Breast Cancer

Wearable early breast cancer screening for mass populations

  • Personalized breast cancer screening for the woman and automated alerts to the physician to the earliest possible metabolic cancer state initiation.

  • Breast cancer kills 500,000 women worldwide each year and the incident rate in China has grown at twice the global rate over the past two decades.

  • US physician market opportunity is over $250M and over the counter exceeds $1B. Asia/EU opportunity is untapped.


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Founder : See Below
Location : Silicon Valley, CA
Target : $6,500,000
Share Type : Common Stock

Business Overview


    The Company delivers a medical grade biosensor personalized wearable device which utilizes predictive analytics to detect early breast cancer in women. Through a 2 to 24-hour wear time, conformable breast patches equipped with sensors track metabolic thermal dynamic changes. Results are sent to the Company’s proprietary analytic core lab returning results directly to the woman and physician within minutes. The Company’s correlation to breast cancer is believed to represent a circadian cellular change over all breast tissue caused by a reduced PER1 and PER2 protein expression in the presence of breast cancer. With over 250 clinical cases completed and 7 years of predictive analytic research conducted through Nanyang Technological University in Singapore, the Company’s results are equating to mammographic and ultrasound in normal tissue and superior in dense tissue which affects 40% of the population who have a higher propensity for cancer.

Transaction Overview

    The Company has raised $4.5+ Million in Common to fund initial clinical trials, product development and regulatory processes. The Company is seeking $6.5 million Preferred to develop scalable commercial product, final regulatory filing, patent expansion and product launch by H2 2017.

Investment Highlight


  • Competitive Advantage: The Company is a non-irradiative tissue agnostic solution which has demonstrated accuracy of 77% in dense tissue population, vs. mammographic interpretation which published accuracy is less than 50% in the densest of tissue. Dense tissue affects over 40% of women. 28 states in the US are now requiring, and national legislation is pending, notification of 40% of the population that their dense condition leads to a higher propensity for cancer and that mammography and ultrasound are both challenged with their condition. An improved mass screening device such as the Company is in high demand. There is currently no other wearable in the market that would address mass populations with the accuracy that the Company possesses.

  • Revenue Expectations: With an infusion of $6.5 million in our current Series A raise, with a minimum of $3M by January 2017, we plan to launch outside of the US, through CE clearance, in the second half of 2017. Revenue estimates will be made available to interested parties.

  • We anticipate FDA clearance by mid-2017 to allow US entrance, China to follow. This is a low-cost product, which replaces a very high cost, irradiative, hospital-based technology, will allow for the minimum business expectation to be achieved.

  • Independent Assessment Projections: Life Science Strategy Group, LLC, a well-respected Silicon Valley, CA biopharmaceutical consultancy company surveyed 2000 women, 300 physicians and 5 payor groups which lead to the following US model assessment. OTC System revenue forecast approaches $1.4B. US forecasts for the Physician Office Systems exceed a total of $225M driven by the anticipated adoption of the technology in ongoing clinical breast exams and biopsy reduction. Copies of survey will be made available to interested parties.

About Management Team


  • CEO and Chairman: Was recognized as one of the Top 40 Transformers in Health Care by MM&M Magazine in 2016. With 20+ years in medical diagnostics he has led global efforts of both public and private venture backed technologies, with demonstrated successes from start-up to over $550M in P & L responsibilities.

  • Acting Chief Medical Officer: Founding Director and Surgical Oncologist at El Camino Cancer Hospital, Mt. View, CA., she completed her undergrad from Johns Hopkins University and her M.D. and Ph.D. from the Albert Einstein College of Medicine in New York.

  • VP – Predictive Analytic Core Lab: Has over ten years of experience in the medical analytics field, has published 88 journal papers, conference articles and book chapters, and her work is internationally recognized by her peers as evidenced by more than 725 citations.

  • Jim, Founder and Treasurer: Having served with Pricewaterhouse Coopers, his background includes corporate mergers/acquisitions, having consolidated, financed, or listed over a dozen companies.

About Our Product


  • “Identifying a cancer lesion in dense breasts with current imaging solutions such as mammography or ultrasound is like finding a single snow flake in a snow storm – impossible to differentiate. The tissue agnostic the Company approach could be a life saver for those 40% of women who suffer from dense breast tissue!” - Barb Dehn RN, MS, NP - Woman’s health advocate and author

  • With over 250 patients and 7+ years of machine learning predictive analytic analysis completed, an original FDA 510K Class II clearance and 4 patients issued, the Company’s wearable technology promises to achieve 80% accuracy, sensitivity and specificity on all tissue types including the dense tissue population which has up to 6 times higher probability of cancer. The Company’s smart phone enabled wearable go-to-market technology will be worn from 2 to 12 hours by women as their monthly breast exam as they go about their daily routines. The automated alert to the insurance provider and physician on potential cancer cases will lead to earlier detection, and improved survival rates for breast cancer.

  • Market launch will be in Asia and the EU by H2 2017, supported by established distribution, leading clinical though leadership support and insurance industry acceptance. US and China will follow closely based upon final FDA/SFDA clearance.

About Industry


  • The Company’s targeted utilization is as an early screening solution for the dense breast tissue population. With 28 states in the US now requiring, and national legislation pending notification of 40% of the population that their dense condition leads to a higher propensity for cancer and that mammography and ultrasound are both challenged with their condition, an improved mass screening device such as the iTBra is in high demand.

  • The secondary application is as a pre-biopsy screening device. With 73% of all biopsies recommended via mammography interpretation being on non-cancerous tissue, over 1.2M patients in the US could benefit by the Company technology saving over $1.6B in health care cost annually.

  • The mass populations of emerging countries, where breast cancer is becoming an epidemic due to lack of medical access or religious or social rejection of mammography, would benefit from the two-hour wear of this discrete personalized breast cancer screening device.

Financials

Available on further discussion with registered investors.

About Competitor


  • Personalized wearable healthcare falls under the category of Precision Medicine and population health screening. There are very few competitors in this space specifically in the area of early cancer detection. The largest barrier is the understanding of revolutionary, breakthrough technology that enables day-to-day monitoring of a cancerous condition, versus diagnostic modalities which are all clinical or hospital.

  • We are seeing precision medicine is a key initiative to drive new insurance digital health offerings and the Company is actively communicating with several the larger insurance companies about the Company’s wearable solution being supported as a breast cancer screening solution. The shifting focus from hospital in-clinic based care to personalize precision medicine is occurring and will yield dramatic changes, especially when combined with early biomarker identification and therapeutic intervention leading to improved survival rates.

Exit Strategy

Available on further discussion with registered investors.
Risk Warnings
Disclosure: Investing in startups carries a high degree of risk. In general, financial and operating risks confronting both early and developmental-stage companies, as well as more mature expansion-stage companies are significant. Many emerging growth companies go out of businesses every year. It is difficult to know how companies will grow, if at all, or what changes may occur in the market. A loss of an investors entire investment is possible and no profit may be realized. Investors are responsible for conducting their own due diligence. * It should not be assumed that recommendations made in the future will be profitable or will equal the performance of securities in this list

  • “Identifying a cancer lesion in dense breasts with current imaging solutions such as mammography or ultrasound is like finding a single snow flake in a snow storm – impossible to differentiate. The tissue agnostic the Company approach could be a life saver for those 40% of women who suffer from dense breast tissue!” - Barb Dehn RN, MS, NP - Woman’s health advocate and author

  • With over 250 patients and 7+ years of machine learning predictive analytic analysis completed, an original FDA 510K Class II clearance and 4 patients issued, the Company’s wearable technology promises to achieve 80% accuracy, sensitivity and specificity on all tissue types including the dense tissue population which has up to 6 times higher probability of cancer. The Company’s smart phone enabled wearable go-to-market technology will be worn from 2 to 12 hours by women as their monthly breast exam as they go about their daily routines. The automated alert to the insurance provider and physician on potential cancer cases will lead to earlier detection, and improved survival rates for breast cancer.

  • Market launch will be in Asia and the EU by H2 2017, supported by established distribution, leading clinical though leadership support and insurance industry acceptance. US and China will follow closely based upon final FDA/SFDA clearance.

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This section of information is for our registered investor only. Please Sign Up as a Shanghai Valley investor.




This section of information is for our registered investor only. Please Sign Up as a Shanghai Valley investor.




This section of information is for our registered investor only. Please Sign Up as a Shanghai Valley investor.




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