October 28, 2008
NCI Funded Clinical Trial to Study Treatment of Breast Cancer Using Cryoablation
PLEASANTON, Calif., Oct. 28 /PRNewswire/ -- The American College of Surgeons Oncology Group (ACOSOG) which just initiated a National Cancer Institute (NCI) funded clinical trial entitled, "A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma," has selected the Visica 2(TM) Treatment System from Sanarus Medical as the exclusive technology to be utilized in the cryoablation portion of this study.
The ACOSOG study protocol (designated as Z1072) will evaluate not only cryoablation but also the ability of Magnetic Resonance Imaging (MRI) to evaluate post-cryoablation efficacy in approximately 100 patients and 20 clinical sites. Patient enrollment into the study is currently anticipated for early 2009. The Phase II Trial is similar to a pilot study conducted by Gary Levine, MD, Medical Director at Hoag Breast Care Center in Newport Beach, Calif., and Steven Poplack, MD, Co-Director of Breast Imaging at Dartmouth Hitchcock Medical Center. Results of the pilot study will be presented for the first time at this year's Radiological Society of North America (RSNA) 94th Scientific Assembly and Annual Meeting in Chicago. Both the pilot study and pending ACOSOG clinical trial share the common clinical protocol elements of cryoablation followed by MRI, surgical resection of the tumor and subsequent pathological evaluation.
"Cryoablation has been used effectively for years to treat a number of medical conditions, including benign breast tumors, so it is a natural progression to study its use in the treatment of breast cancer," said Dr Levine. "We are very encouraged about the promising initial results in our pilot study and believe further research is warranted in order to develop and refine this potential breakthrough breast cancer treatment."
Cryoablation is a minimally invasive non-surgical procedure that uses extreme cold to destroy tumors. The Sanarus Visica System has predominately been used in the cryoablation of non-cancerous tumors called fibroadenomas since its initial FDA market clearance in March of 2002. This office-based procedure, which usually takes less than 20 minutes, involves placing a small needle into the center of the tumor using ultrasound guidance and subsequently freezing and killing the tumor. The safety and efficacy of cryoablation have been well established in over 2,000 fibroadenomas that have been treated with the System to date.
"We are very pleased that ACOSOG chose cryoablation as the preferred thermal ablation modality over other ablation modalities such as radio- frequency (RF), interstitial laser, microwave, or focused ultrasound," said John F. Howe, President and Chief Executive Officer of Sanarus. "We are equally pleased that the award winning Sanarus Visica 2 Treatment System was selected as the preferred cryoablation system. This speaks volumes to the future potential of our System in expanded applications."
The Visica 2 System recently received national recognition with a Wall Street Journal Technology Innovation Award; and the Humanitarian Application of the Year Award from National Instruments.
The ACOSOG is one of 10 cooperative groups funded by the National Cancer Institute (NCI) to develop and coordinate multi-center clinical trials and is the only cooperative group whose primary focus is the surgical management of patients with malignant solid tumors. Additional information regarding the ACOSOG clinical trial is available to ACOSOG members via the organizations website http://www.acosog.org/ under the heading of the Z1072 Clinical Protocol.
About Sanarus Medical
Sanarus Medical is based in Pleasanton, Calif., and is focused on providing patients and physicians with minimally invasive, office-based breast care management solutions from diagnosis to treatment. Using cryoablation technology, Sanarus has developed proprietary technologies to provide breast surgeons and radiologists with a comprehensive and minimally invasive way to diagnose and treat breast patients. The Sanarus technologies change the way that patients are managed, from an operating room-based, surgically intensive care pathway to a more comfortable, cost effective, office-based care pathway. The company's Website is http://www.sanarus.com/.
CONTACT: John Howe, President and CEO of Sanarus Medical,+1-925-460-6080
Web site: http://www.sanarus.com/http://www.acosog.org/