A Medical Device Daily

Nine-month clinical follow-up results of the HEALING II study involving the Genous R stent from Orbus Neich (Fort Lauderdale, Florida/Hong Kong) were presented earlier this week at the 15th annual Singapore Live congress by Robbert de Winter, MD, PhD, director of the catheterization laboratory at Academic Medical Center (Amsterdam, the Netherlands).

The objective of the 10-center, 63-patient study is to demonstrate the safety and stent-related healing response to the Genous stent, which received the CE mark last August.

In a statement, the company noted that the Achilles’ heel of stenting, restenosis, has been “significantly reduced” with drug-eluting stents (DES), but that restenosis has been supplanted by stent thrombosis due to “purposely delayed” healing.

Orbus Neich said such stents require long-term, dual-antiplatelet therapy, “which if discontinued prematurely may result in stent thrombosis, with its inherent high mortality rate.”

The company said its Genous device is the first stent designed to accelerate the natural healing response by capturing a patient’s own endothelial progenitor cells (EPCs) from the bloodstream. “Once captured, EPCs rapidly form a protective endothelial layer over the stent, providing protection against thrombus and minimizing restenosis,” it said.

de Winter said the nine-month study results demonstrated a clinically driven target lesion revascularization rate of 6.3% and a major adverse cardiac events rate of 7.9%. No sub-acute or late thrombosis was reported despite the protocol recommendation of only one month of dual-antiplatelet therapy.

“Tellingly, there were no additional events since the six-month angiographic follow-up, indicating that the healing process was stabilized,” he said.

OrbusNeich sells medical devices for vascular disease in more than 60 countries through sales offices in 10 countries, manufacturing operations in the Netherlands and China, and research and development facilities in the U.S. Its product portfolio includes the R stent, the Avita PTCA dilatation catheter and the SafeCut dual-wire dilatation catheter.

Orthofix restructuring international operations

Orthofix International (Huntersville, North Carolina) said it is restructuring its international business operations to better serve customers outside the U.S. The move will create three distinct business zones: Europe, Asia/Pacific and Emerging Markets, which will be organized to address customer needs and opportunities within specific geographic markets.

The company said the realignment would enhance its ability to focus on core market segments, while also ensuring that regional customer requirements are incorporated into the design and distribution of its products and therapies.

Chief Operating Officer Alan Milinazzo, who will succeed CEO Charles Federico in April, said: “In addition to providing enhanced customer and product service, this structure will allow us to leverage our distribution channel to its fullest, creating synergies at the country and customer level.”

He added that the move also allows the company’s field organization “to focus purely on satisfying customer needs at the local level, providing additional opportunities to grow both our market presence and our market share.”

Orthofix also reported the acquisition of International Medical Supplies Distribution GmbH (Cologne, Germany). It said the acquisition is primarily expected to enhance growth opportunities for the German and Austrian operations of BREG , a wholly owned subsidiary of Orthofix specializing in bracing, cold therapy and pain management products, by enhancing its market visibility, improving control over distribution of its products and increasing profit margins.

“We believe there are numerous opportunities for Orthofix’s profitable expansion in Europe, and this acquisition, on top of our restructuring, is a good opportunity for us to leverage our presence in markets where our BREG subsidiary currently delivers products,” said Federico.

Milinazzo added, “Our long-term growth strategy includes not only organic growth through new product introductions, but also through opportunistic acquisitions in markets where we believe there will be increased patient demand in the coming years. This acquisition strategy involves a targeted approach intended to address the specific needs of various regional healthcare communities in Europe.”

Orthofix offers a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, reconstruction and trauma market sectors.

Chembio cites advances in Nigeria, Ethiopia

Chembio Diagnostics (Medford, New York) said the Nigerian Ministry of Health has designated the company’s HIV 1/2 Stat-Pak as a screening test in four out of the eight testing protocols that comprise Nigeria’s Interim National Testing Algorithm.

The company said Nigeria initially is implementing a parallel-testing algorithm, and as such uses two screening tests from different manufacturers on each patient tested. It said the program is being launched “very soon” to quickly and accurately identify HIV positive individuals so that the nation’s treatment goals can be achieved.

Chembio noted that Nigeria is Africa’s most populous country, with an estimated 135 million inhabitants. It has an estimated 3.6 million HIV-infected individuals, of whom only 28,500 are currently receiving anti-retroviral treatment, according to a recent report to Congress by PEPFAR, the acronym for President George Bush’s $15 billion Emergency Plan for AIDS Relief.

PEPFAR’s goal is for 350,000 Nigerians to receive anti-retroviral treatment by 2008.

Chembio said rapid HIV tests that allow patients to be screened and confirmed at the point of care will help in Nigeria’s efforts to scale up testing and thereby meet its treatment goals more rapidly.

It said that in addition to the PEPFAR targets, the Nigerian National AIDS Control Administration is aiming to put 250,000 people on anti-retroviral viral treatment as soon as possible.

Chembio said estimates by the Global Business Coalition on HIV/AIDS and other experts indicate that on average some 100 people need to be tested in order to identify one person eligible for treatment. This results in a projected need for 35 million patients to be tested just to meet the goals established by PEPFAR for Nigeria.

“We . . . believe that millions of individuals will need to be tested in order to identify HIV patients suitable for ARV treatment and to meet treatment targets,” said Avi Pelossof, Chembio’s vice president of sales, marketing and business development.

In late 2005, Chembio established Chembio Diagnostics Nigeria Ltd. , a wholly owned subsidiary headed by Dr. Joseph Nnorom, MD, who previously was the medical epidemiologist of the U.S. Centers for Disease Control and Prevention (Atlanta) Global AIDS Program in Nigeria.

In other news, Chembio said it has appointed Setema Ltd. as distributor of its rapid HIV tests in Ethiopia. Ethiopia has a population of more than 73 million, of which an estimated 1.5 million are infected with HIV.

As part of a planned scale-up of rapid testing programs, Ethiopia is currently evaluating rapid HIV tests, including Chembio’s two HIV 1/2 Stat-Pak tests, for possible inclusion in Ethiopia’s testing protocol.

Chembio said Setema is one of the largest medical device distributors in Ethiopia and the country’s sole supplier of HIV viral load tests, which monitor patients already identified with HIV to determine if and when they require anti-retroviral therapy.

New Australian facility for Xytos

Xytos (Indianapolis), which introduced a new cancer diagnostic procedure and treatment in November of last year, said it has completed the purchase of a new medical facility in Mulgrave, a suburb of Melbourne, Australia.

The company said the new facility represents “a major step forward in our aggressive goal to globalize our next-generation biomedical technologies.”

Xytos said the facility would allow it to “significantly increase the number of patients that need treatment in Australia and Southeast Asia.” It will also, it said, “allow us to assist patients from other areas of the world who are in need of treatment while Xytos is preparing to open other treatment centers worldwide.”

The company said the Australian facility would be renovated to include two surgery theaters dedicated specifically to training in its new technologies. The facility will have on-site viewing in each surgical theater, as well as closed-circuit televisions for training Xytos doctors and medical staff elsewhere in the world.

Xytos is focused on research, development and introduction of procedures in the areas of stem-cell therapies, tissue engineering and cellular medicine.

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