Welch Allyn (Skaneateles Falls, New York) has acquired Malaysian medical products distributor MediAids – a move that the company said would give it “critical mass within a centralized Asian hub and complement its existing R&D 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 R&D 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 R&D operations 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,” Hickey said. “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.”

MIV Therapeutics’ establishes U.S. HQ

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.

Abraxis to buy Puerto Rico facility

Abraxis BioScience (Los Angeles) reported that it has formed an agreement with Pfizer (New York) to purchase Pfizer’s Cruce Davila manufacturing facility in Barceloneta, Puerto Rico. Financial details were not disclosed.

This 56-acre site consists of a 172,000-square-foot validated manufacturing plant with capabilities of producing EU- and U.S.-compliant injectable pharmaceuticals, as well as protein based biologics and metered dosed inhalers. The acquisition includes a computer-controlled 90,000-square-foot active pharmaceutical ingredients manufacturing plant, and two support facilities with quality assurance and laboratories, totaling 262,000 square feet.

This facility, expected to employ from 400 to 500 people when fully-operational, will provide a third manufacturing site using the company’s proprietary nanoparticle albumin bound (nab) technology to produce chemotherapeutics such as Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), the first commercial product based on this technology.

Abraxis will lease the chemical raw material plant back to Pfizer to continue the manufacturing of Pfizer’s celecoxib, the active ingredient of Celebrex.

This facility adds to Abraxis’ manufacturing capacity in Melrose Park, Illinois, Grand Island, New York, and Barbengo, Switzerland, and expands its European and cGMP manufacturing capabilities to provide infrastructure for worldwide growth.

Kendle acquires 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, but the specific terms were 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 -to meet customer needs.

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.

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

ThermoGenesis wins Canadian license

ThermoGenesis (Rancho Cordova, California) reported receiving a license from the Medical Devices Bureau of Health Canada to market the company’s TPD, a hand-held, disposable device that produces thrombin from a patient’s own plasma in less than 30 minutes. The license allows Biomet and Medtronic, ThermoGenesis’ non-exclusive global distributors for the TPD, the right to begin sales and marketing efforts in Canada.

The TPD as a stand-alone product has been CE Marked and is currently marketed in Europe by Biomet subsidiary Cell Factor Technologies, Medtronic, in conjunction with their platelet gel products and independent distributors.

Micromedic, BioRap in collaboration

Micromedic Technologies (Tel Aviv, Israel), a publicly-traded holding company specializing in medical devices and cancer therapies, with a market cap of about $4.5 million, has signed an agreement to collaborate with BioRapTechnologies (Haifa, Israel), a private company established in 2001 to commercialize the intellectual assets of the Technion-Institute of Technology’s Faculty of Medicine.

BioRap is fully owned by the Rappaport Family Institute for Research in the Medical Sciences, and is a soup-to-nuts business development organization providing patenting, legal representation, strategic alliance development, negotiation with investors to startup initiation, device design and testing, management and guiding full commercialization.

Micromedic may also invest in some of the startups that Biorap owns, said Chairman David Solomon, but the focus of the company is on diagnostics and monitoring of cancer. “We have organized an advisory team of experts on the area and are searching for strategic relationships with other serious research institutes, with the aim to position the company as a leader in this area,” he said, referring to the April announcement of the Micromedic board of directors.

Micromedic previously made two investments: a 60% controlling interest in Medvision, which is developing SkinScan, a follow-up device to allow simple consistent non-invasive detection of skin growths at the very earliest stages, with highly repeatable follow up measurements, and 20% of MET (Microvascular Eye Technology). Both start-ups are located in the Yozmot - Granot Initiative Center, a privatized incubator (Hefer).

Elekta receives $11 million order from U.S.

Elekta Synergy (Stockholm, Sweden) said that six of its systems for intensity modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT) have been purchased by Providence Health System (Seattle). Providence, which operates 18 acute care facilities in four states, signed an exclusive, five-year provider contract with Elekta in September, 2005. Elekta said that the total value of these orders is in excess of $11 million and was booked by Elekta in April.

The six Elekta Synergy systems will be installed at Providence Portland Medical Center (Oregon), Valley Radiation Oncology Center (California) and the new Roy and Patricia Disney Cancer Center (California).

Providence said it chose Elekta Synergy for image-guided and stereotactic radiation therapy (IGRT and SRT) based on Elekta’s unique technology for integrated 3-D volumetric imaging at the time of treatment.

Providence offers care across a four-state area – Alaska, Washington, Oregon, and California. Its services target acute and primary care, outpatient services, transitional care, home and hospice care, substance abuse programs, mental health treatment, comprehensive outreach programs including prevention and wellness, long term care, assisted living and housing.

3M Deutschland to acquire SBG

3M Deutschland (Neuss, Germany) has agreed to acquire SBG (Berlin), a developer of diagnosis related groups (DRG) software for hospitals, including related trademarks and patents. Terms of the transaction were not disclosed. 3M said this acquisition expands its portfolio in its health information systems division and strengthens its position in the core segments of coding, grouping and quality assurance. The transaction is expected to close in June.

SBG develops software for medical documentation, coding and DRG determination, as well as management. The company’s flagship product is KODIP, a coding and grouper software solution for hospitals and funding agencies.

SBG will be integrated into 3M Deutschland this year and the Berlin location retained, the company said.

GI View raises C round $10 million

GI View (Ramat Gan, Israel) has raised $10 million in its third financing round, led by veteran investors Israel Healthcare Ventures (Tel Aviv, Israel), Delta Ventures (Hertzlia Pituach, Israel) and other private stakeholders in the company.

GI View is proving its flagship product, the Aer-O-Scope, which it describes as an air-driven, self-propelling, self-navigating, endoscope with a vision system that is also disposable, miniaturized, with minimal discomfort and maximal efficiency, intended for early diagnosis of precancerous tumors.

The company was founded in late 2003 by serial entrepreneurs CEO Benad Goldwasser, a professor of surgery at Tel Aviv University School of Medicine, with Vice President of R&D Oz Cabiri and Yossi Gross.

Goldwasser describes the GI View device for early diagnosis of cancer in the large intestine as an instrument that – in contrast to colonoscopes operated by expert physician practitioners, drives itself – requires no special skill, and thus is the perfect instrument to take over colonoscopic screening.

A feasibility clinical study in healthy volunteers to evaluate the motion mechanism of the Aer-O-Scope’s passage through the colon, was completed with impressive results less than a year ago, and a clinical trial in February on healthy volunteers demonstrated that the omni camera, used for the first time in humans, provided the 360-degree viewing of the inner surface of the colon, with “excellent resolution,” due to the air expansion.

Bruker Daltonics wins Russian registration

Bruker Daltonics (Billerica, Massachusetts) reported obtaining registration of its complete MALDI-TOF product line of microflex, autoflex TOF or TOF/TOF, and ultraflex TOF/TOF mass spectrometers, as well as of its ClinProRobot sample preparation platform, as medical devices from the Ministry of Health and Social Development of the Russian Federation.

MALDI-TOF mass spectrometry is being applied as a clinical research tool in biomarker discovery, clinical proteomics, functional genomics, molecular imaging, and microorganism identification. Registering its spectrometers as medical devices in the Russian Federation facilitates regulatory approvals of novel mass-spectrometry based in vitro diagnostic assays by its Russian customers, Bruker Daltonics said.

Bruker Daltonics has developed the CLINPROT solution for peptide and protein biomarker profiling, discovery, identification and validation from body fluids or tissue samples. The CLINPROT solution offers a combination of reproducible and scalable sample preparation using functionalized magnetic bead surfaces, high-performance MALDI-TOF and TOF/TOF detection and advanced analysis and visualization software packages.

On the same mass spectrometer platform, the company’s MALDI BioTyper enables identification and taxonomical classification of microorganisms, like bacteria, yeasts, and fungi, for infectious disease research and other microbiology applications. In addition, the company’s new MALDI Molecular Imageris a novel system for in vitro imaging of peptide and protein biomarker distributions in tissue sections and cell clusters, for example in tumor regions, that addresses the need for high-sensitivity imaging of the spatial distribution of protein biomarkers in biology, pathology and clinical research.