January 2, 2014 — Focal Therapeutics announced that its BioZorb 3-D tissue marker has been successfully used in over 100 patients.
BioZorb is a 3-D 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 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.
"This device represents a significant advancement towards the precise delivery of radiation treatment," said Robert Kuske Jr., M.D., radiation oncologist, Arizona Breast Cancer Specialists. "It gives us a reliable, visible marker of exactly where the tumor started in three dimensions to target with radiotherapy, which has never been available before. With the BioZorb, we know exactly where to aim the dose, so we can irradiate a smaller amount of tissue. That gives us the ability to get better results with less risk to healthy tissues nearby."
BioZorb's open-spiral design incorporates six permanent titanium clips in a 3-D, 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 United States and New Zealand, is made of a bioabsorbable material, allowing it to be absorbed by the patient's body over time rather than requiring a surgeon to remove it at a later date.
"The learning curve for placing this device is straightforward, and it fit smoothly into my routine from day one. I've been using it in most of my patients," said Michael Cross, M.D., FACS, surgical oncologist, Breast Treatment associates, and the first U.S. surgeon to place the BioZorb tissue marker. "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.”
BioZorb has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is available in a range of sizes to accommodate a variety of clinical situations.
For more information: www.focalrx.com
November 17, 2025 
