Neothermia Corporation Presents Clinical Data at the Annual Radiological Society of North America Meeting Indicating that the en-bloc(R) Breast Biopsy System Results in a Significant Improvement in the Diagnosis of Breast Cancer

CHICAGO, Nov. 29 /PRNewswire/ -- Neothermia Corporation, an emerging leader in the development and marketing of minimally invasive systems for the diagnosis of cancer, announced today the results of a multi-center study of its FDA-cleared en-bloc(R) breast biopsy system in comparison with standard biopsy methods. The data was presented at the 90th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) in Chicago (Abstract 4405243) and offers continuing evidence that en-bloc(R) is a more accurate method of performing percutaneous breast biopsy. The presentation was made by lead investigator, Angela Sie, M.D., Director of The Breast Center at Long Beach Memorial Hospital at Long Beach, CA, and was the result of a collaboration of 10 institutions and 14 physicians. These researchers are a representative sample of the many physicians in the United States to adopt the en-bloc(R) system into their clinical practices. The study, entitled "Comparison of the Diagnostic Accuracy of a Vacuum- Assisted Percutaneous Intact Specimen Sampling Device to 11g Vacuum-Assisted Core Procedures for Biopsy of Breast Cancer: A Multi-Center Experience," compares 742 en-bloc(R) breast biopsy procedures with an equal number of Mammotome(R) breast biopsy procedures. More than 1.5 million breast biopsies are performed in the U.S. every year. The results of this study indicate that by using Neothermia's en- bloc(R) system, physicians are significantly more likely to correctly diagnose patients with the initial biopsy. "We appreciate the efforts of Dr. Sie and the other physicians who participated in this study," said Thomas Tully, President and Chief Executive Officer of Neothermia Corporation. "The Mammotome(R) is an excellent diagnostic tool and, when it was introduced almost 10 years ago, represented a major advance in the field of breast biopsy. However, this study confirms that the en-bloc(R) is a significant advancement in core biopsy technology in the diagnosis of breast cancer. These data, which replicated a single-center study presented at last year's RSNA meeting, indicate that the number of underdiagnoses of certain forms of breast cancer is three times more likely with the Mammotome(R) than with en-bloc(R)." The en-bloc(R) is a minimally invasive out-patient procedure similar to Mammotome(R) core biopsy, but producing a large, intact specimen. The data present evidence that many women may have more definitive diagnostic results in their breast biopsy procedures with en-bloc(R). The study compared a population of 742 en-bloc(R) procedures and 742 Mammotome(R) procedures. Patients who were found to have cancer or certain forms of benign proliferative conditions were referred to open surgical biopsy, or a lumpectomy. Of those in the en-bloc(R) arm of the study, only five of 107 (4.7%) of patients who were diagnosed with the less invasive, ductal carcinoma in-situ (DCIS), were upgraded to the more invasive condition of infiltrating ductal carcinoma (IDC). By comparison, of those in the Mammotome(R) arm, 15 patients out of 112 (13.4%) with an initial diagnosis of DCIS were upgraded. These results were statistically significant. Additionally, only three of 32 (9.8%) of en-bloc(R) patients were upgraded from the benign proliferative condition of atypical ductal hyperplasia (ADH) to either DCIS or IDC. By contrast, 11 of 30 (36.7%) of the ADH cases diagnosed with the Mammotome(R) were upgraded to DCIS or IDC. These differences were also statistically significant. Commenting on the study, Dr. Sie stated, "The statistically significant data from our study are very encouraging in demonstrating the potential for en-bloc(R) to provide patients and their physicians with a more accurate tool for minimally invasive breast biopsy. Additional studies are planned to further define and expand upon the results of this study." Mr. Tully noted, "Clinical studies continue to demonstrate that the en- bloc(R) procedure can result in a more accurate diagnosis than percutaneous core biopsy. This is, in part, because the en-bloc(R) removes more intact tissue from the region of the suspicious lesion, reducing the potential for procedural sampling error. This provides the pathologist with more tissue from the region of interest and less from outside that region than core devices. Other aspects of the en-bloc(R) procedure, such as procedure time, cosmetic outcome, patient comfort, etc., are similar to percutaneous core biopsy. We believe that these results will help make en-bloc(R) a standard in the interventional diagnosis of breast cancer." About the en-bloc(R) System The en-bloc(R) procedure is a vacuum-assisted, image-guided (by ultrasound or stereotactic X-Ray) procedure in which a slender probe is inserted through a small incision to remove a small lump of suspicious tissue for pathological analysis. The procedure is performed under local anesthesia and the incision is closed with a steri-strip (bandage). About Neothermia Corporation Founded in 1998, and based in Natick, Massachusetts, Neothermia is a privately held company focused on the design, development and marketing of innovative minimally invasive systems for the volumetric excision of tissue for diagnostic and therapeutic applications in select cancer markets. The Company's lead product, the en-bloc(R) biopsy system, received approval from the Food and Drug Administration in June 2001. Initial products are targeted at breast biopsy and tumor excision. For more information on Neothermia, please visit the Company's website at http://www.neothermia.com. Contact: Neothermia Corporation Rx Communications Group Thomas M. Tully, President & CEO Paula Schwartz (investors) 917-322-2216 508-655-7820 Tony H. Loke (media) 917-322-2164