A Medical Device Daily

VisEn Medical (Woburn, Massachusetts) has signed an exclusive Japanese distribution agreement with Olympus (Tokyo) covering VisEn's fluorescence molecular tomography (FMT) imaging systems and portfolio of in vivo near-infrared fluorescence probes.

Olympus will begin selling the products in Japan as of Sept. 1.

The FMT systems and near-infrared fluorescence probes were developed to enable leading in vivo performance in fluorescence molecular imaging.

The companies said that by combining VisEn's products with the Olympus OV100 and IV100 molecular imaging systems, it will be possible to generate an “unprecedented range” of molecular imaging data in vivo, from the cellular and tissue levels to the quantification of molecular activities, real time within the whole body.

They said these products would accelerate progress in disease research and in drug development by “significantly expanding molecular imaging applications and enhancing data quality in diseases including cancer, inflammation, cardiovascular disease and bone disease.”

In vivo molecular imaging is now widely used in advanced life science research to observe and analyze the in vivo dynamics of cells, proteins and molecules. By analyzing these dynamics, said VisEn, it is possible to detect, understand and characterize diseases earlier, and to achieve a better understanding and characterization of the mechanisms that cause such diseases and the effectiveness of related treatments.

In a statement, VisEn said near-infrared fluorescence imaging using biocompatible molecular probes is “an extremely effective and highly sensitive method of in vivo imaging and is increasingly playing a central role in disease research and drug development, from animal research today through medicine tomorrow.

VisEn's fluorescence probes are designed to target and read out various disease-related molecular activities in vivo, including protease activity, angiogenesis, vascular permeability and bone turnover.

The company said its FMT system “provides true quantification of fluorescence within the living animal.” Together, the companies said their technologies can be used to observe and quantify a range of biological phenomena in vivo, including molecular activities in disease states such as cancer, inflammation, cardiovascular disease and bone disease.

The molecular imaging systems developed and sold by Olympus are the OV100 in vivo imaging system, which can be used for a wide range of observations, from full views of small animals to the cellular level, and the IV100 in vivo laser scanning microscope, which supports direct in vivo observation of small animals.

Olympus said that signing an exclusive Japanese distribution agreement with VisEn will allow it to combine its imaging systems with VisEn's products, enabling Olympus to supply its customer with fluorescence technologies that can be used for in vivo observations and data generation from cells and tissues throughout the entire body.

Hiroyuki Yoshimori, division manager of Olympus' Bio Business Division, said, “Because of its power and sensitivity in imaging molecular activities in vivo, near-infrared fluorescence imaging is playing an increasingly central role in research and drug development. VisEn's technology platforms bring a clear level of technology and market leadership to our programs in the space. These platforms and the data they generate . . . will ultimately enable doctors to see, understand and treat disease in new and better ways tomorrow.”

Kirtland Poss, president and CEO of VisEn, said, “Olympus is a clearly recognized leader in developing and marketing top-quality systems for both the research and clinical markets, and they have a growing emphasis on bringing the industry's central fluorescent technologies from translational research into personalized medicine. Our combined technologies, products and shared vision in molecular imaging will have a major impact in providing real time readouts of biologic activity in a wide range of disease states.”

VisEn's FMT system and in vivo near-infrared fluorescence probes will be on display at the 65th annual meeting of the Japan Cancer Association , which will be held at Pacifico Yokohama from Sept. 28-30.

VisEn Medical was established based on technologies developed at Massachusetts General Hospital and Harvard Medical School (both Boston). The company is financed in part from major venture funds, including Flagship Ventures and The Bollard Group.

Aussie ortho firm gets first U.S. hip order

Portland Orthopaedics (Sydney, Australia) said it has received its first order from new U.S. distributor Plus Orthopedics for the company's DTC revision hip. The DTC Hip is used for difficult hip replacement cases, typically where a patient suffers poor bone quality and often when a standard hip implant has been less than successful.

Portland's first hip implant was inserted in 1997 and so far more than 1,700 implants have been sold worldwide.

The hips ordered by Plus Orthopedics will be supplied from Portland's inventory and the first implants are expected to be made available to U.S. surgeons late this month.

“This order is significant because it is our first with the Plus group of companies,” said David Sekel, managing director of Portland Orthopaedics.

He added that the Plus contract also extends to Portland's other products. “Over a contracted minimum three-year period, Plus Orthopedics will distribute Portland's products including the DTC revision hip, the M-COR primary hip and the Equator Plus Cup. The M-COR primary hip and the Equator Plus Cup will be subject to separate orders in the near future.”

Sekel said that while this batch of replacement hips will be sourced from inventory, Portland is now moving to increase its manufacturing capacity as distributor arrangements begin to be realized in new territories and as the product line expands.

Plus Orthopedics Inc., a wholly owned subsidiary of Plus Orthopedics AG, headquartered in Switzerland, has a distribution infrastructure and sales force in 29 states across the U.S.

PREVU reader OK'd in Canada

Predictive medicine company PreMD (Toronto) said that its second-generation spectrometer, or color reader, for the PREVU(x) Point of Care Skin Sterol Test has been cleared for sale by Health Canada's Therapeutic Products Directorate (TPD).

“This clearance allows the new reader to be marketed in Canada and follows on the CE mark designation we recently received for the reader in Europe,” said Dr. Brent Norton, president and CEO. “We anticipate that this stand-alone, portable reader will enhance the appeal of PREVU(x) POC in all markets.”

The new reader was developed in conjunction with Boehringer Ingelheim microParts and will be manufactured in the U.S. by Jabil Circuit.

PREVU(x) non-invasively measures the amount of cholesterol (sterol) that has accumulated in the skin tissues, as opposed to blood. There is no fasting or other patient preparation required for the test.

PreMD said clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels of skin sterol are correlated with higher incidence of coronary artery disease.