During a routine Clinical Breast Examination, SureTouch’s tactile elasticity digital technology immediately provides critical data about the location, size, shape and hardness of breast lesions in women of all ages, aiding physicians with more information with which to assess the overall breast health of their patients. Just as a stethoscope enhances the physician’s sense of hearing and a microscope enhances one’s visual ability, Suretouch enhances the sense of touch and is four times more sensitive than the human hand. We believe that SureTouch is a critical component to improved CBE.
According to the American Cancer Society, about 1.3 million women will be diagnosed with breast cancer annually worldwide and about 465,000 will die from the disease. In the United States, one out of 8 women will be diagnosed with breast cancer in their lifetime and 40,000 women die from the disease each year.[1] Early detection is the ONLY means to improve the survival rate, but current screening procedures have not achieved high effectiveness at a reasonable cost. Screening mammograms are only performed for women over 40 because they are generally ineffective in younger women with dense breast tissue. Women under 40 have higher metabolic rates, which may affect the morbidity and mortality in those diagnosed with breast cancer. Recent studies have shown that a vast majority of women over 40 in the U.S. do not have annual mammograms. Reasons include significant discomfort issues, repeated radiation exposure and cost. Clinical breast exams are considered subjective and non-scientific, despite the fact that most breast cancers are still detected by the patient through palpation. SureTouch Medical Tactile, Inc's SureTouch Clinical Breast Exam System is a self-contained tactile sensing device that documents the shape, hardness, location and size of breast lesions. The National Institutes of Health funded research which was published in the American Journal of Surgery, has shown the SureTouch exam to be 94% accurate at identifying true palpable lesions, as well as in determining if the mass itself was cancerous. The sensing technology measures the reactive pressures generated by cancerous tissue, which is more than 100 times harder than normal tissue. And unlike clinical breast exams (CBEs), SureTouch produces results that are quantifiable, repeatable and electronically documented. It is easy to operate, and the training required is minimal. SureTouch has been cleared by the U.S. Food and Drug Administration for sale in the United States since late 2005. Since that time, the system has been commercially available to select physicians, specialists and clinics. Also, in 2007, SureTouch received approval to carry the CE marking, which is mandatory before certain products can be sold in Europe. Approval to display the marking means that the manufacturers of SureTouch have demonstrated that its product conforms to the European community’s rigorous health and safety standards. In 2008, SureTouch received the State Food & Drug Agency (SFDA) approval to market and sell the product in China. For women under forty, the SureTouch Clinical Breast Exam offers an accurate, affordable and comfortable screening solution. Unlike a mammogram, where the entire breast is compressed, SureTouch is a simple hand-held device that mimics a manual clinical breast exam. It can be used safely with women of all ages. This unique technology is a revolutionary and cost effective medical device that aims to assist in the early detection of breast cancer. The Company SureTouch is developed and manufactured by Medical Tactile, Inc. (MTI), of Los Angeles. Dr. Jae Son, the company’s founder is the key developer behind SureTouch’s patented technology. Dr. Son holds an Engineering Sciences Ph.D. from Harvard University. MTI has unique technical expertise and a strong intellectual property position (8 patents issued and 2 pending). . Given MTI’s unique technical expertise and strong intellectual property, direct competition any time in the near future is unlikely. Summary Every primary care, or women's health specialist, should perform routine clinical breast exams. In the early detection of breast cancer it can help save lives. SureTouch takes much of the guesswork out of the clinical breast exam and can be especially beneficial for women under 40 with denser breast tissue. SureTouch when used as part of the CBE can offer improvements in outcomes for economically disadvantaged women who tend to be uninsured or underinsured, and for whom more expensive forms of screening are unaffordable. These women also may postpone health care, resulting in delayed diagnosis of diseases such as breast cancer. The enhanced CBE using SureTouch offers an improvement in routine clinical breast exam that previously did not exist in terms of providing more information, real time results, and digital documentation of each exam that can be added to a patient's medical record. [1] American Cancer Society, Global Cancer Facts & Figures, 2007.
Medical Tactile, Inc's SureTouch Clinical Breast Exam System is a self-contained tactile sensing device that documents the shape, hardness, location and size of breast lesions. The National Institutes of Health funded research which was published in the American Journal of Surgery, has shown the SureTouch exam to be 94% accurate at identifying true palpable lesions, as well as in determining if the mass itself was cancerous. The sensing technology measures the reactive pressures generated by cancerous tissue, which is more than 100 times harder than normal tissue. And unlike clinical breast exams (CBEs), SureTouch produces results that are quantifiable, repeatable and electronically documented. It is easy to operate, and the training required is minimal. SureTouch has been cleared by the U.S. Food and Drug Administration for sale in the United States since late 2005. Since that time, the system has been commercially available to select physicians, specialists and clinics. Also, in 2007, SureTouch received approval to carry the CE marking, which is mandatory before certain products can be sold in Europe. Approval to display the marking means that the manufacturers of SureTouch have demonstrated that its product conforms to the European community’s rigorous health and safety standards. In 2008, SureTouch received the State Food & Drug Agency (SFDA) approval to market and sell the product in China. For women under forty, the SureTouch Clinical Breast Exam offers an accurate, affordable and comfortable screening solution. Unlike a mammogram, where the entire breast is compressed, SureTouch is a simple hand-held device that mimics a manual clinical breast exam. It can be used safely with women of all ages. This unique technology is a revolutionary and cost effective medical device that aims to assist in the early detection of breast cancer.
SureTouch is developed and manufactured by Medical Tactile, Inc. (MTI), of Los Angeles. Dr. Jae Son, the company’s founder is the key developer behind SureTouch’s patented technology. Dr. Son holds an Engineering Sciences Ph.D. from Harvard University. MTI has unique technical expertise and a strong intellectual property position (8 patents issued and 2 pending). . Given MTI’s unique technical expertise and strong intellectual property, direct competition any time in the near future is unlikely.
Every primary care, or women's health specialist, should perform routine clinical breast exams. In the early detection of breast cancer it can help save lives. SureTouch takes much of the guesswork out of the clinical breast exam and can be especially beneficial for women under 40 with denser breast tissue. SureTouch when used as part of the CBE can offer improvements in outcomes for economically disadvantaged women who tend to be uninsured or underinsured, and for whom more expensive forms of screening are unaffordable. These women also may postpone health care, resulting in delayed diagnosis of diseases such as breast cancer. The enhanced CBE using SureTouch offers an improvement in routine clinical breast exam that previously did not exist in terms of providing more information, real time results, and digital documentation of each exam that can be added to a patient's medical record.
[1] American Cancer Society, Global Cancer Facts & Figures, 2007.
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