A Medical Device Daily

Exactech (Gainesville, Florida), a developer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, said that its Taiwanese subsidiary, Exactech Taiwan, has entered into an exclusive license agreement with the Industrial Technology Research Institute (ITRI) and the National Taiwan University Hospital (NTUH) for the rights to technology and patents related to the repair of cartilage lesions.

Using this technology platform, Exactech plans to launch a cartilage repair program that will include a device and method for the treatment and repair of cartilage in the knee joint.

The agreement terms include a license fee based on the achievement of specific regulatory milestones and a sales-based royalty arrangement once regulatory clearances are received.

The company said it expects that it will be required to complete human clinical trials under the guidance of the FDA in order to obtain pre-market approval for the device in the U.S.

Chief Technology Officer Dr. Steve Lin said the research team was led by Professor Ching-Chuan Jiang, MD, PhD, chairman of the department of orthopedic surgery at the National Taiwan University Hospital in collaboration with Dr. Chun-Jen Liao PhD, lead researcher of biomaterial applications in the Biomedical Engineering Research Laboratories at ITRI.

He said Exactech will complete the development of the cartilage repair implant technology, with a goal of beginning human clinical trials within two years. We look forward to reporting more details on the company s entry into cartilage repair as the project is transferred from ITRI and NTUH, and the development program gets under way.

Bruce Thompson, general manager of Exactech s Biologics Division, said the company has made a long-term commitment to finding biologic solutions for joint restoration. We are continuously looking for innovative technology focused on improving patient outcomes through treatments that restore the human anatomy and reverse the progression of orthopedic disease. This technology license agreement allows Exactech to enter a field of treatment that is on the frontier of orthopedics.

He added, The synergy between this orthobiologic treatment and our other joint restoration products is significant.

Exactech markets its bone and joint products in the U.S. and Australia, in addition to more than 25 countries in Europe, Asia and Latin America.

Wound care market growing in Brazil

A new report from global consulting firm Frost & Sullivan (F&S) says the growth and aging of the Brazilian population, teamed with the expansion of public and private healthcare systems, are driving a growing demand for healthcare services, such as the use of wound care products.

F&S s report, Brazilian Wound Care Dressings Market, says that the market had revenues of $97.7 million in 2005 and estimates that it will grow to $121.1 million in 2010.

According to the Instituto Brasileiro de Geografia e Estat stica (IBGE), Brazilian population over 60 is estimated to increase at a 3.4% CAGR from 2005 to 2010, while the population under 59 is anticipated to grow at a 1.1% rate, said Tania Mito, research analyst for the Healthcare Group at Frost & Sullivan s Sao Paulo office. As population and consumption per capita of medical supplies are intrinsically correlated, the growing and aging population is expected to significantly increase the demand for wound care products.

The Brazilian government has recently increased public expenditure on the healthcare sector, positively affecting basic healthcare supplies such as traditional wound care dressings and ambulatory material, which in turn has raised the per capita expenditure by 40%, F&S said. Public investments in the healthcare sector will remain stable following the new per capita ratio, thereby stimulating market growth.

However, high prices and the lack of awareness of product benefits make it difficult to penetrate the advanced market, according to the report. Hence, end users should be educated on these cost benefits, through workshops and training programs.

The report cites cultural and behavioral barriers that hinder the acceptance of these products. It adds that the public sector in Brazil displays a highly price-oriented purchasing behavior and it tends to concentrate its purchases on a narrower product portfolio. Contrarily, the private sector demonstrates a more balanced decision behavior that stresses on quality.

Due to the disparity in purchasing habits, market participants must clearly understand end users to build a more focused strategy for each sector, Mito said.

Millipore to open training facility in Singapore

Millipore (Billerica, Massachusetts) reported plans to open a new state-of-the-art applications and training facility in Singapore. The U.S.-based company is making the investment to meet the growing needs of its biotech customers who have operations in Asia.

Millipore s Singapore facility will be located in Science Park, and is scheduled to open in early 2009. The facility will be designed to support biopharmaceutical manufacturing, continuing Millipore s tradition of providing technical support in products and services. The company said the facility will allow local and regional customers to investigate, explore and optimize their separations, purifications and monitoring processes and be supported by local, regional and international experts.

Millipore is a provider of technologies, tools and services for bioscience research and biopharmaceutical manufacturing.

Iris Diagnostics ships urine analyzer

Iris Diagnostics (Chatsworth, California), a division of IRIS International, a leading provider of urinalysis systems and consumables for use in hospitals and commercial laboratories, said that it has shipped five iQ 200 ELITE automated urine microscopy analyzers to one of the largest clinical reference laboratories in Canada. The laboratory purchased the units from ESBE Scientific, Iris Canadian distributor.

The iQ 200 uses Auto-Particle Recognition, a well-trained neural network, to classify and quantitate twelve formed elements. The results can be auto-reported based on user-defined criteria and the images captured may be viewed on demand at the workstation monitor, dramatically reducing the need for manual microscopy and improving laboratory productivity, the company said.