Lund, Sweden, 2012-08-20 12:01 CEST (GLOBE NEWSWIRE) --
The software EXINI bone™, which provides valuable clinical information in prostate and breast cancer, has received FDA approval. This announcement provides great opportunities in USA, the world´s largest market, for EXINI bone™, and its unique Bone Scan Index (BSI) value. The approval also paves the way for future worldwide OEM contracts.
Marketing and selling EXINI bone™ in the U.S. require an approval from the U.S. Food & Drug Administration (FDA). EXINI has now received this FDA 510 (k) clearance, which is expected to have a major impact on the results to come.
Prostate cancer is the most frequent form of cancer in the Western world, closely followed by breast cancer. Nowadays prostate cancer often is detected early, through the PSA blood test screening. PSA values are used to follow the progress of the disease, Healthcare providers have for a long time requested more reliable "Imaging biomarkers ", to better assess when treatment should be initiated, and to monitor the effect of the therapy, for example regarding bone metastases. In this area EXINI's unique BSI calculation is predicted to be of great future importance.
The basic idea to calculate BSI was presented by a group of researchers at the respected Memorial Sloan-Kettering Cancer Center in New York. Published reports have clearly demonstrated BSI to be a valuable diagnostic contribution. But the method has not seen its significant breakthrough, since useful clinical tools to calculate BSI have been lacking. EXINI however, have for some time been able to offer a unique product within this area. Now this EXINI bone™ is also available for the U.S. market.
“This allows us, in addition to developing the method together, also the possibility to install EXINI bone™ in the clinical flow at Memorial Sloan -Kettering Cancer Center and other reference hospitals on the U.S. market. This will be important for future sales worldwide,” says Magnus Aurell, CEO EXINI Diagnostics AB.
Bo Håkansson, Board of directors, EXINI Diagnostics AB, comments:
“This is an essential milestone for EXINI. It is important both for the future U.S. market, but also for the possibilities of the agreement with the so-called OEM companies, who all have the U.S. as one of their largest markets. This is a further seal of quality for EXINI's products and its staff, as well as our agreement with FUJIFILM Pharma last year was.”
For more information, please contact:
Magnus Aurell, CEO
Phone: +46 46 286 54 25
E-mail: magnus.aurell@exini.com
About EXINI Diagnostics AB (publ)
EXINI Diagnostics AB (publ) offers advanced solutions for medical decision support to hospitals worldwide. The system is based on advanced image analysis by artificial intelligence and can make its own interpretation of radiology images and provide diagnostic suggestions. In this way the system is used as a decision support for the diagnosing doctor. EXINI is working with products for the diagnosis of some of the most frequent endemic diseases such as coronary heart disease, cancer, dementia and Parkinson's disease. The company was founded in 1999 by Professor Lars Edenbrandt. EXINI is listed on the stock market NASDAQ OMX First North and has about 400 shareholders. Principal owner is Bo Håkansson. Thenberg & Kinde Fondkomission AB acts as Certified Adviser.
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EXINI Diagnostics AB, Ideon Science Park, Scheelevägen 19A, SE-223 70 Lund, Sweden
Phone: +46 46 286 54 20, Fax: +46 46 286 54 29, info@exini.com, www.exini.com
