Skin Cancer Scanning, Ltd. (OTC.PK: MBHS)
Skin Cancer Scanning Ltd. (SCS) is a medical device company focused on developing and marketing a non-invasive, painless test that can be completed quickly in the doctor’s office. Its objective is to improve early detection and more accurately diagnose skin cancer and precancerous lesions.
The company believes SkinScan 650 will enable physicians to diagnose skin cancer at an earlier, most curable stage with fewer false positive biopsies. This would reduce both treatment costs and the number of unnecessary biopsies, and improve quality of life.
The devise is dedicated to diagnosing lesions by the use of light reflectance in the Visual and Infra Red range of the spectrum. In addition, our technology has the ability to diagnose non-melanoma skin cancers with a high-sensitivity rate and a specificity rate, which at this, not final, stage of development, is more accurate than the GP and the unaided dermatologist. Used correctly, by the GP and the Dermatologist, their device, SkinScan 650 will significantly improve the entire diagnostic capabilities in diagnosing skin cancer.
To date they have completed two stages of clinical trials at the Rabin Medical Center in Petah Tikva, Israel. These trials validated their Non Melanoma Skin Cancer (NMSC) capabilities resulting with a 92.4% sensitivity rate. The Second stage medical trials, which provided these results, were blinded and were completed in accordance with the Declaration of Helsinki criteria.
At SCS, they are now focusing our entire facilities on completing the development of SkinScan 650 and enabling it to diagnose Melanoma Skin Cancer (MSC), with improved capabilities
They expect the Hybrid Device, SkinScan 650, operating in the visual and the infra red range of the spectrum, to be fully developed in the near future.
This will enable diagnosis of MSC and NMSC to be achieved with a higher sensitivity rate than the present results, in both MSC and NMSC.
SkinScan 650 enables physicians to improve their diagnostic abilities using state-of-the-art technology. This replaces current diagnostic procedures that have many disadvantages, such as being relatively subjective and dependent on the experience of the examiner. Errors in diagnosis can be fatal. Cancers can remain undetected, grow further and reduce to chances of survival. A biopsy, the intrusive removal of tissue sample, is usually needed for further diagnoses.
SkinScan 650 provides a clear value proposition, both to the patient and healthcare system:
· Diagnoses cancerous lesions on the spot. Diagnosing cancer at an early stage enables a greater opportunity to cure and lower treatment costs.
· Reduces the number of referrals for biopsies. This has many clear disadvantages:
o Less scarring: A biopsy can result in cosmetic scarring
o Less pain: Biopsies require intrusive removal of tissue that can be painful and expensive
o Less patient anxiety: There is a time lag between the examination and the biopsy results. This increases costs, inconvenience to the patient, and the risk the disease will reach a point where it is harder to treat. In addition, this waiting period causes significant anxiety to the patient.
Patents Pending
Patent applicants have been submitted in both the US (Patent pending 11/464,838) and worldwide under the PCT framework (PCT/IL2006/000954).
Clinical Trials
The patients taking part in the trials had already been diagnosed by a physician who said they needed a biopsy.
The patient arrived for the biopsy and was screened once more by the operating surgeon. The patient was then referred to SkinScan 650, without any diagnosis, for screening.
Following the screening by the system the patient entered surgery. The results of the systems’ screening were matched with the biopsy results a couple of weeks later. The clinical trials of 128 scanned nevi demonstrated a 92.4% accuracy in diagnosing skin cancer. These results are significantly higher than the 75% accuracy achieved by an experienced physician and 65% accuracy achieved by a general practitioner
SCS is planning additional clinical trials to demonstrate the potential of the SkinScan 650 to improve patient care for diagnosing cancer. They expect the results of these trials to be published in peer-reviewed journals and presented at scientific and medical meetings.
Detecting Skin Cancer
Most people, approximately 75%, check for skin cancer first by examining themselves and then going to their doctor for a second opinion and evaluation. Generally, the physician will examine the skin with the naked eye or if available, by dermascope, a hand-held magnifying glass with a special light, in an effort to accurately determine if there is some sort of skin cancer.
Currently, dermatologists and other primary care physicians mainly use visual (naked-eye) clinical evaluation to diagnose skin cancer. Physicians assess pigmented skin lesions using the “ABCDE” criteria, Asymmetry, Border irregularity, Color variation, Diameter, and Evolving. This is often followed by biopsy of suspected lesions to confirm if the tissue is cancerous.
However, this process is subjective and can result in missed melanomas. The ratio of benign lesions biopsied to melanomas confirmed that is highly variable, as high as 40 to 1 for dermatologists and as high as 80 to 1 for primary care physicians. In addition to their own vision, doctors sometimes use a dermascope, a hand-held magnifying glass with a light to illuminate the skin area, to decide whether a spot or wart merits a biopsy. This type of assessment is still subjective and can also result in missed skin cancers. Further analysis, such as biopsy, is still required to confirm the presence of cancerous tissue.
The effectiveness of these current procedures is dependent on the experience of the examiner, and errors in diagnosis can be fatal. Occasionally, cancers remain undetected, grow further and lead to a decrease in survival chances.
The SkinScan 650 Advantage
There are many methods for spectral analysis and imaging of skin anomalies in limited use or under development. These methods include optical spectral and thermal imaging, visible and infrared, electromagnetic microwave, acoustic, magnetic, ultraviolet X-rays and others.
Several new technologies are at relatively early stages of development. These include developments by companies such as MELA Sciences Inc., and Balter Medical.
Most of these methods still rely mainly on the enlarged digital or optical photograph which is basically improving the Doctors subjective assessment.
A few methods use various combinations of processing spectral reflectance backed by a database of photographs of different types of skin cancers.
These methods can give a standardized diagnosis with a risk of not being able to diagnose the specific differences between each and every patient.
All this results in an increase of false diagnosis.
The best thing about the SkinScan 650 is that it does not rely on anything other than the information the diagnosed patients’ skin itself gives us. All the information is gathered from the examined lesion. The device uses spectral reflectance technology to diagnose the scanned lesions. That means that light rays reflected from the scanned body send signals to our device. The signals are collected and analyzed by a unique set of algorithms which recognize various lesion patterns and define each one.
The results will allow the device to define benign and malignant lesions and non-melanoma skin cancers on the spot.
No unnecessary anxiety waiting for the results. No risk of scarring. No unwelcome pain. No additional costs.
The fact that there is no need for surgical biopsies means fewer complications. And because the technology measures the lesion on the spot, it also means shorter waiting time for results.
Industry Overview
According to the American Cancer Society[1], more than two million cases of skin cancer are diagnosed in the United States each year. Current estimates are that one in five Americans will be diagnosed with skin cancer in their lifetime. More than 11,000 Americans die each year from skin cancer, but when detected early, skin cancer can have a cure rate of 99 percent.
While exposure to the sun is the most common trigger for skin cancer, it is in no way the only one. Today it is also known that industrial pollution, which damages the ozone layer, plays an important role in the development of skin cancer. Genetic predisposition to the disease also contributes to the statistics.
Most skin cancers are basal and squamous cell carcinomas – these are non-melanoma skin cancers, which, if detected early, have a very high recovery rate. The other type of skin cancer is called melanoma and it is the most deadly form of the disease.
Today, the most widely used screening procedure for skin cancer is a visual examination, first by the patient and then by the doctor. Unfortunately, such an examination is subjective and sometimes results in further problems:
· misdiagnosis;
· unnecessary spending on further testing;
· unnecessary surgery;
· complications from intervention; and
· the psychological effects of being labeled with a potentially fatal disease.
Physicians sometimes use dermascopes, hand-held magnifying glasses with a light, to illuminate questionable areas and determine whether or not a growth warrants a biopsy – the removal of a tissue sample for diagnostic purposes. However, the accuracy of this method is about 80-85% and it is dependent on the experience of the examiner.
The only way to really know if you have skin cancer is to undergo a biopsy. And biopsies have limitations. For example, they require an incision to collect a tissue sample, they are costly, they can be painful and it takes several days to get results. Therefore, there is a growing demand for a cost-effective, non-intrusive, painless, early diagnostic system.
Other methods of spectral analysis and imaging skin anomalies are being developed such as optical spectral and thermal imaging, visible and infrared, electromagnetic microwave, acoustic, magnetic, ultraviolet and x-ray.
Leadership
Professor Nathan Blaunstein, MSc, DSc, PhD., Scientific Advisory Board Member
Professor Blaunstein is Professor of the Department of Information Systems Engineering, at Ben-Gurion University, Israel. Blaunstein is a recognized expert in Wireless Cellular. He is also a recognized expert in radio wave propagation, diffraction. Prof. Blaunstein has authored more than ten books and over 150 articles in scientific journals, and conference papers.
Col. Yossi Biderman, CEO
Mr. Biderman brings 34 years of command and managerial experience. 22 years with the Israel Defense Forces in command of field units. Retired regular service as Brigade commander. 12 years in executive positions as business development manager, CEO of financial advisory company. Col. Biderman brings experience in the commodity market in large organizations.
Mr. Bunim Brimer, MSc., Director
A Senior Executive, Mr. Brimer brings with him 22 years of developing international markets in the highly competitive field of Perimeter security. Mr. Brimer holds the position of head of the projects division operating in the field of perimeter protection systems; in the Magal group Ltd., a publicly traded Company on the Tel Aviv Stock
Mr. Alex Blaunstein, Director
An experienced executive Mr. Blaunstein was a marketing consultant for Arkia International airlines. Mr. Blaunstein has served in the public service, as an advisor to a Parliament Member (MK) active and consulting in legislation issues, public relations and public complaints.
Dr. Arkady Zilberman, PhD E.E, Project Manager
Dr. Zilberman is currently Project Co-Supervisor at the Electrical and Computer Engineering Department, Ben-Gurion University. He has authored many academic and scientific journals in the field of lasers and optics.
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