A Medical Device Daily

Kyphon (Sunnyvale, California) reported that it is establishing an operational presence in Switzerland to support the company's rapid international growth.

The newly created Swiss company, Kyphon Sarl , located in Neuchatel, will house manufacturing and distribution activities for Kyphon's international markets, as well as administrative activities, including clinical, regulatory, marketing and shared financial services.

Kyphon Sarl is beginning administrative operations immediately, and anticipates that it will have full manufacturing, distribution, R&D and administrative activities in effect by the end of 2007.

Certain global research and development activities will be performed by Kyphon Sarl, which will serve to augment Kyphon's current R&D center in Sunnyvale.

Kyphon said its international revenues increased 87% in 2005 over the prior year, and represented just under 20% of the company's total sales during the most recent reporting quarter.

It said the decision to establish a major facility overseas was in response to the growing needs of the company's international markets, coupled with its desire to establish additional manufacturing capacity and gain access to new technical talent.

Richard Mott, president and CEO of Kyphon, said one of the company's key priorities in its 2006 operating plan is to continue to drive the expansion of its international business.

“With our strong sales performance in overseas markets and the substantial progress we've been making on the regulatory and reimbursement fronts there, we believe additional investment in these markets should allow us to further capitalize on the opportunities they present,“ he said.

Mott said that by establishing manufacturing, logistics and R&D activities in Europe, “we also are increasing the company's overall manufacturing capacity and innovation pool. We consider the establishment of our Swiss operations as a sign of our commitment to our international markets and a milestone in our growth as a global company.“

Robert Vandervelde, president of Kyphon's international operations, said the new operations in Neuchatel “will provide us with the logistical flexibility, scalability and technical talent to better serve our existing markets and to pursue development of additional overseas markets.“

He said the company selected Neuchatel in part due to its proximity to leading universities, R&D centers, orthopedic industry suppliers and the existing cluster of healthcare, medical device and biotechnology companies. “Our location in the heart of such a region ensures access to a pool of highly educated, multi-lingual talent and innovative partners,“ Vandervelde said.

“In addition, the central location within Europe and the area's excellent infrastructure should allow us to provide optimal support to our customers' logistical and administrative needs.“

Kyphon develops devices designed to restore spinal function using minimally invasive technologies. Its KyphX line of products are used in balloon kyphoplasty, a minimally invasive procedure to treat spinal fractures caused by osteoporosis or cancer.

Prionics buys Dutch animal diagnostics firm

Prionics (Zurich, Switzerland) has acquired CEDI-Diagnostics , a Dutch firm that is part of Wageningen University and Research Center . Through the purchase, Prionics said it would acquire a number of new products and gain commercialization rights to developments made by the research center.

Terms of the agreement include that Wageningen will acquire a stake in Prionics. Further details were not disclosed.

Prionics and Wageningen also have agreed on a strategic partnership for the development of future farm animal diagnostics products.

The products made by CEDI include tests for the early diagnosis of foot and mouth disease or swine fever. In all, it supplies more than 20 products for the early detection of diseases in farm animals. It has customers in more than 60 countries.

“The CEDI products are excellent tests that make an ideal addition to our existing portfolio of farm animal diagnostics,“ said Ernst Zollinger, head of marketing and sales at Prionics.

A global leader in the diagnosis of bovine spongiform encephalitis and other prion diseases, Prionics was founded in 1997 as a spin-off from Zurich University . The company focuses primarily on diseases that are transmissible from animals to human beings.

Warsaw center gets Elekta Synergy unit

Elekta (Stockholm, Sweden) said its advanced solutions for radiation oncology have recently been put into operation at the Warsaw Cancer Center in Poland. Elekta Synergy now allows the clinicians at the center to deliver more targeted treatments using intensity modulated radiotherapy (IMRT) and image-guided radiation therapy (IGRT).
The company said the Warsaw clinicians already have established some new protocols for treatment, the results for which they intend to present at the ESTRO annual meeting later this year.

The launch of X-ray volume imaging makes the Warsaw center the first hospital in Poland to offer some of the latest and most advanced methods for IGRT.

During the verification period for the new equipment, the clinicians said they were encouraged by the results they obtained in such a short duration, especially in the irradiation of head and neck tumors in children.

“We are very satisfied with the new system. It has been implemented very smoothly and provides us and the Polish community with many new treatment opportunities,“ said Dr. Anna Skowronska-Gardas, MD, PhD, head of the radiotherapy department at the Warsaw center. “From an internal perspective, patient setup verification procedures have been improved dramatically.“

She said doctors and therapists at the center adopted the VolumeView 3-D imaging functionality quickly and easily, even though “[it was] a real step change in technology for us.“