A Medical Device Daily

Health Canada has granted IntraLase (Irvine, California) a device license amendment for the company's IntraLase FS femtosecond laser, which replaces the hand-held blade historically used to create the corneal flap in LASIK (laser-assisted in situ keratomileusis) procedures.

The company said it plans to immediately commercialize the laser in Canada, expanding its global presence to 18 countries. To date, more than 250,000 IntraLase-initiated LASIK procedures have been carried out worldwide.

As of last September, 180 IntraLase FS lasers had been installed in ophthalmic practices worldwide, and the company said the product had a 15% market share of all corneal flap procedures in the U.S. for the quarter.

Robert Palmisano, president and CEO, said the expansion of IntraLase's presence in the Canadian market “further demonstrates the global potential of the IntraLase FS laser technology.“

The company describes the IntraLase FS laser as “the first LASIK advancement to improve the first step of LASIK — creating the corneal flap.“ Traditionally, the corneal flap has been made using a hand-held device with an oscillating metal razor blade, called a microkeratome.

IntraLase said clinical studies report that its laser “significantly decreases the occurrence of blade-related complications, including invasive corneal incisions, corneal abrasions, 'button-hole' cuts and improperly formed flaps,“ adding that it is “dramatically less likely to produce overly thin flaps or extremely thick flaps, events that could lead to serious complications.“

Studies also have confirmed that patients see better with IntraLase-initiated LASIK than with bladed LASIK, the company said.

The IntraLase FS laser creates the flap from below the corneal surface, using an “inside-out“ process. An infrared beam of laser light separates tissue at the molecular level. A computer interface allows the surgeon to pre-program flap specifications unique to the individual patient. From start to finish, the IntraLase laser flap process takes about 45 seconds.

DiaSys in Mexican distribution agreement

Global diagnostics products firm DiaSys (Waterbury, Connecticut) said it has entered into an agreement with Grupo Mex Lab, a distributor of diagnostics products, to distribute its products in Mexico. Grupo Mex, founded 10 years ago, has offices in Guadalajara and Mexico City and a network of 300 distributors throughout the country.

The distribution agreement is expected to allow DiaSys to offer its parasite tests to both the private lab sector and public social security administration. The reimbursed value of the market for such tests is estimated at about $140 million.

Jose Puig, DiaSys sales manager for Latin America, said, “The Mexican market represents a significant opportunity for us. Based upon Grupo Mex Lab's large distribution network and significant demand for parasite testing among both the public and private sectors, there exists a significant opportunity to grow sales rapidly.“

He added that the company thinks the distribution agreement “will allow us to offer a complete line of rapid tests and ELISA kits, through the recently announced agreement to acquire Biocheck and Evernew Biotech, as Grupo Mex Lab is a provider of rapid diagnostic tests to the Mexican government as well as the country's armed forces.“

The Mexican Institute of Social Security and the Social Security Institute for State Workers perform 26 million parasite tests annually, while the private sector performs an additional 2 million such tests a year. The reimbursement for a parasite test in the country is approximately $5 per test, Diasys said.

The company previously entered into distribution agreements with Tecnodiagnsostica, the largest distributor of clinical diagnostic products in Costa Rica, and Repreclin, a large clinical diagnostics distributor based in Venezuela.

South African office for Kendle

Kendle (Cincinnati), a clinical research organization (CRO), reported the establishment of a new office in Johannesburg, South Africa, expanding its access to patients across a broad spectrum of therapeutic areas, including HIV/AIDS, cancer, diabetes, infectious diseases (tuberculosis, malaria and pneumonia) and neurological disorders.

Kendle said its new location would provide full-service Phase I to Phase IV clinical development solutions for its global biopharmaceutical customers.

“South Africa's diverse population, coupled with an efficient approvals process and high-quality data, make it an increasingly ideal location for the conduct of clinical trials,“ said Christopher Bergen, president and chief operating officer. “Strong relationships between patients and physicians historically have resulted in a high level of patient compliance and retention.“

Leadership for the new office will be provided by Country Manager Mary-Ann Richardson, with responsibility for Kendle's clinical operations in South Africa, including business development, financial performance, clinical project management, human resources and facilities management. Prior to joining Kendle, she worked for a large international CRO in South Africa, most recently as acting clinical operations manager.

Richardson is chairperson for the South African Clinical Research Association and a founding member of the Industry Representative Task Group, comprised of representatives from the biopharmaceutical and CRO industries.

With more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory and validation services in more than 60 countries.

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