A Medical Device Daily

Welch Allyn (Skaneateles Falls, New York), a leading global manufacturer of frontline medical products and solutions, reported that it has acquired Malaysian medical products distributor MediAids – a move that the company said will give it “critical mass within a centralized Asian hub and complement its existing research and development facility in Singapore.”

The company said the operation will allow it to utilize and expand on its core technologies to offer medical products that are specific to the needs of frontline caregivers in Asia and other emerging markets throughout the region.

“MediAids has been a strong Welch Allyn distributor for more than 20 years,” said Con Hickey, vice president, Asia Pacific at Welch Allyn. “This acquisition provides us with a tremendous opportunity to build on the many years of success MediAids has had selling our products in Malaysia.”

Welch Allyn's new Malaysian operation will enhance its Singapore-based research and development facility established in 2004 to focus on the development of next generation technology for patient vital signs monitoring and advanced wireless technologies. The company currently has four other research and development facilities located across North America and Europe, and has received four Medical Design Excellence Awards and three R&D 100 Awards for its advanced product designs in recent years.

“Southeast Asia is undergoing a healthcare revolution,” added Hickey. “The Malaysian government has signaled further investment in the refurbishment and expansion of hospitals and poly-clinics in the coming years, and private hospital investments provide a very real growth opportunity for us.”

The new Welch Allyn Malaysia facility will remain at its current location and will be refurbished and modernized over time, the company said.

MIV Therapeutics' new U.S. HQ in Atlanta

MIV Therapeutics (MIVT; Vancouver, British Columbia), a developer of next-generation biocompatible coatings and drug delivery systems for cardiovascular stents and other implantable devices, reported that it has established its U.S. headquarters with the opening of a new corporate office in Atlanta.

Its establishment follows the recent appointment of Dr. Mark Landy, a medical device analyst, as the president of MIVT, based in the Atlanta office.

“The opening of the Atlanta office expands our operations and capability to bring a robust pipeline of novel therapeutic solutions to the high-growth cardiovascular treatment marketplace,” said Alan Lindsay, CEO of MIVT. “our new U.S. office will be dedicated to raising our profile and establishing new strategic partnerships that will help us to realize MIVT's full medical, technological, business and financial potential within the United States, North America, and around the world.”

MIVT is a developer of biocompatible and polymer-free coatings for vascular stents, internal drug delivery systems and other medical applications. Its first product line will be launched in 2007 and will target the estimated $160 billion marketplace for localized drug delivery technologies.

Kendle buys Latin CRO

CRO Kendle (Cincinnati) reported completing completed its acquisition of Latin America CRO International Clinical Research Limited (IC-Research) and related companies, strengthening its global clinical development capabilities, it said, “in the Phase II-IV arena through new operations in Argentina, Brazil, Chile and Colombia.” The deal was made with cash, the specific terms not disclosed.

The move builds on the company's operations in Mexico and Peru, with Kendle now offering coverage “across more Latin American countries than any other CRO,” it said. The company's offices in six major countries represent 80% of the region's population, providing customers with expanded access to one of the most important ascending regions for clinical research. Kendle announced its agreement to acquire IC-Research March 9.

The new locations are part of Kendle's global network and report to Dennis Hurley, DrSc, vice president, global clinical development - Latin America.

Kendle's global clinical development business is organized in five regions - North America, Europe, Asia/Pacific, Latin America and Africa.

Calypte completes trial in South Africa

Calypte Biomedical (Lake Oswego, Oregon) reported completing clinical studies in South Africa permitting the company to initiate sales of its Aware HIV-1/2 Oral Fluid (OMT) rapid test product in that country. This is a new approval for OMT in addition to the company's already approved blood test.

Studies conducted by the University of KwaZulu-Natal (Durban, South Africa) on the Aware HIV-1/2 OMT rapid test for oral fluid specimens showed sensitivity of 99.62% and specificity of 100% for a total of 600 subjects attending voluntary counseling and testing (VCT) services in two Durban municipality clinics. The National Institute for Communicable Diseases (NICD) has issued a statement noting “that the design and execution of the study is in keeping with the standard approach used by the NICD reference lab to assess HIV-1/2 rapid kits for evaluation as part of the National Department of Health tender procedures.” Therefore, “the results of the study are in keeping with the defined limits of acceptability and as such [the test] can be considered for tender purposes.”

Roger Gale, CEO and chairman of Calypte, commented: “The conclusion of this clinical study allows the company to market oral fluid rapid tests within the private markets in South Africa and to participate in government tenders as they are announced. AIS 's 22 years of serving the South African clinical markets makes them an ideal partner to introduce Calypte's new non-invasive HIV-1/2 oral fluid test that we believe is ideally suited for the South African market.”

According to the UNAIDS December 2005 epidemic update, “infection levels in Sub-Saharan Africa remain among the highest in the world.” The latest data underline the astonishing speed “at which South Africa's epidemic has evolved.” National prevalence grew from less than 1% in 1990 to almost 25% in 10 years. Deaths among people 15 years of age and older increased by 62% from 1997-2002.

And, according to 2005 data from the Department of Health South Africa, almost 30% of pregnant women are HIV-positive. UNAIDS discusses these statistics as underscoring “the need to bolster prevention activities.”

Calypte said it believes that a noninvasive HIV-1/2 rapid test is ideal for the fight against AIDS in South Africa.