Dr. Steven Harms, a clinical professor at the University of Arkansas for Medical Sciences and an authority on breast MRI, looked at follow-up images from a group of 110 patients who received Focal’s BioZorb device for three years. Harms saw that the marker could help physicians target radiation treatments after a lumpectomy, and that it allowed them to better visualize the site where the tumor was removed during follow-up mammograms and MRIs — a potentially salient finding as scar tissue following surgery can hide or mimic cancer.
BioZorb also helped reduce certain negative effects of lumpectomy. “The 3-D shape of the device helps to maintain the contour of the breast and helps to promote growth of healthy tissue into the area where the lumpectomy was done,” Harms said in a statement. The device, which consists of a small, absorbable coil that holds 6 titanium clips in a 3-D pattern, also helps cut down on internal scarring within the breast, he added. Harms will present his findings at the International 2015 Breast Cancer Symposium in San Francisco. “In the patients we studied who had the marker implanted, I was pleasantly surprised when I viewed the mammograms after surgery,” Harms said in a statement. “The device seems to provide a mechanism to assist the growth of healthy tissue, and we can clearly see the difference on the follow-up mammograms. I have to admit, these findings were unexpected. But as a radiologist, this is very exciting since the marker has made it easier for us to monitor these patients.”
The findings mark a win for Focal, which scored FDA 510(k) clearance for the BioZorb in 2012. Since then, the company has worked slowly but steadily to expand the product’s global reach, charting a milestone in 2013 with more than 100 patients in the U.S. and New Zealand using its device. But Focal is not stopping there. The company continues to tout studies of its device, talking up its promise in helping doctors target and monitor breast cancer in patients who have already undergone surgery. Last year, the company at the 2014 Breast Cancer Coordinated Care (BC3) conference showed that BioZorb improved visualization of the breast cancer lumpectomy cavity. With the latest findings in tow, Focal could be poised to grab a bigger piece of the market.
REFERENCE: Fierce Medical Devices; 24 SEP 2015; Emily Wasserman