Focal Therapeutics, a medical device company, has announced that its BioZorb three-dimensional tissue marker has now been successfully used in over 100 patients – marking a significant milestone for the company and the field of post-surgical radiation treatment for breast cancer.
BioZorb is a three-dimensional device that is designed to clearly and accurately identify the surgical site of tumor removal.
The device, which is placed by surgeons, enables clinicians to easily target the surgical site for radiation treatment and follow up. This approach, which is applicable to various kinds of radiation treatment, assists with radiation treatment planning, patient positioning during treatment, and long-term follow-up.
BioZorb’s unique open-spiral design incorporates six permanent titanium clips in a three-dimensional, fixed arrangement, which provides specific ‘landmarks’ of the surgical site for treatment planning, delivery, and follow-up.
The device, which has been used successfully in both the US and New Zealand, is made of a bioabsorbable material. That feature allows it to be absorbed by the patient’s body over time rather than requiring a surgeon to remove it at a later date.
Dr Michael J Cross, a surgical oncologist who was the first U.S. surgeon to place the BioZorb tissue marker, noted the learning curve for placing this device is straightforward, and it fit smoothly into his routine from day one.
"I’ve been using it in most of my patients. The best thing about using it is the confidence we have that our patient’s tumor site will be well-defined for the radiation oncologist.
"Instead of having surgical clips that can migrate to a different area, the BioZorb is sutured directly to the tissues surrounding the cavity where the tumor was removed. That way, the marker stays in the right spot and enables more precise targeting of the radiation after surgery," Dr Cross added.
The BioZorb tissue marker was developed by Focal Therapeutics.
BioZorb has received 510(k) clearance from the US Food and Drug Administration. The device is available in a range of sizes to accommodate a variety of clinical situations.