BioLucent Introduces New SAVI Breast Brachytherapy Device at ASTRO.

ALISO VIEJO, Calif. -- BioLucent, Inc. today announced the launch of its SAVI[TM] applicator. The SAVI device offers a multi-catheter, single-entry approach to breast brachytherapy as part of breast-conserving cancer treatment.

The product introduction occurs at the annual meeting of the American Society for Therapeutic Radiation and Oncology (ASTRO), November 5-9 in Philadelphia. BioLucent will exhibit the new device at the company's Booth No. 1439.

The SAVI applicator is for use in accelerated partial breast irradiation (APBI) after lumpectomy. The applicator is a hybrid of two earlier APBI approaches, combining the tissue-sparing dosimetry of interstitial brachytherapy with the single-entry ease of intracavitary ("balloon") brachytherapy.

SAVI's ability to deliver a precisely targeted dose of radiation is designed to give more flexibility in treatment planning to the radiation oncologist and physicist.

APBI was developed as an alternative to whole-breast irradiation. Both whole-breast irradiation and APBI are used after breast-conserving surgery to decrease the risk of ipsilateral breast tumor recurrence.

The course of daily treatment for whole-breast irradiation is five to seven weeks.

With APBI, treatment is completed in 5 days. Other potential advantages of APBI include improved access to breast-conserving therapy, lower risk of injury to healthy tissue, and a faster transition to chemotherapy.

"BioLucent developed SAVI in part as a response to research showing that the inconvenience of whole-breast irradiation causes many women to forgo breast-conserving therapy and to be treated with mastectomy," said Jill Anderson, BioLucent's president.

SAVI may offer a better option for these women, Anderson said: "There is no reason for women to avoid risk-reducing radiation therapy. We believe SAVI may give them another option, by providing a breast-conserving approach that minimizes disruption to their work and family life."

The SAVI device includes an expandable bundle of catheters that surround a central lumen. The applicator is placed by the physician into the lumpectomy cavity through a small incision.

The physician expands the catheter bundle by turning a mechanism from outside the breast. The catheters expand to form an ellipsoidal shape inside the cavity. Delivery of radiation through the device's individual catheters allows the doctors better control of the radiation dose.

"After breast-conserving surgery, ideal radiation therapy tailors the radiation dose to only the breast tissue that is at high risk for microscopic cancer cells, sparing healthy tissue," said Robert R. Kuske, Jr., M.D., Arizona Oncology Services (Scottsdale, Ariz.). "Many breast brachytherapy procedures have the downside of risking radiation damage to the skin or chest wall. Because SAVI allows a shaping of the radiation dose, its design may reduce breast toxicities. This approach could also permit treatment of certain patients who were previously ineligible for other methods, thereby making partial breast irradiation available to more women."

SAVI was developed by BioLucent, Inc., a women's health company dedicated to early detection and treatment of breast cancer. BioLucent also manufactures and markets the MammoPad breast cushion, a radiolucent, FDA-cleared foam cushion that covers the cold, hard services of all commercially available mammography equipment. When MammoPad is used, three out of four women experience a 50 percent decrease in mammography-related pain.

For more information about BioLucent, call (toll-free) 866-460-4141 or access www.BioLucent.com.