Biotech Values

[DewDiligence]

Non-invasive breast cancer diagnostic advances toward marketing approval:

[One of the closed-end biotech funds I follow owns a large stake in this company, FWIW.]

http://biz.yahoo.com/prnews/040316/nytu096_1.html

>>
Biofield Corp. Submits 510(k) Application for Its Breast Cancer Diagnostic Device to KEMA Initiating the FDA Approval Process

ATLANTA, March 16 /PRNewswire-FirstCall/ -- Biofield Corp. (OTC Bulletin Board: BZET - News), developer of the Biofield Diagnostic System ("BDS"), a non-invasive, radiation-free diagnostic testing system which may be of assistance in the early detection of breast cancer, announced today that it has submitted a 510(k) application to the notified body, KEMA Registered Quality, Inc., for review prior to formal submission to the Food and Drug Administration, the first step to obtain regulatory clearance that will allow the marketing and sale of the BDS in the United States. The 510(k) application requirements include the submission of information relating to clinical accuracy (based on the referenced results of women who have used the BDS as an adjunct for breast cancer detection), electrical safety, environmental testing and design control.

"This submission is a major milestone achievement and represents a significant step forward for Biofield," said David M. Long, M.D., Ph.D., Biofield's CEO. "I am very proud that the Biofield team was able to complete the submission ahead of our anticipated schedule."

Biofield, a medical device technology company has developed a non-invasive system to deliver objective results that may be helpful in the detection of epithelial cancers, including breast cancer. Use of the BDS may distinguish those lesions likely to progress and cause significant disease and death. The BDS may reduce diagnostic uncertainty as well as decrease the number of diagnostic procedures, including surgical biopsies, performed on suspicious palpable breast lesions.
<<