A Medical Device Daily

Wright Medical Group (Arlington, Tennessee) reported approval of its Micronail intramedullary distal radius implant by Japan's Ministry of Health. Introduced in the U.S. in 2005, the minimally-invasive Micronail Fixation System provides immediate stabilization for wrist fractures, utilizing fixed-angle locking screws.

Wright said the system is unique to the global wrist fracture market because it can be implanted through a small incision on the radial side of the wrist and remains completely inside the intramedullary canal of the radius while the fracture heals.

“For many patients, the Micronail device design and surgical approach allow movement of the wrist almost immediately following the procedure,” Wright said. “These features represent significant improvements over conventional distal radius plates, which are inserted through much larger incisions and affixed to the outer surface of the bone. Conventional plates create the potential for irritation to the surrounding tendons and soft tissue, which may produce swelling and slow down recovery of motion because of the surgical trauma required to implant them.”

Some 100,000 distal radius fractures are reported annually throughout Japan. The majority of these injuries are treated with a cast, while about 25% are treated surgically using a distal plate.

The company said that initially, the Micronail procedure will likely be indicated for cases currently suitable for surgical treatment. Ultimately, the Micronail Fixation System also could offer improved outcomes for the many fractures currently being treated with a cast because the procedure may allow for earlier movement, reduced stiffness and less atrophy than what can result from a standard period of cast immobilization, usually six to eight weeks.

Karen Harris, Wright's vice president of international sales and distribution, said, “The Japanese market is one of our strongest and most important. The Micronail system is [a] leading-edge technology which we believe over time will become the new standard of care for wrist fracture fixation in Japan.”

New China operations for Biacore

Biacore International (Uppsala, Sweden) said it has launched its own operation in China, and is taking over full business responsibility for its products in that country.

The company said the new organization is designed to take its business to the next stage of its development in the rapidly growing market for life science instrumentation in China.

The new operation will be headed by Peter Lee, former regional sales manager for GE Healthcare (Waukesha, Wisconsin) in southern China. He will lead a team of six people based in Shanghai that will be responsible for the sales, marketing, applications support and service of Biacore's systems in China.

In the outlying areas of the country, Biacore will be supported by a network of local dealers and distributors. The organization will target customers in the life science research, pharmaceutical and biotechnology and food sectors.

Biacore said the market for life science instrumentation in China was estimated to be worth $1.6 billion in 2005. Over the next several years the market is expected to grow significantly as the Chinese government continues to invest in new centers of excellence in the areas of proteomics and genomics.

The industrial customer base for Biacore's systems also is forecast to increase at a rapid pace, given the growing number of pharmaceutical and biotechnology companies who are setting up significant research organizations in China. Along with developing conventional western pharmaceutical products, the pharmaceutical industry in China is looking more closely at traditional Chinese medicines as a potential source of new drugs, a trend that is expected to be an important positive in driving the demand for Biacore's systems.

Erik Walld n, Biacore's president and CEO, thanked GE Healthcare, the company's previous distributor, for a good job of establishing Biacore's Chinese business. “We believe that China has the potential to become a major market for our products and having our own organization will be crucial in achieving our medium-term sales targets.”

Biacore is a supplier of systems for protein interaction analysis, an area of increasing importance for scientists in the academic, pharmaceutical, biotechnology and diagnostic markets. The company's systems generate data on the interactions between proteins and other molecules.

Canadian distributor for STAAR

Staar Surgical (Monrovia, California), a manufacturer of minimally invasive ophthalmic products, said it has entered into a new distributor agreement for Canada with Coherent-AMT, a medical products distributor headquartered in Ontario.

Under the terms of the exclusive agreement, Coherent-AMT will have the right to sell Staar's products that are currently approved for sale in Canada, including the Visian ICL, the Visian TICL, cataract lenses and related products.

Coherent-AMT will not market any products that compete with Staar products that it offers for resale.

“We . . . believe that [Coherent-AMT's] strong positioning in the ophthalmic medical device market in Canada will allow us to continue to build market share and mindshare for Staar products,” said David Bailey, president and CEO of Staar Surgical. “Coherent-AMT is a proven leader in bringing innovative vision solutions to this market. We believe our strategic agreement with Coherent-AMT will allow us to capitalize on the opportunities in the region.”

NanoMaterials wins $333,000 in funding

NanoMaterials Technology (Singapore), together with the University of Sydney , has been awarded an Australian Research Council Linkage Grant of $333,000 for R&D concerning the high-gravity precipitation of nanoparticles for pulmonary drug delivery.

The project will explore the market potential of drug delivery by inhalation aerosols using nanoparticles. Nanoparticles can penetrate deeper into the lung where they deposit and dissolve faster for enhanced therapeutic effects.

The project will focus on both the production process and the particle properties for aerosol administration.