Multiple Benefits of BioZorb Surgical Marker Reported at BC3 Breast Cancer Conference

Study Shows More Precise Definition of Surgical Site

2014 Breast Cancer Coordinated Care Conference

WASHINGTON--()--The BioZorb™ three-dimensional surgical marker improved targeting for radiation therapy by enhancing visualization of the breast cancer lumpectomy cavity, according to a presentation at the 2014 Breast Cancer Coordinated Care (BC3) conference in Washington D.C.

The scientific poster reported that substantial advantages were observed when the tissue marker was used with both post-operative radiation boost therapy and partial breast irradiation (PBI).

The study, which involved 22 patients, compared the use of the 3-D tissue marker to traditional tissue landmarks such as seroma and clips as well as post-operative density changes seen on treatment planning CT scans.

“Overall, this tissue marker allowed us to achieve more than a 50 percent reduction in the planned treatment volume,” said poster co-author Robert R. Kuske, Jr., M.D., an internationally known radiation oncologist who uses BioZorb in his medical practice at Arizona Breast Cancer Specialists. “With the BioZorb in place we didn’t have the guesswork that we have with traditional markers, so we had confidence that we were only irradiating the minimum tissue necessary. This means better results for our patients and also less risk to healthy tissue near the surgical cavity.”

Besides the improvement in target volume delineation, the researchers reported that all patients tolerated placement of BioZorb without complications and cosmetic outcomes were excellent.

“When traditional techniques are used to delineate the precise location that needs radiation, it can be very hard to identify the precise region of the surgical cavity,” said co-author Linda Smith, M.D. of Comprehensive Breast Care in Albuquerque, N.M. “This is especially true of patients with dense breasts, patients who’ve had chemotherapy first, and patients whose cavity has been closed with oncoplastic (reconstructive) techniques. So it was a revelation to see the surgical edges so clearly with the BioZorb device in place. I've integrated BioZorb into my practice and appreciate this innovative advancement for my patients.”

Prior to the advent of BioZorb, there was no standardized method for marking the surgical site of tumor removal, which made post-operative radiation planning difficult. Methods typically used for radiation planning may overestimate the volume of the treatment area, and may result in excess radiation exposure to normal tissues such as the heart and lungs, causing inadvertent complications.

The unique open-spiral design of the BioZorb marker incorporates six permanent titanium clips in a fixed three-dimensional array and provides specific landmarks at the site of the excised tumor. This poster and other clinical presentations note that the BioZorb marker is useful for radiation treatment planning, patient positioning during treatment, and the ability to facilitate advanced methods of radiation treatment, such as respiratory gating.

The only device of its kind, BioZorb 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, and allows the patient’s body to absorb the material slowly, so it does not require surgical removal after treatments are completed.

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

About Focal Therapeutics

Focal Therapeutics is a medical device company based in Portola Valley, Calif. The company developed and manufactures the BioZorb tissue marker. Focal's management team and investors include three medical device pioneers: George D. Hermann, the CEO; Gail S. Lebovic, MA, MD, FACS, the Chief Medical Officer; and investor Thomas J. Fogarty, MD. Together, they have played instrumental roles in the development of numerous commercially successful medical devices in women's healthcare, including the Mammotome® breast biopsy technology (Devicor Medical Products, Inc.); the MammoPad® Breast Cushion (Hologic); and the SAVI® Applicator for radiation therapy (Cianna Medical). Dr. Lebovic has also served as President of the American Society of Breast Disease, and is Chair of the 2014 World Congress of Breast Healthcare, in Orlando, Florida.

The company’s BioZorb tissue marker is 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. For more information about the company, call (U.S.) 650-530-2394, email customerservice@focalrx.com, or visit www.focalrx.com.

Contacts

Dowling & Dennis Public Relations
Liz Dowling, 415-388-2794
Liz@DowlingDennis.net

Release Summary

The BioZorb three-dimensional surgical marker improved targeting for radiation therapy by enhancing visualization of the breast cancer lumpectomy cavity, researchers reported at 2014 BC3 conference.

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Contacts

Dowling & Dennis Public Relations
Liz Dowling, 415-388-2794
Liz@DowlingDennis.net