Posts Tagged ‘mBeach’

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

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