|09-18-2009, 01:20 AM||#1|
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FDA Play: Redefining Breast Cancer Detection (OTC:LLBO)
With the recent gains in Hard to Treat Diseases Inc. (PINK:HTDS) and BioElectronics Corp. (OTC:BIEL), investors were left hungry for more undervalued, high potential biotech companies — Then came LifeLine Biotechnologies Inc (OTC:LLBO). As technology continues to redefine the modern era of medical advancements, certain companies will stand apart from the rest, as is the case with Lifeline Biotechnologies Inc. This company is an innovative medical technology company committed to the improvement of the quality of life through exceptional health care systems, focusing on prevention, early diagnosis, and quick recovery. Recently, the company has made headlines with their innovative Breast Cancer detection system, the First Warning System ™, a dynamic test which collects information over time with an uncanny efficacy. The next several months will prove to be critical for LifeLine Biotechnologies, as they await the FDA’s decision on a classification for their device, which will in turn paint a more clear picture of the company’s future direction.
About LifeLine Biotechnologies Inc:
Lifeline Biotechnologies, Inc. operates as a medical technology company in the United States. Its technologies focus on prevention, early detection, diagnosis, and quick recovery of various disease conditions. The company is developing a non-imaging technology, known as the First Warning System, which measures tissue activity for the early detection of breast cancer in women. Lifeline Biotechnologies was incorporated in 1981 and is based in Reno, Nevada.
Lifeline BiotechnologiesTM is developing a non-imaging technology called First Warning™ that measures tissue activity. The technological concept behind First Warning™ is that new blood vessels supplying a breast cancer do not respond to normal physiological control mechanisms (vasoconstriction and vasodilatation). Therefore, cancers produce time-related circadian (24 hour) pattern change not seen in normal tissue. It is proposed these changes in the circadian rhythm “chaos” is taken as a signal of high risk for breast cancer even in the absence of mammographic evidence.
Essential to understanding how Lifeline’s First Warning™ system can effectively detect tiny tumors at such an early stage is an understanding of how a tumor develops. Click here to read the company’s website.
First Warning™ is a dynamic test (like a motion picture) collecting information over time, unlike traditional imaging systems, which are static providing a snapshot of information at the time of the test. The monitor records information every 5 minutes for the duration of the test, collecting over 9,000 data points. The data is then subjected to non-linear algorithmic computer analysis designed to identify abnormalities or disruptions in the normal breast physiology.
The First Warning™ system can be applied in the primary care physician’s office. This non-invasive, painless and easy to wear system consists of sixteen tiny sensors (5 mm), eight on each breast. The sensors connect to a small monitor (about the size of a pager) that is attached to the bra. The system (designed to be worn under normal clothing) enables the woman to maintain normal daily life. First Warning™ will provide additional valuable information to supplement palpation and mammographic findings. Helping the physician answer the question “What am I feeling?” or “What am I seeing?”
Potential Target Market
With more than 200,000 diagnoses and 40,000 deaths each year, breast cancer is the most frequently diagnosed malignancy in the U.S. and is the second-leading cause of cancer mortality in women. More than 2 million women in the U.S. have been treated for breast cancer; as with other cancers, early detection and treatment of breast cancer dramatically improves survival rates.
Sales of breast-specific screening and diagnostic products (e.g., biological tumor markers, breast biopsy products, computer-aided detection systems, conventional and digital mammography systems, emerging breast cancer detection products, pharmacogenetic and prognostic testing products, and susceptibility testing products) totals approximately $690 million. In addition, sales of non-breast-specific diagnostic technologies (e.g., nuclear imaging products, magnetic resonance imaging products, and ultrasound products) totals approximately $4 billion. Sales of these products are expected to increase significantly within the next few years as incident rates continue to increase exponentially.
For breast cancer, of course, the mammogram is generally regarded as the best means of early detection. Mammograms, however, usually require a referral and a separate visit to a radiology center – and can potentially miss over 30 percent of breast cancers. And for cancers of the reproductive organs, the Pap smear is only indicated for the early detection of cervical cancer. Meanwhile, more than 25,000 cases of ovarian cancer are diagnosed a year, usually at the stage where they are symptomatic. As a result, the overall mortality rate for ovarian cancer is currently between 53 and 75 percent.
Many health authorities favor attempting to distinguish women who are likely to develop breast cancer, based on varying elements of risk, from those who are not. The flaw in any risk-based approach to screening for breast cancer becomes apparent if one considers that as many as 60%-70% of all breast cancer patients have no obvious risk factor. Simply stated, the available screening programs, despite being directed toward finding early stage disease, do not adequately warn women or their physicians that breast cancer is present in its earliest or preclinically detectable stages.
Over 30 million mammograms will be done this year; of this group, 1.1 million women will be subjected to breast biopsies. From these biopsies, 185,000 new breast cancer cases will be found. Unfortunately, another 915,000 or 83% of women will be told their biopsies were benign. The accurate detection of pre-cancerous lesions is the key to making a major step forward in the eradication of this disease.
Clinical Trials & FDA News
On January 7, 2009, LifeLine Biotech announced that management will focus efforts to bring its First Warning System™ to market, since then the company has had a very busy year. Jim Holmes, CEO of Lifeline Biotechnologies said “The First Warning System™ with test results from over 700 women, the computer software has achieved technology levels in its capabilities of identifying and classifying abnormalities of the breast with sensitivities of 95% to 100% and specificities of 87% to 90%. Last year we filed for a patent covering these technology advances.”
Holmes continued to say that “With these levels of capabilities the First Warning System™ could potentially be commercialized later this year. There is some work ahead of us in order to be in position for market introduction, but it is possible we could, and hopefully, will introduce the system later this year.”
Lifeline Biotechnologies, Inc. is focused on market introduction, either directly or through a strategic alliance with a industry partner, the First Warning System™, which is designed to assist in the early detection of breast cancer. Of the approximately $138 billion spent on cancer each year, Lifeline could potentially save the health-care industry billions of dollars annually, assuming the following are successfully completed: Additional clinical trials (if required) and filing and receiving a 510(k) from the FDA, upgrading of hardware and market acceptance of the product.
Four Patents on The First Warning™
These filings relate to four essential elements in its system for analyzing temperature readings of breast tissue to identify cancerous tissue. The patents address the First Warning System’s ™ method for the placement of temperature sensors to obtain reliable temperature readings, its method for analyzing the temperature readings, and its placeholder for assuring proper sensor placement. In addition, a fourth application was filed under the Patent Cooperation Treaty (PCT) to extend Lifeline Biotechnologies’ protection, internationally, on all of the existing patent filings and existing intellectual property including these new filings. See more information here.
To view more patent information, as well as the filing date, please visit the government’s website here.
Technical Chart Analysis (Link to chart)
These past two months have seen an explosion in volume for LLBO as it appears to be gaining momentum for another healthy increase in share price. The year to date price action has established a well defined price channel shown in Blue on the chart. The top of this price channel is currently at .02 cents and we’ve seen the price visit this level twice already. The first time was back in February and the run took 12 days for a gain just over 340%. The second time was in July and the run only took half the time (6 days) for a gain of just under 3000%! Currently, there appears to be a resistance level around .005 cents and this corresponds closely to the ¼ trend-line of the Blue channel. Today, the price took a look above this trend-line up to .0059 cents and closed right at the .005 cent resistance level with a tall Green candle on almost 290,000,000 shares of volume. The last time the price closed above this .005 cent level with similar volume was that monster run back in July to the very top of the price channel. In fact, the price took a look above the top line of the channel up to .0245 cents and indicates there could be much more height to the channel. It’s good to keep in the back of your mind that the top of the price channel has already been tested twice and, as we have seen numerous times, the third time is the charm to finally break out.
Investors in LifeLine Biotechnologies have many reasons to continue believing in the company both in the short term, and the long term. Firstly, they are updating the information on Pink Sheets, which is always a good sign indicating that management expects a positive flow of revenues and income ahead. Add to that the four patents, and an FDA filing alongside a stock which is at one of its lowest price points year-to-date and you have yourself one of the most undervalued micro-cap biotech plays around. A potential target market estimated in the billions, with the product having being tested on over 700 women with the capabilities of identifying and classifying abnormalities of the breast with sensitivities of 95% to 100% and specificities of 87% to 90% and you have yourself one of the most undervalued micro-cap companies in the biotech industry.
FDA Play: Redefining Breast Cancer Detection (OTC:LLBO) |
Last edited by Miles; 09-18-2009 at 02:14 AM..
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|09-18-2009, 09:20 AM||#2|
Join Date: May 2009
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LLBO is already up premarket!! watching closely to add more into my position or sell out!
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