Lifeline Biotechnologies Inc (LLBO)

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06.26.18 Reno, NV Cyrcadia Health Announces New Medical Advisor, Kevin Buckman, M.D.
by admin | Jun 26, 2018 | News
Dr. Buckman has over 35 years of Emergency Medicine Experience and is currently a Physician with Team Health in Lodi, CA. He has served as Medical Director or Associate Medical Director in hospitals and institutions for over 20 years and has over 40 years of clinical experience. He has served as Medical Director in the Emergency Department and as a member of the Executive Committee for six years at St. Dominic’s Hospital in Manteca, California. He also served as Director of the Emergency Department at Navy Lemoore Hospital in California. Dr. Buckman is the author of many books, including Find & Stop Breast Cancer, The Metabolic Origin of Cancer. He was a Fellow in the American Association of Integrated Medicine, and is a Board Certified Medical Review Officer. He has been certified with the National Registry of Certified Medical Examiners since 2014. His other specialties include: Internal Medicine, Forensic Medicine, Medical Acupuncture. He has presented research, published articles and books in the field of medicine, and given lectures at numerous hospitals and at International Medical Conferences. He has received Post Graduate Training at Stanford University School of Business and attended seminars with the Securities Exchange Institute. He has numerous Medical Publications, including topics on breast cancer, oncology, and other topics. He was the first US Physician to be accepted into the European Group for Breast Cancer Screening after his research in this field was accepted for publication and presentation at their international conference in Cyprus. During the last 30 years he has worked to advance a number of medical technologies with a focus on Non-Harmful early detection of disease,...
Reno, NV June 12, 2018, Cyrcadia, Inc. New Member of Board of Directors
by admin | Jun 12, 2018 | News
Cyrcadia, Inc. is pleased to announce the addition of Ed Wertzberger to the Board of Directors as we continue to focus on implementation of our aggressive growth strategy and Go-To-Market plan. Jim Holmes, Chairman of the Board, says, “We are pleased to have an executive join our Board who possesses extensive leadership and global experience. We are confident Ed’s 35 years of leadership, financial management and operational consulting and governance experience will bring a fresh perspective and insights as we implement our product plans.” Matt Benardis, CEO, added “We have already seen impact from Ed’s involvement as we review and negotiate company contracts and develop corporate policies and governance”. Ed’s leadership background includes management experience in global leadership roles with the “Big Four” accounting firms, consulting for Fortune 500 companies, led hospital transformations, and is the co-founder of a boutique management consulting firm. In addition, Ed’s experience includes over 20 years as a partner with Arthur Andersen and Deloitte, Big Four firms. He has led global strategy planning and implementation initiatives, business transformation and customer loyalty programs. He has been a member of numerous leadership and governance teams to align operations and implementation teams. He has served on numerous not-for-profit organization Board’s, including as President for several. Ed’s educational background includes a Bachelor of Business Administration – Accounting from the University of Iowa and he obtained his CPA in 1976. Next steps: Announce new product and new chief medical...
Reno, NV May 29, 2018, Cyrcadia Health “B” Warrant Acceleration Option
by admin | May 29, 2018 | News
Based on 2018 Go-To-Market plans, investment infusion is paramount in keeping on track and maintaining our accelerated pace. Our stakeholders have been essential in supporting our march to bring the most advanced Breast Health product to market. For those stakeholders holding “B” warrants, the warrants will expire December 31, 2018, meaning conversion to shares in the company will no longer be an option, losing all value. Accordingly, we are offering a “B” Warrant acceleration option effective now until June 30, 2018 allowing our stakeholders to continue to be part of and support the next phase of company operations: “B” Warrant Conversion price: $0.50 per warrant. “E” Warrant Addition: for each “B” Warrant converted to shares on or before June 30, 2018, Cyrcadia, Inc. will offer one (1) “E” warrant for each “B” Warrant converted, with an exercise date of December 31, 2019 at $1.00 per warrant. “This acceleration option allows our warrant holders to extend their expiration date while supporting our plans with the investment infusion at this time”, says Jim Holmes, CFO. “Warrant holders should note that new investors are investing at $1.00 per share and this acceleration option extends the time to participate in the increased value of the company as we achieve our market and sales milestones”, adds Holmes Direct inquiries to Jim Holmes at 775-852-3222 or email to...
Reno, NV May 21, 2018, Key Partnerships for Cyrcadia Health
by admin | May 21, 2018 | News
Three key partner relationships are in place to bring “Best of Breed” subject matter experts into the Cyrcadia Health, Go-To-Market sales launch plan: Consumer Marketing: Dupuis Marketing, Chicago: branding, packaging, social media advertising, and user experience design. “We develop and create business opportunities that establish new meaning for people–digging for deeper truths beyond commonly leveraged insights, evolving brand relevance and creating breakthrough products and services. We translate our clients’ business challenges into sustainable, responsible growth opportunities.” Clinical Marketing: Life Sciences Strategy Group, San Jose: product visualization, product and market strategy. “Our approach employs best practices to align strategy with portfolio management and product development and commercialization processes. This integrated solution results in alignment of near, short and long–term planning cycles and development of strong and actionable marketing/brand, portfolio, new product, licensing and managed market strategies.” Nerdy Dragon, Boise: IT infrastructure and web site management. “Nerdy Dragon is a connector and collaborative agency focused on digital asset design, production, and management. We deliver for clients – consistently, reliably, with world class quality and super-reasonable turnaround. We have designed and developed hundreds of web and app experiences since 2009. We are a team of over 300, located on 5 continents, working tirelessly to execute on digital projects – making, doing, connecting, and thriving. We have team members located in the US, South America, Australia, Asia, and Africa.” “Principals of these companies have been involved with Cyrcadia Health for a number of years and have a deep understanding of our value proposition to bring significant value to our Go-To-Market launch,” says Matt Benardis, CEO. “Their depth of experience in our markets means...
May 14, 2018, Reno, NV. Artificial Intelligence Advancements
by admin | May 14, 2018 | News
New discoveries have been achieved with our artificial intelligence (AI) algorithms. Recalling the foundational basis for the Cyrcadia Health intellectual property and patent filings is five algorithms that analyze tissue temperature and circadian body rhythm disruptions over a time period (dynamic) to identify tissue abnormalities. “Recently, our AI software scientists have made new discoveries that will bring additional value to our users who want to understand their health condition”, says Matt Benardis, CEO. Advanced data analysis and formula modification has achieved three goals: The science of ability to locate a tissue liesion abnormality location has now been verified. This means a doctor will know where to start more advanced therapies. Location is significant, as this will allow the physician to focus on a specific area for further investigation. With additional data from our clinical studies, we can advance our tissue knowledge without having to re-engineer our device and sensors. A new Wellness score can be computed based on metabolic patterns that can be used to begin tracking behaviors on the basis of clinical trial data. Wear time can now be as little as two hours. Analysis of datasets has detected the same statistical probability in a two hour dataset as in an 8 hour dataset. This means the Circadian disruption is perpetuated throughout the circadian cycle, leaving a detectable “signature”. This signature means the metabolic behavior can be identified for continued observation. Our four clinical trials continue to show the same successful outcomes through our analysis of this thermo-circadian disruption caused by abnormal breast tissue (via morphological and endocrine factors) and the resulting dynamic temperature patterns. In addition, we...
May 4, 2018, Reno, NV. Expanded Go-To-Market Team
May 4, 2018, Reno, NV. Expanded Go-To-Market Team
by admin | May 4, 2018 | News
Cyrcadia, Inc. is pleased to announce the addition of Marly Heidkamp, Chief Operating Officer, R.N., MSEd to the executive team to focus on execution of the Go-to- Market plan. Jim Holmes, CFO, say, “We are pleased to have an operations executive join our team who possesses medical product management experience as well. We are confident her leadership will bring added perspective to a product targeted for the female population.” Matt Benardis, CEO, added “We have already seen results from her leadership of the recent kick-off meeting with the comprehensive Go-To- Market team and her engagement of each department regarding oversight, organization and accountability.” Please see the attached Team photo from a very successful kick-off. Marly brings over 30 years of healthcare and corporate operations depth, as well as consulting and management experience to our team. Her career also includes experience as a pediatrics and specialty care nursery nurse. Consulting lessons learned include experience in Healthcare, Big Four, Fortune 500 professional services and software environments, plus co-founding and managing a boutique management consulting business for over 10 years. Ms. Heidkamp’s operations experience in healthcare and software environments include leadership roles in electronic health records software, healthcare consulting, hospital-wide training and education, vendor credentialing program and software for hospitals, hospital business transformation, strategic planning and execution and customer loyalty programs. Her educational background includes Masters of Science in Adult Learning, with emphasis in Organizational Development, Instructional Design and Change Management (Northern Illinois University in DeKalb, IL), Bachelor of Science in Nursing (Benedictine University, Lisle, IL) and Certificate in Leading People, Leading Organizations (USC Marshall School of Business). Please join us in...
April 30, 2018, Reno, NV. Clinical Trial Resumption Update
by admin | Apr 30, 2018 | News
As Cyrcadia prepares to move to clinical markets, Matt Benardis, CEO; Jim Holmes, CFO; along with our Clinical Research associate (CRA) met with clinical trial investigators and administration at El Camino Hospital, in San Mateo, CA, to discuss previous participant follow-up and trial resumption with our modified clinical product and associated study protocol. Do note trial details are not revealed in advance nor can Cyrcadia, Inc., the study Sponsor, have any impact on the procedures in order to maintain FDA trial integrity. However, they did ascertain a number of positive aspects with El Camino trial manager Initial trial participant follow-up continues to contribute to the Artificial Intelligence analytics improvement and population of the database. Trial managers confirmed their agreement and enthusiasm for protocol revisions regarding the reduction of wear time for trail participants to 2 hours, potentially accelerating participant subscription. Trial managers were very positive and affirmed their ongoing interest in the resumption of the study and its completion providing study outcome data for FDA disclosure. It is important to understand one of our issues was women recently diagnosed with breast cancer were reluctant to be committed to an up to 24-hour wear time. All agreed that our revised 2-hour wear time protocol would potentially increase participation and accelerate trial completion. It is notable that our artificial intelligence algorithm research has developed verifiable evidence to substantiate a 2-hour wear time with equivalent accuracy results as compared to the historical 24-hour wear time. Next steps Updated production schedule from Jabil Electronics and Cyrcadia Asia to provide product revisions related to shelf life and improved ease of use, as well as...
Cyrcadia, Inc. – 2017 Year End and 2018 Look Forward Newsletter
by admin | Feb 21, 2018 | News
February 27, 2018 Cyrcadia, Inc. (“CI”) extends its thanks and appreciation in your interest and support of our endeavors. We are taking this opportunity to provide an update, as well as apprise you of upcoming expectations. License and Cooperation Agreement with Cyrcadia Asia (“CA”) – Status Earlier in 2017 CI entered into an Agreement with CA, whereby CA assumed the responsibility and funding of the design, development and delivery of a scalable, commercializable iTBra™ system including upgraded hardware and the full suite of application software as well as automation of our proprietary Artificial Intelligence Analytics. The estimated cost of development with Jabil and Mobile Now is approximately $1.2 to $1.5 million US. As such, the agreement calls for CA to provide timely reporting and status of product development including timelines, milestones and dates of completion and delivery of product (market readiness, product volume availability and delivery terms and schedules). Many strides have been made in the evolution of the relationship as CA has established its operations, initial staffing and funding. Both CI and CA are in a mode of cooperation, as called for by the Agreement and, presently, both entities are to hold routine meetings where comprehensive updating and reporting will be delivered to CI, enabling implementation of our business, operations and marketing plans. We will be reporting the outcomes of that meeting to move forward on our ability to commercialize the iTBra™ system this year. Given the above, we would like to update on the internal operations that will allow for CI to “hit the ground running” upon product delivery. Status of Product Development and Manufacturing Under CA’s...
Cyrcadia, Inc. Wins Prestigious Cannes Lions Awards
by admin | Jul 25, 2017 | News
Cyrcadia, Inc. (CI) announced it has won two prestigious awards at the Cannes Lions International Festival of Creativity, a global event for the creative communications, marketing and advertising world. Held in Cannes, France and attended by over 10,000 delegates, Lion awards are considered the most coveted in the industry. The first award was a Bronze Lion in the category of Innovation, which honors ground-breaking technology and problem-solving. It specifically looks at how technology, data and ideas, when working in unison, can revolutionize lives. Cyrcadia shared the Bronze award with industry giants such as Google, Shell and Apple. The second award was a Silver Glass Lion award, recognizing ideas that could change the world and positively impact gender inequality or injustice. Cyrcadia’s ability to deliver early breast cancer health monitoring to the mass populations of women who have little or no access to quality health care was key to Cyrcadia’s award achievement. Cyrcadia is developing and marketing a device and software that monitors for biometric changes that correlate to breast cancer . Known as the iTBra, the device is based on wearable sensor patches that are placed under a woman’s own garments and worn for two hours. The sensor data results processed through Cyrcadia’s artificial intelligence (AI) lab can be automatically communicated to the patient, her physician and insurance company. Based on Cyrcadia’s monitoring device, a patient will be recommended for further investigation by a physician. The company’s technology has obtained U.S. FDA 510(k) Class II clearance. While the technology is based on historic data from a trial of 200 patients, recent validation trials on 46 patients have confirmed prior...
Lifeline announces transfer of breast cancer detection technology to subsidiary
by admin | Jun 30, 2017 | News
Reno-based Lifeline Biotechnologies, Inc. (OTC PINK: LLBO) recently transferred breast cancer detection technology to Cyrcadia, Inc. in exchange for 4,670,000 shares of Cyrcadia, Inc. common stock and a $110,000 cash and $220,000 promissory note. The additional 4,670,000 shares added to Lifeline’s original 8,000,000 shares totals 12,670,000 shares. Lifeline’s ownership is increased to over 45 percent of Cyrcadia, Inc., making Lifeline Cyrcadia, Inc.’s largest single shareholder. The technology transfer enabled Cyrcadia, Inc. to license Cyrcadia Asia Limited for the marketing of Cyrcadia, Inc. products throughout the Asian markets. Rob Royea, Cyrcadia, Inc.’s former CEO, is moving to Hong Kong to manage the Asian opportunity, representing a population of 1.8 billion people. Cyrcadia, Inc. received the following compensation for the license to Cyrcadia Asia Limited: An $830,000 Cyrcadia, Inc. equity investment at $1.00 per share with an equal $1.00 warrant; a $1,050,000 promissory note; Cyrcadia Asia, Limited assumed approximately $3,000,000 in product development costs for the Bluetooth and added sensor costs. Cyrcadia, Inc. received an equity interest in Cyrcadia Asia, Limited. Additionally, Cyrcadia Asia Limited assumed approximately $500,000 of Cyracdia, Inc.’s annual general and administrative expenses. Cyrcadia Asia Limited will license Cyrcadia, Inc. for the developed Bluetooth and additional sensors products once development is completed. The transaction is valued at approximately $5 million. The Bluetooth capabilities will enable patient data to be transmitted directly, over the Internet, to the testing physician, and/or the data interpretation center. The added sensors will enable the systems to exactly locate the tissue abnormality or cancer within the breast tissue. By locating the abnormality, the physician performing the biopsy will know exactly where the probe should be inserted into the tissue. Cyrcadia, Inc., a Nevada corporation, founded by...
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Cyrcadia, Inc. Prepares for iTBra™ Product Launch and Expands Strategic Operations to Asia
by admin | Apr 25, 2017 | News
Cyrcadia, Inc.(CI) announced this week a strategic expansion to accelerate operations and market launch into Asia for early breast cancer monitoring. CI has entered into a License and Cooperation Agreement Cyrcadia Asia, Ltd. (CA), a newly formed company in Hong Kong which will serve as the base for the Asia market launch of CI’s proprietary iTBraTM technology expected to commence in late 2017 or early 2018 under the global CI brand of Cyrcadia Health. Under the License and Cooperation Agreement, Cyrcadia Asia has exclusive marketing rights to the iTBra technology and products in Asia. CA will assume and fund certain further product development and other activities with respect to the iTBra technology and products for the benefit of both CI and CA. The License and Cooperation Agreement also provides for certain other financial terms between the two parties intended to enable the launch of the technology and products in Asia. CI retains exclusive marketing rights to the United States, Mexico and Canada, with the marketing strategy for the iTBra technology and products in other countries to be further discussed by the parties. Having obtained U.S. FDA 510(k) Class II approval for its iTBra technology, CI has conducted clinical trials in the U.S. with its newly developed scalable product, which demonstrates greatly improved outcomes, beyond historical product results. CI’s predictive analytic artificial intelligence (AI) based technology now demonstrates 80%+ accuracy with a two-hour wear when compared with the original trials which required 48-hour wear and achieved 74% accuracy. CI and CA expect this greatly improved performance to support the use of the 510(k) approval to launch the technology and products...
Sports Business Advisor Mandy Antoniacci Joins Cyrcadia Health
by Rob Royea | Jun 3, 2016 | News
CYRCADIA HEALTH EXPANDS ADVISORY BOARD WITH NATIONALLY RECOGNIZED AUTHOR AND SPORTS BUSINESS ADVISOR MANDY ANTONIACCI Magazine Columnist, Sports Business Advisor and Advocate for Social Change Fills Key Position for Cyrcadia Reno, Nev. – June 2, 2016 – Cyrcadia Health, awarded the 2016 Gold Edison Award as Top Healthcare Wearable for its early breast cancer screening technology, is pleased to announce the addition of Mandy Antoniacci to serve as sports business advisor and women’s health advocate for Cyrcadia. As an in-demand speaker and nationally recognized author whose published works have been featured in Inc., Business Insider, Huffington Post, Yahoo Sports and Yahoo Finance, Antoniacci fuses her extensive marketing and advertising experience in the fields of sports, technology and health and wellness to advocate social change in business. “Is a great honor to have Mandy fill such a key position in her business advisory role,” said Rob Royea, president of Cyrcadia. “Her success in both business and in public communications within professional sports, as well as her passion to serve the underserved, will help to accelerate our message about the empowerment of women taking control over their individual personal health knowledge. Mandy’s personal understanding of the impact of breast cancer brings a unique ownership to our cause, which will help in her ability to passionately spread our key message to all women, medical professionals and financial and strategic supporters. Antoniacci is also an advocate for women in her work as a Leadership Committee Member for the nonprofit Futures Without Violence, where she advises on policy and education for domestic violence prevention in conjunction with the National Football League and Major League Baseball. In her role...
“‘iTBra’ Could Be the Key to Early Breast Cancer Detection”
by Matt Benardis | May 13, 2016 | News
Cyrcadia’s technology was recently featured and Columbus, Ohio’s WBNS-TV10, notifying the viewing public of the expansion of our clinical trials at The Ohio State University. We are pleased to have Dr. William Farrar’s support in this endeavor. Please have a look. ‘iTBra’ could be the key to early breast cancer detection....
Cyrcadia Health Takes Home Gold 2016 Edison Award for Top Health and Wellness Wearable
by Matt Benardis | Apr 27, 2016 | News
Reno, Nev. (PRWEB) April 27, 2016 — Cyrcadia, Inc. was recently awarded the gold level citation for Health and Wellness, Wearable and Sensors category from the prestigious Edison Organization presented last week at the annual gala in New York. The company’s breakthrough technology is designed to enable early breast cancer detection through use of a wearable device, the iTBra.™ The technology measures specific circadian biomarkers, which can be early indicators of breast cancer cell infusion. “Not only did Cyrcadia win, but the company beat hundreds of other innovators and dozens in this category to achieve this designation,” said Jason Starbird, CEO, Aebli Group/ Edison. “One in eight women in the U.S. are diagnosed with breast cancer annually and approximately 500,000 women die worldwide from the disease each year, many due to lack of early detection. The Cyrcadia technology may become a substantial game changer.” Cyrcadia’s wearable, smart phone-enabled iTBra technology, uses 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 Cyrcadia-patented process to identify abnormalities at the earliest stages of cellular change over time. The results collected from the technology are transferred through a smart device to a global cancer library, where advanced analytical analysis occurs. The results then are communicated back to the patient and physician. “We are honored to be receiving this highly regarded award,” said Rob Royea, president of Cyrcadia. “There are numerous and exciting technologies being developed in the healthcare field, which makes the selection of Cyrcadia as the...
The human element of IoE changing the way breast cancer is detected.
by Matt Benardis | Nov 5, 2015 | News
Vatsun Thirapatarapong November 3, 2015 8:47 am In Thailand, breast cancer is the number-one cancer killing women, averaging seven women dying per week. More than 19 million Thai women are now in risk of having breast cancer. Such statistics on the occurrence of breast cancer are terrifying, but incredible strides across all forms of cancer are taking place. In many cases, they come in the form of early detection through ground-breaking technology and the Internet of Everything (IOE) Read more here:...
Cyrcadia Featured in Cisco’s Monthly Digitial Magazine, Focus: Healthcare Goes Digital
by Matt Benardis | Oct 28, 2015 | News
Focus: Healthcare Goes Digital Setpember 2015 • Issue 26 • The Internet of Everything revolutionizes the healthcare industry Why Why your Next Bra Could Save Your Life...
Cyrcadia, Inc. Collaborates With the Canary Foundation for Early Breast Cancer Research
by Matt Benardis | Oct 28, 2015 | News
Reno, Nev. (PRWEB)September 22, 2015 via http://www.prweb.com/releases/2015/09/prweb12974574.htm Cyrcadia Health and the Canary Foundation announced their intention to enter into collaborative research on improved early cancer detection screening through the use of Cyrcadia’s wearable devices. Through funding support from the Canary Foundation, Cyrcadia has established a multi-site trial, beginning at a leading Bay Area cancer hospital with near term expansion to the Stefanie Spielman Comprehensive Breast Foundation at The Ohio State University. This research will involve a 173 patient study focused on early breast cancer health screening. “We are excited that the Canary Foundation has taken an interest in our personalized health screening technology,” said Rob Royea, president of Cyrcadia, Inc. “The potential of collaboration with the only foundation in the world, which over the past 10 years has focused solely on early cancer detection, is highly prestigious. Working together on early biomarker identification for multiple states of cancer will be of significant benefit to our research. Our ability to correlate our findings with those biomarkers which are early indicators of breast cancer infusion is invaluable and could lead to additional applications for our wearable products.” One in eight women in the U.S. alone are diagnosed with breast cancer annually. Approximately 500,000 die worldwide from the disease each year, many due to lack of early detection. The company’s wearable, smartphone enabled technology, called the iTBraTM, uses a comfortable data collection device placed under a bra to collect from two to 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...
Cyrcadia in the News with New Focus on American Cancer Society Recommendations
by Matt Benardis | Oct 28, 2015 | News
The iTBra has been spotted on social media. One is another Huffington Post ImpactX article by Cisco CMO Karen Walker, published Tuesday. Another is an article by Wearable-Technologies.com . Thank you Huff Post And Wearable...
American Cancer Society Changes Breast Cancer Screening Guidelines
by Matt Benardis | Oct 28, 2015 | News
On the heels of new American Cancer Society breast cancer screening guidelines, CNN explores the potential pitfalls of mammography, including false positives that can lead to unnecessary biopsies and radiation. iTBra may provide an alternative screening method. http://cnn.it/1M8CDsw...
Cyrcadia, Inc. Announces ClinicalTrials.gov Listing for Its Entry into Clinical Trials for Wearable Breast Cancer Detection Device
by Matt Benardis | Aug 11, 2015 | News
Reno, Nev. Aug. 11, 2015 — Cyrcadia, Inc. (“Company”) announces its clinical trial listing on ClinicalTrials.gov for its wearable breast cancer early detection device at El Camino Hospital, in Mountain View, California and upcoming additional clinical study sites. ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 130,000 trials from more than 170 countries in the world. “We are enthused that we have initiated the El Camino Hospital trial in Mt. View, CA and have now finalized the ClinicalTrials.gov registry. We look forward to the additions of The James Cancer Hospital at The Ohio State University and the Canary Center at Stanford’s upcoming inclusion into our early breast cancer screening trials,” says Rob Royea, President of Cyrcadia, Inc. For those interested in learning more about the Cyrcadia clinical studies, ClinicalTrials.gov is the registry to use including all details about the study and its status. It is the only location where Cyrcadia will divulge information about the studies and will update the registry from time to time. All information desired about the clinical studies can be obtained there and will not otherwise be divulged by Cyrcadia, its staff or other related parties. All details about the study including descriptions, eligibility and contacts can be obtained there. Please follow this link: ClinicalTrials.gov/Cyrcadia or go to the clinicaltrials.gov website using the identifier NCT02511301 to learn more and follow progress of the study as it is reported. Utilizing its previous FDA cleared device as a...
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Cyrcadia, Inc. Enters Clinical Trials for Wearable Breast Cancer Detection Device
by Matt Benardis | Jul 17, 2015 | News
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: Hight Tech Bra to Help with Early Breast Cancer Detection
by Rob Royea | Feb 2, 2015 | News
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ABC 7 NEWS: A new technology that could revolutionize breast cancer screening is about to begin clinical trials in the Bay Area.
by Rob Royea | Jan 31, 2015 | News
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
by admin | Sep 30, 2014 | News
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
by admin | Sep 30, 2014 | News
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 admin | Sep 22, 2014 | News
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
by admin | Sep 15, 2014 | News
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 admin | Aug 21, 2014 | News
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
by admin | Apr 16, 2014 | News
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....
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FIRST WARNING SYSTEMS APPOINTS NURSE BARB DEHN TO ADVISORY BOARD
by admin | Mar 18, 2014 | News
Popular TV and Blog Healthcare Expert Joins Pioneer in Early Breast Cancer Detection Reno, Nev. – March 18, 2014 – First Warning Systems, Inc. (FWS), a digital health, wearable body media and large data company for early breast cancer detection, announced it has appointed Barb Dehn, RN, MS, NP to the company’s Clinical Advisory Board. Known as “Nurse Barb” to legions of her television and blog followers, Dehn is the host of Nurse Barb’s Daily Dose which is broadcast throughout the country on ABC and The Live Well Network. She is a practicing women’s health nurse practitioner, award winning author and a nationally recognized health expert. “It is a great honor to have Barb Dehn join our team as a key member of our Clinical Advisory Board,” said Rob Royea, president and CEO of FWS. “She is a highly regarded healthcare expert with extensive experience in women’s health. Her credibility and medical insights have truly led to her being recognized as America’s Leading Nurse Practitioner.” Dehn holds a BS from Boston College and earned her masters degree at the University of California, San Francisco. An in-demand and popular national speaker on all aspects of women’s health, she also lectures at Stanford and is a go-to health expert on television. She has appeared on CBS, CNN, Good Morning America Now and NBC’s iVillageLive. Nurse Barb’s first book, A Hot Guide to a Cool, Sexy Menopause (Basic Health Publications) is being released in May 2014. “Women are in great need of new technology, such as First Warning Systems’, as we continue our efforts to bolster early breast cancer detection,” said Dehn....
Bonnie Rush Joins Cyrcadia Health Clinical Advisory Board
by admin | Oct 15, 2013 | News
Bonnie M. Rush, RT(R)(M)(QM), President of Breast Imaging Specialists, recently joined the Cyrcadia Health, Clinical Advisory Board Cyrcadia Health, a Reno-based life sciences, wearable body media and large data company, recently welcomed Bonnie M. Rush, RT(R)(M)(QM) to the company’s Clinical Advisory Board. Rush brings more than 25 years of expertise in breast health to Cyrcadia Health, a company producing a non-invasive, intelligent, wearable, biofeedback early breast cancer-screening device. With her own breast cancer diagnosis in 2012, Bonnie is on a fast track to advance early detection tools and promote risk reduction information that can help save women from invasive cancers. The addition of Rush to the Board brings another superior voice to Cyrcadia Health global mix of experts. Rush currently serves as president for Breast Imaging Specialists of San Diego, Calif., providing education, in-services, clinical practice management, regulatory compliance and outreach programs to the breast imaging community. She established the first low-cost mammography screening program in San Diego and helped launch the San Diego Breast Cancer Early Detection Program. A long-time expert in the breast health field, Rush also authored the definitive explanation of the Mammography Quality Standards Act. Currently she serves as the AHRA (Association of Medical Imaging Management) liaison to the Are You Dense Advocacy, Inc., to advance the cause of early detection for women with dense breasts. “I am so pleased to have this opportunity to work with such an extraordinary team of dedicated (and smart) individuals,” said Rush. “The goal is so exciting – the motivating driver to raise the bar on early detection and thus to save lives – with the appreciated potential of...
Retains Joshua D.I. Ellenhorn, M.D., as Principal Investigator
by admin | Aug 26, 2013 | News
Dr. Ellenhorn, a leading expert in surgical oncology, partners with Reno-based life sciences company to conduct clinical validation studies of a non-invasive early cancer detection product. Reno, Nev. August 26, 2013 Cyrcadia Health, a Reno-based life sciences software and medical device company, recently retained Joshua D. I. Ellenhorn, M.D., as the Principal Investigator (PI) in preparation for the anticipated clinical validation studies slated for later this year. This is the latest development in Cyrcadia Health progress toward the realization of its non-invasive, intelligent, wearable, biofeedback early breast cancer screening device. Retention of an expert PI is a critical step toward bringing Cyrcadia Health proprietary breast health product and service to market in the near term. Ellenhorn, a leading expert in surgical oncology, has been at the forefront of breast cancer treatment for years. In addition to being Clinical Professor of Surgery at Cedars-Sinai Medical Center and Adjunct Professor at the John Wayne Cancer Center, Ellenhorn has directed extensive laboratory research to develop new cancer vaccines that work on the immune system to identify and eliminate cancer cells. U.S. News & World Report ranks him among the top one percent of surgeons in the United States and he is ranked as a Super Doctor in Los Angeles. A medical educator, Ellenhorn has trained over 60 surgical oncologists. The sum of his extensive qualifications positions Ellenhorn to be a driving force for the advancement of the Cyrcadia Health technology, which has concluded three successful clinical trials as well as completed over five years of advanced algorithm development in preparation for launch. “The technology shows significant promise of supplementing today’s imaging standards for a...
Breast Cancer Myths: Separating Fact from Fiction
by admin | Oct 24, 2011 | News
By Ted Gansler, MD, MBA, MPH You have probably seen and heard a lot about breast cancer during the past few weeks, but as we approach the end of this year’s breast cancer awareness month this is a good time to ask how much of the information you encountered is actually true. See if you know which of the following statements are true and which are false… TRUE OR FALSE: Most breast cancer is hereditary. You don’t need to worry if you don’t have a family history of breast cancer. FALSE. Only about 5% to 10% of breast cancer cases are thought to be the result of gene defects (called mutations) inherited from a parent. The lifetime risk for breast cancer can be as high as 80% for members of some families who inherit certain mutations of BRCA genes. The risk is not nearly as high for most women with a family history of breast cancer. On average, having 1 first-degree relative (mother, sister, or daughter) with breast cancer approximately doubles a woman’s risk, and having 2 first-degree relatives triples her risk. About 20% to 30% of women with breast cancer have a family member with this disease (although most of these families do not have abnormal BRCA genes). This means that most women (70% to 80%) who get breast cancer do not have a family history of this disease. _____________________________________________ TRUE OR FALSE: If you have a family history of breast cancer, there is nothing you can do to protect yourself from this disease. FALSE. If 1 or more of your relatives have had breast cancer, be sure...


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