A Medical Device Daily

HIV diagnostic test maker Calypte Biomedical (Lake Oswego, Oregon) has reported the first sale of its Aware HIV-1/2 OMT rapid oral fluid test in India. The tests were purchased by one of the paramilitary forces of the government of India.

Roger Gale, Calypte president/CEO, said, “This sale marks a major milestone for us both as our first sale in India and as our entry into the Indian governmental market. Our Aware oral fluid test is ideally suited for large institutions such as India’s paramilitary forces which need to protect the welfare of their workforces.”

He added, “We applaud the government of India’s ambitious plans to combat HIV/AIDS. We believe that the safety and ease of use of non-invasive tests such as our Aware HIV-1/2 OMT will be instrumental in containing costs and improving efficiencies as India scales up its testing initiatives. [Our] test is the first and currently only oral fluid test approved in India.”

Sujata Mital, director of Sumit Biosciences, Calypte’s distributor in India, said, “India’s paramilitary forces have a vested interest in guarding the health and welfare of their personnel. These personnel are highly trained and make important contributions to guarding India’s security. Non-invasive testing will help India’s paramilitary organizations safeguard their commitment to and investment in human capital. Further, the experience with non-invasive testing gained by these organizations will concretely demonstrate the advantages of oral fluid testing.”

India recently embarked on its Third National AIDS Control Program (NACP-III) with the overall goal of halting and reversing its HIV/AIDS epidemic. The major focus of NACP-III will be on scaling up prevention and control initiatives. One of the major goals cited for NACP-III is increasing the number of people tested from 3 million in 2006 to 22 million by 2011.

CHINA MED set for April dates

The 20th International Medical Instruments and Equipment Exhibition, CHINA MED, will take place from April 3—5 at the China International Exhibition Center in Beijing.

The event is jointly organized by Messe Düsseldorf China, China World Trade Center Co. Ltd., Hui Tong Xingye International Exhibition Co. Ltd. and the Health Department of the General Logistics Department of the Chinese People’s Liberation Army.

Messe Düsseldorf, the organizer of the huge MEDICA trade fair held in Germany each October, will support CHINA MED 2008.

The organizers said CHINA MED 2008 will feature the latest medical equipment showcased by more than 500 exhibitors. Exhibit categories will include medical diagnostics and imaging equipment, surgical instruments and medical software, as well as electro medical technology and hospital equipment.

A highlight will be a dedicated exhibit hall for medical consumables, IT technology, rehabilitation devices and dental products.

The event’s organizers expect more than 20,000 visitors to take part in the three-day congress. “The need for new equipment will ensure rapid growth in the Chinese medical appliances market over the next 10 years or longer,” they said.

Powerlink system earns Japanese approval

Endologix (Irvine, California), manufacturer of the Powerlink endoluminal stent graft system for the minimally invasive treatment of abdominal aortic aneurysms (AAA), said that it has received notice of Shonin approval from the Japanese Ministry of Health, Labor and Welfare and will soon be initiating product shipments to that country.

President/CEO Paul McCormick said, “We will begin by shipping an initial stocking order this month to our Japanese distributor, Cosmotec, and expect that the first Powerlink System implants will be performed at Tokyo Medical University Hospital. Those physicians will serve as proctors to further train additional physicians with the Powerlink System procedure.”

McCormick said Endologix envisions a long-term market opportunity for the Powerlink System in Japan. “We estimate that [about] 14,000 open repair surgeries are performed annually in this country and the timing of our approval coincides well with the reimbursement for endoluminal stent graft procedures established last year.”

Japanese distributor for Niox Mino

Aerocrine (Solna, Sweden) said it has entered into a distribution agreement with Chest M.I. to market and sell the company’s Niox Mino device in Japan.

The Swedish company said Chest sells a large range of products to measure lung function as well as oxygen delivery systems for home use. It said the firm has “a strong reputation and impressive market coverage, with over 10 local sales offices.”

Chest will apply for market authorization of Niox Mino in Japan and then proceed to product launch.

Aerocrine CEO Paul de Potocki, CEO said the Japanese distributor “has established relations and years of experience from selling medical devices to our prime target groups.”

Niox Mino is a hand-held device that in a couple of minutes gauges inflammation in the airways, the underlying cause of asthma. Aerocrine noted that treatment of asthma “focuses primarily on keeping the inflammation under control, which leads to fewer symptoms and less acute asthma exacerbations.”

It said that 8 million people suffer from asthma in Japan and the disease causes around 3,000 deaths yearly, primarily due to inferior disease control.

Aerocrine markets its Niox Flex device globally, and also markets Niox Mino in Europe.

Unit of AMDL signs Chinese spa agreements

AMDL (Tustin, California), which has operations in Shenzhen, Jiangxi and Jilin, China, through its wholly owned subsidiary, Jade Pharmaceutical, reported that more than 100 individual owners of health spa centers in China have signed strategic cooperation agreements with JJB, a Jade subsidiary.

The agreements allow JJB to re-brand the locations as JPGreen anti-aging and spa clinics. JJB is the exclusive supplier of the anti-aging product, Goodnak.

Frank Zhang, managing director of Jade Pharmaceutical, said that “these new strategic cooperation agreements will allow JJB to increase the sales of the expanding family of Goodnak anti-aging injections, capsules, creams and spray products into the China market during 2008.”