<ul><li>SFDA, CE and FDA cleared medical device </li></ul><ul><li>Self-contained tactile sensors assess the characteristic...
 
Clinical Lesion Images Shape and Hardness
Clinical Comparison <ul><li>Tumor measurement size in comparison to mammography & breast ultrasound </li></ul>
Overall Goals of the SureTouch System <ul><li>Improve the overall performance of Clinical Breast Examination (CBE) </li></...
Clinical Breast Examination (CBE) <ul><li>Most universal examination utilized for the detection and assessment of breast h...
Clinical Breast Examination (CBE) <ul><li>SABC 2008 </li></ul><ul><ul><li>Study by California Pacific Medical Center Resea...
Focus of SureTouch Clinical Trials <ul><li>Can SureTouch identify more breast lesions when compared to standard CBE? </li>...
Objective Measurement of the Physical Exam Using a New Device: Cary S. Kaufman ET AL. SABC 2004 <ul><li>72 patients with s...
Differentiation of benign and malignant breast lesions by mechanical imaging (SureTouch) BCRT 2009 Kearney et al. <ul><li>...
Digital documentation of the physical examination  The American Journal of Surgery 192 (2006) 444–449 Kaufman et al. <ul><...
Quantifying  the sense of touch in clinical breast examination …  Devi & Shailaja  Osmania Medical College, Hyderabad, AP ...
ASBD Abstract 2009  Palpation imaging (SureTouch)for breast tumor screening in developing countries  (Kaufman et al.) <ul>...
Other Current Clinical Work <ul><li>University of Washington – Dr. Kaufman </li></ul><ul><li>National Cancer Society - Dr....
Comparison of Imaging Methods
Benefits of SureTouch
Focus of SureTouch Clinical Trials <ul><li>Can SureTouch identify more breast lesions when compared to standard CBE? </li>...
Focus of SureTouch Clinical Trials <ul><li>Can we distinguish between benign and malignant lesions? </li></ul><ul><ul><ul>...
Focus of SureTouch Clinical Trials <ul><li>Can SureTouch accurately measure lesion size compared to other technologies? </...
Focus of SureTouch Clinical Trials <ul><li>Can SureTouch reduce user variability? </li></ul><ul><li>By providing a standar...
Thank you
Market Opportunity for SureTouch Second Market Opportunity Detection Diagnosis CBE  Mammography  Breast US  MRI  FNA, Core...
Breast Tissue Elasticity Krouskop TA, Wheeler TM, Kallel F, Garra BS, Hall TJ. “Elastic moduli of breast and prostate tiss...
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Sure Touch Clinical Studies

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Breast Cancer Detection

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Sure Touch Clinical Studies

  1. 2. <ul><li>SFDA, CE and FDA cleared medical device </li></ul><ul><li>Self-contained tactile sensors assess the characteristics of breast tissue </li></ul><ul><ul><li>Size, shape, hardness, position and motility of lesions relative to surrounding healthy tissue </li></ul></ul><ul><li>Demonstrated effectiveness in multiple clinical trials </li></ul><ul><li>Accurate, affordable and comfortable in all women of all ages </li></ul><ul><li>Objective, quantifiable, repeatable </li></ul><ul><li>Compact, portable and easy to set up in a physician’s office </li></ul>
  2. 4. Clinical Lesion Images Shape and Hardness
  3. 5. Clinical Comparison <ul><li>Tumor measurement size in comparison to mammography & breast ultrasound </li></ul>
  4. 6. Overall Goals of the SureTouch System <ul><li>Improve the overall performance of Clinical Breast Examination (CBE) </li></ul><ul><li>Reduce the inter and intra operator variability associated with the CBE </li></ul><ul><li>Provide simple and quick test that can be utilized in out patient setting as part of normal patient work-up </li></ul><ul><li>Establish a common set of lexicons to describe the CBE results </li></ul>
  5. 7. Clinical Breast Examination (CBE) <ul><li>Most universal examination utilized for the detection and assessment of breast health </li></ul><ul><ul><li>Every three years for women under 40 </li></ul></ul><ul><ul><li>Every year for women over 40 </li></ul></ul><ul><ul><li>More often for high risk women </li></ul></ul><ul><li>Overall sensitivity and specificity ranges from 50 to 60% and 94% respectively </li></ul><ul><ul><li>Barton et al 54% & 94% </li></ul></ul><ul><ul><li>US national screening report 59% & 93% </li></ul></ul><ul><li>High variability among physicians (~30%) </li></ul>
  6. 8. Clinical Breast Examination (CBE) <ul><li>SABC 2008 </li></ul><ul><ul><li>Study by California Pacific Medical Center Research Institute (1522 women) suggests that properly documenting the CBE nearly doubled the rate of breast mass detection. </li></ul></ul><ul><ul><li>Study by Duke University (147 women) suggested that BSE & CBE were as effective in detection of cancer in risk women as conventional imaging such as mammography and MRI. </li></ul></ul><ul><li>Since 70% of all cancers are presently found through palpation, a method that mimic CBE but with enhanced sensitivity and specificity could improve screening yield in the general population as well as high risk women </li></ul>
  7. 9. Focus of SureTouch Clinical Trials <ul><li>Can SureTouch identify more breast lesions when compared to standard CBE? </li></ul><ul><li>Can SureTouch distinguish between benign and malignant lesions? </li></ul><ul><li>Can SureTouch accurately measure lesion size compared to other technologies? </li></ul><ul><li>Can SureTouch reduce user variability? </li></ul>
  8. 10. Objective Measurement of the Physical Exam Using a New Device: Cary S. Kaufman ET AL. SABC 2004 <ul><li>72 patients with suspected breast lesions comparing standard CBE with SureTouch as confirmed by biopsy </li></ul><ul><li>SureTouch compared favorably to CBE in both sensitivity (91%) & specificity (90%) with fewer false negative exams (9%) </li></ul><ul><li>In 60 patients with normal tissue, SureTouch correctly identified 92% of normal glandular tissue </li></ul>
  9. 11. Differentiation of benign and malignant breast lesions by mechanical imaging (SureTouch) BCRT 2009 Kearney et al. <ul><li>179 symptomatic patients in multicenter trial subjected to biopsy after SureTouch exam ( 147 benign, 32 malignant lesions) </li></ul><ul><ul><li>91.4% sensitivity & 86.8% specificity </li></ul></ul><ul><ul><li>Comparable mammographic sensitivity 85.8%, and specificity 87.7% (Barlow WE - J Natl Cancer Inst - 7-AUG-2002) </li></ul></ul><ul><li>The possibility of real time breast lesion characterization and differentiation as benign or malignant. </li></ul><ul><li>Potential to be used in differentiating benign from malignant lesions that would effectively reduce the benign biopsy rate. </li></ul><ul><li>Use as adjunct to mammography and prescreening device for breast cancer detection. </li></ul>
  10. 12. Digital documentation of the physical examination The American Journal of Surgery 192 (2006) 444–449 Kaufman et al. <ul><li>110 patients with suspected breast mass examined by SureTouch. </li></ul><ul><li>Results confirmed by biopsy or follow up </li></ul><ul><li>The sensitivity and specificity of identifying mass were 88% and 88%, compared to 81% and 81% for CBE </li></ul><ul><li>Of the 36 breast cancers, SureTouch identified six cancers not identified by CBE (PPV of 94% and 78% respectively) </li></ul>
  11. 13. Quantifying the sense of touch in clinical breast examination … Devi & Shailaja Osmania Medical College, Hyderabad, AP <ul><li>100 high risk patients examined with SureTouch as compared to CBE </li></ul><ul><li>SureTouch picked up 52 potential areas as compared to 18 by CBE </li></ul><ul><li>20 dominant masses were subjected to breast ultrasound followed by FNA </li></ul><ul><li>SureTouch picked up the sole cancer (papillary ductal carcinoma) missed by CBE and by initial ultrasound screening. </li></ul>
  12. 14. ASBD Abstract 2009 Palpation imaging (SureTouch)for breast tumor screening in developing countries (Kaufman et al.) <ul><li>74 barely palpable breast masses were examined with CBE, mammography, ultrasound and SureTouch, and then excised </li></ul><ul><li>Average size variation was compared to final pathologic size </li></ul><ul><li>SureTouch provided breast tumor size measurements in 93% of patients. All modalities of breast tumor size estimates were within 0.5-0.7cm of true pathologic size. </li></ul><ul><li>While mammography was most accurate estimate of size (0.48 + 0.14cm ), SureTouch was very close to mammography (0.71 + 0.14cm ) and was most reliable provider (93% versus 51%) </li></ul>
  13. 15. Other Current Clinical Work <ul><li>University of Washington – Dr. Kaufman </li></ul><ul><li>National Cancer Society - Dr. Baskies </li></ul><ul><li>Cambridge University UK </li></ul><ul><li>St. Mary’s Hospital – London UK </li></ul><ul><li>Osmania Medical College, Hyderabad </li></ul><ul><li>Peking Union Hospital </li></ul><ul><li>National Institute Health (proposed) </li></ul><ul><li>Wireless Outreach Program (proposed ) </li></ul>
  14. 16. Comparison of Imaging Methods
  15. 17. Benefits of SureTouch
  16. 18. Focus of SureTouch Clinical Trials <ul><li>Can SureTouch identify more breast lesions when compared to standard CBE? </li></ul><ul><ul><li>In structured clinical trial, we have demonstrated that SureTouch can pick up a higher number of lesions compared to CBE </li></ul></ul>
  17. 19. Focus of SureTouch Clinical Trials <ul><li>Can we distinguish between benign and malignant lesions? </li></ul><ul><ul><ul><li>In structured clinical trials, we have demonstrated sensitivity and specificity in identifying malignant lesions equal or greater than current technologies such as x-ray and ultrasound. </li></ul></ul></ul>
  18. 20. Focus of SureTouch Clinical Trials <ul><li>Can SureTouch accurately measure lesion size compared to other technologies? </li></ul><ul><ul><ul><li>In a structured clinical trial, we have our ability to reliably and adequately measure lesion size compared to other technologies </li></ul></ul></ul>
  19. 21. Focus of SureTouch Clinical Trials <ul><li>Can SureTouch reduce user variability? </li></ul><ul><li>By providing a standardized testing method, reporting structure and lexicons to describe palpable breast lesions, we contribute to the reduction of operating variability and improve the confidence of the physician performing CBE </li></ul>
  20. 22. Thank you
  21. 23. Market Opportunity for SureTouch Second Market Opportunity Detection Diagnosis CBE Mammography Breast US MRI FNA, Core & Open Biopsy OB/GYN, Women’s Health, PPC Radiology Surgeons North America Western Europe Australia Eastern Europe Middle East China, India, Asia ROW Standard of Care Major Market Opportunity
  22. 24. Breast Tissue Elasticity Krouskop TA, Wheeler TM, Kallel F, Garra BS, Hall TJ. “Elastic moduli of breast and prostate tissues under compression,” Ultrasonic Imaging 20:260-74, 1998. <ul><li>Cancerous tissue is much “stiffer” than normal, benign tissue </li></ul><ul><li>SureTouch measures the reactive pressure of the tissue underlying the tactile probe. </li></ul><ul><li>SureTouch measures the hardness, size and shape of abnormal tissue relative to surrounding tissue. </li></ul><ul><li>SureTouch is a simple repeatable exam. </li></ul>Wellman PS, PhD Thesis Tactile Imaging, Harvard University, 1999.

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