IRVINE, Calif.--(BUSINESS WIRE)--NeoMatrix© announced today that it has received CE Mark approval for European commercial sales of its HALO® Pap Test for the Breast. The company also said it has received regulatory approval in Brazil to commercialize HALO and the first order was recently shipped to that country.
The HALO test is a 5-minute, noninvasive test performed with a proprietary device that delivers a combination of warmth, massage, and vacuum in order to collect nipple aspirate fluid -- which can then be examined to identify women who are at high risk of developing breast cancer.
“We are pleased to receive the CE Mark and are excited about our business prospects in Europe where, as in the U.S., breast cancer remains a major health problem. In fact, breast cancer is the primary cause of cancer deaths in women worldwide,” said Matt Heindel, Chief Operating Officer of NeoMatrix. “We are currently evaluating several distribution opportunities and expect to initiate European sales later in 2009.”
Regarding the beginning of sales in Brazil, Heindel said: “There has been excellent local organization preparing for the launch of HALO in Brazil. Brazil has a great reputation for healthcare and there has been significant interest in screening and prevention of breast cancer, both of which rely on identifying the high-risk population. There are several other countries in various stages of the registration process and we look forward to bringing HALO to women all over the world in the near future.”
Many experts believe that identifying high-risk women is the key to reducing the incidence and death rate from breast cancer. Currently, most women diagnosed with breast cancer have no known risk factors. The previous inability to identify those most likely to develop the disease has made it difficult to apply proven preventative treatments, and may result in late detection of the disease, reducing a woman's chance of a cure and making treatment options more invasive.
Breast cancer is more curable when detected early. Knowing who is at risk for developing breast cancer provides both the clinician and the patient the opportunity to create a personal management plan. That plan can vary from simply increased surveillance to using more sophisticated imaging technology, such as MRI, which has been shown to be more sensitive in diagnosing early-stage breast cancer.
Over the past 18 months since HALO was launched in the U.S., approximately 35,000 tests have been performed. In addition to the many women identified as high-risk who were previously unaware of this fact, HALO testing has also led to discovery of early-stage breast cancer in patients who had been routinely screened by other methods.
HALO is not a replacement for current routine screening with breast exams and mammograms, which are designed to identify lesions and typically find tumors after they have been growing for eight to 10 years. Rather, HALO is an adjunct to these methods with a different objective: to find women at high risk in order to facilitate prevention and/or early detection when the disease is still 100% curable. HALO is further indicated in younger women who are not good candidates for mammography because of dense breast tissue that can obscure the detection of lesions by X-ray.
NeoMatrix develops innovative devices that allow women and their doctors to promote optimal breast health. The HALO Breast Pap Test is the first fully automated, noninvasive breast disease-screening device designed for use in the primary care setting. For further information, visit www.neomatrix.com.
Matt Heindel, COO, 949-753-7844