A Medical Device Daily

Siemens Medical Solutions (Malvern, Pennsylvania) and Chongqing Haifu Technology (Chongqing, China) reported a collaboration to develop an MRI-guided, high-intensity focused ultrasound (HIFU) therapy system, with a focus on women's health treatments, including benign uterine fibroids and cancer, and malignant and benign tumors of the liver, kidney, pancreas and bone.

“Combining Siemens' MRI technology with Haifu's unmatched clinical expertise in non-invasive, fast HIFU protocols will further the ability to identify and treat tumors, improving care options for doctors and patients alike,“ said Nancy Gillen, vice president of Siemens Medical's MRI Division. “With innovations such as TIM [Total imaging matrix] technology and powerful applications, [our] MRI solutions provide the ideal partner with their ability to visualize disease states and thus allow for earlier treatment.“

The combination of MRI and HIFU is intended to enable improved visualization of tumor morphology and more precise thermal dose control to reduce treatment times. Further developments involve MRI applications for diagnosis, therapy planning and outcome assessment.

Patient treatment will be performed on a special HIFU patient bed inside the bore of Siemens' MRI scanners. “Magnetom Espree with TIM technology provides the HIFU beam excellent access to the tumor location as it offers maximum freedom for patient positioning,“ the companies said in a statement. Sonication of uterine fibroids is expected to take considerably less time than with traditional technology.

Since the 1950s, HIFU has been proposed as a therapeutic method, and now is used daily around the world, with ultrasound technology commonly used as a guided imaging modality. Positive clinical outcomes involving HIFU have been documented in more than 25 international peer-reviewed publications, the companies said.

Chongqing Haifu, founded in 1999, specializes in developing therapeutic ultrasound systems. The company has its own Clinical Center for Tumor Therapy and cooperates with the Institute of Ultrasound Engineering in Medicine at Chongqing University of Medical Sciences .

International expansion for Kendle

Kendle (Cincinnati), a global clinical research organization, has unveiled plans to expand its global clinical development operation further into the Asia/Pacific region and Latin America through two new operating units focused on Phase I-III services in those high-growth markets.

Leadership for the new units will be provided by Sarah Beeby and Dennis Hurley, DrSc, who will serve as vice president, global clinical development-Asia/Pacific and vice president, global clinical development-Latin America, respectively.

Beeby joined Kendle in 2001 as assistant director, clinical services, responsible for the clinical monitoring function across Europe. Most recently, she served as director, strategic business services, Europe, leading the company's expansion in the developing regions of Central and Eastern Europe, India and South Africa.

Hurley joined Kendle in 2003 as vice president, Latin America, in conjunction with the company's acquisition of Mexican CRO Estadisticos y Clinicos Asociados (ECA). Hurley co-founded ECA, the largest Phase I-IV CRO in Mexico and the second-largest in Latin America, in 1987. He has more than 20 years of CRO experience in Latin America and the U.S.

Beeby and Hurley are charged with targeting new geographies for expansion in their respective regions.

“Delivery of Phase I-III global clinical development services is a core competency for [us],“ said Candace Kendle, PharmD, chairman and CEO. “This move further enhances Kendle's position to serve our customers in these developing regions and capitalize on the tremendous market opportunity for Phase I-III clinical development services globally, which is estimated to reach $3.6 billion this year.“

Kendle has been active in the Asia/Pacific region and Latin America since 1998 and 2003, respectively. The company's existing operations include China, Australia and India in Asia/Pacific and Mexico and Peru in Latin America.

Collaboration set on catheter coatings

Biosignal Ltd. (Sydney, Australia) and the Institute for Eye Research said they have finalized a collaboration with an unidentified U.S. medical device company to test Biosignal's anti-biofilm compounds coated on catheters. Some catheters have an infection rate of more than 20% with serious health consequences for patients and increased healthcare costs.

Catheters will be coated with Biosignal's anti-biofilm compounds and tested in vitro for antibacterial activity. The testing will compare the company's technology with uncoated catheters and current silver coated anti-bacterial catheters. Results are expected in 3Q06.

“[Our] anti-biofilm compounds are novel and have been proven to prevent biofilm formation on contact lenses,“ said Biosignal CEO and Managing Director Michael Oredsson. “The technology relies on a unique mechanism of action [that] appears to sidestep the problem of bacterial resistance.“

Oredsson said the “logical next step“ for Biosignal is to adapt its anti-bacterial lens coating to other types of medical devices.

New Shanghai facility for PerkinElmer

PerkinElmer (Boston) has opened a new technology center in Shanghai, China, that it said would expand the company's presence in that country and consolidate three current Shanghai locations. The center will bring together PerkinElmer's sales, service, customer care and technology support functions, and also serve as the company's regional headquarters for greater China.

“The new Technology Center furthers our commitment to expanding in China, which is a rapidly growing market for health sciences and photonics technologies,“ said Gregory Summe, PerkinElmer chairman and CEO. “Our business units will benefit from greater leverage of technical and customer support resources, consolidated materials sourcing, and close proximity to key customers whose needs drive our product innovation.“

In addition to accommodating PerkinElmer's current operations, the space at Zhangjiang Bio-Pharma Park will allow for easy expansion to support further product and application development, the company said.

Its health sciences end markets include genetic screening, environmental, service, biopharma and medical imaging, while photonics markets include sensors and specialty lighting.