Accurate, Accessible, and Affordable Breast Cancer Screening

Product Profile First WarningTM System
Non-invasive, non-radiogenic, early
breast cancer discovery.”

Nedra's Story of Survival

The First Warning Solution

First Warning Systems (FWS) has developed a cutting edge wearable body media, early breast tissue abnormalities and breast cancer detection device intended for use as an adjunct to currently accepted screening modalities. Successfully tested with over 500 patients, the FWS solution has a demonstrated 74%+ correlation to the actual state of cancer in all types of breast tissue. The FWS Circadian Biometric Recorder (CBRTM) is applied to the breasts in a bra insert, records thermodynamic metabolic data, gathering metabolic changes in cell activity over a 2 to 12 hour bases. The recording detects abnormal dynamic tissue processes which are indicative of the state of cancer. FWS initial clinical results proven by biopsy were extremely encouraging with an equal-to and improved accuracy rate when compared to the gold stand of mammography. Without utilizing radiation or compression, the FWS CBRTM had optimal successes in those patients who were under the age for mammography screening, or had dense breast tissue, a condition which mammography and ultrasound are both challenged with as a diagnostic modality.

  • FWS predictive analytic technology has undergone 5 years of advanced development at Nanyang Technological University, Singapore, rated in the top 5 engineering aerospace and software universities globally.
  • FWS has three issued software patents on its patient data interpretive system awarded in 2012.
  • The original data acquisition device is FDA 510(k) cleared, and will be used as predicate for our upcoming FDA Class II submission in early 2014.
  • Life Sciences Strategy Group, a highly respected medical consulting company, projected FWS US pre market valuation at $22.8M and project sales for FWS in year five of $207M.
  • Global distribution relationships are established with well-established business partners in Australia, New Zealand, UK, Russia, and Singapore which will serve all of Asia.
  • Continued funding will impact product development for an updated FDA filing product completion in Q1 2014; support limited clinical 173 patient trial overseen by Principal Investigator, Dr. Joshua Ellenhorn, Cedars-Sinai Medical Center by mid-2014; and complete international CE mark and commercial product launch in Asia by late-2014.
  • In February of 2012 FWS hired Rob Royea, an experienced and successful medical management CEO. FWS brought Rob aboard to prepare, and commercially launch the FWS products into critical international markets by 2014 and into the EU and US markets by early 2015.
  • With over a million projected patients having utilized FWS technology within the first five years of operation, FWS’s Centralized Breast Cancer Data Library will be one of the largest and potentially most valuable singular breast cancer libraries globally by 2019.

Breakthrough Breast Health Legislation

In April of 2013, California will be the 5th state mandating that a physician notify a patient if they have dense breast tissue. Eleven more states, and now the federal government, have similar laws in process today. Thanks to the efforts of an advocacy group of breast cancer survivors, D.E.N.S.E (Density Education National Survivors Network), women will now be informed that their condition interferes with the effectiveness of mammograms to identify tumors in their breasts. With an early diagnosis (Stage 1), survival rate is exceptional at 95%, however the later the diagnosis the lower the survival rate, with only 35% surviving if diagnosed in Stage 3. With the limitation of diagnostic tools such as mammography and ultrasound to detect cancer in dense breasts, another medium of screening must evolve.

Get in Touch

First Warning Systems, Inc. 1325 Airmotive Way, Ste 175-L Reno, NV 89502

Phone: 775-324-3822
Fax: 775-852-7551

Benefits Summary

  • Improved quality of care non-radiogenic, non-invasive, and non-toxic
  • Testing and retesting is encouraged because of low cost and non-invasiveness
  • Post market feedback to build personal breast tissue history in Breast Health NowTM Personal History
  • Minimum time to learn the application—no specialized medical training required
  • Designed to be used at the point of entry for women into the medical care system
  • Potential of Over-the-Counter applications
  • Disruptive economics for the patient and medical delivery system
  • Reduction in the use and number of unneeded diagnostic procedures due to the high level of accuracy and low false negative/positive results

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