FIRST WARNING SYSTEM^TM

The First Warning System™ is a non-invasive, non-compressive and non-radiogenic device developed to assist in the early discovery of breast tissue abnormalities as an adjuvant to other diagnostic and screening methods. Through a proprietary (patents issued and patent applications filed…see the Intellectual Property section of this website), algorithm based interpretive software program called CAAP (computer aided physiological profile) it provides a physical assessment of over 4,750 data points (temperature readings) from the underlying tissue in the breast. It is believed that variations in breast temperatures and their related circadian rhythm (24-hour cycle in the biochemical, physiological, or behavioral processes of living entities) chaos may be caused by tumor angiogenesis (a physiological process involving the growth of new blood vessels from pre-existing vessels often associated with tumor growth).

Data capture and CAAP are not related to thermography. Instead, temperature fluctuations in the breast tissue are recorded over a period of time and analyzed for pattern recognition with powerful algorithms (trained by neural network analytic systems) creating a dynamic (as opposed to a static image as would be the case with a mammogram or MRI) impression of the changes in breast tissue temperature over time. The use of a neural net analytic system results in better sensitivity and specificity. Sensitivity measures the proportion of actual positive test results which are correctly identified as such. Specificity measures the proportion of negative test results which are correctly identified. Sensitivity and specificity are statistical measures of the performance of a binary classification test. A binary classification test is the task of classifying the members of a given set of objects into two groups on the basis of whether they have some property or not. A typical binary classification task is a medical test to determine if a patient has a certain disease or not. The CAAP analytic system is thoroughly and completely automated and without human visual interpretation, as no picture is produced. In contrast, thermography uses an infrared camera to create an image which is then interpreted by a trained individual. Because the image obtained from thermography is subjectively interpreted, output is low in sensitivity and specificity.

The First Warning System^TM is a contact active thermal analysis system recording vibrant changes in true temperatures with contact thermistors designed specifically for biological use. The temperature recordings are then analyzed by multiple neural networks. The biological thermistors are interchangeable and accurate to within .001 of one degree centigrade.

The First Warning System^TM is capable not only of identifying breast tissue abnormalities at their earliest stages, but can also identify the general location of such abnormalities in three dimensions to each of the four quadrants of each breast. It is, therefore, not intended as an additional step in the breast cancer screening process, but as an accurate identifier of early breast abnormalities which generate heat via the presence of new blood vessels that nourish the area in question. As such, it is a more precise feeder to other diagnostic modalities that are invasive as well as more costly. This approach to discovery aids in reducing the number of unnecessary procedures such as MRI and mammograms, as well as reducing the number of misdiagnosed issues related to the more accepted means of screening/detection.

The goal of the First Warning System™ is to enhance clinical breast examination aiding in the reduction of superfluous mammograms, needless biopsies, and other screening/diagnostic procedures, as well as to develop a physiological profile of the changing breast temperature picture over time, thereby identifying breast tissue abnormalities at their earliest stage.

The Process:

At the patient’s physician’s office, sixteen tiny color-coded sensors are attached (taped) to the patient’s breasts in a predetermined (patent issued) areas directly related to the National Tumor Registry’s record of reported breast cancer occurrences. These sensors measure temperatures at programmed times over a predetermined testing period. The data is stored in a small proprietary recording device (patent issued) that is worn by the patient. During the testing period the patient can go substantially about her daily activity. At the end of the test period the patient returns the storage device to their physician’s office. The sensor’s are removed and the data downloaded and sent via the Internet under HIPAA guidelines to First Warning’s interpretive center, where it is analyzed by the proprietary (patent applied) neural network software.

The patient’s physiologic data is compared against data from a database of pathologically proven cases of breast tissue abnormalities including cancer showing physiological abnormalities which may require follow up with mammography, MRI, biopsy or other diagnostic modalities. The test will show one of four conditions of the breast tissue: Normal, Benign, Suspected for breast tissue abnormalities, or Probable for breast tissue abnormalities.

A report is immediately returned to the physician. The physician and the patient can then discuss the physician’s clinical recommendations.

Over 500 women have been tested with the First Warning System™ in three venues: Ohio State University, Division of Surgical Oncology Center, Arthur G. James Hospital and Richard J. Solove Research Institute; Green Memorial Hospital, Dayton, Ohio and the C.L.E.M.P.L.A.M Breast Clinic, La Plata University, La Plata, Argentina.

The development of First Warning System™ and the testing of over 500 patients has produced a Sensitivity in the 94% range and a Specificity in the 90% range. These results compare to an estimated 70% specificity/sensitivity for mammography.

MASTASCOPE

The Mastascope is a ultraslim, hand held endoscope designed to enter the breast nipple via one of its milk ducts, thus permitting the physician to visualize the interior aspects of the breast. Because many cancers actually begin within an individual milk duct, these intaductal tumors are visualized easily and can be biopsied. This product has been used in leading breast centers in the United Kingdom and other countries with great success. Lifeline has obtained a CE mark for marketing and distribution in Europe.

OVASCOPE

Lifeline has developed and tested an ultraslim endoscope to directly visualize the ovarian surface in the search for cancer. This is of great advantage to physicians, because neither MRI, Xray or Ultrasonography can provide accurate assessment of subtle surface changes. Initial reports of clinical usage have been encouraging.

INTELLECTUAL PROPERTY

PATENTS ISSUED:

5,941,832 issued 8/24/99, Utility: Method and Apparatus for Detection of Cancerous and Precancerous Conditions in a Breast.

7,056,293 issued 6/6/06, Utility: Apparatus and Method for Identifying and Monitoring Women at Risk of Developing Ovarian Surface Epithelium Derived Carcinomas.

PATENTS APPLICATIONS PENDING:

12/198,967 filed 8/27/09, Method/Process: A Device for Analyzing Thermal Data Based on Breast Surface Temperature for the Detection for Use in Determining Cancerous Conditions.

12/583,969 filed 8/27/09, Utility: System for Analyzing Thermal Data Based on Breast Surface Temperature to Determine Suspect Conditions.

12/583,951 filed 8/27/09, Utility: Methods for Collecting and Analyzing Thermal Data Based on Breast Surface Temperature to Determine Suspect Conditions.

TRADEMARKS/COPYRIGHTS

Serial No. 78340795; Registration No. 2966626, Mark: Lifeline Biotechnologies, Inc.

Serial No. 78340830; Registration No. 2980880, Mark: First Warning

Serial No. 78342034; Registration No. 2983003, Mark: Ovascope

Serial No. 78364593; Registration No. 2962430, Mark: Licam

Serial No. 78467938; Registration No. 3065257, Mark: Mastascope

REGUALTORY AFFAIRS – 510(K)’S

510(k) Number K881813: Issued by the FDA November 4, 1988 to Chronodynamics Ltd. Description: A Medical Device, as an Intelligent Portable Data Recorder for Skin Temperature Measurement. Up to 16 Sensors at Various Locations. Lifeline Biotechnologies acquired the 510 (k) from Chronodynamics in the early 1990s.

510(k) Number K962246: Issued by the FDA November 14, 1996 to Saber Endoscopy, titled Rigid FiberOptic Gynecologic Laparoscopes. Five Star Medical acquired this 510 (k) from Saber Endoscopy in December 1997. Lifeline Biotechnologies, Inc. acquired this Rigid FiberOptic Gynecologic Laparoscopes 510 (k) from Five Star Medical December 30, 2003.