Posts Tagged ‘mBeach’

mBeach software inc. into second phase clinical trials procedures

October 4th, 2010

mBeach Software Inc. today announced that SCS, its wholly owned subsidiary, is initiating procedures to conduct second phase clinical trials with our medical device, SkinScan 650. These trials come at the end of an upgrading program of SkinScan 650. We expect the results of the trials to show improved accuracy in diagnosing NMSC .

The planned, second phase, clinical trials are based on the successfully conducted, first phase trials. The results of the first phase trials demonstrated a 92.4% accuracy in diagnosing non-melanoma skin cancer (NMSC). Those results are significantly higher than the 75% accuracy rate, achieved by an experienced dermatologist and 60% accuracy achieved by a general practitioner.

We expect the planned trials to show material improvement in the diagnostic capabilities. The second phase trials will be conducted in compliance with FDA protocol requirements. It is our intention to start the trials Mid January, 2011.

Following the second phase clinical trials, we intend to extend SkinScan 650’s technical capabilities into the Infra Red range of the spectrum. Succeeding in this technological improvement coupled with our unique proprietary algorithms, will dramatically improve results in diagnosing both Melanoma and Non Melanoma Skin Cancers.

We expect the finalization of this stage, the Infra Red range, of development by mid 2011. This will enable us to introduce and revolutionize the entire approach to Skin Cancer Early detection and diagnosis.

Source:http://www.marketwatch.com/story/mbeach-software-inc-into-second-phase-clinical-trials-procedures-2010-10-04?reflink=MW_news_stmp

mBeach Software inc. focusing on end results and goal achievements of first, post merger milestone

September 30th, 2010

mBeach Software Inc. (“MBHS”) (MBHS 0.26, +0.03, +13.04%) , in accordance with company policy which recognizes the importance of regular communication and timely information delivered to investors, is committed to sharing with our stockholders regular updates on progress.

We have reached our first, post merger milestone and have assessed our goal achievements for the past four months.

mBeach’s goals for the first milestone included redefining the activities of mBeach and Skin Cancer Scanning Ltd., instigating initial international marketing activities, progressing in the development of SkinScan 650, and strengthening and increasing shareholder value.

Redefining the core competence activities — SCS is now focused on its core competencies of research and development, regulatory issues, and conducting further clinical trials in Israel. MBHS is focused on worldwide business and marketing activities. This restructuring will maximize companies’ synergies.

Marketing activities — mBeach has recently signed an MOU with a Russian company for initiating marketing activities in Russia and the Commonwealth of Independent States (CIS). We have identified the Japanese, Hi-Tech orientated market as a potential pivotal market, with increasing awareness to skin cancer related issues. We are now operating to initiate marketing steps into this market.

The U.S. market has been, since inception, the major target market and all development has been conducted in light of DFA and Reimbursement programs’ requirements.

We expect these combined activities will increase and create stronger, long term, shareholder value.

Source:http://www.marketwatch.com/story/mbeach-software-inc-focusing-on-end-results-and-goal-achievements-of-first-post-merger-milestone-2010-09-29?reflink=MW_news_stmp

Mbeach software inc. issues stockholder update

September 7th, 2010

The Company believes in the importance of regular communication and timely information delivered to investors. To this end, mBeach is committed to share with its stockholders release regular updates on its progress.mBeach, through its wholly owned subsidiary Skin Cancer Scanning Ltd. (“SCS”) is pioneering the development and commercialization of a revolutionary and proprietary diagnostic device for the early detection and diagnosis of skin cancer. Our product, an advanced stage prototype,

SkinScan 650, is a non-invasive, point-of-care (in the doctor’s office) system to detect and identify different kinds of skin nevi, tumors, lesions and cancers.
To date, we have successfully conducted two stages of clinical trials. The results from 128 scanned nevi demonstrated 92.4% accuracy in diagnosing non-melanoma skin cancer (NMSC). These results are significantly higher than the 75% accuracy achieved by an experienced dermatologist and 60% accuracy achieved by a general practitioner.

These initial results were gained by operating the device in the visual range (the light that we can see with an unaided eye) of the light spectrum.We expect that further development of the devices’ capabilities, into the Infra Red range, will dramatically improve results in diagnosing both Melanoma and Non Melanoma Skin Cancer.
We intend to complete the second stage development by July 2011. This will enable us to introduce into the market our SkinScan 650 diagnostic device with its full capabilities.
Our medical device, SkinScan 650’s state-of-the-art technology will enable physicians to improve their diagnostic abilities using SkinScan 650. This will replace 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 lower chances of survival. A biopsy, the intrusive removal of tissue sample, is usually needed for further diagnoses.
For more information on SCS, visit the company’s new website at www.scs-med.com.
Forward Looking Statements

This release contains forward-looking statements, including, but not limited to, statements regarding the future commercialization of SCS’ products, the market demand for these products and the proprietary protections the Company will obtain with regard to the technology, all of which statements are subject to market risks, and the possibility that the Company will not be able to obtain patent protection or obtain sufficient customer demand. These statements are made based upon current expectations and actual results may differ from those projected due to a number of risks and uncertainties.

Source:-http://www.marketwatch.com/story/mbeach-software-inc-issues-stockholder-update-2010-09-07?reflink=MW_news_stmp

mBeach Software Inc. Updates on Progress in Regulatory Qualifications Applications

August 30th, 2010

mBeach Software Inc. (“MBHS”) /quotes/comstock/11i!mbhs (MBHS 0.30, +0.02, +7.14%) today announced its initiation of early stage activities to enter requests for regulatory approvals, required for every Medical Device. The approvals will be for clinical trials and marketing qualifications. The qualifications to be requested at this early stage will include FDA approvals, CE approvals for marketing in the EU, and being recognized by Reimbursement programs.

Completing these regulatory procedures will pave the way for local clinical trials and a full commercial launch of SkinScan 650, SCS’s non-invasive, point-of-care system to detect and identify different types of skin cancers. mBeach expects to receive the initial approvals, for clinical trials mainly, by mid 2011. These requested clinical trial approvals, follow the clinical trials conducted by mBeach wholly owned subsidiary, Skin Cancer Scanning Ltd. (“SCS”), in Israel, with the Ministry of health, Medical Device qualification Department and the international Helsinki approval for conducting clinical trials.

mBeach CEO Yossi Biderman commented, “The early stage regulatory approach, adopted by mBeach, is due to the lengthy regulatory procedures. We expect the approvals to be staggered over a two year period, unless facing unforeseeable obstacles. These requested and required approvals form a basic component in the heath and marketing strategy defined by mBeach. This will help mBeach achieve its two major goals of improving quality of life for millions of people around the world and will greatly increase shareholder value. These approvals combined with a growing market demand and technical innovative approach, will have on the final product what we think will be a boosting impact. We expect our SkinScan 650, a non-invasive, point-of-care, doctors decision supporting device, to provide the Medical practitioner a much needed user friendly diagnostic solution.”

Source:http://www.marketwatch.com/story/mbeach-software-inc-updates-on-progress-in-regulatory-qualifications-applications-2010-08-30?reflink=MW_news_stmp

Mbeach Software Inc. Further Targeting Markets For Non-Intrusive Technologies For The Detection Skin Cancer

August 23rd, 2010

Mbeach Software Inc. (“MBHS”) recently issued a stockholder update on the growing market for skin cancer diagnostic solutions. These market developments represent significant opportunities for the wholly owned subsidiary, Skin Cancer Scanning ltd. (“SCS”) to grow the company and become a leading industry player.

In particular, the company has identified the Japanese, Hi-Tech orientated market, as a potential pivotal market, with increasing awareness to skin cancer related issues in the past decade.

Total population of Japan exceeds 125 million people, and there is increasing demand for advanced medical technologies.

In Japan, the number of patients with malignant skin tumors has increased year by year. The most prevalent skin tumor was basal cell carcinoma, followed by squamous cell carcinoma, and then by malignant melanoma.

The recent annual increased proportion of deaths from Non Melanoma Skin Cancer (NMSC) was 3.8%. (Hisashi Ohtsukaa, Shogo Nagamatsub).

Early detection is critical to survival, and can lead to almost a one hundred percent cure rate. However, the effectiveness of current cancer detection procedures is heavily dependent on the experience of the examiner, and errors in diagnosis can be fatal. Occasionally, cancers remained undetected, grow further and lead to lower chances of survival. An additional disadvantage with current diagnostic methods is that they rely on a biopsy, the intrusive removal of tissue sample, to confirm the presence of cancerous tissue.

Biopsies can be painful, leave scarring, and often cause unnecessary patient anxiety. SCS is clearly focused on meeting this growing market need for a safe, non-intrusive technology to detect skin cancer.

Mbeach CEO Yossi Biderman commented,” The Japanese market and other intended market surveys are being initiated at these early stages due to the lengthy regulatory procedures in each country, before receiving marketing approval. We expect these proceedings to be finalized within the coming year,2011, coinciding with the final development and clinical trial stages of SkinScan 650, our simple-to-use, noninvasive, point-of-care, skin cancer detection solution.”

Source:http://www.healthcaretechnologyonline.com/article.mvc/Mbeach-Software-Inc-Further-Targeting-0001?VNETCOOKIE=NO

Mbeach Software Inc. Further Targeting Markets For Non-Intrusive Technologies

August 20th, 2010

Mbeach Software Inc. (”MBHS”) (OTCBB: MBHS) today issued a stockholder update on the growing market for skin cancer diagnostic solutions. These market developments represent significant opportunities for the wholly owned subsidiary, Skin Cancer Scanning ltd. (”SCS”) to grow the company and become a leading industry player.

In particular, the company has identified the Japanese, Hi-Tech orientated market, as a potential pivotal market, with increasing awareness to skin cancer related issues in the past decade.

Total population of Japan exceeds 125 million people, and there is increasing demand for advanced medical technologies.

In Japan, the number of patients with malignant skin tumors has increased year by year. The most prevalent skin tumor was basal cell carcinoma, followed by squamous cell carcinoma, and then by malignant melanoma.

The recent annual increased proportion of deaths from Non Melanoma Skin Cancer (NMSC) was 3.8%. (Hisashi Ohtsukaa, Shogo Nagamatsub).

Early detection is critical to survival, and can lead to almost a one hundred percent cure rate. However, the effectiveness of current cancer detection procedures is heavily dependent on the experience of the examiner, and errors in diagnosis can be fatal. Occasionally, cancers remained undetected, grow further and lead to lower chances of survival. An additional disadvantage with current diagnostic methods is that they rely on a biopsy, the intrusive removal of tissue sample, to confirm the presence of cancerous tissue.

Biopsies can be painful, leave scarring, and often cause unnecessary patient anxiety.
SCS is clearly focused on meeting this growing market need for a safe, non-intrusive technology to detect skin cancer.

Mbeach CEO Yossi Biderman commented,” The Japanese market and other intended market surveys are being initiated at these early stages due to the lengthy regulatory procedures in each country, before receiving marketing approval. We expect these proceedings to be finalized within the coming year,2011, coinciding with the final development and clinical trial stages of SkinScan 650, our simple-to-use, noninvasive, point-of-care, skin cancer detection solution.”

Source:http://news.topwirenews.com/2010/08/20/Mbeach-Software-Inc-Further-Targeting-Markets-For-Non-Intrusive-Technologies_201008208891.html

mBeach Software Inc. Issues Stockholder Update

July 16th, 2010

mBeach Software Inc. (“MBHS”) (MBHS 0.38, 0.00, 0.00%) today issued a stockholder update. The Company believes in the importance of regular communication and timely information delivered to investors. To this end, MBHS is committed to share with its stockholders regular updates on its progress.

MBHS, through its wholly owned subsidiary Skin Cancer Scanning ltd. (“SCS”) is pioneering the development and commercialization of a revolutionary and proprietary diagnostic device for the early detection and diagnosis of skin cancer. Our product, an advanced stage prototype, SkinScan 650, is a non-invasive, point-of-care (in the doctor’s office) system to detect and identify different kinds of skin nevi, tumors, lesions and cancers.

SkinScan 650’s state-of-the-art technology will enable physicians to improve their diagnostic abilities using SkinScan 650. This will replace 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 lower chances of survival. A biopsy, the intrusive removal of tissue sample, is usually needed for further diagnoses.

To date, we have successfully conducted two stages of clinical trials. The results from 128 scanned nevi demonstrated 92.4% accuracy in diagnosing non-melanoma skin cancer. These results are significantly higher than the 75% accuracy achieved by an experienced physician and 65% accuracy achieved by a general practitioner.

For more information on SCS, visit the company’s new website at www.scs-med.com.

Forward Looking Statements

This release contains forward-looking statements, including, but not limited to, statements regarding the future commercialization of SCS’ products, the market demand for these products and the proprietary protections the Company will obtain with regard to the technology, all of which statements are subject to market risks, and the possibility that the Company will not be able to obtain patent protection or obtain sufficient customer demand. These statements are made based upon current expectations and actual results may differ from those projected due to a number of risks and uncertainties.

Source:http://www.marketwatch.com/story/mbeach-software-inc-issues-stockholder-update-2010-07-16?reflink=MW_news_stmp

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