A Medical Device Daily

PLC Systems (Franklin, Massachusetts), a company focused on cardiac and vascular device-based technologies, reported that it has entered into a three-year exclusive agreement with Medimen, headquartered in Pakistan, for distribution of its RenalGuard System into Bangladesh and Pakistan.

Medimen is an established distributor of medical technology and devices in this region, and has previously worked with PLC on distribution of the Heart Laser System. Medimen has already launched RenalGuard in Bangladesh, and will target early adopters in both countries who recognize the benefits of utilizing the unique fluid balancing capabilities of RenalGuard in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).

PLC's President/CEO, Mark Tauscher, said, "We are very pleased to extend the launch of our RenalGuard technology to another region of the world, working with our partners at Medimen. We believe Medimen's efforts will help raise awareness of the benefits of RenalGuard to a wider community of physicians in both Bangladesh and Pakistan."

Bangladesh and Pakistan join Italy and Spain as countries where PLC has now launched RenalGuard. PLC received the CE mark certificate for the RenalGuard System in late December 2007, and concluded its pilot safety trial in the U.S. late in 2007. Two investigator-sponsored randomized clinical trials to evaluate the use of RenalGuard in the prevention of CIN are currently underway in Italy. Recently, PLC was awarded its first patent for RenalGuard technology, in Canada.

PLC developed the CO(2) Heart Laser System, which cardiac surgeons use to perform CO(2) transmyocardial revascularization to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device.

Rosetta enters Canadian distribution with Warnex

Rosetta Genomics (Philadelphia/Rehovot, Israel), a developer of microRNA-based molecular diagnostics, and Warnex Medical Laboratories (Laval, Quebec), a division of Warnex (Laval), have signed an exclusive distribution agreement in Canada for three currently-available diagnostic tests.

Warnex will market Rosetta Genomics' miRview tests. Samples will be sent from Canada to Rosetta Genomics' Philadelphia-based CLIA-certified laboratory for analysis. The terms of the deal were not disclosed.

"We are excited to have a well established molecular diagnostic laboratory such as Warnex as our distribution partner in Canada," said Ronen Tamir, chief commercialization officer at Rosetta. "Canada is an important market, and this agreement is a significant step as we expand the market for our products in North America. This agreement joins our existing contracts with Prometheus Laboratories in the U.S., and with Teva Pharmaceuticals in Israel and Turkey. We continue in our efforts to expand our global distribution network to other parts of the world, and expect to have additional agreements in place in the near future."

"These tests offered by Rosetta Genomics will allow oncologists to accurately trace the origin of the tumor in the body and to better characterize the tissue type, which can lead to a more efficient chemotherapy treatment," said Mark Busgang, president/CEO of Warnex.