Our first product, called the CivaString®, has been cleared by the FDA for use in localized solid tumors or residual disease, and the product began use to treat prostate cancers in 2013. The Company’s second product, is a bioabsorbable, planar sheet called the CivaSheet®, received FDA clearance in 2014 and is the first commercially available brachytherapy device that has integrated radiation shielding built into the implantable device, making it more safe and allowing broader applications where previously risk of harming healthy tissue was problematic.
Both products are customized for the patient and the strengths can be varied according to the prescription. CivaTech Oncology’s products are significantly more accurate to prescription than traditional metal encapsulated seeds.
- CivaString and CivaSheet are the only implantable radiation therapy devices encapsulated with polymers and approved by the Nuclear Regulatory Commission as a sealed source.
- CivaSheet is the only bioabsorbable and directional radiation therapy device approved by the FDA.
- The Company is the recipient of the NCTA 21 Awards 2010 for Best Emerging Technology and was a finalist in 2013 for the NCTA Best Life Science Company.
- CivaTech Oncology is the first therapeutic radiation therapy company to be licensed as a manufacturer and distributer in the State of North Carolina.
- Manufacturing meets FDA guidelines for medical devices and highest international standards of ISO 13485 for production in a clean room environment.
- The Company has two licenses with the NRC Agreement State of North Carolina. One license allows CivaTech to conduct broad research and the other allows for the manufacture and distribution of products containing radioactive material.
- The CivaSheet has been supported by the NIH/NCI
- CivaString and CivaSheet have both been FDA cleared to treat cancers of any solid tumor such as Prostate, Pancreas, Sarcoma, Head and Neck, Gyn, Colorectal, Breast, Brain, etc.
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