard, less invasive, implant devices.

Dr. Brian J. Moran, 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 bi-directional.

About CivaTech Oncology

CivaTech Oncology Inc. develops innovative low dose rate (LDR) brachytherapy devices. The company’s flagship brand, the CivaString™, has been granted a 510k clearance by the FDA for therapeutic use in localized tumor sites. This polymer-based low-dose rate (LDR) brachytherapy device is pioneering a new standard of care in treatment of early stage cancers such as prostate and breast cancer. The Company’s second product, a bioabsorbable sheet called CivaSheet®, has also received FDA clearance and 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 NIH and NCI and the North Carolina Biotech Center.

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