NATICK, Mass., Dec. 3 /PRNewswire/ -- Neothermia Corporation, an emerging leader in the development and marketing of minimally invasive systems for the diagnosis of cancer, announced today that the first clinical presentation of data for its en-bloc(R) breast biopsy system was made at the 89th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) in Chicago. The presentation was made by Larry K. Killebrew, MD, Medical Director of the Oklahoma Breast Care Center. Dr. Killebrew was one of the first physicians in the United States to adopt Neothermia Corporation's en-bloc(R) system into his clinical practice after its approval by the U.S. Food and Drug Administration in 2001.
The paper, entitled "Comparison of the Diagnostic Accuracy of a Percutaneous Intact Specimen Sampling Device to a Core Needle Sampling Device for Biopsy of Breast Cancer: Initial Experience," compares Dr. Killebrew's clinical experience with more than 800 en-bloc(R) breast biopsy procedures with more than 800 Mammotome(R) breast biopsy procedures that he conducted in the past.
The results indicate that by using the en-bloc(R) system, physicians are significantly more likely to correctly diagnose patients with the initial biopsy.
"When the Mammotome(R) was introduced almost 10 years ago, it was a major advance in the field of breast biopsy," said Dr. Killebrew. "In my opinion, the introduction of the en-bloc(R) is of equal importance. The incision size required to extract the specimen is similar to the Mammotome(R), and the en-bloc(R) procedure is much more rapid. More importantly, since the en-bloc(R) is more accurate, the medical community can now spare a significant number of women from unnecessary surgical procedures to confirm the severity of their cancer or to confirm a benign diagnosis -- both of which often occur with the Mammotome(R) system. I am three to four times more likely to have an equivocal diagnosis on a benign lesion, and five to ten times more likely to have an initial diagnosis of a noninvasive cancer upgraded to an invasive cancer with the older, vacuum-assisted core needle approach. This means that for every 100 biopsies I perform, there are almost 10 who, because of this procedure, are spared an unnecessary second surgical biopsy or a second surgery to determine lymph node status."
The study compared a population of 811 en-bloc(R) procedures and 801 Mammotome(R) procedures. Patients who were found to have cancer were referred to open surgical biopsy, or a lumpectomy. Of those in the en-bloc(R) arm of the study, only one of 30 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, eight patients out of 36 (with an initial diagnosis of DCIS) were upgraded. Additionally, fewer patients who underwent the en-bloc(R) breast biopsy procedure were upgraded from atypical ductal hyperplasia (ADH) -- a non-cancerous diagnosis -- to either DCIS or IDC (only two of 14 en-bloc(R) patients vs. six of 18 patients in the Mammotome(R) group). Upgrades to a more invasive form of cancer typically result in a second surgical procedure and could result in an alteration in patient counseling and therapy.
Commenting further on the findings, Dr. Killebrew said, "My experience with the en-bloc(R) leads me to believe that there are fewer diagnosis upgrades, in part, because the en-bloc(R) removes a spherical tissue specimen. This provides the pathologist with more of the target tissue and less excess normal tissue than other devices, like the Mammotome(R). Since other aspects, such as procedure time, cosmetic outcome, patient comfort, etc., are the same or better than other percutaneous procedures, I can think of no reason why I wouldn't use the en-bloc(R) for every indicated procedure presented to my practice."
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/.
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