A Medical Device Daily

NeoMatrix (Irvine, California) said it has received CE-mark approval for European commercial sales of its HALO Pap Test for the Breast. The company also has received regulatory approval in Brazil to commercialize HALO, and the first order was shipped to that country recently.

The HALO test is a 5-minute, noninvasive test performed with a 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.

The company said the HALO Breast Pap Test is the first fully automated, noninvasive breast disease-screening device designed for use in the primary care setting.

"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 COO Matt Heindel.

He said the company is "evaluating" several distribution opportunities and expects to initiate European sales later this year

Regarding the beginning of sales in Brazil, Heindel said, "There has been excellent local organization preparing for the launch of HALO in Brazil, [which] has a great reputation for healthcare. There has been significant interest in screening and prevention of breast cancer, both of which rely on identifying the high-risk population."

He added that several other countries are 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 breast cancer experts believe that identifying high-risk women is the key to reducing the incidence and death rate from the disease. "Currently, most women diagnosed with breast cancer have no known risk factors," NeoMatrix said. "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."

The company said that over the past 18 months since HALO was launched in the U.S., about 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," NeoMatrix said.

HALO is not a replacement for 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, according to the company. "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."

The company said 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.

Swiss trial planned for Oxycyte

Oxygen Biotherapeutics (Costa Mesa, California) said it has hired PFC Pharma Focus AG (Volketswil, Switzerland), a contract research organization, to supervise the planned Phase II, dose escalation, clinical trial in that country for use of Oxycyte in traumatic brain injury (TBI).

Oxycyte is the company's perfluorocarbon therapeutic oxygen carrier.

The company has initiated the filing process for its protocol in Switzerland with the relevant cantonal ethic committees and Swissmedic, the Swiss counterpart to the U.S. FDA. The protocol is the same as the one the company plans to submit to the FDA.

Principal investigator will be Michael Reinert, MD, of University Hospital Berne. The company said trial sites and further trial details will be reported after they are finalized.

"We have interest from what I consider to be some of the best neurosurgeons in Switzerland who want to be clinical investigators in these trials and from leading Swiss hospitals interested in being study sites," said Chairman/CEO Chris Stern. "Depending on the timing of the review process in Switzerland, we could begin enrolling patients in the second quarter."

He added, "Because of the way we are structuring the trials and the quality of the Swiss medical community, we should have data compliant with the requirements of a multi-national study that can be submitted to the FDA as well as Swissmedic. If this moves along at the pace that I expect, we could be seeing data on results in the summer."

European patent for PurCotton

Winner Medical Group (Shenzen, China), a Chinese manufacturer of medical and wound care products, said the European Patent Office has decided to grant a patent for producing PurCotton products to the company.

Specifically covered by the patent are the method for producing spunlace non-woven cloth, method for producing spunlace non-woven cloth with X-ray detectable element and spunlace non-woven cloth with X-ray detectable element produced thereby.

CEO Jianquan Li said, "This [marks] the achievement of another important milestone. The European patent enables us to plan on a long-term basis and to advance the market entry for our PurCotton products steadily. Now we have valid national rights in approximately 34 member states" of the European Union.

Winner Medical holds patents for PurCotton products in several countries, including China, the U.S., Russia, Singapore, South Africa, and now Europe. Patent applications also are pending in other regions such as Japan, South America, India and the Middle East.

PurCotton products combine the characteristics of both natural cotton and materials made using nonwoven technology. The company said PurCotton has "many advantages over both woven cotton and synthetic nonwoven fabric."

Winner Medical said its patented manufacturing process enables the company to produce PurCotton at a lower cost than woven cotton products, and that it can thus offer customers a lower price without sacrificing its margin.

The company has eight wholly-owned manufacturing and distribution facilities, four joint-venture factories and more than 5,000 employees. Its products are sold worldwide, with Europe, the U.S. and Japan serving as its top three markets.

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