A Medical Device Daily

Cynosure (Westford, Massachusetts), a manufacturer of lasers and pulsed light sources, said that it has become the first U.S. aesthetic laser company to have a wholly owned subsidiary in China.

Cynosure has acquired the remaining 48% interest in Suzhou Cynosure Medical Devices, a joint venture with Suzhou 66 Vision-Tech Co. Ltd., and will operate the company as a wholly owned subsidiary that will be called Cynosure China .

“Our wholly owned subsidiary represents an opportunity to leverage the strong customer relationships we have established over the course of our successful joint venture with Suzhou 66 Vision-Tech,” said Cynosure President/CEO Michael Davin. “With the acquisition of the remaining interest in Cynosure China, our strategy is to build long-term marketing momentum by emphasizing our reputation for providing patients with outstanding results and enabling our customers to build their practices with a variety of aesthetic laser offerings.”

He added that the company’s newest flagship products are currently in the regulatory review process in China, and Cynosure expects to begin receiving market approvals there over the next 12 to 15 months.

Cynosure China currently employs 15.

Cynosure develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive procedures to remove hair, treat vascular lesions, rejuvenate skin through the treatment of shallow vascular and pigmented lesions and temporarily reduce the appearance of cellulite. Its products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse-dye, Nd:YAG and diode lasers, as well as intense pulsed light.

1st Russian order for Calypte HIV tests

Calypte Biomedical (Lake Oswego, Oregon) reported receiving an initial order from its distributor in Russia, Ordynka Investments , for 25,000 of its Aware Oral Fluid HIV-1/2 rapid tests for the over-the-counter market in the Russian Federation. The product, designed for use in non-clinical settings, permits significantly greater access to HIV testing.

Calypte is a manufacturer of diagnostic tests for the detection of antibodies to the human immunodeficiency virus (HIV) for the professional point of care and over-the-segments of the market

Vladimir Saveliev, managing director of Ordynka Investments, said, “We are happy to be working with Calypte in the hope to be able to help Russia in its fight against the prevention of the spread of the HIV/AIDS epidemic and this initial order of 25,000 test kits should help the cause.”

He added: “In addition to being safe and painless, oral fluid sampling is very efficient and thereby facilitates high-throughput testing in settings such as the military, prisons, schools and universities. Additionally, oral fluid sampling facilitates testing in many settings, such as outreach or prevalence surveys in remote locations, where drawing blood is difficult or even impossible.”

Saveliev said his company intends to deliver no fewer than 500,000 tests to the Russian Federation over the next 12 months, and said it is confident that “the need for these products can be [even] greater.”

Roger Gale, CEO and chairman of Calypte, said, “While HIV testing in Russia is already extensive, our recently approved Aware HIV-1/2 oral fluid rapid test overcomes several barriers to testing. As a non-invasive test ... we believe it will form the basis for a quality post-testing counseling system — for prevention as well as treatment.”

According to the 2006 Report on the Global AIDS Epidemic jointly published by the Joint United Nations Program on HIV/AIDS and the World Health Organization , there are 940,000 people living with AIDS in the Russian Federation (as of the end of 2005). WHO said the number of people officially registered with HIV increased almost 100-fold in the past eight years, from 3,623 cases in 1997 to about 350,000 cases by the end of 2005.

The 2006 report said Russia now has an HIV/AIDS epidemic that is both the biggest in Europe and said to be the fastest-growing in the world. Calypte said it believes that its non-invasive OTC test can have “an immediate positive impact on the effort to increase diagnosis and treatment of HIV/AIDS in this region.”

Uroplasty adds EasyCont device to portfolio

Uroplasty (Minneapolis) reported signing an exclusive agreement with SI.EM (Milan, Italy) to distribute that company’s EasyCont P/Q urodynamic diagnostic device. With the agreement, Uroplasty retains exclusive distribution rights in all countries except Italy.

The company said it plans to begin marketing the EasyCont device in certain western European countries and the UK in early 2007.

SI.EM developed the EasyCont, which includes a proprietary Q-Tip device, for the diagnosis of urinary incontinence. The self-contained compact device enables the performance of fast and repeatable diagnostic tests in the office, outpatient clinic or hospital outpatient unit.

David Kaysen, president/CEO of Uroplasty, said, “The EasyCont is a significant addition to our portfolio of office-based solutions for voiding dysfunctions. We expect it will enable gynecologists, uro-gynecologists and urologists to determine the optimal treatment for patients suffering from urinary incontinence.”

Kaysen said the diagnostic device will complement the use of other uroplasty products such as its Macroplastique bulking agent, indicated for the treatment of stress urinary incontinence primarily due to intrinsic sphincter deficiency; the I-Stop Sling, indicated for the treatment of stress urinary incontinence due to bladder hypermobility; and the Urgent PC, indicated for the treatment of symptoms of overactive bladder.

Chinese accreditation for company’s lab

China Sky One Medical (Los Angeles) has been notified that the R&D center of Harbin First Bio-engineering , a subsidiary of China Sky One , has been named by the Heilongjiang Provincial Science and Technology Department as one of the key provincial laboratories in the province.

It said this designation is a result of the company’s advanced laboratory equipment, strong research department and intellectual property.

The company’s subsidiary was chosen from more than 1,000 laboratories that have submitted applications during the 2006 calendar year. The Heilongjiang Provincial Science and Technology Department has authorized 15 applicants as provincial-level key laboratories, of which four designated key laboratories are in the medical industry, including Harbin Bio-engineering.

Each laboratory selected as a provincial key laboratory will be entitled to receive awards in a number of forms, including non-refundable financial support for laboratory construction, in amounts to be determined, and funding for annual research and development projects, as well as preferential policy support for selected projects.