Through the guidance of Dr. Joshua Ellenhorn, we will be able to begin our final round of clinical validation trials later this year. That brings us closer to a launch in Singapore and Asia by mid 2014, with Europe and the US to follow shortly thereafter.
Reno, Nev. (PRWEB) August 26, 2013
First Warning Systems, Inc. (FWS), 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 FWS’ 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 FWS’ 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 FWS 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 more concise early prediction of breast cancer,” said Ellenhorn. “We are anticipating engaging a multi-center trial to ensure a timely and accurate outcome to our validation trial.”
First Warning Systems CEO Rob Royea says that Ellenhorn’s proven dedication to providing the highest quality of surgical care with an emphasis on a personalized approach to the individual patient aligns perfectly with the FWS mission. The company has devoted years of clinical research and significant funding toward the development of a process that promotes a proactive, compassionate, personalized approach to patient wellness and breast health.
“Through the guidance of Dr. Joshua Ellenhorn, we will be able to begin our final round of clinical validation trials later this year,” said Royea. “That brings us closer to a launch in Singapore and Asia by mid 2014, with Europe and the US to follow shortly thereafter. With the recent mandate requiring dense breast notification for patients here in the US and an epidemic of breast cancer in Asia, the release of this technology could not be more timely.”
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 only image tissue characteristics, the FWS system detects tissue alterations down to the cellular level allowing for earlier, safer, more accurate cancer prediction for woman of all ages and tissue types. Ultimately, the FWS system is intended to reduce the number of necessary radiation procedures, while eliminating potentially unnecessary surgeries.
Designed to fit a wearable garment similar to a sports bra, FWS anticipates bringing their technology to market for an affordable price that will make it widely accessible to all markets.
To learn more, visit http://www.firstwarningsystems.com/.
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 650 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 (OTC Market: LLBO). 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 http://www.firstwarningsystems.com/.