FDA Medical Device: Non-Invasive Cervical Cancer Detection (OTC:GTHP)
Guided Therapeutics, Inc.
(Public, OTC:GTHP)
Guided Therapeutics, Inc. (OTC:GTHP) contains perhaps one of the most promising medical devices aiming for an annual global $1 billion dollar non-invasive cervical cancer market. Now, lets take a look at how it sits alongside the likes of Nephros (OTC:NEPH) and Imaging3 (OTC:IMGG). Their device LightTouch is a powerful and innovative non-invasive screening device for early detection of cervical cancer. Before getting started, lets dust our shoulders off right off the bat and address and important issue which is rarely discussed. One problem that many rookie investors will argue these days is, the price per share for a stock. Within the small cap industry, everyone seems to be lovestruck by stocks worth under the fifty cent mark, without even considering the current market cap, outstanding shares, and the market potential of the product being developed and/or released for distribution. This is where GTHP comes in, it has one notable difference which separates it from the others, and that is the highly undervalued market cap of GTHP relative to its product. When taking a look at the respective market caps of IMGG ($173M), and NEPH($53M), it then becomes evidently clear that GTHP’s highly conservative (11M) will undoubtedly follow in the foot steps of these golden nuggets. GTHP’s product, LightTouch is indeed impressive when taking into consideration that there exists only two screening options for cervical cancer detection in the Pap smear and HPV tests, which are painful, and highly inaccurate procedures. GTHP had its product tested on over 3000 women to date, and over 1900 in a critical FDA pivotal clinical trial on route to providing a 46% improvement over the Pap smear test, and thus leading to the company receiving a multi-million dollar grant from the National Cancer Institute on 10/5/09. Based on the outcome of the study, GTHP plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.
Undervalued and high potential couldn’t be more evident for GTHP. A company that with its recent $2.5M grant from the National Cancer Institute has come a long way from bankrupcy fears stated in the 08/18/2009 10-Q. Oh, and it doesn’t hurt when 81% of women want the LightTouch to replace the current conventional Pap smear. If you’re wondering why they mention SpectRx in the study, it is because that was the old name prior to their name change to Guided Therapeutics.
About Guided Therapeutics, Inc.
Guided Therapeutics, Inc. is a medical technology company developing and providing products for the non-invasive cervical cancer detection and diabetes markets. The Company uses its technologies to develop non-invasive diagnostic devices, such as its cervical cancer detection product. The Company’s products in development cancer detection are based upon its biophotonic technologies. The Company’s technology, including products in research and development, includes biophotonics technology for the non-invasive detection of cancers, including cervical cancer, and methods of measuring biologically important molecules in blood and interstitial fluid, such as glucose, alcohol and cortisol using specialized sensors and collection devices.
LightTouch™ Non-invasive Cervical Cancer Detection
LightTouch™, under development by Guided Therapeutics, is being designed as a new non-invasive test that has the potential to significantly improve the early detection of cervical precancers and cancers. LightTouch™ is designed as a fast, painless test – that unlike Pap smears and HPV testing – does not require a tissue sample or the delay of laboratory analysis. Early detection of cancer and precancers greatly improves survival, and LightTouch™ is designed to help preserve the reproductive health of women.
LightTouch™ uses proprietary technology to identify cancers and precancers quickly by analyzing light reflected from the cervix. LightTouch™ creates an image of the cervix for the doctor that highlights the location and severity of disease. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.
A pre-pivotal clinical study of LightTouch™, sponsored by the National Cancer Institute indicated that the non-invasive test could reduce by 55% the number of unnecessary follow-up procedures as a result of false positive Pap test results. The potential savings to the U.S. healthcare system could be as high as $181 million annually if the technology is widely adopted.
According to published reports, cervical cancer is the third most common cancer among women worldwide. Globally, there are approximately 471,000 cases of cervical cancer diagnosed annually and approximately 233,000 deaths per year. Approximately 60 million Pap tests are performed annually in the United States.
Cervical Cancer Market
In the U.S. alone, over $6 billion is spent annually on the screening, diagnosis and treatment of women with cervical cancer. Diagnosing cervical cancer is often a long and uncertain process, requiring repeat visits by anxious patients. Approximately three million colposcopy procedures are performed annually, with many repeat exams aimed at arriving at a definitive diagnosis. The U.S. colposcopy market alone is approximately $1 billion annually.
Cervical cancer is the sixth most common form of malignancy in U.S. women with 10,000 new cases per year. An additional 600,000 women are identified each year as having pre-invasive cervical cancer. Early detection of these precancerous conditions allows clinicians to treat patients more effectively, less expensively, and with fewer lasting health effects. Currently, women with abnormal Pap tests are diagnosed with a colposcope, a decades-old, low-powered binocular microscope technology, which provides only a limited visual assessment of the cervix. In fact, a recent large-scale National Cancer Institute-sponsored clinical trial demonstrated that colposcopy failed to detect 33% of high-grade precancerous lesions in women referred with questionable Pap results.
More than three million U.S. women have abnormal Pap tests each year, and they typically undergo a series of repeat, stressful and expensive diagnostic tests. For women with precancerous lesions, the long diagnostic cycle can allow the disease to progress and develop into invasive, life-threatening cancers. By providing a more definitive test, the LightTouch test will allow clinicians to more effectively manage and treat millions of women who are at risk of cervical cancer.
Innovative Advantage
The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively, by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue, by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately. The technology is designed as a device employing a single-use disposable patient interface.
FDA News
*The following is provided via BioMed Reports FDA Calendar
Biophotonics Science
Biophotonics is the science of generating and harnessing light to image, detect and manipulate biological materials.
Biophotonics is used in medicine to study tissue and blood at the macro (large-scale) and micro (very small scale) organism level to detect, diagnose and treat diseases in a way that are non-invasive to the body. (Courtesy of NSF Center for Biophotonics Science and Technology)
The LightTouch™ Non-invasive Cervical Cancer Analyzer uses light to detect both physical and chemical changes in tissue that may be markers of cervical disease.
Patents
The company truly has a vast arsenal of patents, which should provide a comforting feeling as to their diligent work during the research and development of their products.
US 7,006,220 Apparatus and method for determining tissue characteristics
US 6,975,899 Multi-modal optical tissue diagnostic system
US 6,870,620 Apparatus and method for determining tissue characteristics
US 6,590,651 Apparatus and method for determining tissue characteristics
US 6,577,391 Apparatus and method for determining tissue characteristics
US,6,400,875 Method for protecting a fiber optic probe and the resulting fiber optic probe
US 6,226,541 Apparatus and method for calibrating measurement systems
US 6,192,734 Disposable Calibration Target
US 6,045,502 Analyzing system with disposable calibration device
US 6,055,451 Apparatus and method for determining tissue characteristics
US 6,002,482 Disposable calibration device
US 5,924,981 Disposable calibration target
US 5,860,421 Apparatus and method for calibrating measurement systems
US 5,792,049 Spectroscopic system with disposable calibration device
US 5,582, 168 Apparatus and methods for measuring characteristics of biological tissues and similar materials
US 5,203,328 Apparatus and methods for quantitatively measuring molecular changes in the ocular lens
Latest News Updates
Published Study Shows 81% of Women Want SpectRx Non-Invasive Cervical Cancer Test to Replace the Standard Pap Smear
Eighty-one percent of women tested with SpectRx’s (OTCBB: SPRX) non-invasive cervical cancer detection prototypes wanted the test to be used as a replacement for the invasive Pap test, according to a study published in the current edition of the Journal of Lower Genital Tract Disease. Additionally, 87 percent of women who took the SpectRx test would recommend it to a friend who is to undergo an exam for cervical disease. More than 96 percent of women surveyed favored the SpectRx test as a method for locating the presence of disease and reducing the number of biopsies. Additionally, the study reported that 85 percent of participants wanted their doctor to have the test and 91 percent wanted their insurance company to pay for it. Source of news
Guided Therapeutics, Inc. Reports Preliminary Findings from FDA Pivotal Clinical Trial
Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced that its LightTouch™ non-invasive cervical cancer detection technology properly identified cervical disease missed by Pap tests and conventional pathology in a multi-site Food and Drug Administration (FDA) pivotal clinical trial. Based on the outcome of the study, GT plans to submit the trial results to the FDA as part of the Premarket Approval (PMA) application for the LightTouch.
“We are very pleased that the results of the study indicate that the LightTouch is capable of discovering disease that may be missed by conventional cervical disease detection,” said Mark L. Faupel, Ph.D., GT President and CEO at the Southeastern Medical Device Association annual conference in Atlanta. “Based on the study results, we believe that our technology also demonstrates the capability to detect cervical disease early, when it is most effectively treated.”
Since the pivotal trial began, more than 1,900 women were tested to demonstrate the technology’s safety and efficacy in detecting cervical disease, including an arm of the study that assessed effectiveness of an investigational commercial version of the device and single-use disposable.
The study protocol indicated that all subjects were referred after undergoing a Pap test, or had some other risk factor that fulfilled the referral criteria of the study. Each subject was tested with the LightTouch investigational device and underwent an additional Pap test, colposcopic exam and biopsy. Two generations of the investigational LightTouch were used in the trial.
Preliminary results from the study showed that the LightTouch performed better than the Pap test. The investigational commercial version of the LightTouch detected approximately 46 percent more cervical disease than the Pap test – a statistically significant improvement.
The company expects to complete analyzing the study results and present the findings to the FDA in the second quarter of 2009. Source of news
Guided Therapeutics, Inc. and Konica Minolta Opto, Inc. to Jointly Develop Cancer Detection Products
Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced that it has entered into an agreement with Konica Minolta Opto, Inc. (KMOT) of Tokyo to co-develop non-invasive cancer detection products. The new development agreement follows two years of collaborative preparations to identify large market opportunities that would benefit from GT’s proprietary technology.
The new products, for the detection of lung and esophageal cancer, are based on GT’s LightTouch™ non-invasive cervical cancer detection technology, which is undergoing the U.S. Food and Drug Administration’s premarket approval process. Lung cancer is the most prevalent cancer in the world and esophageal cancer ranks just below cervical cancer in newly diagnosed cases, according to the World Health Organization (WHO).
“We look forward to working with Konica Minolta to bring these products to market and build upon our cervical cancer detection platform,” said Mark L. Faupel, Ph.D., President and CEO of GT. “Our primary focus continues to be completing the FDA process and preparing for launching LightTouch internationally. Now that this work is largely completed, we can begin the planned expansion of our product pipeline. We are fortunate to have available the considerable resources and assistance of Konica Minolta to help accomplish the product line extensions.”
Technical Chart Analysis ( Click image to enlarge )
These past six months have seen a substantial increase in volume for GTHP as it appears to be gaining momentum for a healthy jump in share price. This week, the price clearly exceeded the corresponding top trend-line (dashed Blue line on the chart) of the well established price channel that has been in control for over two years. This move indicates the price channel (Blue lines on the chart) may have expanded and the previous top trend-line (dashed Blue line) now appears to be the new mid-line. Typically, one doubles the height of the previous channel and this could indicate the new top trend-line is near the .83 cent level. In fact, the price closed right on the 3/4 trend-line of the Blue channel today. This is the third time the price has breached this trend-line and, as is usually the case, the third time is the charm to finally break up and above the line. Currently, there appears to be a resistance level around .70 cents. However, given the ¾ trend-line support at .66 cents and the ever increasing volume these past 6 months (especially the heavy volume this week indicated by the Grey volume bars), the interest in this company’s recent activity seems very positive and this stock is poised to carry on into the upper level of the freshly expanded price channel and beyond. As always, it’s good to keep in mind that the price has reached over 1 dollar before (a 59% increase from today’s closing price) and indicates the price channel is much taller than the conservative channel currently on the chart.
Overall Sentiment
What you have with GTHP is a highly undervalued, high potential company. Take into consideration that this company’s current market cap is hovering around a conservative $10M. Their product LightTouch targets an annual global $1 billion dollar non-invasive cervical cancer market, and has been tested on over 3000 women, 1900 in a critical FDA pivotal clinical trial on route to providing a 46% improvement over the Pap smear test, and thus leading to the company receiving a multi-million dollar grant from the National Cancer Institute on 10/5/09. Factor in the fact that eighty-one percent of women tested wanted it to be used as a replacement for the invasive Pap test, according to a study published in the current edition of the Journal of Lower Genital Tract Disease. Add to that their recent $2.5M grant from the National Cancer Institute which now leaviates their ongoing concerns of potential bankruptcy, and you have yourself one of the most undervalued medical device plays within the small cap bio-tech industry.
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Disclosure: Short term position in GTHP
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