A Medical Device Daily

Top Care Korea and Exalenz (formerly BreathID Ltd.; Modiin, Israel) said they have signed a deal to build closer collaboration between the companies in marketing and product distribution in South Korea. The agreement also grants Top Care Korea exclusive rights to distribute Exalenz’s BreathID System in South Korea.

Top Care Korea has a plan to launch BreathID System in first half of 2008.

Hyun Mo Chung, CEO of Top Care Korea, said, “Together with Exalenz, we will provide a powerful set of diagnostic tools for patients with gastrointestinal and liver disease. We believe this agreement will immediately strengthen our competitive position.”

“[South] Korea is a highly advanced market with a superior medical community and is an encore for our activity in Asia. Together with Top Care, we will make the BreathID a standard in the diagnostics of liver and gastrointestinal diseases in Korea,” said Uri Geiger, CEO of Top Care.

BreathID is a point-of-care, breath-testing system that enables gastroenterologists and hepatologists to diagnose and manage a wide range of diseases and disorders of the digestive system.

In other agreement news, Palomar Medical Technologies (Burlington, Massachusetts), a developer of light-based systems for cosmetic treatments, reported an agreement with Gillette Company to extend the launch decision of a home-use, light-based hair removal device for women until no later than Feb. 29, 2008.

Under the existing agreement entered into by Palomar and Gillette on Feb. 14, 2003, and as amended and restated on Feb. 14, 2007, Gillette had until Jan. 7, 2008, to make the launch decision. During this extension period, the companies have agreed to enter into negotiations for a new agreement to replace the existing one.

They said it is anticipated that a new agreement would include the release of Palomar from exclusivity and the retention by Gillette of non-exclusive rights to Palomar’s technology and intellectual property. In return for a release from exclusivity, Palomar anticipates that there would be a reduction in the percentage of net sales that Gillette pays to Palomar and a change from annual payments under the existing agreement to reduced calendar quarterly payments for a certain period.

If the parties do not agree, the existing agreement could be terminated.

The consumer light-based hair removal device would be the first to receive a 510(k) over-the-counter clearance from the FDA.