A Medical Device Daily

Nidek (Gamagori, Japan) said it has received CE mark approval for its Optical Path Difference Customized Aspheric Treatment (OPDCAT) algorithm and software for the Nidek EC-5000 Excimer Laser System.

The company said the approval clears the way for marketing of its laser and OPDCAT algorithm throughout the world, especially in Europe and the Middle East. They are used for the correction of myopia and myopia with astigmatism with aberrations of the entire optical system.

“This is a major milestone for Nidek and our refractive surgery business in Asia, Europe, the Middle East and South America,” said Hideo Ozawa, president and founder of the company. “With this approval, Nidek takes a step forward in providing our customers around the world and their patients with the best possible clinical outcomes in the market for laser vision correction.”

He said Nidek “can now provide an innovative system designed to improve refractive outcomes for patients and treat aberrations of the entire optical system, with wide ranges of myopia and astigmatism.”

OPDCAT uses a proprietary ablation algorithm based on topography and wavefront data generated by the Nidek OPD-Scan. The company said that with a combination of slit scan and multi-point ablation, OPDCAT is intended to correct refractive errors as well as optical aberrations of the entire eye.

“We expect an unsurpassed level of patient and physician satisfaction with this improvement in refractive surgery,” Ozawa said.

“Aberrations based on corneal and entire eye irregularities can result in visual blur and other undesired visual phenomena are reduced with this new ablation algorithm,” the company said. “This results in a shorter visual recovery period and better post-operative visual acuity.”

The company said clinical data submitted to gain CE mark approval showed “excellent clinical outcomes,” with 97% of patients having an uncorrected visual acuity of 20/20 or better. In addition, 86% of patients gained at least one line of best-corrected visual acuity and a similar percentage of patients were within 0.50 diopters of the targeted refractive correction. Average contrast sensitivity was maintained three months post-operatively, indicating the potential of excellent quality of vision after the procedure.

“The use of the OPDCAT software algorithm with [our] excimer laser technology potentially increases the visual acuity and quality of vision while addressing two major issues in refractive surgery: treatment of aberrations of the entire optical system and reducing higher order aberrations that can occur post-ablation,” Ozawa said.

The company said its excimer platform now offers “a full suite of treatment algorithms that use wavefront and topography data from the Nidek OPD-Scan to treat a patient’s refraction needs.”

B&L to acquire interest in Chinese firm

Bausch & Lomb (B&L; Rochester, New York) has entered into a definitive agreement to acquire a 55% controlling interest in the Shandong Chia Tai Freda Pharmaceutical Group (CTF; Jinan, China), an ophthalmic pharmaceutical company, from Sino Biopharmaceutical Ltd.

The cash purchase price of $200 million represents the equivalent of 18.6 times 2004 net earnings. B&L said the acquisition would accelerate its expansion into the growing ophthalmic pharmaceuticals market in China.

Bausch & Lomb also agreed in principle to a future acquisition of an additional 15% interest in CTF held by two other entities, for $54.5 million, an amount equivalent on a per-share basis to the price being paid to Sino Biopharmaceutical Ltd.

Described by B&L as “the leader in the China ophthalmic pharmaceuticals market,” CTF primarily manufactures medications used to treat ocular inflammation and infection, glaucoma and dry eye, including the Moisten and Mioclear lines of eye drops.

In 2004, the Chinese company had sales of $62 million. CTF has roughly 1,300 employees and an extensive national network of sales representatives and distributors that reach the country’s hospitals and pharmacies.

The acquisition is expected to close in the third quarter, subject to certain conditions including formal, final approval by the shareholders of Sino Biopharmaceutical, at which time asset valuation and purchase price allocations will be finalized.

More African distributors for Calypte

Calypte Biomedical (Pleasanton, California) said it has executed agreements with two distributors for the marketing and sale of its Aware rapid HIV antibody tests in eight countries in sub-Saharan Africa.

Lily-Max (Pty) Ltd. (Kampala, Uganda) will have exclusive distribution rights in Uganda, Rwanda, Burundi and Democratic Republic of Congo, while Bioweb (Pty) Ltd. will have similar rights in Kenya, Tanzania, Cameroon and Chad.

Calypte previously reported that it had received a positive recommendation that the Uganda National Drug Authority grant approval for the importation of the Aware rapid HIV 1/2 Antibody Tests. Subsequent to that recommendation, Calypte received its first purchase order from Lily-Max Ltd. and will complete shipment of that order out of its Thailand manufacturing facility.

Dr. J. Richard George, president and CEO of Calypte, said, “We’re making great progress in moving our strategy forward in the African continent by building what we believe to be a solid foundation that leverages the strengths and resources of these distributors. We have expanded our representation from two sub-Saharan countries to 10 in total, and we will be aggressively pursuing sales as the regulatory process is completed in the appropriate territories.”

He said the company expects to complete regulatory trials in at least four countries during the second half of this year.

Additionally, regulatory trials have been initiated in Zimbabwe for Aware BSP, a rapid test for HIV antibodies using whole blood, serum and plasma samples. Calypte also has signed agreements to begin trials for all three Aware rapid tests in Kenya and Cameroon. Those trials are scheduled to begin this month.

Calypte has developed three rapid tests for the detection of antibodies to HIV-1 and HIV-2 viruses. Each is designed for use on a different sample type – Aware BSP uses whole blood, serum or plasma samples Aware OMT uses oral fluid samples and Aware U uses urine samples.

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