RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--CivaTech Oncology, a medical device company dedicated to developing innovations in radiation therapy, announced today it has received a Registry Number as a “Sealed Source and Device” for its CivaSheet™ low dose rate (LDR) Palladium 103 source. The FDA cleared CivaSheet™ registration was issued by the State of N.C. Division of Health Service Regulation (DHSR), Radiation Protection Sections (RPS) which is now maintained by the U.S. Nuclear Regulatory Commission (NRC) in the National Sealed Source and Device Registry (NSSDR).
The implantable CivaSheet™ 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 CivaSheet was designed to treat many cancer tumor types including early stage lung cancer, soft sarcomas, head and neck, gynecological, colorectal or others.
“We are particularly proud to be the only manufacturer in North Carolina approved by the FDA and RPS to manufacture a medical radiation implantable device,” said CivaTech Oncology Chairman and CEO Suzanne Babcock. “We are fortunate to be located in a State that has a very supportive regulatory body.” North Carolina, through DHSR/RPS is an agreement state and has assumed NRC regulatory authority over byproduct radioactive material. “They have worked with us from the beginning, making it very clear as to the regulatory requirements for the product and we incorporated this information into our product design specifications.”
For the first time, radiation oncologists will have a configurable planar LDR array that is customizable to a specific patient’s condition, allowing clinicians to specify a tailor-made dose distribution that can be uni-directional and applied during surgery to remove tumors.
This product is truly positioned to be the first line of defense in the fight against early stage cancers.
About CivaTech Oncology Inc.
CivaTech Oncology develops innovative low dose rate (LDR) brachytherapy devices. The company’s flagship brand, CivaString®, has FDA clearance for therapeutic use in localized tumors. The polymer-based LDR brachytherapy devices are pioneering a new standard of care in treatment of early stage disease such as prostate and breast cancer. The bioabsorbable CivaSheet™, has FDA clearance and is the first polymer encapsulated brachytherapy with integrated radiation shielding, allowing broader applications where previously risk of harming healthy tissue was problematic.
CivaSheet™ development was partially supported by NIH and NCI and the NC Biotech Center.