BB&T

STUTTGART, Germany — The European economy that is built on medical technology now tops e155 billion annually ($83.6 billion), and Germany accounts for two-thirds of that trade, a whopping e135 billion ($53.2 billion). And like any healthy economy, two-thirds of Germany's med-tech bus-iness comes not from giants like Siemens (Erlangen, Germany) or Draeger (Lubeck, Germany), but instead is built upon myriad small- and medium-sized businesses that rarely make headlines and almost always are privately held, never reporting sales figures.

About 1,200 of these manufacturers are located in Germany, according to figures from by the U.S. Department of Commerce, and their robust, export-driven business contributes substantially to the country's vigorous economy and positive trade balance that makes it the envy of its neighbors.

Germany is known internationally for its precision manufacturing, that prowess well represented at the MedTec 2008 exposition in the new Stuttgart Landemesse, with 650 companies sprawled across 110,000 square feet of space. MedTec offers a view far upstream in the flow of technology toward clinics and patients.

• Visitors to the exhibit space for Kl ger Spritzguss (Dornstetten, Germany) were fussing over pellets of aluminum oxide and zirconium that one day may be used to form the medical-grade ceramic tip encased in an endoscope. The final endoscope tip on display was all but ignored. The company's Jens Graf said the pellets are a problem-solver for medical device designers due to their bio-friendly qualities, combined with an ability to withstand high temperatures, extreme durability and resistance to chemicals that would be encountered in sterilization of an endoscope, for example.

The pellets lend themselves to injection molding of components as small as the head of a needle that feature both internal and external geometries in a single-shot extrusion while withstanding tolerances for thin wall-thicknesses.

• Micro Precision Systems (MPS; Biel-Bienne; Switzerland) is the manufacturer of an implantable titanium pump used for Medtronic's (Minneapolis) SynchroMed II drug infusion pump that precisely delivers a prescription according to pore-programmed instructions.

"We build the key component and it is assembled in Minneapolis," said Markus Hug, project manager for MPS, showing a second generation of the pump weighing a mere half-ounce. "It is titanium, which weighs nothing but is extremely durable," he saiWe are studying how to make it even smaller, of course, and to make it cheaper. We have to do so — we are always doing so." The third generation is still four years from market.

• W.C. Heraeus Medical Components Division (Hanau Germany), specializing in precious metal alloys for implantable devices, makes electrodes that give the life-saving impulses to the heart in pacemakers, as well as the wire from the pacemaker to the electrode.

Alexander Syndikus said he is not allowed to say which manufacturers use the products, "but it is safe to say that our components are used on at least six different models. And for pacemakers where we are not the direct supplier, we sell the components, such as the wires, to those companies that have the direct contract with a manufacturer."

• Heinz Busch from NTTF (New Technologies for Thin Films; Rheinbreitbach, Germany) is betting the future of his small company of eight employees on a new hydrophilic solution for titanium. While the first product application is for a dental implant that went into a testing phase mere weeks ago, titanium screws are used to hold implants throughout the human body, he said, in spines, knees and hips.

In the first minutes of screwing titanium into the bone, blood needs to have a good contact against the surface of the screw at every encounter point, Busch said. An enhanced biocompatibility through hydrophilic properties will accelerate healing from four months to six weeks and greatly reduce the risk of complications from infection. However, liquids bead up on titanium, as it is naturally hydrophobic. NTTF's solution reduces the angle of the liquid bead from 85 degrees to near zero.

"We are now looking for a partner to take this to market," said Busch, who said that he had his first meeting with a distributor on the first morning of MedTec.

He said NTTF launched another surface coating last year that is returning excellent results from follow-on studies and is reducing costs to the German healthcare system for treatment of urinary infections in women after implantation of a urethral stent.

Molecular imaging facility opened in China

Siemens Healthcare (Hoffman Estates, Illinois) reported the establishment of its first molecular imaging biomarker production facility in Chennai, India. The company said the new facility will enable healthcare providers in and around Chennai to access the positron emission tomography-computed tomography (PET-CT) technology to diagnose patients with life-threatening diseases, such as cancer and cardiac and neurological ailments.

PETNET Solutions, a fully owned subsidiary of Siemens Medical Solutions USA (Malvern, Pennsylvania), operates the largest PET radiopharmacy network, with 49 radiopharmacies and distribution centers in the U.S., South Korea and the UK that produce and distribute PET radiopharmaceuticals to hospitals, clinics and research facilities for PET imaging.

The new facility in Chennai "will produce and supply the required radiopharmaceuticals to hospitals that have positron emission tomography-computed tomography facilities, which will help ease the burden of healthcare providers to produce their own radiopharmaceuticals," Siemens said.

The Indian facility will feature a Siemens Eclipse HP cyclotron and will be Siemens' first molecular imaging biomarker production facility in India.

Mindray to buy Datascope's patient monitoring unit for $202 million

Mindray Medical International (Shenshen, China) said it will acquire the patient monitoring business of Datascope (Montvale, New Jersey) for $202 million in cash.

During a conference, Xu Hang, Mindray's co-CEO and chairman called it a "landmark deal," allowing Mindray to "overnight, dramatically, expand our on-the-ground presence in the U.S. and Europe."

Hang said the acquisition would create the third-largest player in the global patient monitoring device industry. Datascope's patient monitoring business brought in revenues of $161.3 million in 2007, roughly the same revenues generated from Mindray's home China market, the company noted.

The deal has been approved by the boards of both companies and is expected to close in 2Q08. The transaction is expected to be accretive to Mindray's EPS on a non-GAAP basis starting in 2009, the company said.

"We are confident that this deal will create excellent value for our shareholders, the customers of both companies, and the patients who will ultimately benefit from greater access to the highest quality, most affordable, medical devices anywhere," Hang said.

Mindray CFO Joyce I-Yin Hsu told listeners the deal includes Datascope's patient monitoring business, its manufacturing facility in Mahway, New Jersey, trademarks, its global technology services business associated with the patient monitoring business, its direct sales force, intellectual property, and its Netherlands warehouse facility.

In addition to broadening Mindray's international presence and increasing its U.S. operational footprint, Hsu said the deal is expected to increase Mindray's 2007 revenue base by more than 50%.

"We have acquired a strong and well-known brand name in the U.S. and Europe," she said. "Under the current licensing deal we can continue to use [Datascope's] brand until 2015. The current manufacturing base which we will be purchasing as part of this transaction in Mahway, New Jersey, is going to be a very important strategic base for our global business going forward."

Metabolon collaborating with European insulin study group

Metabolon (Research Triangle Park, North Carolina), a company focused on metabolomics-driven biomarker discovery and analysis, reported a collaboration with the European Group for the Study of Insulin Resistance (EGIR; Pisa, Italy).

EGIR reports that it has compiled large numbers of biological samples from studies conducted at 19 clinical research centers across Europe in an effort to understand insulin resistance and how it affects disease. Metabolon will discover and validate the biomarkers found in these samples that relate to insulin resistance. Those markers will be used to help further develop Metabolon's diagnostic test for pre-diabetic patients.

"This collaboration with EGIR will help Metabolon accelerate the development of Quantose IR, our diagnostic test for better screening of pre-diabetic patients," said Dr. John Ryals, president/CEO of Metabolon. "This routine test will help identify pre-diabetic patients years before they become diabetic. With this information in hand, doctors can intervene with lifestyle or drug therapies which may delay or prevent the onset of Type 2 diabetes."

Insulin resistance is estimated to affect about one-third of the adult population in the U.S. alone — about 75 million people. One of the primary contributors to the development of Type 2 diabetes, insulin resistance is characteristically an asymptomatic condition that precedes the development of diabetes by many years.

"We are [pleased] to be working with Metabolon in analyzing our samples," said Dr. Ele Ferrannini, principal investigator at the University of Pisa and coordinator of the EGIR's Relationship between Insulin Sensitivity and Cardiovascular Disease project. This biomarker discovery platform "will give us valuable insight into the biochemical changes related to insulin resistance," he said.

EGIR is a group of investigators with a range of research backgrounds — epidemiology, endocrinology, basic science and public health — interested in insulin resistance.

Product approvals

S&N's Oxinium alloy wins regulatory approval in Japan

The Orthopaedic Reconstruction (Memphis, Tennessee) business of Smith & Nephew (S&N; London) reported Japanese regulatory approval of its Oxinium oxidized zirconium technology, a proprietary transformed metal alloy with a ceramic-bearing surface. The material provides low friction and wear resistance combined with the strength of a metal implant, S&N said.

The company said that it is the only orthopedic company to offer this joint replacement material. It said Oxinium is the only orthopedic implant material to receive the ASM International Engineering Materials Award for outstanding achievement of a material used in the design and manufacture of products.

The approval marks the first time the Oxinium technology will be available in the world's second largest orthopedic market, S&N Orthopaedic said. The company's Genesis II knee system, which has been used in more than 500,000 surgeries worldwide and has 10-year clinical data showing 98% survivorship, will be the first implant system available in Japan with Oxinium.

Joseph DeVivo, president of S&N Orthopaedic, said, "Our premier technology is revolutionizing joint replacement around the world by providing and maintaining unparalleled wear resistance" and the material "has proven to be a superior metal in implants .... Japanese physicians and patients ... have been anxiously awaiting this approval."

The first Oxinium oxidized zirconium component was implanted in 1995 and more than 230,000 hip and knee components have since been implanted.

• Deep Breeze (Beijing), a developer of what it bills as Vibration Response Imaging (VRI) technology, said that China's State Food and Drug Administration (SFDA) has approved the registration of its VRIxp device. VRIxp is a non-invasive, radiation-free imaging system that creates dynamic functional imaging of the lungs. It was approved for assisting in the diagnosis and management of patients suffering from respiratory complaints.

The VRIxp device records lung vibrations from sensors applied to a patient's back. The system then uses an algorithm to convert these data into a dynamic functional image. Changes in tissue composition and airflow affect the vibration intensity, dynamics and distribution within the lung which are then reflected in the image produced by the VRIxp system.

Deep Breeze said the system has been designed for the management and diagnosis of lung diseases such as COPD, lung cancer, pleural effusion and airway obstructions. It said better management "can accelerate the commencement of improve patient treatment." The company will market the product, via Ultimate Science Technology, to specialists and physicians at hospitals, clinics and screening centers.

• Abbott Laboratories (Abbott Park, Illinois) reported receiving CE-mark approval for a 2.25 mm version of its Xience V everolimus-eluting coronary stent system that it said offers physicians a smaller stent "based upon the proven efficacy and excellent deliverability of Xience V." The company said the addition of the 2.25 mm stent to the Xience V portfolio "gives physicians access to a wider range of stent sizes for treating a variety of patient types."

Charles Simonton, MD, divisional VP, medical affairs and chief medical officer of Abbott Vascular (Redwood City, California), said, "With Xience V 2.25 mm, physicians now have access to a smaller stent that combines [key] attributes with the safety outcomes we have seen with Xience V.

The 2.25 mm stent will be launched immediately in the majority of European markets and select countries in Asia and Latin America. Xience V also is available in diameters of 2.5 mm, 2.75 mm, 3.0 mm, 3.5 mm and 4.0 mm for lesions 28 mm or shorter.

From 30% to 40% of coronary lesions occur in arteries 2.5 mm or less in diameter.

Xience V was launched in Europe and other international markets in late 2006. It is under review by the FDA.

• St. Jude Medical (St. Paul, Minnesota) reported regulatory approval from Japan's Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, of the SJM Tailor Flexible Ring and SJM Tailor Flexible Band, the company's first products in Japan for repairing diseased heart valves. The Tailor Flexible Ring and the C-shaped Tailor Flexible Band are designed to provide surgeons with a range of easy-to-implant options for the repair of the heart's mitral and tricuspid valves.

The Tailor Flexible Ring and Band are designed to accommodate the natural movement of the annulus, and St. Jude said physicians can tailor the products to meet precise patient needs. The Ring provides anterior and posterior support of the valve while allowing necessary motion as the valve opens and closes.

In 2005, the number of valve repair procedures performed in Japan increased more than 20% from the prior year, to nearly 6,400 procedures, according to statistics on thoracic and cardiovascular surgery (as reported in the September 2007 issue of General Thoracic and Cardiovascular Surgery). And surgeries to repair faulty valves are likely to increase as the average age of the population increases.