Medical research firm debuts in Lakewood Ranch

LAKEWOOD RANCH — Another player in the medical research industry has moved to Manatee County.

Trod Medical US LLC, with headquarters in Paris, France, has opened an office/warehouse facility on Lakewood Ranch Boulevard at State Road 64 East.

The company is now manufacturing a Food and Drug Administration-approved surgical device in Europe used to treat soft tissues involving the prostate, liver and kidney. It uses radio frequency technology to heat diseased tissue and halt its growth.

The device, which will be marketed to hospitals, outpatient centers and private clinics for use on prostate cancer patients, is expected to be launched in July, said Manfred Sablowski, vice president and chief operating officer, and at least five to seven people will be hired at that time for the Manatee facility.

Sablowski said the company applied for FDA approval at the beginning of 2008 for its patented Encage device and received approval in October, a key factor allowing the company to enter the U.S. market and open a U.S. facility.

A third-party reviewer in Germany was used for the pre-approval of the device before submitting the FDA application.

“There was a lot of bureaucracy,” said Sablowski. “You better make sure the information in your 800-page document is correct; if there is one wrong word, you are in trouble.”

The United States is the largest market for the device because of its population, he said.

In February or March, the first patients in the U.S. will receive the new treatment, Sablowski said. The company is in negotiations with Moffitt Cancer Centers to use the center for training on the product and procedures for the treatment.

Treatments now being used for prostate cancer all have negative consequences, Sablowski said.

“Our focus was to eliminate those negative side effects,” he said.

Dr. Andre Faure, chief executive officer for Trod Medical and founder of the company, is the inventor of Encage. He developed the device and procedure in 2005 and decided he wanted to introduce it to the U.S. market. He recruited Sablowski and Brook Peterson, who both have extensive experience in the medical technology field that includes working with Pfizer. They also had their own consulting firms.

Trod Medical is a great addition to the group of medical research facilities already in Manatee County, said Eric Basinger, executive director of the Economic Development Council.

“Manatee County is cultivating a cluster of medical equipment designers and manufacturers, and Trod’s entry from its European base is an exciting chapter in that story,” he said. “Trod’s arrival is further evidence of Manatee County’s appeal to European businesses wanting to expand into the U.S. market.”