A Medical Device Daily

Lumenis (Yokneam, Israel), a global manufacturer of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, said it has received approval from China's medical device regulating authority to sell its Selecta II (SLT) system in that country.

SLT works by using a specific wavelength to irradiate and target only the melanin-containing cells in the trabecular meshwork. Because of the specific wavelength of light generated, as well as the power and duration of the exposure, SLT selectively targets pigmented cells in the trabecular meshwork and causes no discernable damage to adjacent tissue.

The company said experts postulate that the single largest ethnicity with glaucoma will be Chinese by the year 2010. Worldwide, there will be more than 60 million people with glaucoma, which will continue to be the second-leading cause of preventable blindness. Patients with the disease will continue to increase to nearly 80 million by 2020.

Lumenis said that currently, 80% of the visually impaired in China live in rural areas, while 70% of the country's 24,000 ophthalmologists work in urban hospitals, making glaucoma drug compliance monitoring “extraordinarily difficult.”

“With Lumenis' Selecta II Selective Laser Trabeculoplasty (SLT) technology, doctors in China will now be able to treat their glaucoma patients with 'a drop of light' – and secure 100% therapeutic compliance,” the company said.

Avner Raz, president and CEO, said, “While the use of SLT has increased rapidly since Lumenis' family of Selecta laser systems gained FDA clearance, we continue to identify and pursue untapped markets for our technologies. Our entrance into China with the Selecta II and SLT signifies a major milestone in this effort.”

Dr. Ding Lin, MD, PhD, director of Aier Eye Hospital Group (Changsha, China), one of that country's largest private hospitals, said, “The problem of glaucoma in China is a staggering one. As a clinician treating glaucoma, I can say the challenge of patient compliance to a pharmaceutical treatment paradigm is complex. In China, as in many other countries, patient compliance to these drops is dismal. We welcome SLT as part of the glaucoma management tools.”

Lumenis said researchers have found treated and untreated tissue to be nearly indistinguishable. When treated with SLT, a primarily biologic response is induced in the trabecular meshwork which involves the release of cytokines that trigger macrophage recruitment and other changes, leading to a reduction in intraocular pressure (IOP).

The company said that since its introduction in 2001, Selecta II has demonstrated to clinicians the ability to reduce IOP associated with glaucoma – vs. the need for on-going and repeated medication for therapy – and directly addresses patient compliance concerns.

BioMag finalizes Thailand agreement

BioMag (Orangeville, California) said it has finalized an agreement with Bangkok RIA Group (BRIA), a laboratory, manufacturer and distributor of diagnostic services in Thailand. The companies last week reported signing a memorandum of understanding relative to the distribution accord (Medical Device Daily, June 12, 2006).

BRIA will be responsible to apply to the Health Ministry of Thailand to acquire approval to initiate clinical trails in Thailand. BioMag's HTS-MTP Diagnostic System, including the proprietary HIV and hepatitis B assays, are to be tested during these trials.

Upon completion, BRIA will have the exclusive distribution rights for the products in Thailand.

Clayton Hardman, president and CEO of BioMag, said, “Ninlawan Petchardaburanin, PhD, president and founder of BRIA, said that Biomag's revolutionary technology could 'put BRIA out of business.' Joining and leading the company into clinical trials and having the exclusive distribution rights in Thailand ensures that BRIA will remain on the leading edge of diagnostic testing, while expanding sales.”

BRIA was founded in 1989 to provide medical laboratory diagnostics services to hospitals, clinics and other medical care units. It later decided to transform itself into a holding company with a group of subsidiaries and has expanded geographic locations through its franchises throughout Thailand.

BioMag, through its wholly owned subsidiary Biospectrum Technologies, is focused on identifying market “inadequacies” and filling those needs with new technologies and highly specific and sensitive assays.

PTS eyes doing business in China

PTS (Las Vegas) said it has signed a consulting agreement with Yu Jian Meng and his firm, Shang Hai Yi Heng Hang Business Consulting Co. Ltd., (Shanghai, China) to assist the company in marketing the Glove Box throughout China. The Glove Box system is a freestanding dispenser of disposable latex gloves.

The goal is to further develop and expand the marketing of the Glove Box, which offers contamination reduction through automated glove dispensing, and to find a manufacture and possible joint venture partner with a company in China.

The consulting firm also will be exploring the possible need for PTS's Disability Access Consultants line of business in China, for improving disabilities issues in that country.

Yu Jian Meng formerly served as senior economist and general manager of Shanghai Information Investment Technology Development and was a senior consultant of a prestigious law firm, DeHeng, headquartered in Beijing.

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