Breast Cancer Screening Device

Below is the un-edited press release which describes a recent project Omnica Corporation (www.omnica.com) contributed to for NeoMatrix, LLC.  We were involved on the project from the initial concepting phase. As the primary development group, we performed all of the industrial design, mechanical and electronic engineering for the Neomatrix HALO breast cancer screening device. Contact Omnica Corporation

NeoMatrix Previews Innovative HALO System at ACOG Meeting
Tuesday May 6, 9:07 am ET

IRVINE, Calif.--(BUSINESS WIRE)--May 6, 2003-- Attendees at this year's American College of Obstetricians and Gynecologists Annual Clinical Meeting flocked to the booth of Southern California based medical device company, NeoMatrix. Crowds of curious and enthusiastic physicians were the first to see the HALO NAF Collection System(TM), the first fully automated, non-invasive Nipple Aspirate Fluid (NAF) Collection device, specifically designed for use in the OB/GYN office.

The HALO System, which received FDA clearance in September 2002, is intended as a simple, reliable method for NAF collection. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells. NAF analysis may be used as an objective assessment of a patient's breast health and may detect early warning signs of ductal cellular changes. Regular assessment and tracking of cellular changes in the milk ducts, where most breast cancer begins, enables clinicians and patients the ability to routinely evaluate and manage breast cancer risk.

"We're thrilled by the excellent response we received at the ACOG meeting," said Kevin Morton, NeoMatrix President and CEO. "We knew we had something special, but had no idea we'd create such a high level of excitement at the booth." Morton added that hundreds of attendees saw the unique HALO device, with many of them wanting purchasing information on the spot.

"As I expressed to my colleagues at the ACOG Meeting," said Dr. Michael Ross, Professor of OB/GYN at the David Geffen School of Medicine at UCLA, "I believe that the HALO System will be met with a great deal of enthusiasm by physicians who are searching for better measures of breast health. The HALO System allows a simple, five minute, reproducible test that, when performed routinely, can help in the monitoring and assessment of intraductal changes within the breast, before a palpable tumor forms."

After more than fifty years of research, it is now recognized that virtually all breast cancers begin in the breast milk ducts. Clinical studies have also confirmed the ability to detect early cellular changes within the breast ducts -- similar to the Pap test detection of early cervical cellular changes -- through analysis of nipple aspirate fluid (NAF). Long-term clinical follow-up of patients has established the utility of NAF cytology to predict breast cancer risk. Additionally, NAF screening may detect a cancerous growth years before mammography or physical examination.

Dr. Ross continued, "Early detection of breast cancer greatly improves the treatment options, the chances for successful treatment, and survival. It is therefore especially important to identify women at high risk of the disease as early as possible so that an appropriate monitoring and management program can be implemented."

In other news, NeoMatrix has been granted its first two United States patents. US PATENT #6,471,660 and #6,517,513 provide protection for NeoMatrix's novel approach for intraductal fluid collection. This patented technology is the foundation of NeoMatrix's HALO NAF Collection System.

"We are delighted with the progress we have made in the recent months," stated Morton. "Receipt of our 510(k), the issuance of our first two U.S. patents and our showcase of the HALO System at the ACOG Meeting are significant milestones for NeoMatrix." Morton said that post-ACOG, NeoMatrix is making plans to significantly ramp up the company's manufacturing, sales and distribution efforts to meet clinician demand.

Based in Irvine, Calif., NeoMatrix is a privately held company that develops, manufactures and markets innovative devices that allow women and their physicians to evaluate and manage their individual breast health. The company's premier product, the HALO NAF Collection System(TM), is the first fully automated, non-invasive nipple aspirate fluid (NAF) collection device designed specifically for use in the OB/GYN office.

     NeoMatrix, LLC
     Kevin Morton, 949/753-7844, ext. 12

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*Image of NeoMatrix Halo was not included in the original press release.

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