CivaTech Oncology and NYU Langone Health Launch NIH-sponsored trial to fight lung cancer

The NYU Langone team, led by thoracic surgeon Michael Zervos, MD and radiation oncologist Benjamin Cooper, MD, affixed a custom sized CivaSheet to the area of the patient’s lung needing treatment, following a robotic tumor resection. The patient was thereby treated with a full course of radiation in a one-time therapy.

CivaSheet’s integrated shielding protects healthy surrounding organs, enabling a higher dose than can be administered using other treatment options. Implanting CivaSheet was completed in approximately 30 minutes. “CivaSheet provides patients optimal chance for a cure while also preserving lung tissue and maintaining maximum pulmonary function,” said CivaTech Oncology’s Chief Medical Officer George Paschal MD.

Approximately 234,000 patients in the U.S. are diagnosed with lung cancer each year, and of those, 30- 55% with non-small cell lung cancer develop recurrence. CivaSheet, a new bio-absorbable, internal radiation treatment, is designed to help prevent a recurrence of lung cancer by delivering a highly targeted dose of radiation directly to the surgical margin where residual cancer cells may remain.

Designed and manufactured by CivaTech Oncology, CivaSheet is a flexible, implantable intra-operative radiation therapy device (brachytherapy), which emits unidirectional radiation using integrated gold shielding. The unidirectional property makes the device active on one side to provide a homogenous radiation dose. This feature is entirely unique to CivaSheet, allowing physicians to safely deliver aggressive radiation doses immediately adjacent to healthy, sensitive tissue. No complications or radiation related side effects have been reported in patients treated to date. Radiation is delivered over the course of several weeks as the isotope naturally decays, eliminating the need for repeat hospital visits, and no follow up procedure is necessary to remove the device.

CivaSheet has broad FDA clearance to include lung cancer and many other malignancies. This multi-center, NIH/NCI- sponsored research protocol will determine CivaSheet’s impact on local control rate. NYU Langone Health is participating in this clinical trial with several other nationally recognized cancer centers in the U.S.