A Medical Device Daily
Portland Orthopaedics Ltd. (Sydney, Australia) said it has finalized the design of a modular cemented hip replacement product, in preparation for testing and submission for approval to the FDA in the U.S. and the Thera-peutic Goods Administration in Australia.
The company said it expects to receive those approvals by December of this year.
With the introduction of the cemented system, Portland Orthopaedics said it would cover all total hip market segments, joining the company's M-COR primary hip product, which is hammered into place, and its revision DTC hip, which is screwed into the bone.
Portland noted that cemented implants generally are used in older, less-active patients. The benefits of such implants include rapid fixation, which in turn allows patients to put stress upon the implant sooner. The company said this can be particularly important with older patients who cannot remain immobile for long periods of time due to health concerns.
Cemented hip replacements involve adding a bone cement mixture to fix the new hip prosthesis into the top of the thighbone, or femur. Portland said cemented hips represent 15% to 20% of all hip replacements performed worldwide and in 2003 represented close to a $550 million global market.
Portland Orthopaedics said that when approved, the cemented hip would be the only two-piece modular cemented hip on the U.S. market. It said the modular design gives the surgeon considerably greater scope to make adjustments to size in order to optimize fitting, “thereby increasing clinical outcomes.“
Managing Director David Sekel said all of the company's hip products have “strong points of difference that will significantly help surgeons and patients with better-fitting and potentially longer-lasting hip implants.“
He said that if all goes well in the regulatory review process, the new cemented hip will have its first Australian and U.S. sales in calendar 2006.“
Sekel said the first prototypes would be manufactured by Portland's in-house team, using specialized instrumentation and machinery. He said the M-Thor instrumentation “enables the locking of the two pieces of the hip together without disturbing the cement mantle.“
CombiMatrix expands Asian efforts
Acacia Research (Newport Beach, California) said its CombiMatrix (Mukilteo, Washington) group has expanded its relationship with its existing Australian partner, INBIO, for the Asia Pacific region. Major components of the expanded relationship include the transfer of day-to-day operational responsibility and majority ownership of CombiMatrix's wholly owned subsidiary, CombiMatrix KK, along with an expanded distribution agreement that encompasses Japan.
INBIO has obtained 67% of the voting interests in CombiMatrix KK and will expand its distribution agreements with the CombiMatrix group. INBIO will assume all operational and financial responsibilities of the subsidiary, including its liabilities.
“As we continue to focus on the U.S. market with our direct sales efforts, we are pleased that our partner INBIO has agreed to take on majority ownership of CombiMatrix KK, including financial and operational responsibilities,“ said Dr. Amit Kumar, president and CEO of CombiMatrix. “The experience of INBIO executives in the Japanese markets, as well as their proximity, will enable more efficient management of our now jointly owned Japanese subsidiary.“
INBIO is the life science arm of BioInsight Pty Ltd. and provides comprehensive distribution coverage for the Australian and New Zealand life science market.
The CombiMatrix group is developing a platform technology to rapidly produce customizable arrays, semiconductor-based tools for use in identifying and determining the roles of genes, gene mutations and proteins. The technology has a wide range of potential applications in the areas of genomics, proteomics, biosensors, drug discovery, drug development, diagnostics, combinatorial chemistry, material sciences and nanotechnology.
CombiMatrix also has entered into a non-exclusive distribution agreement with Cold Spring Biotech to distribute CombiMatrix products and services in China, Taiwan and Hong Kong. Under the terms of the agreement, Cold Spring Biotech will market and sell CustomArrays and CatalogArrays, including the recently introduced Influenza A Research Microarray.
Cold Spring Biotech has three offices in Taiwan and five offices in China.
Hong Kong hospital gets Elekta systems
Elekta's (Stockholm, Sweden) radiation oncology systems have been installed at the cancer center in Tuen Mun Hospital (Hong Kong), making it the first hospital in Asia to offer the latest methods for radiation treatment of cancer.
The hospital is equipped with three treatment systems from Elekta, including one Elekta Synergy S, a medical linear accelerator-based system capable of performing image-guided radiation therapy (IGRT) and equipped with cone-beam computerized tomography for 3-D imaging of internal organs.
Elekta said IGRT is the “next generation“ in high-precision radiation treatment delivery, giving the oncologists the ability to use high-resolution 3-D X-ray imaging to image a patient at the point of treatment, make corrections to better target a tumor and avoid surrounding healthy tissues.
All three systems installed at the clinic are equipped for intensity-modulated radiation therapy techniques for planning and delivering treatment to a wide variety of solid tumors.
More distributors for DiaSys
DiaSys (Waterbury, Connecticut) said it has signed three-year exclusive distribution agreements with Rochem Biocare for territories that cover Colombia, Peru, Ecuador and Panama.
The agreements guarantee minimum orders of $1.46 million for the company's parasitology and urine sediment workstations and consumable products over the period covered by the agreement.
Jose Puig, DiaSys sales manager, Latin America, said, “In addition to our recent agreement in Mexico and the award in Venezuela, these new transactions provide DiaSys with a network of capable, experienced diagnostic distributors in each market.“
DiaSys manufactures laboratory equipment, consumables and infectious disease test-kits to healthcare and veterinary laboratories worldwide.