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SFDA, CE and FDA cleared medical device

Self-contained tactile sensors assess the characteristics of breast tissue

• Size, shape, hardness, position and motility of lesions relative to surrounding healthy tissue

Demonstrated effectiveness in multiple clinical trials

Accurate, affordable and comfortable in all women of all ages

Objective, quantifiable, repeatable

Compact, portable and easy to set up in a physicians office

3. 4. Clinical Lesion Images Shape and Hardness 5. Clinical Comparison

Tumor measurement size in comparison to mammography & breast ultrasound

6. Overall Goals of the SureTouch System

Improve the overall performance of Clinical Breast Examination (CBE)

Reduce the inter and intra operator variability associated with the CBE

Provide simple and quick test that can be utilized in out patient setting as part of normal patient work-up

Establish a common set of lexicons to describe the CBE results

7. Clinical Breast Examination (CBE)

Most universal examination utilized for the detection and assessment of breast health

• Every three years for women under 40

• Every year for women over 40

• More often for high risk women

Overall sensitivity and specificity ranges from 50 to 60% and 94% respectively

• Barton et al 54% & 94%

• US national screening report 59% & 93%

High variability among physicians(~30%)

8. Clinical Breast Examination (CBE)

SABC 2008

• Study by California Pacific Medical Center Research Institute(1522 women) suggests thatproperly documenting theCBE nearly doubledthe rate of breast mass detection.

• 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.

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

9. Focus of SureTouch Clinical Trials

Can SureTouch identify more breast lesions when compared to standard CBE?

Can SureTouch distinguish between benign and malignant lesions?

Can SureTouch accurately measure lesion size compared to other technologies?

Can SureTouch reduce user variability?

10. Objective Measurement of the Physical Exam Using a New Device: Cary S. Kaufman ET AL. SABC 2004

72 patients with suspected breast lesions comparing standard CBEwith SureTouch as confirmed by biopsy

SureTouch compared favorably to CBE in both sensitivity (91%) & specificity (90%) with fewer false negative exams (9%)

In 60 patients with normal tissue, SureTouch correctly identified 92% of normal glandular tissue

11. Differentiation of benign and malignant breast lesions by mechanical imaging (SureTouch) BCRT 2009 Kearney et al.

179 symptomatic patients in multicenter trial subjected to biopsy after SureTouch exam ( 147 benign, 32 malignant lesions)

• 91.4% sensitivity &86.8% specificity

• Comparable mammographic sensitivity 85.8%, and specificity 87.7%(Barlow WE -J Natl Cancer Inst- 7-AUG-2002)

The possibility of real time breast lesion characterization and differentiation as benign or malignant.

Potential to be used in differentiating benign from malignant lesions that would effectively reduce the benign biopsy rate.

Use as adjunct to mammography and prescreening device for breast cancer detection.

12. Digital documentation of the physical examinationThe American Journal of Surgery 192 (2006) 444449 Kaufman et al.

110 patients with suspected breast mass examined by SureTouch.

Results confirmed by biopsy or follow up

The sensitivity and specificity of identifying mass were 88% and 88%, compared to 81% and 81% for CBE

Of the 36 breast cancers, SureTouch identified six cancers not identified by CBE (PPV of 94% and 78% respectively)

13. Quantifyingthe sense of touch in clinical breast examination Devi & ShailajaOsmania Medical College, Hyderabad, AP

100 high risk patients examined with SureTouch as compared to CBE

SureTouch picked up 52 potential areasas compared to 18 by CBE

20 dominant masses were subjected to breast ultrasound followed by FNA

SureTouch picked up the sole cancer (papillary ductal carcinoma) missed by CBE and by initial ultrasound screening.

14. ASBD Abstract 2009Palpation imaging (SureTouch)for breast tumor screening in developing countries(Kaufman et al.)

74 barely palpable breast masses were examined with CBE, mammography, ultrasound and SureTouch, and then excised

Average size variation was compared to final pathologic size

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.

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%)

15. Other Current Clinical Work

University of Washington Dr. Kaufman

National Cancer Society - Dr. Baskies

Cambridge University UK

St. Marys Hospital London UK

Osmania Medical College, Hyderabad

Peking Union Hospital

National Institute Health (proposed)

Wireless Outreach Program (proposed )

16. Comparison of Imaging Methods 17. Benefits of SureTouch 18. Focus of SureTouch Clinical Trials

Can SureTouch identify more breast lesions when compared to standard CBE?

• In structured clinical trial, we have demonstrated that SureTouch can pick up a higher number of lesions compared to CBE

19. Focus of SureTouch Clinical Trials

Can we distinguish between benign and malignant lesions?

• • In structured clinical trials,we have demonstratedsensitivity and specificity in identifying malignant lesions equal or greater than current technologies such as x-ray and ultrasound.

20. Focus of SureTouch Clinical Trials

Can SureTouch accurately measure lesion size compared to other technologies?

• • In a structured clinical trial,we have our ability to reliably and adequately measure lesion size compared to other technologies

21. Focus of SureTouch Clinical Trials

Can SureTouch reduce user variability?

By providing a standardized testing method, reporting structureand lexicons to describe palpable breast lesions, we contribute to the reduction of operating variability and improve the confidence of the physician performing CBE

22. Thank you 23. Market Opportunity for SureTouch Second Market Opportunity Detection Diagnosis CBEMammographyBreast USMRIFNA, Core&OpenBiopsy OB/GYN, Womens Health, PPCRadiology Surgeons North America Western Europe Australia Eastern Europe Middle East China, India, Asia ROW Standard of Care MajorMarket Opportunity 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.

Cancerous tissue is much stiffer than normal, benign tissue

SureTouch measures the reactive pressure of the tissue underlying the tactile probe.

SureTouch measures the hardness, size and shape of abnormal tissue relative to surrounding tissue.

SureTouch is a simple repeatable exam.

Wellman PS, PhD Thesis Tactile Imaging,Harvard University, 1999.