General Electric (GE; Fairfield, Connecticut) and USP Hospitales (Barcelona, Spain), Spain’s largest hospital group, signed a strategic agreement last month to join forces and resources for the next 10 years in order to achieve what the companies referred to as “maximum efficiency and optimum quality of service.” GE said this is the first time it has signed an agreement of this type outside the U.S., one that establishes collaboration in all spheres in which the company operates. Although most of the projects will be with GE Healthcare (Chalfont St. Giles, UK), the agreement involves all of GE’s sprawling list of businesses.

“This collaboration will evoke within this industry less of a push for finding a single cure for illnesses as they appear but rather embrace a more holistic, long-term and personalized approach in order to predict, diagnose, inform and treat,” the companies said. GE’s expertise in diagnostic imaging, information technologies, medical diagnosis, patient monitoring systems, research into disease, and R&D in medicines and biopharmaceuticals, is focused toward detecting illnesses at an early stage and to treating those diseases with treatment tailored to each patient.

USP Hospitales has 23 health centers located in the cities of Barcelona, La Coru a, Madrid, Marbella, Murcia, Santa Cruz de Tenerife, Seville and Vitoria. With 1,800 employees and 1,350 doctors, the company’s facilities treat more than 1 million patients (including 180,000 inpatients) each year. Some 70,000 surgical procedures, 8,500 births and 200,000 emergency cases are treated at those facilities annually.

Under the agreement, which the companies said is the only one of its type in Europe, GE Healthcare will provide equipment, technology and services, best practices for clinical excellence and financing solutions. The company said that with more firsthand information available to it from USP Hospitales, it would be able to anticipate forthcoming needs and provide customized solutions to the hospital sector, thereby allowing USP’s facilities to benefit from the latest innovations.

The companies said their strategic partnership would make possible improved technological, industrial and financial planning, “by optimizing resources and anticipating the needs” of all USP Hospitales facilities. “We believe that healthcare must be personalized,” said Miguel Eslava, president of GE Healthcare’s Spain business unit. “One day we will be able to use genetic information to ascertain the genetic antecedents of each person and his or her predisposition to a disease.” He said the company’s objective is “to detect the disease before it appears. We want to provide the right treatment to the right patient at the right time.”

The first center in which all the terms of the agreement will fully apply will be the USP Institut Universitari Dexeus (Barcelona), which is under construction and due to open in 2007. The new hospital will become the most technologically advanced center in Spain, the companies said, including equipment for diagnosis and treatment or research. Two other USP Hospitales centers currently under construction – a new building attached to USP San José Hospital (Madrid) and a new outpatient surgical center of USP Sagrado Coraz n Clinic (Seville) – also will benefit from the agreement.

GE Healthcare also said last month that it has received a contract award from the Chilean Health Ministry to make the company’s advanced imaging technology available to thousands of patients in that country.

The company said its wide variety of “breakthrough” healthcare technologies would help physicians diagnose a broad range of diseases throughout Latin America. GE Healthcare said that under the terms of the long-term sales and service agreement, it will provide Chilean hospitals with technologies and services that simplify workflow, enhance diagnostic certainty, and improve outcomes.

The GE technologies that will help Chilean physicians provide better care for patients with Parkinson’s disease, diabetes, cancer and heart disease include:

* Three 1.5T ExciteXC HD MR systems, advanced MRI systems that offer patients more sophisticated exams, such as functional imaging and spectroscopy.

* Four Lightspeed Ultra systems, computed tomography systems that provide clinicians with a feature called variable speed scanning, which offers greater flexibility to customize patient procedures and perform new types of patient exams.

* The first Innova 2100 in Latin America, which will help physicians view and treat potential coronary artery blockages that could cause heart attacks or other serious cardiovascular damage.

In other GE Healthcare news, the company and Daiichi Pharmaceutical Co. Ltd. (Tokyo) have executed a collaboration agreement for the research and development of non-nuclear contrast media. The Japanese firm launched Omnipaque, a contrast media for X-ray and computed tomography (CT) examinations, under license from GE Healthcare in 1987. It also has marketed in Japan the Omniscan MRI contrast media, launched in 1996, and Visipaque, a X-ray contrast media launched in 2000.

In addition to these licensed products, Daiichi has collaborated with GE Healthcare since 1988 on the R&D of non-nuclear contrast media to obtain development candidates. It submitted Sonazoid, an ultrasound contrast media, for regulatory approval in Japan in May 2004.

Peter Loescher, president and CEO of GE Healthcare BioSciences, said, “With this agreement, GE Healthcare will continue to explore opportunities for the development of new contrast media for the Japanese market, where our strategic partner Daiichi Pharmaceuticals has a very strong foothold. Daiichi will simultaneously have rights to new products and can continue utilizing its core skills in clinical development, manufacturing, marketing and sales of imaging products in Japan.”

EC clears J&J deal for Guidant

Johnson & Johnson (J&J; New Brunswick, New Jersey) said it has been notified that the European Commission (EC) has cleared its proposed acquisition of Guidant (Indianapolis).

That deal was valued at $25.4 billion when it was unveiled last December, but the troubles Guidant has had this year with recalls of several models of its implantable cardioverter defibrillators (ICDs) may impact the final valuation.

As part of the clearance by the EC, Johnson & Johnson has agreed to divest its Cordis (Miami Lakes, Florida) steerable guidewires business and Guidant’s Endovascular Solutions (Menlo Park, California) busi-ness in Europe. J&J also said that “remedies addressing overlap in the endoscopic vessel harvesting product lines are also being pursued.”

CE mark for DuraSeal system in lung surgery

Confluent Surgical (Waltham, Massachusetts) said it has received the CE mark for the DuraSeal Sealant System for use as a surgical sealant during elective pulmonary resection as an adjunct to standard closure techniques of visceral pleural air leaks. The company said about 300,000 lung resection procedures are performed worldwide each year and about 80% of those cases result in at least some level of air leak.

Confluent said that by providing an airtight seal in lung surgery, DuraSeal Sealant offers surgeons operating on the lung a valuable tool to prevent post-operative complications associated with alveolar air leaks. The device involves a synthetic, absorbable hydrogel delivered by a dual-syringe applicator. It can be stored at room temperature and prepared in less than two minutes. When sprayed on the pleura, a strong, adherent hydrogel is formed that effectively seals the suture or staple line within seconds, the company said.

Confluent said a feature unique to the DuraSeal Sealant is its blue colorant, which provides the thoracic surgeon “excellent visualization of coverage and thickness of the material upon application to the lung.” Postoperatively, the DuraSeal Sealant continues to seal the resected site as healing progresses under the gel. After several weeks, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.

Adlyfe gets UK grant for prion disease test

Adlyfe (Rockville, Maryland), a privately held firm that is focused on early diagnostics for animal and human brain diseases, reported being awarded a $650,000, two-year grant from the UK Department of Environment, Food and Rural Affairs (DEFRA) for continued development of a sensitive early blood test for animal prion diseases. Misfolded prion proteins are correlated to sheep scrapie disease, “mad cow” disease in cattle, chronic wasting disease in deer and elk, and Creutzfeldt-Jakob disease in humans.

DEFRA is the UK agency whose mission is to fund emerging technologies that can thwart the spread of animal and human disease. The agency has a long history of supporting R&D in chronic diseases that impact animal and human health, along with the safety of the food supply and the environment. The grant award is focused on addressing issues in the development of the Adlyfe test that will enable early blood detection and live animal screening for disease in both sheep and cattle.

Adlyfe will work in collaboration with the Moredun Institute (Penicuik, Scotland), a leading research institute in the field of animal disease.

“This is an important step for our company to broaden our international base of support and collaboration for development of our test for prion diseases,” said Alan Rudolph, CEO and president. He added: “These diseases are global, with significant impact on animal and human health. “

Kyphon gets OK for Japanese trial

Kyphon (Sunnyvale, California) said last month that it has received approval from the Japan Ministry of Health, Labor and Welfare’s Organization for Pharmaceutical/Medical Device Safety and Research (also known as KIKO) to enroll patients in a clinical trial to treat spinal fractures with the balloon kyphoplasty procedure.

The company’s KyphX products are used in balloon kyphoplasty, a minimally invasive procedure to treat spinal fractures caused by osteoporosis or cancer. Richard Mott, president and CEO, cited the large market potential for kyphoplasty in Japan, “given the current lack of surgical therapies for treating vertebral compression fractures.”

Kyphon said approval of enrollment to start the trial represents “a significant step” toward its ability to serve the Japanese patient population that suffers an estimated 500,000 new vertebral compression fractures each year due to osteoporosis, one of the highest fracture rates in the world.

About 80 patients with vertebral compression fractures are projected to be enrolled in the single-arm study in up to six centers, with enrollment anticipated to begin before year-end and completion expected in 2006. Patients enrolled in the trial will be observed for up to two years. Kyphon said data from the trial, in addition to data obtained from studies previously completed in the U.S. and Europe, would be used to support an application for regulatory approval for kyphoplasty in Japan.

The company said this is the first clinical trial application approval KIKO has authorized for medical devices in the spine under Japan’s new good clinical practice guidelines, which went into effect in April.

Fonar reports German market entry

Fonar (Melville, New York) has reported the sale of its first Upright MRI in Germany, marking the company’s entry into that country, the largest market for medical devices in Europe. Raymond Damadian, company president and founder, said, “With the increasing recognition of Fonar’s Upright MRI as the most advanced MRI technology for optimal pathology and patient care, competitive markets such as Germany are ideal for our enhanced sales initiatives. We intend to leverage our technological edge and our entry into Germany to capitalize on this market, with its installed base of approximately 1,200 MRI units.”

Fonar has been increasing its marketing efforts in the European market this year, selling four Upright MRIs there during FY05 compared to a total of just two prior to that. Its latest Upright MRI customer is a radiology medical practice based in Cologne, Germany. The company said the customer selected the Fonar unit after extensive research, with particular focus on the diagnostic advantages of position imaging (pMRI), which is available only on the Upright MRI.

South Korean distributor for CTLM

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) reported the appointment of LeoMedics as exclusive distributor of its CT Laser Mammography (CTLM) in South Korea.

“LeoMedics has a history of excellent customer service and a broad medical product line,” said Janusz Ostrowski, IDSI’s vice president of international sales. “Their business model supports the expansion of their medical product line into breast imaging via our revolutionary technology. We expect them to establish a CTLM clinical site very soon.”

He added: “With a population approaching 50 million, South Korea faces the challenges of screening for and diagnosing breast cancer. Breast cancer is one of the most prevalent types of cancer for women in South Korea, with the number of deaths from the disease increasing annually.”

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