Focal Therapeutics today released data from 2 studies of its BioZorb device designed to provide radiographic markings of soft tissue sites.
The marker is made up of a bioabsorbable framework holding 6 titanium clips. The framework dissolves over a year in the body, the company said, while the clips stay in place so the surgical site can be recognizable during long-term monitoring.
The studies explored the use of the BioZorb device’s use during breast cancer procedures, according to the Aliso Viejo, Calif.-based company.
The BioZorb device can be placed during lumpectomy surgery to identify the 3 dimensional region where the tumor was removed. The company said the device is ‘particularly effective’ when sutured to the tumor bed for future indication of where the cancer was located.
Data from the 1st study was published in the World Journal of Surgery and reported that the device provided “clear visualization” of the surgical site where the tumor was removed and allowed for better communication between the surgeon and the radiation oncologist. The device also aided in post-treatment mammograms and other long-term follow-ups for cancer, according to the study.
“Through our experience with this marker, we’ve observed that its use results in less radiation dose to the patient compared to whole breast radiation, plus a better overall cosmetic outcome. We were also pleased to note in our research that there were no device-related complications in this group of patients, and that none of them had a recurrence of cancer,” study lead author Dr. Michael Cross of Fayetteville, Ark.’s Breast Treatment Associates said in prepared remarks.
Data from the 2nd study indicated that use of the BioZorb device can lower the amount of time normal breast and surrounding tissues are exposed to radiation treatment.
“The process of delivering radiation treatment is substantially streamlined by having the 3D marker in place. The marker tells us where the tumor was and helps us determine appropriate forms of treatment, whether with partial breast irradiation or standard whole breast irradiation and a boost dose at the end of the treatment process,” study author Dr. William Hall said in a press release.