A Medical Device Daily

MedMira (Halifax, Nova Scotia) a developer of rapid flow-through diagnostic technology, said it has successfully completed the registration process with the Ministry of Health in the United Arab Emirates (UAE).

The registration enables MedMira to participate in government tenders and sell its rapid HIV and hepatitis C tests to government healthcare facilities, where 70% of all HIV and hepatitis C testing is conducted in the UAE.

MedMira said its distributor, Prestige Group, which is part of the $4.5 billion Al Jaber Group of companies, has established a “solid position” in the Middle East’s private healthcare sector with sales of the MiraWell Rapid HIV Test and MiraWell Rapid HCV Test.

MedMira said its rapid tests are the fastest flow-through diagnostic tests in the world, providing results in three minutes. The company said rapid diagnostic tests present significant value in the UAE market, where expatriates make up 80% of the population and must be tested for HIV every two years as part of the visa renewal process.

Giles Crouch, vice president of marketing and business development for MedMira, said, “We expect to expand this market in the near future by introducing the first over-the-counter (OTC) rapid HIV test to the Middle East market.”

The World Health Organization (Geneva, Switzerland) estimates that about 83,000 people were newly infected with HIV in the Middle East region in 2003 and that some 0.3 percent of adults in the region are currently infected.

MedMira’s Reveal G2 and MiraWell rapid HIV tests are currently 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 the People’s Republic of China.

MedMira markets its rapid tests worldwide in the U.S., Canada, South Africa and China. In addition to its corporate offices and manufacturing facilities in Halifax, it has a representative office in Beijing, China.

Gish Biomedical gets Japanese clearance

CardioTech International (Wilmington, Massachusetts) said that its wholly owned subsidiary, Gish Biomedical (Rancho Santa Margarita, California), has received clearance to sell its Stat-Sat oxygen saturation monitor in Japan.

The Stat-Sat device measures venous and arterial oxygen saturation, hematocrit and hemoglobin in-line as part of cardiopulmonary bypass procedures. Its disposable arterial filter separates air from blood and filters particles from the circuit during bypass surgery.

About 48,000 cardiac surgery procedures are conducted annually in Japan, representing an important export market for Gish.

Douglas Whittaker, president of Gish, said the company’s Japanese distributor, Heiwa Bussan, received regulatory clearance from the Ministry of Health and Welfare to sell Stat-Sat Oxy-Sat Monitor and Arterial Filter products in that country.

Interest in Korean company

Bio-Warm (Los Angeles) said it has signed an agreement to acquire a 51% equity interest in Myung Shin Medical, a South Korean medical products manufacturer, for a combination of cash and stock.

Myung Shin’s main products include home and commercial-grade infrared saunas, which are able to help the body release toxins, lose weight, relieve pain and improve skin tone.

John Park, president of Bio-Warm, said that Myung Shin Medical, which has annual revenues of about $5 million, “has proven itself as a leader in the health and medical device industry, with a strong presence in Korea, Japan and Europe.”

Bio-Warm, through its wholly owned subsidiary in South Korea, Mirae Tech. Co., is engaged in the development and production of electrical energy and environment-related products.

Distribution eyed in Thailand

Current Technology (Vancouver, British Columbia) has received medical approval from the Thailand Health Authority for its ETG (ElectroTrichoGenesis) Mark 1 device for treatment of hair loss.

“Medical approval opens the door for finalization of negotiations with the prospective distributor in Thailand,” said COO Anthony Harrison, COO of Current Technology. “We are working closely with our Singapore-based distributor, Gromark Consumers Enterprise, and anticipate completion of the formal distribution agreement very quickly.”

In business for more than 20 years and with strong regional business interests and networks throughout the Asia Pacific region, Gromark has evolved in recent years from general trading to a focus on health and beauty products.

MSI Nigerian contract is signed

Medical Services International (MSI; Edmonton, Alberta) said it has received a contract from the Federal Ministry of Health of Nigeria to supply that country with rapid VScan HIV 1 & 2 test kits.

The contract was announced by the company last month following notification that MSI had been awarded the tender offer to supply $25 million worth of its VScan HIV test kits to Nigeria. The company will begin delivery of the kits in June.