Civatech Oncology Inc.

CivaTech Oncology Inc. is a North Carolina-based medical device manufacturer specializing in innovative low dose rate (LDR) brachytherapy systems for cancer treatment. The company designs and commercializes polymer-encapsulated radioactive source devices that deliver localized radiation therapy to solid tumors while minimizing procedure time, trauma, and patient morbidity. Primary product lines include CivaString®, a linear polymer-encapsulated LDR brachytherapy source for treating prostate and other localized solid tumors; CivaSheet®, the only FDA-cleared unidirectional, bioabsorbable planar brachytherapy source; and CivaDerm™, a temporary radiation therapy product for intraoperative or surface treatment of skin cancer and other lesions. All products feature proprietary polymer encapsulation technology that eliminates hot/cold dose distribution spots, prevents source migration, and avoids long-term metal toxicity concerns associated with traditional metallic seeds. CivaString® and CivaSheet® are approved by the FDA and Nuclear Regulatory Commission as sealed sources for treating cancers of any solid tumor type, including prostate, pancreatic, sarcoma, head and neck, gynecologic, colorectal, breast, and brain malignancies. The company holds two NRC licenses in North Carolina (Agreement State), permitting broad research and manufacture/distribution of radioactive materials. Manufacturing operations comply with FDA guidelines and ISO 13485 international standards for medical device production in a cleanroom environment. The company has received NIH/NCI support and has published clinical outcomes demonstrating efficacy and safety. CivaTech's brachytherapy devices integrate seamlessly into existing clinical workflows from imaging through treatment planning and post-implant dosimetry.