SURETOUCH™, A PAIN-FREE, RADIATION-FREE DIGITAL BREAST EXAM, TO BE PRESENTED AT THE 2014 SAN ANTONIO BREAST CANCER SYMPOSIUM ON DECEMBER 10TH, 2014
SureTouch identifies breast cancer with comparable sensitivity and specificity as other standard imaging modalities, summary of studies in over 1,000 patients finds.
Los Angeles, CA (December 10, 2014) – Medical Tactile, Inc. (MTI), manufacturer of SureTouch, a digital tactile imaging screening device for breast cancer detection, today announced that a summary of published clinical studies using tactile imaging in more than 1,000 patients will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10th, 2014. Cary Kaufman, M.D., past President of the National Consortium of Breast Centers and Associate Clinical Professor of Surgery at the University of Washington, led the team that reviewed clinical data demonstrating that Tactile Imaging (SureTouch) not only is more sensitive in detecting breast masses in symptomatic patients when compared with the manual clinical breast exams but also identifies breast cancer with similar sensitivity and specificity compared with standard imaging modalities such as mammography and ultrasound (see Table 1).
SureTouch is a FDA-cleared (FDA #K010514) device utilizing tactile imaging technology. Patients are examined with a transducer the size of a computer mouse which is passed over the breast reading any areas of increased hardness commonly associated with tumors. The SureTouch exam is conducted in the physician’s office in a short time and is reimbursed using existing CPT codes. Its ease of use and low equipment cost makes it accessible to address healthcare disparities. Tactile Imaging delivers immediate results without pain or radiation at lower cost than other standard breast imaging modalities. With SureTouch, the examiner can identify the size, shape, hardness and location of suspicious masses during the real-time examination. Many breast cancers, especially those that are more serious, can be identified with the sense of touch. As demonstrated in the summary of clinical studies to be presented at SABCS, Tactile Imaging (SureTouch) was more sensitive than clinical breast exam (human touch).
"SureTouch represents a significant expansion in our ability to perform a breast examination. It provides consistency, sensitivity, accuracy, and documentation that improve our abilities to examine the breast." said Dr. Kaufman. "The results of our presentation further validate the promising potential of Tactile Imaging (SureTouch) in the screening and diagnosis for breast cancer."
There were nine clinical studies reviewed involving 1,155 symptomatic patients using SureTouch in the U.S., China, and UK. All studies included in this meta-analysis were on symptomatic patients. In studies that examined the ability to identify the presence of a breast abnormality, the sensitivity of Tactile Imaging was 89% in comparison with clinical breast exam which was 83%. The studies that examined the identification of breast cancer using imaging modalities, the comparisons are summarized in Table 1.
Table 1. Breast Cancer Detection Summary on Symptomatic Patients
|Sensitivity for Cancer Detection||85||76||90|
|Specificity for Cancer Detection||79||71||79|
|Accuracy for Cancer Detection||82||74||84|
“Sure Touch was created to provide women with early awareness of any abnormalities and give peace of mind for the vast majority of women who are examined with no abnormalities during periodic wellness exams. SureTouch is beginning to achieve clinical acceptance at major medical centers and physician offices in the U.S. The impressive data presented at SABCS is another milestone in the SureTouch journey to become a vital examination for breast cancer screening,” said Dr. Jae Son, Chairman & Interim CEO of MTI.
About Medical Tactile
Medical Tactile, Inc. (“MTI”) is a Delaware Corporation that manufactures and markets SureTouch, a screening device for breast cancer detection using its proprietary tactile imaging technology. Its mission is to deliver more accurate breast cancer detection without pain or radiation at lower cost. SureTouch is a safe, painless, radiation-free digital breast exam. It is FDA-cleared (FDA #K010514) for producing surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast exam. SureTouch utilizes tactile sensing technology, originally developed at Harvard University, to capture the sense of touch which has been used for cancer detection for thousands of years and accounts for 80% of breast cancers found today. Breasts are examined quickly and comfortably without compression or radiation. The patented, hand-held, SureTouch sensor glides easily over the entire breast and underarm area. Its 192 sensing elements capture and document the shape, location, size and hardness of breast lesions. Any breast lesions are displayed on SureTouch console screen as two- and three-dimensional full-color images. Because images are digitally stored for future reference, results can be tracked and compared for changes over time.