A Medical Device Daily

MedMira (Halifax, Nova Scotia), a developer of rapid flow-through diagnostic technology, said it has won the first rapid HIV test tender in the province of Jilin in China. The tender is structured as an annual standing order through which all levels of provincial public health organizations in the province will be able to order MedMira's MiraWell Rapid HIV Test.

The company said the first shipment for this standing order is expected within the next 30 days and is estimated to be for about 100,000 tests.

Stephen Sham, chairman and CEO, said, "Although we anticipated our success in winning this public tender as part of the next step in our China marketing plan, this accomplishment has reassured us of the China government's commitment to control HIV by using only the highest-quality and best-performing rapid HIV test in the front lines of public health."

According to the Chinese National CDC 2004 evaluation report, MedMira's MiraWell Rapid HIV Test performed the best of the 10 rapid HIV tests evaluated, and was found to be as accurate as traditional testing methods.

"We anticipate that the demand for our rapid HIV test will reach new levels in 2005 as the China government continues its battle to reduce HIV transmission within its population of approximately 1.3 billion," said Sham. "We expect that many more China provinces will offer similar public tenders and we are confident that [our] test will lead this market."

MedMira has a representative office in Beijing, China.

It is estimated that 1 million Chinese are HIV-infected and that, without intervention, China can anticipate this to increase to 10 million by 2010.

Jilin, called the most urbanized province in China, is home to some 26 million people. The provincial capital, Changchun, is remembered in history as the capital of Manchukuo – the puppet state established by the Japanese in 1932 after invading Manchuria in September 1931.

MedMira refers to itself as "the leading global manufacturer and marketer of in vitro flow-though rapid diagnostic tests for the clinical laboratory market." Its tests provide results in just three minutes for the detection of diseases such as HIV.

The company's Reveal G2 and MiraWell rapid HIV tests are used in clinical laboratories and hospitals where professional counseling and patient treatment are immediately available.

The MiraCare Rapid HIV Antibody Test is available over-the-counter in pharmacies throughout the Hong Kong and Macao special administrative regions in China.

Asahi Kasei, Nephros in hemodiafilter accord

Nephros (New York) has entered into an agreement granting Asahi Kasei Medical (Tokyo) exclusive rights to manufacture and distribute filter products based on the Nephros OLpur MD190 hemodiafilter in Japan for 10 years. Sales of the filter in Japan are subject to regulatory approval in that country.

In addition to an initial license fee, royalties and milestone payments, Asahi Kasei Medical will make an investment in Nephros common stock.

Asahi Kasei Medical is the leading provider of dialysis filters in Japan and one of the three largest dialyzer providers in the world.

Kenji Nakamae, president of Asahi Kasei Medical, said, "OLpur MD190 technology, coupled with our hollow-fiber technologies, will result in a hemodialyzer filter product that further contributes to the quality of life of ESRD [end-stage renal disease] patients in Japan, whose numbers exceed 230,000."

The OLpur MD190 is an advanced cartridge that refines the process of hemodiafiltration by combining two forms of therapy known as post-dilution and pre-dilution diafiltration into a single filter. As a result, the OLpur MD190 combines the superior clearance of small molecular weight toxins such as urea attributed to post-dilution hemodiafiltration with the superior clearance of middle-molecules such as Beta 2 microglobulin (b2m) associated with pre-dilution hemodiafiltration.

Eric Rose, MD, chairman of the department of surgery at New York-Presbyterian Hospital/Columbia University Medical Center and chairman of the board of Nephros, said, "I believe hemodiafiltration offers a substantially better modality for ESRD therapy over hemodialysis. Studies show that patients on hemodiafiltration have fewer complications and hospitalizations, require fewer drugs and live longer."

The OLpur MD190 is designed for use with existing hemodiafiltration machines, has received CE marking and is currently in sales in Europe.

"Asahi is one of the major global forces in this marketplace," said Nephros CEO Norman Barta. "[Its] decision to manufacture and distribute hemodiafilters based on the OLpur MD190 technology is an important validation of our product design."

Asahi Kasei Medical is a business unit of Asahi Kasei Corp., a $7 billion technology company that provides science-based solutions to a diverse range of markets including chemicals and plastics, apparel, housing and construction, healthcare and electronics.

Coronado eyes Caribbean market

Coronado Industries (Fountain Hills, Arizona), maker of proprietary PNT pneumatic devices for the non-invasive treatment of glaucoma, and its wholly owned subsidiary, Ophthalmic International, said they have begun to explore the major Caribbean markets and have appointed Owen Bethel as regional consultant to the company.

The companies said that in the past, discussions with the National Health System of Caribbean Island Nations about PNT were impeded due to Coronado Industries' lack of having a health authority registration within a major market such as the U.S., Canada or key European countries. It said that with the successful completion of the European Union's 2A certification process and the active marketing of the PNT technology within the European community, interest has been rekindled with the Caribbean toward making PNT available to the medical community and national health systems.

Bethel is managing director of Montague Securities (Nassau, the Bahamas). His firm specializes in international finance and trade negotiations and will assist Coronado's management on their Caribbean marketing program.

Dr. John Sharkey, president of Ophthalmic International and Coronado's director of operations, has already has had what he described as "positive meetings" in the Bahamas, and is scheduling additional meetings with interested island governments.

"We are very pleased to have Owen's advice and support in helping us gain access to a region [where] glaucoma has become an increasing concern," he said.

Coronado Industries describes the PNT procedure as "a cost-effective treatment of the most common types of glaucoma, which are open angle and pigmentary, as well as for the treatment of ocular hypertension."