A Diagnostics & Imaging Week

Biofield (Alpharetta, Georgia), developer of the Biofield Breast Proliferation Detection System (BDS), a non-invasive, radiation-free testing system, said it has agreed to a potential merger or acquisition with Bay Point Group (BPG; Miami), developer of the Fournier Feminine Multi-Test, a self-sampling cervical diagnostic test.

BPG has developed devices used to assist in the diagnosis of cervical and vaginal diseases in women of all ages.

The merger is contingent upon due diligence by both parties, a Biofield debt restructuring, equitable valuation of both companies and terms and conditions required to raise capital for both BPG and Biofield to continue their respective commercial clinical and regulatory compliance activities that would carry forward after a merger. Biofield said it would begin the debt restructuring immediately.

According to a Securities and Exchange Commission filing on June 22, Biofield had a net loss of $717,381 and no revenue in 1Q05, compared with a net loss of $758,612 on $10,500 in revenue in 1Q04. Since the company's inception in 1987, it has lost $70.8 million and has generated $135,132 in revenue. Its total liabilities exceed its total assets by nearly $6.5 million.

The filing also noted Biofield has depleted its cash resources and had to terminate all of its employees except COO John Stephens and David Long Jr., MD, PhD. Long, chairman and CEO of Biofield, and his family own more than half of Biofield.

Long said that the proposed merger "is the appropriate step in pursuing development of our product lines while offering several strategic alliances to leverage the research, development, manufacturing and marketing strengths of our two companies."

"Lower-cost breast proliferation tests and cervical cancer-screening technologies are needed in both well-funded medical systems as well as in medically underserved communities," said Christian Hilmer, CEO of BPG. "The Biofield and Fournier tests are positioned as methods of affordable early detection of the No. 1 and 2 causes of cancer deaths in women worldwide."

Biofield's breast cancer detection system has not yet received FDA approval.