Cyrcadia, Inc. Enters Clinical Trials for Wearable Breast Cancer Detection Device

Reno, Nev. (PRWEB)July 07, 2015 Cyrcadia, Inc. (“Company”) announces it is entering into a clinical trial for its wearable breast cancer early detection device and is enrolling the first clinical trial participants at El Camino Hospital, in Mountain View, California. Utilizing its previous FDA cleared device as a predicate, Cyrcadia Health™ (a division of Cyrcadia, Inc.) is combining the Company’s fourth generation, wearable device technology, made by Flextronics, and the SalesForce database software, to track the clinical results. “We are targeting both the 70% of the population that undergo biopsies on non-cancerous tissue resulting from mammographic referral, as well as mass screening of patients with dense breasts,” said Rob Royea, president of Cyrcadia Health. “Patients with dense breast tissue have a higher propensity for cancer. Furthermore, mammography is challenged by detecting cancer in dense breast tissue as it can mask cancer cells and lesions.” Following successful completion of the clinical trials, the Company intends to produce a wearable, smart phone enabled technology, called the iTBraTM, which will utilize a comfortable data collection device placed under a bra to collect from two to twelve hours of breast cell data (dynamic cell chaos). Circadian rhythm-based temperature variances of cell cycles are then measured through a patented process to identify abnormalities at the earliest stages of cellular change, the results of which are transferred through a smart device to a global cancer library, where advanced analytical analysis occurs, and results are communicated back to the patient and physician. “El Camino Hospital is pleased to be involved in Cyrcadia Health’s research study to evaluate this potential new technology,” said Katherine Sutherland, MD, co-investigator...

ABC 7 NEWS: A new technology that could revolutionize breast cancer screening is about to begin clinical trials in the Bay Area.

ABC 7 NEWS: High-tech bra helps detect breast cancer High-tech bra helps detect breast cancer. Friday, January 30, 2015 12:11AM MOUNTAIN VIEW, Calif. (KGO) — A new technology that could revolutionize breast cancer screening is about to begin clinical trials in the Bay Area. Rather than a mammogram or ultrasound, this system can be used at home, with potentially life-saving information transmitted through a smartphone. For Dian Gaxiola, a routine breast screening at El Camino Hospital in Mountain View turned out to be a lifesaver. Doctors caught her cancer at a very early stage and saved her breast. “I was very lucky, I think because of the early detection,” cancer survivor Dian Gaxiola said. El Camino Hospital Radiologist Dr. Sila Yitta says routine mammograms and self-screening are the best defense, although many women don’t always take advantage. “In my experience it is hit or miss, I think women, some women are consistent in doing breast exams at home, some women don’t do them at all, and I often times get questions from women, asking simply, ‘How do I do an exam,'” Yitta said. However soon, an experimental technology could help thousands of women and doctors screen for breast cancer in a new way. It’s called the iTBra. “So you’ll be putting that on, so it’ll now be centered over you,” Cyrcadia Health CEO Rob Royea says the patches can be worn inside any normal bra. He said, “It’s a wearable device with a number of sensors that check what happens with your circadian patterns of heat change on your breast over time.” Roye says the heat changes correlate to...

Early Detection – Nedra

The opportunity of early detection and management of breast tissue abnormalities is a reality and has already made significant impacts in many lives. Nedra’s story is just one of those. Please take a moment to hear about the impact of the Cyrcadia Health technology in Nedra’s life, along with support and thoughts of the primary investigator of this particular study, Dr. Ronald...

First Warning Systems Changes Name to Cyrcadia Health

FIRST WARNING SYSTEMS CHANGES NAME TO CYRCADIA HEALTH TO BETTER REFLECT CORE COMPETENCY AND GOALS OF COMPANY Pioneer in Early Cancer Detection Receives $1 Million in Angel Funding Enabling the Final Stages of Clinical Validation Reno, Nev. – Sept. 30, 2014 – First Warning Systems, a pioneer in early cancer detection through measuring abnormal circadian cellular changes throughout the body, announced the company is changing its name to Cyrcadia Health, Inc. to better address the company’s breadth of upcoming product releases. The initial focus will be on wearable early breast cancer screening technology. “Our initial focus will be an ‘Internet of Everthing,’ wearable early breast cancer system which detects abnormal circadian cellular changes over time,” said Rob Royea, president and CEO of Cyrcadia Health. “With our most recent infusion of capital, we are able to take this unique technology into final clinical validation trials in the U.S. starting in November. It is our intention to launch this product into South Asia and Europe in mid-2015 followed by the U.S. after final FDA clinical clearance.” The company’s wearable, smart phone enabled technology, called the iTBraTM, uses a comfortable data collection device placed under a bra to collect 2-12 hours of breast cell data (dynamic cell chaos). Circadian rhythm-based temperature variances of cell cycles are then measured through a patented process to identify abnormalities at the earliest stages of cellular change, the results of which are transferred through a smart device to a global cancer library and communicated back to the patient and physician. “We have historically raised $1.9 Million in seed monies for the launch of our upcoming technologies” said...

BREAST HEALTH AWARENESS AN INTEGRAL PART OF YOUR WELLNESS PROGRAM

By:  Bonnie Rush, RT(R)(M)(QM) Did you read that Mammography screening IS being abolished in Switzerland? It may not happen. But there’s continued controversy swirling around the value of early detection and mammography. Naysayers suggest that early detection with screening mammography may not be providing the biggest bang for the medical buck. They may be right about the value of mammography, but let’s make sure they do not forget, we want early detection and we are worth more than a buck – or even two. The concern is that this continued debate may cause insurance companies to throw out the baby (early detection) with the bathwater (mammography). While it is true that some breast cancers cannot be overcome no matter the timing of detection, earlier allows a better outcome in most cases and reduces the impact of treatment. Similar to having a cavity, if caught early enough one does not have to lose the entire tooth. I think the controversy on the value of this “early detection tool” points to the lack of adequate and realistic education about the limitations of mammography and how dense tissue impacts the ability to “see” cancers (white cancer in a white dense tissue background). Even the much-touted newest mammography technology – digital breast tomosynthesis – failed to find the invasive cancer buried in my dense tissue. And guess what – there are lots of me’s around. This includes ALL women when their hormones are the most active and makes mammography of less value in finding cancers and increases the amount of radiation to those “younger” breasts. Thus the generally accepted United States policy to...

Why Mammography Screening is being Abolished in Switzerland

Whether breast cancer screening does more harm than good has been debated extensively. Earlier this year the Swiss Medical Board published a report recommending that no new systematic mammography screening programs be introduced. Here is how and why they came to this conclusion. The Swiss Medical Board is part of an independent health technology assessment initiative in Switzerland. In 2013 they were asked to review the current mammography screening program. The team of experts on the board included amongst others a medical ethicist, a clinical epidemiologist, a pharmacologist, an oncologic surgeon, a nurse scientist, a lawyer, and a health economist. “Systematic mammography screening” is the term generally used to describe the serial radiological examination of women within the framework of a screening program whereby all women in a specific age group are invited to an X-ray examination of their breasts which is not conducted by a doctor. At the time the country had in place a comprehensive screening program which was offered to all women aged from 50 to 69. The board spend twelve months reviewing all available evidence and its implications. They reported becoming “increasingly concerned” about the widely believed notion that mammograms were safe and capable of saving lives. They said “As we embarked on the project, we were aware of the controversies that have surrounded mammography screening for the past 10 to 15 years. When we reviewed the available evidence and contemplated its implications in detail, however, we became increasingly concerned.” In fact they concluded that statistics clearly indicated that mammograms appeared to be preventing only 1 death per 1,000 women screened, and actually caused harm...

Cyrcadia: A Wearable, Social Breast Cancer Screening Bra

by Pat Salber Rob Royea, CEO of Cyrcadia (formerly First Warning Systems) And now for something completely different in breast cancer screening:  a wearable (aka electronics embedded bra) with a social component. _________________________________ I had a chance to chat with Rob Royea, the CEO of First Warning Systems (FWS – soon to be renamed Cyrcadia Health) about their novel approach to breast cancer screening  – one that has no compression and no X-rays (yeah!). And it is useful in the subset of women where mammography is either not indicated or not as useful (e.g., young women with dense breast tissue). MRI has been used in this group, however it has less specificity and is far more costly. Cyrcadia’s technology The company has developed a complex sensing grid that can sense temperature changes in throughout the tissues of both breasts.  The raw data from the sensors (collected over 12 hours) is then fed into a cloud-based big-data analytic processor that allows the detection thermal fingerprints that are highly correlated with breast cancer.  Unlike prior attempts to use thermography, Cyrcadia’s technology is able to detect abnormal circadian changes in heat production that are characteristic of breast cancer.  The analytic processor is comprised of proprietary self-learning predictive analytic algorithms that are “self-learning” — that is, they can learn from each new case and thus refine outcomes. Cyrcadia has been issued three patents on the process and technology and have multiple patents pending.  If you want more technical details about the science behind their approach, you can find multiple papers/chapters on their website:  http://www.firstwarningsystems.com/publications.html. Because the device is not toxic, is comfortable, and...

Cyrcadia Kicks Off Series A Funding Round with $540,000 Infusion

PRWeb Cyrcadia Health, a digital health, wearable body media and large data company for early breast cancer detection, announced it has received $540,000 as the lead in to the company’s Series A funding round of $10 million. The initial investment group is a syndicate of investors primarily from Singapore, as well as a major lead by Steven Welch, an influential private investor based in Reno, Nevada.”I believe Cyrcadia Health offers a unique global business proposition and one which can materially and positively impact early breast cancer detection,” said Welch. “The company’s strong, experienced management team gives me confidence that this company will deliver successful results.”The company’s BioMedia system uses a small data collection device placed under a bra to collect two – 12 hours of breast cell data (dynamic cell chaos). Circadian rhythm-based temperature variances of cell cycles are then measured through a patented process to identify abnormalities at the earliest stages of cell augmentation, the results of which are transferred through a smart device to a global cancer library.More than 296,000 women in the U.S. alone are diagnosed with breast cancer annually and approximately 39,000 die from the disease each year, many due to lack of early detection. Contributing factors can be due to dense breast tissue which masks cancer on mammograms for women of all ages, but especially those under 40. In other parts of the world, such as developing Asian countries, breast cancer has become an epidemic. Cyrcadia Health CEO Rob Royea was recently invited to present the Cyrcadia Health technology and solutions at the prestigious Mobile and Wearable Technology: Healthcare 2014 conference held in Singapore earlier this month....