First Warning Systems Kicks Off Series A Funding Round with $540,000 Infusion

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Initial Investment Enables Filing of FDA Class II 510k Now Underway for Pioneer in Early Breast Cancer Detection

I believe FWS offers a unique global business proposition and one which can materially and positively impact early breast cancer detection.

First Warning Systems, Inc. (FWS), 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 FWS 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. FWS CEO Rob Royea was recently invited to present the FWS technology and solutions at the prestigious Mobile and Wearable Technology: Healthcare 2014 conference held in Singapore earlier this month.

“Breast Cancer is an epidemic in evolving Asian countries,” said Royea. “Our goal is to provide earlier, safer and more accurate breast cancer screening in a wearable form. In addition, our solution can enable the populating of an international big data library with phenotype and genotype information on global breast cancer due to the ability of FWS's ‘Internet of Everything’ based technology to reach the masses so desperately in need of new choices for breast cancer screening.”

With extensive clinical trials, and years of advanced algorithm refinement completed, FWS' patented intelligent predictive models are projected to improve accuracy for breast cancer assessment to over 75 percent. Unlike mammography and ultrasound, which image tissue characteristics, the FWS system measures tissue alterations at the cellular level allowing for early, safe, and accurate cancer prediction for women of all ages and tissue types. Ultimately, the FWS system is intended to reduce the number of potentially unnecessary biopsy procedures, while refining the need for surgeries. The company has begun the process of filing an FDA Class II 510K application for the technology which was enabled by the initial $540,000 investment.

About First Warning Systems Process

Dynamic thermal readings of breast tissue cellular changes creates a patented time sequenced profile which correlates to circadian cellular processes expressed through specific circadian genotypes. Multiple bioinformatics algorithms compare the circadian gene expression profiles to identify breast tissue abnormalities at different stages of development of disturbed breast tissue cells. FWS delivers an objective Clinical Decision Support Service report to the primary care physician with industry leading accuracy.

About First Warning Systems

First Warning Systems, (FWS) founded in 2008, is based in Reno, Nev. The FWS product line is a device and software service that detects breast tissue abnormalities leading to health risk assessment and management including early breast cancer identification. Three clinical trials with over 500 participants have achieved proof of concept and superior outcomes when compared to other diagnostic protocols. FWS’ technology is exclusively licensed for development, manufacturing and marketing worldwide from Lifeline Biotechnologies, Inc. FWS is planning a final, limited clinical trial and a 510k device classification to validate the fourth generation of the FWS product. FWS is preparing to apply for a Euro CE Mark to market in the European Union and Asia Pacific markets. See FWS’ video, “Breast Cancer Tumor Progression” at


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Laurie Hallwyler

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