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A quantified temperature sensor infused bra and comprehensive solution to identify, analyze and predict breast tissue abnormalities as part of an overall breast wellness routine.
About
Breast abnormalities can be the result of benign (noncancerous) or malignant (cancerous) legions. Carcinoma refers to any cancer that begins in the skin or other tissues that cover internal organs. Ductal carcinomas represent 80% of all breast cancers. Cancer cells can also invade blood vessels and lymph ducts which can lead to metastases. Within a growing tumor, newly formed blood vessels lack organized, smooth muscle cells that are not controlled by the sympathetic nervous system (SNS). The result is increased blood flow in and around the tumor that is less than responsive to control by the nervous system. The increased blood supply to a malignant lesion causes a local temperature increase relative to the surrounding healthy breast tissue. Body temperature is a commonly used diagnostic circadian biomarker. Cancerous breast tissue, with decreased nervous system control, results in reduced thermo-circadian rhythm variation. This reduction and lesion temperature differentials in conjunction with learning computational algorithms can be used to identify and differentiate between healthy, malignant and benign breast tissue. We have combined sensitive temperature measurement technology with proprietary learning algorithms to analyze thermos circadian rhythms in breast tissue. The result is the ability to monitor and detect changes in breast tissue health and identify benign and malignant legions - The Breast Wellness System. The system is comprised of a sports bra insert with a total of 16 temperature sensors, Bluetooth receiver, Sensoria Core, mobile app and web portal. The Sensoria Core microelectronics connects to the 16 temperature sensors, provides storage, SoC, low frequency sampling rates and is rechargeable. The system, combined with regular self-breast examinations, provides a holistic picture of your breast health and can provide earlier detection of potential irregularities. The system is backed by 10 years of clinical research/trials, is comfortable, non-invasive, discreet, able to be used at home and you can share your results with your physician. The breast sensor array is cup size appropriate, thermistor array that fits inside a customized fitness bra that measures minute variations in breast tissue temperature over a 2-hour period. The breast wellness app is free and available for both iOS and Android devices. The breast wellness portal is a secure, online portal for visualization, analysis and storage of BWS data. The BWS collects breast temperature data for 2 hours. Data is sent via Bluetooth transceiver to a customer's mobile device. Temperature data is analyzed using proprietary algorithms for variances from normal, circadian breast temperature patterns and reports back a "score". If the score in within normal ranges, no further action is needed. If the range is abnormal, a report reflecting this abnormality is sent to the customer. BWS sensor array is functional for 12 reads or 6 months. Sensor array replacement packs are also available for purchase. Lastly, the customized fitness bra is washable and comfortable.
Key Benefits
The main benefit is the improvement over manual breast exams providing earlier detection mechanisms. The invention has been backed by clinical research and trials for 10 years. It is convenient and comfortable (does not squish the breasts) as well as discreet and affordable. It is for at-home use where you results can be shared with your physician. You only need to wear the bra for 2 hours once per month. The breast sensor array is good for 12 uses or 6 months at which time you can purchase replacement sensor array packages. The bra itself will be washable and the Sensoria Core microelectronics can be detached and attached to other proprietary smart offerings.
Applications
Women over 20 years of age with normal breast tissue who should be performing monthly breast self-exams (BSEs). Women with dense breast tissue (approximately 40% of the population) who receive an "inconclusive findings and a high propensity for cancer" letter following their mammography. Women with a family history of breast cancer who understand the importance of and who may be performing monthly self breast exams but who seek a higher level of accuracy and confidence as they track their breast wellness.