BioZorb Surgical Marker Reported to Help Radiation Targeting and Improve Cosmetic Results for Breast Cancer Patients

In In The News by Barbara Jacoby

Thumbnail for 8706Presentation at ASCO Meeting Says 3D Device Proves

Valuable in Breast Reconstruction and Postoperative Radiotherapy

The BioZorb™ three-dimensional tissue marker contributed to both better surgical outcomes and more precise radiation treatment of breast cancer patients, according to a scientific poster presented at the recent American Society of Clinical Oncology (ASCO) 2014 Breast Cancer Symposium (#BCS14).

Oncology and surgery researchers reported that the BioZorb surgical marker proved to have advantages for both standard partial-mastectomy patients and those who underwent oncoplastic reconstructive surgery.

“As someone who has been using the BioZorb since it was first introduced, I feel fortunate to have an opportunity to share my surgical experiences at this meeting,” said Michael Cross, M.D., F.A.C.S., a breast surgeon and lead author of the 65-patient series. “To have these great cosmetic results without any complications is particularly exciting.”

Oncoplastic surgery combines plastic surgery techniques with surgical oncology methods, to help maintain the treated breast’s natural shape and contour. While this approach can improve cosmetic outcomes for breast cancer surgery patients, it involves rearranging the patients’ own tissues, which can make it difficult to visualize the exact surgical site that may need radiation treatment.

BioZorb is unique, since it can be used in conjunction with oncoplastic techniques to optimize the final surgical result. Many of these surgical techniques were outlined in this presentation.

Accurate visualization of the surgical site is known to be problematic with standard breast surgery patients, because of seroma formation and the drawbacks of traditional surgical markers, such as clips. When the surgical site cannot be clearly marked in a precise three-dimensional manner, radiation treatment planners may enlarge the volume of the treatment area to make sure the tumor site is not missed. This can result in radiation exposure to normal healthy tissues such as the heart and lungs, causing inadvertent complications.

Treating an overly large volume of tissue can also negatively affect cosmetic results for breast cancer patients.

The BioZorb surgical marker’s unique open-spiral design incorporates six permanent titanium clips in a fixed 3D array and provides specific landmarks at the site of the excised tumor. This allows the surgeon to secure the tissue to the device and use it for oncoplastic reconstruction, patient positioning and radiation treatment planning.

The BioZorb device has been used successfully in both the U.S. and New Zealand. It is made of a bioabsorbable material commonly used in other medical devices, allowing the patient’s body to absorb the material slowly so it does not require surgical removal after treatments are completed.

The device, which has received 510(k) clearance from the U.S. Food and Drug Administration, is available in a range of sizes to accommodate a variety of clinical situations.

The ASCO 2014 Breast Cancer Symposium was held Sept. 4-6, 2014 in San Francisco.

About Focal Therapeutic

Focal Therapeutics is a medical device company based in Aliso Viejo, Calif. The company developed and manufactures the BioZorb tissue marker, a proprietary bioabsorbable device that provides radiographic marking of soft tissue sites. The BioZorb device is placed at the time of surgical removal of tissue, such as during breast surgery, and the device’s three-dimensional array of marker elements has unique clinical utility for patient imaging.