DIY Health Monitoring
With breast cancer being one of the leading causes of death among women, there is a need for more consumer pro-activity. We aim to actively promote breast self-exams (BSE), and will be offering the BSE Aware smart phone app to do just that (see companion column). But many women feel the need to do more, particularly if they have a family history of breast cancer, have already experienced breast cancer, or have fibrocystic breasts. They want something to supplement their monthly BSE and their annual mammogram. An early warning system, so to speak. And to date, there is no consumer product that fills that need.
BreasTel is unlike anything else that the market has to offer. It is a small handheld ultrasound device that is paired with a smart phone application. Women will be able to use it in conjunction with their normal monthly BSE to identify, locate, and characterize breast abnormalities, or simply use it when a breast abnormality or lump is found. While there are a number of portable ultrasound devices available on the market, they are for professional use and their purpose is for medical diagnosis only. Not to mention, their cost would be prohibitive at the consumer level. BreasTel is meant to be an affordable consumer product (expected to be priced at under $150) that can provide life-saving information to the user on a smart phone in real time.
What BreasTel Brings to the Women of the World
The detection of cancer is perhaps the most critical component to resolving a life-threatening condition. “Do I have a lump?” is a high-anxiety concern for many women. Individuals with dense tissue or fibrocystic breasts especially tend to obsess over the question. The BreasTel product addresses this issue with a technological solution that extends and improves the human sense of touch. BreasTel supplements the manual self-examination process to aid in the decision to seek a professional examination. It offers pre-screening that an individual can perform in the privacy of their home.
Given its anticipated price point, BreasTel is made to be very accessible to the women of the world, and is expected to provide early detection of abnormal tissue. This early detection, or even the absence of abnormal tissue, can aid in reducing anxiety, provide peace of mind, and cut down on unnecessary medical procedures and costs.
Currently, when a woman detects a lump, she becomes worried. Sometimes it takes weeks to visit a doctor. Insurance policies and accepted medical practice dictate that the patient then be sent for a mammogram. Positive mammogram results will then necessitate an ultrasound conducted by a medical professional, because 90% of positive mammogram readings end up as false positives of an actual tumor and have to be further diagnosed. A medical ultrasound examination can detect breast abnormalities with up to 98% accuracy. (Source: Computer-Aided Detection of Breast Cancer Using Ultrasound Images – Study – Utah State University 5/1/2010) Then a biopsy is performed to confirm cancerous tissue. With BreasTel, this mobile medical application can help a woman locate, identify, and characterize lumps in the comfort of her own home and get confirmation for further testing. If the reading shows normal tissue, she has just avoided a costly doctor visit, a mammogram, and possibly a professional ultrasound and/or biopsy, as well as all the related anxiety that comes with not knowing and undergoing costly procedures.
With our target demographic being women aged 25-60, living in the U.S. or E.U., this has a potential reach of 131 million women, of which 80% own cell phones. Of that 80%, two-thirds currently have smart phones, and that number is on the rise. Having a consumer product that can be used with those smart phones that can be used with or supplement breast self-exams is a huge step forward in affordable women’s health care.
How BreasTel Works
BreasTel is a small handheld ultrasonic device that is paired with a smart phone app. The device is used much in the same way you would do a normal breast self exam, or can be used on a specified area where an abnormality or lump is detected. When you place the BreasTel device over the suspicious lump and initiate the app, the ultrasound transducer sends thousand of pulses of ultrasound waves about 2 to 2.5 inches deep into the breast tissue. The results of these pulses are sent to the smart phone, where a series of complex mathematical algorithms enable the app to distinguish between tissue echoes that have a “normal” signature from those echoes that have an “abnormal” signature.
While the ultrasound is being performed the screen will remain green. Only upon locating, identifying and characterizing an abnormality will the screen turn yellow and display a warning to see a doctor. If the yellow screen is exhibited there will also be an accompanying alarm and in that manner the woman will know she has found something of interest, plus this alarm could enable a blind or handicapped person to use the device as well. In the event of a yellow screen, if a woman repeats this same procedure for several days in a row, it will help to verify the accuracy of the warning and might prevent an unnecessary visit to the doctor i.e. a false positive reading. This is necessary because some tumors are mobile. For example, a benign tumor, or a non-malignant lump may move around somewhat within the breast, whereas potentially malignant tumors do not usually move. They are relatively stationary. In this way the accuracy of the yellow warning screen will be further enhanced and not cause the woman unnecessary stress. Repeated positive results of abnormal tissue will provide an alert with the recommendation that the user see a doctor.
The product does not do diagnosis or make medical claims, other than a recommendation to see a doctor. Instead, it utilizes long-established medical ultrasound technology with the help of complex mathematical algorithms, which some refer to as computer-aided detection. It uses only product integration of established and existing components and technologies and customizes it for our use.
Independent related research shows that B-Mode ultrasound can have a 98% accuracy.(Source: Computer-Aided Detection of Breast Cancer Using Ultrasound Images – Study – Utah State University 5/1/2010) The computer aided-detection software algorithms are our “secret sauce” that makes such a consumer product possible. Our algorithms provide for noise reduction, data smoothing, and data filtering. However, only a doctor can do actual diagnosis. BreasTel is radiation-free and pain-free, and can be used frequently in total privacy and security. The ultrasound hardware is built in to a designed-for-women device that is convenient, lightweight and portable.
We’ve taken the technology behind ultrasound imaging, miniaturization, and smart phone applications and built a convenient, lightweight, portable an affordable handheld device that can detect breast tissue abnormalities.
We not only have proof of principle, but have built a working demonstration model.
Phase 1 (completed) Data Collection through an Institutional Review Board (IRB) located at Mammoth Hospital in California. We successfully obtained 61 results (scans) on women and this data helped to establish our proof of principle using ultrasound echoes from normal breast tissue.
Phase 2 (completed) Clinical Trials were successfully completed at the Harbor-UCLA Medical Center in Los Angeles. These trials involved the collection of at least 10 ultrasound signatures from dozens of women. There are four basic types of breast tissue, ranging from almost entirely fatty, to scattered areas of fibroglandular density, to heterogeneously dense, to extremely dense. We tested a wide variety of women in total, ending with over 2,280 data files, 760 individual ultrasound observations of either full spectrum (full color) or grayscale (1 color) images and have computed 760 time-amplitude echographs from women with suspicious lumps being either malignant or benign abnormalities. The results met our medical expectations and have resulted in direct confirmation that the ultrasound probe is working properly, reading properly, and reporting all the correct and accurate results expected. The protocols were very clear and the decryption worked perfectly. The vector data was in range and the images very clearly showed the presence or absence of an abnormality in the breast. The ultrasound echoes from these women will be used to further customize and improve the algorithm accuracy of detecting breast abnormalities.
Phase 3 (July 2016) We have started testing the entire BreasTel system on up to 400 women with known breast abnormalities. This work is being conducted in Holland at the Nijmegen Medical Center, a world-renowned institution. This will be followed by a formal medical report and a review will be published on the BreasTel efficacy to the medical community.
Phase 4 (to be conducted) will test a larger population (1,000 – 3,000 women). These trials may also be conducted in Europe. These tests will further improve the accuracy of the results on a wide variety of breast types. Our engineers and designers are currently working on system integration of existing components, finalizing the design and functionality of the handheld device. The algorithms will be further developed and uniquely refined by IDS staff using data provided by Phase 2-4 trials.
Three U.S. patent applications have been filed; one has been granted and two are in process. We also have two nationally approved Registered Trademarks.
We are working toward establishing a potential user base prior to debuting BreasTel. This will be done by creating a smart phone application prelude product related to breast self-exam, called BSE Aware (described in the column to the right), along with a consumer website (www.healthy-breast.com), and social media. Additionally, we are in negotiations with the National Consortium of Breast Centers to help promote the smart phone app and website amongst their legion of patients.
Once the product is consumer ready, we will launch online marketing, social media marketing, and search engine optimization (SEO) to drive product purchase, and develop partnerships with online shopping sites, as well as establish channel sales through brick and mortar stores (CVS, Walgreens, etc.). Additional PR efforts will secure coverage in traditional media, focusing on women’s publications.
A Comprehensive Breast Self-Exam App
Why BSE Aware?
Statistics show that 1 in 8 women will develop breast cancer in their lifetime and 1 in 5 of those diagnosed will die of the disease. A woman’s best chance for survival and longevity is early detection. Monthly breast self-exams (BSEs) are one of the best ways to discover abnormalities, detecting 40% of all masses. But these require a consistent routine to be effective. Declining death rates from breast cancer over the past two decades have been largely attributed to this early detection and awareness, yet only 30% of women over the age of 20 perform this regular self-exam.
The American Cancer Society suggests that breast self-examination be a part of a woman’s breast health maintenance routine beginning in her 20s. BSE helps women to get to know how their breasts normally look and feel so that it is more readily apparent if changes occur.
We have developed an easy-to-use smartphone app, called BSE Aware. This comprehensive breast self-examination app is backed by a fully functional geo-tagged website providing localized practitioners and facilities, as well as breast health resources.
What BSE Aware Brings to the Women of the World
We want to provide the tools and resources for every woman to proactively manage her breast health, whether it is a monthly exam reminder, finding the right practitioner to deal with breast issues, or battling cancer and coming out the other side.
Starting with BSE Aware—a user-friendly mobile app accessible through a computer or smart phone—we believe we can make a difference in early breast cancer detection. BSE Aware provides monthly reminders, tutorials on proper techniques for breast self-exam, easy-to-use graphics with the ability to log abnormalities, as well as a cumulative history of BSEs. Its adjunct site, Healthy-Breast.com, will offer the tools to find the right doctor, support group, and resources to fight breast cancer, should the need arise.
How BSE Aware Works
Regular breast self-exams (BSEs) are a key to maintaining breast health and identifying potential problems. All too often, women forget to perform this easy and simple task, but just 5 minutes a month could make a significant difference in a woman’s health. Rather than relying on memory to perform this monthly task, BSE Aware will offer women the following:
• Calendar: By calendaring the date of a menstrual cycle, the app will determine the optimum time for breast self-exam and send a monthly reminder via email or text message. (For women who are menopausal, a static date each month can be chosen.)
• Self-Exam Wizard: This feature walks the consumer through the BSE process. Using a graphic of the left and right breast, with an overlay of seven zones, the consumer can examine and track any abnormalities or changes in breast tissue and enter the results into the application. The data entered is then populated into the My History section of the application.
• My History: In this section, women can capture their menstrual history, prior breast health issues, previous mammogram dates and results, and track monthly BSEs. Any abnormalities found and logged on the overlay graphic can be shared with medical professionals at the consumer’s discretion.
• Resources: There will be a direct link to Healthy-Breast.com, an adjunct website which provides news and expert opinions on breast health, resources, education, support groups, forums, and geographically tagged doctors and certified breast health centers nearest the consumer.
• Tutorial: The app provides a link to a short video tutorial on the current medically approved method to perform the BSE.
The Need for BSE Aware
Breast cancer is the second most common cancer in women, affecting 1 out of every 8. In the U.S. alone, almost 235,000 new cases of invasive breast cancer were expected to be diagnosed in women in 2013, along with over 57,000 new cases of non-invasive (in situ) breast cancer. Annually, almost 40,000 American women succumb to this disease (Breastcancer.org, May 12, 2012) and that number exceeds 400,000 worldwide. Early detection and treatment is crucial, as it increases treatment options, provides for more effective treatment, and allows for a greater chance of survival (Susan G Komen for the Cure).
Breast self-exams are an inexpensive and effective tool women can use to proactively manage their breast health. To better detect breast abnormalities, women need to be aware of how their breasts look and feel in order to notice changes that take place. Performing regular self-exams provides this opportunity.
The American Cancer Society continues to recommend periodic clinical exams, and that women who choose to do self-examination should receive instruction and have their technique reviewed during periodic health examinations. To that end, BSE Aware provides an up-to-date video tutorial, as well as a physician approved notation graphic, to monitor and document breast changes.
How BSE Aware Benefits Women
According to the World Health Organization, “maintaining the practice of BSE has been seen to empower women, taking responsibility for their own health.” And while it is generally recommended that regular breast self-exams should be undertaken by all women over the age of 20, only 30% of this target group actually does so. It’s an easy thing to forget or put off, so BSE Aware will take the burden off the brain and provide regular text messages or email reminders, based on the optimum calculated time for the consumer to perform a self-exam. And for women who are uninformed in the proper procedure for such an exam, we provide the tools to educate.
If an exam should turn up an abnormality, our adjunct website Healthy-Breast.com will provide the next step on a local level, from finding a nearby physician or breast health center to answering questions, from reading expert commentary to locating a support group. While there are thousands of websites fronting breast cancer information, and well-funded sites that are national in scope, our site will be location-based, allowing consumers to find what they need in close geographical proximity.
How BSE Aware Aids Medical Practitioners
Both our BSE Aware app and our Healthy-Breast.com website will benefit physicians. With the mobile app, a patient’s menstrual history, exam history and a record of any abnormalities are recorded and can be easily shared with a physician, providing important information that might not be easily remembered by the patient. In addition, our video tutorial meets the latest medically accepted exam procedure, which will take the burden of instruction off the physician.
Healthy-Breast.com will be a geo-tagged website, providing patients with automatic and instant access to certified clinics, breast care centers, and physicians that specialize in breast cancer that are closest to their home. Initially we will have a listing of all National Consortium of Breast Centers (NCBC) certified practitioners and clinic members, and will expand that to other qualified, certifying organizations and their members.We will also provide a venue for local clinics and support groups to promote their events and services.
BSE Aware Development
We have been working hard to complete the BSE Aware app. There is a need for further testing before it is released to the public. We anticipate being able to debut BSE Aware to the general public in the next 6 months, along with its adjunct website, Healthy-Breast.com.