A Medical Device Daily

DOBI Medical International (Mahwah, New Jersey) reported another step in its continued expansion into international markets with the signing of new distributor agreements in Brazil and the Netherlands.

Advanced Imaging (Sao Paulo, Brazil) and Tromp Medical Engineering (Castricum, the Netherlands) each will conduct a clinical trial using the company's ComfortScan system to aid in obtaining local approvals specific to their respective regions.

The ComfortScan system is a light-based, non-invasive and gentle dynamic optical imaging device designed to assist physicians in the diagnosis and management of breast cancer.

With the addition of these two distributors, the DOBI Medical's global distribution network now has nine distributors representing 13 countries, including Canada, Costa Rica, Columbia, the Czech Republic, Greece, India, Liechtenstein, Nicaragua, Panama, Russia and Switzerland.

The company said it expects to sign additional distribution agreements in 2005 as it continues to expand its international network.

DOBI said that according to the European Network of Cancer Registries, breast cancer is the most common cancer in females in Europe. While the incidence of breast cancer is rising among women in many European countries, the Netherlands currently has the highest incidence of breast cancer in Europe. The incidence of breast cancer also is now more common in South America, with Brazil having the highest number of breast cancer cases in that region, as reported by the International Agency for Research on Cancer.

“Advanced Imaging and Tromp Medical Engineering . . . have excellent reputations as leading medical suppliers within their respective countries,“ said Denis O'Connor, senior vice president of marketing, sales and service at DOBI. “After successful completion of the clinical trials, we expect the ComfortScan system to be available for commercial sale in Brazil and the Netherlands. These newest agreements further strengthen our global distribution network and reflect the growing medical need for the ComfortScan technology throughout the world.“

U.S., Japanese CROs in alliance

PPD (Wilmington, North Carolina) said it has formed a strategic alliance with CMIC (Tokyo), a contract research organization (CRO) providing clinical research services and outsourcing of clinical research professionals in Asia.

The U.S. firm said the collaboration will enable it to extend its clinical operations and consulting services in Japan, while providing CMIC opportunities that result from PPD's extensive drug development infrastructure and network of global resources.

CMIC is Japan's largest CRO. It has seven branches in Japan, China and South Korea, with more than 1,300 employees. It will work with PPD to provide site and investigator identification as well as help expedite patient recruitment and monitoring services through its regional network, medical call center and affiliated independent site management organization.

“This alliance augments our ongoing efforts to streng-then operations in Asia,“ said Fred Eshelman, CEO of PPD. “CMIC has a proven track record in working successfully with Japanese regulatory authorities and a reputation for focus on client needs that mirrors PPD's brand of client service.“

The two companies will mutually conduct training with each other's operational staffs to ensure adherence to standards and guidelines and promote quality services for clients.

CMIC will assist in identifying the optimal regulatory strategy for PPD clients that do not have a domestic presence in Japan or Asia, supporting all phases of new drug development.

Kazuo Nakamura, CEO of the Japanese firm, said, “We believe our alliance with PPD will enable us to broaden our global customer base and speed up multinational studies for pharmaceutical companies in Japan seeking overseas development.“

PPD provides discovery and development services and products for pharmaceutical, biotechnology and medical device companies. It has more than 6,600 professionals in 27 countries around the world.

Delphi in distribution pact with Fresenius

Delphi Medical Systems (Troy, Michigan) a subsidiary of Delphi Corp., signed an exclusive distribution agreement for Delphi's IVantage infusion pumps with Fresenius Kabi (Oburersel, Germany) a subsidiary of Fresenius AG (Bad Homburg, Germany).

An original equipment manufacturer, Fresenius Kabi will exclusively sell Delphi's IVantage, an ambulatory intravenous pump, its accessories, and associated disposables in all of the European Economic Community member countries, Norway, Switzerland, Turkey, South Africa, Australia, China, India, Indonesia, South Korea, Thailand, Taiwan, Malaysia and the Philippines.

Delphi's IVantage will bear that name as well as the Fresenius Kabi brand. Miniature and accurate, the dual battery-operated and AC-powered portable pump is lightweight and small enough to be hand-held, making it ideal for use in homecare and alternate sites.

The pump is designed so it can be easily clipped onto various accessories, such as IV poles and wheelchairs. It includes a shoulder strap and belt-clip for increased mobility, and could play an important role in hospitals, where it could be utilized for mobile in-patient care.