A BB&T

Sorin Group’s (Milan, Italy) Cardiac Rhythm Management (CRM) business unit, which is focused on the hemodynamic management of congestive heart failure (CHF), said the first patient has been enrolled in the CLEAR (Clinical Evaluation of Advanced Resyn- chronization) multicenter clinical study.

Patients included in the CLEAR study have advanced heart failure, which Sorin said affects 10 million Europeans and more than 22 million people worldwide and is expected to almost triple in 2020.

The objective of the CLEAR study is to prove that the PEA (Peak Endocardial Acceleration) sensor, a feature of Sorin’s NewLiving CHF pacemaker, helps physicians to optimize delivery of cardiac resynchronization therapy (CRT) without having to perform lengthy assessment procedures.

In current clinical practice, CRT settings are customized through an echocardiography-based procedure, but Sorin said that with PEA sensor, “physicians no longer need to conduct time-consuming echocardiographic assessments.”

The company said the NewLiving CHF pacemaker analyzes the signal generated by the PEA sensor, which reflects the strength with which the heart contracts, to tailor programming of CRT settings to individual patients in order to maximize therapy efficacy. “Optimal CRT settings can be determined during standard pacemaker checks, which dramatically simplifies patient follow-up,” Sorin said in a press statement.

The first patient, who was enrolled in the CLEAR study on Nov. 25, was a 74-year-old woman in NYHA Class III with a history of congestive heart failure due to ischemic cardiomypathy. The NewLiving CHF implant took place at St. Adolf-Stift Hospital (Reinbek, Germany).

Dr. Herbert Nagele, the study investigator at the hospital, said: “This study will be of particular interest to the cardiologist community because it will confirm that with PEA, heart failure patients can be better managed without having to undergo resource- and time-consuming procedures.”

The CLEAR study is a randomized, single-blind study, with advanced heart failure patients implanted with Sorin’s NewLiving CHF and randomized to two groups. In the first group, a PEA-based optimization of CRT settings will be performed at each follow-up visit, while in the second group those settings will be programmed according to the investigating center’s standard clinical practice.

The study is designed to demonstrate the superiority of the PEA-based approach regarding NYHA class and quality of life improvement, as well as reduction of heart failure-related hospitalizations. A secondary objective is to show that PEA trends stored by NewLiving CHF allow assessment of the patient’s clinical status, especially before and during acute heart failure episodes.

The study will enroll 310 patients at 57 sites in six European countries – Italy, Spain, France, Germany, the UK and the Netherlands. Enrollment is anticipated to be completed by mid 2007. The principal investigator is Dr. Philippe Ritter of InParys (Saint Cloud, France).

Andre-Michel Ballester, president of Sorin Group Cardiac Rhythm Management, said, “We believe CLEAR will change the patterns of patient management in the field of heart failure. This can potentially improve patient care, outcomes and reduce healthcare costs.”

NewLiving CHF was launched in Europe in early October. The device is not available for sale in the U.S.

NewCorTec in EUR 5.8M financing round

NewCorTec (Pomezia, Italy), which is developing a ventricular-assist device (VAD), reported the closing of a financing round totaling EUR 5.8 million. The company’s founding investor is Quantica SGR (Milan, Italy), a venture capital firm specializing in investments in technology-driven projects. Banca Intesa Private Equity also participated in the first-round financing.

NewCorTec, established earlier in 2005, is a spin-off from Tecnobiomedica (also Pomezia), whose VAD business unit had been working for several years on development of a fully synchronous left ventricular assist device.

The new funds will be used to complete device development, in vivo testing and preliminary clinical trials to reach CE marking.

According to Professor Luigi Donato, chairman of NewCorTec, the company is now on track to achieve its goals and prove the longer-term efficacy of the new device not only as a bridge to transplant or as destination therapy, but also as a “formidable tool providing surgeons and clinicians a superior technological platform for recovery therapy.”

Shareholders of NewCorTec include Quantica SGR, Banca Intesa PE, Tecnobiomedica, Umbra Cuscinetti, Tecnobiomedica, Bio Engineering Laboratories and members of the senior management team.

The company’s CEO is Romano Ferrari, an international healthcare executive who previously held top management positions with the Sorin Group, Baxter Healthcare/Edwards Lifesciences and AVE-Medtronic. Ferrari told Biomedical Business & Technology that the company’s VAD, a pulsatile, electromechanical device with an implantable blood pump, is designed to always operate in synchronous counterpulsation.

A unique feature, he said, “is a device that enables the ‘retraining’ of the native heart by gradually increasing the ventricle afterload.” The goal is to allow clinicians to favor a possible recovery therapy.

Ferrari said the device has been extensively bench-tested for periods of up to three years. “We also have [conducted] numerous animal trials with up to five months’ follow-up.” A limited series of animal implants currently is being conducted as part of completing pre-clinical regulatory filings.

He said NewCorTec anticipates beginning clinical trials in humans in 3Q06, with those trials supporting the company’s CE mark filing.

Medical Intelligence adds to Elekta line

Elekta (Stockholm, Sweden) reported the acquisition of Medical Intelligence Medizintechnik GmbH (MI; Schwabmuenchen, Germany) in a cash deal valued at EUR 20 million. Medical Intelligence is a supplier of radiation oncology and interventional guidance products for precise patient positioning and treatment. The company’s product lines include non-invasive immobilization and positioning systems and also robotic treatment couches.

A leading global provider of products for advanced radiation therapy, comprehensive cancer management and non-invasive treatment of brain disorders, Elekta said the deal for MI “reinforces [our] leadership in stereotactic radiation therapy (SRT) of the body and in providing complete solutions for image-guided radiation therapy (IGRT) that address the clinical problems of patient and organ movement.”

It said the combination of the two companies would “create opportunities to develop more integrated products that in the future will complete and further differentiate Elekta’s IGRT and SRT solutions.”

Elekta expects the acquisition to add annualized revenues of EUR 10-12 million in the first year and be neutral to slightly accretive to Elekta’s earnings per share.

Tomas Puusepp, president and CEO of Elekta, described the deal as “a highly complementary acquisition,” adding that Medical Intelligence “fits extremely well into the Elekta Group.”

Citing MI’s “cutting-edge technology for patient positioning and immobilization,” he said the German company would become Elekta’s center of excellence for development of such solutions.

MI was founded 10 years ago by Christian Hieronimi and Michael Vogele, MD, who both will remain with the company, now a 100% owned subsidiary of Elekta. The firm has 33 employees.

Elekta noted that IGRT has developed rapidly in recent years, with several linear accelerator (linac) manufacturers having some form of IGRT system in development or clinical use. It said that such development has driven the need for additional equipment that will:

• Support the patient securely in the treatment machine in order to allow high-quality imaging.
• Prevent the patient from accidentally moving during treatment.
• Make automatic fine adjustments of the patient’s position with high accuracy, with the capability to make both rotational and translational corrections.

Elekta said MI’s product portfolio “explicitly addresses all of these needs,” adding that most of the company’s products already are in clinical use with all current designs of IGRT linac systems.

MI’s most recent product is HexaPOD RTC, an image-guided robotic patient positioning system that provides patient positioning with 6 degrees of freedom and sub-millimeter accuracy. Other products include BodyFIX for precise patient immobilization and iBeam carbon fiber tabletop.

Elekta said MI will continue to supply its Medical Intelligence brand products to all suppliers of radiation therapy solutions and also will seek to establish new OEM agreements.

MI’s research and development team will continue the development of positioning and immobilization technology, including optimizing workflow and software interfaces to Elekta Synerg and Mosaiq, the image-enabled electronic medical record developed by its Impac (Mountain View, California) subsidiary.

Bespak plans to acquire U.S. firm

Bespak plc (Milton Keynes, UK) has agreed to acquire King Systems (Indianapolis), a supplier of disposable airway management devices in a deal valued at $95 million ( 54.3 million).

Calling the planned deal “a significant step in implementing [our] new strategy of diversifying into medical devices sold to hospital customers,” Bespak said the acquisition would help refocus it away from what it described as “unpredictable pharmaceutical programs” and should provide “steady cash flow,” the company said.

The $95 million would include an initial payment of $75 million in cash and $10 million in new Bespak shares, based on King attaining $9.3 million in adjusted earnings before interest, tax, depreciation and amortisation (EBITDA) in 2005. A second payment of $10 million in cash would be based on King attaining $11 million in EBITDA in 2006.

Bespak said the cash consideration in the deal would be funded from new borrowing facilities, including a new $35 million term loan facility and a new 40 million revolving credit facility, entered into with the Royal Bank of Scotland, acting as agent for National Westminster Bank.

The acquisition agreement is conditional on shareholder approval by Bespak shareholders, with deal completion expected by Dec. 23.

The UK firm said King’s medical device business is “highly complementary” to Bespak, supplying single-use face masks, breathing circuits and laryngeal tubes used in surgery and critical care settings. Bespak said the acquisition would give it a strengthened footprint in the U.S., where it said King enjoys “good market positions and strong brand recognition.”

King’s 2004 sales were $45.1 million ( 25.8 million). The company has 505 employees at plants in Indianapolis and Kent, Ohio.

Key management will remain in place to assure a successful transition, Bespak said. Kevin Burrow, King’s vice president of sales & marketing, will become president and will report to Mark Throdahl, Bespak chief executive.

Throdahl said: “King will . . . provide a platform for further acquisitions in the U.S. and Europe.”

Bespak’s existing business is focused on developing new delivery systems for the pharmaceutical industry, with a product line including metered dose inhalers, dry powder devices, actuators and compliance aids. It also manufactures drug-delivery devices for pharma firms. Sales in its last financial year were 79.4 million.

HIFU coming to South Africa, Costa Rica

S.A. HIFU Ltd., the South African subsidiary of U.S. HIFU (Charlotte, North Carolina), said it has entered into an agreement with STAAR Pty Ltd. to introduce high-intensity focused ultrasound (HIFU) therapy with the Sonablate 500 for prostate diseases in South Africa.

The Sonablate 500 was developed by Focus Surgery (Indianapolis) and is manufactured by Misonix (Farmingdale, New York). U.S. HIFU is the exclusive distributor of the Sonablate 500 in North, Central and South America, as well as South Africa, and is a minority shareholder in Focus Surgery.

HIFU with the Sonablate 500 is a targeted, outpatient procedure that uses focused sound waves to rapidly heat and destroy tissue within the prostate in a matter of seconds. Treatment is delivered through a transrectal probe after the patient receives epidural or spinal anesthesia. The procedure is bloodless, non-invasive and can be repeated if necessary.

The Sonablate 500 is licensed by the South African Department of Health and the first treatments in that country will take place at the Wits University Donald Gordon Medical Center (Johannesburg). S.A HIFU said it hopes to establish HIFU centers of excellence in the major cities in South Africa.

U.S. HIFU also reported that it has partnered with International Hospital Corp. (IHC) and the CIMA hospital chain to make HIFU available in Costa Rica. HIFU with the Sonablate 500 will first be available in Costa Rica at Hospital CIMA San Jose. CIMA operates private hospitals throughout Mexico and Latin America.

The Sonablate 500 received its CE mark for European distribution in 2001 and is being used to treat patients in the UK, Germany, Italy and other European countries. It is not yet approved in the U.S.

Quintiles opens office in Vietnam

Global contract research organization Quintiles Transnational (Research Triangle Park, North Carolina) has reported the extension of its operations in Asia with the opening of an office in Hanoi, Vietnam.

“Vietnam is an increasingly important market in the region, with its population of 80 million, a strong educational system and a robust healthcare industry,” said Michael Stibilj, Quintiles’ executive director, clinical development services, Southeast Asia. “Economic growth in Vietnam has been averaging more than 7.5% over the past 10 years.”

The country has an urban hospital infrastructure comparable to other Southeast Asian countries, physicians who have trained in Europe or the U.S., and “tremendous motivation to participate in international clinical trials,” Stibilj said.

Quintiles said the Vietnam Ministry of Health recently issued a revised set of guidelines for the conduct of clinical trials, thereby setting a consistent regulatory framework for such trials.

The company said it would work closely with the Ministry of Health to increase the number of sites trained in Good Clinical Practice standards, which are designed to assure the accuracy of information obtained in clinical trials while protecting the rights and confidentiality of patients and other volunteers participating in the trials.

Quintiles has clinical development offices across eight countries in its East Asia region, including China, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. Since 1995, the Quintiles clinical team in the region has completed more than 160 Phase II and III studies from 1,000 sites and recruited in excess of 35,000 patients into international clinical trials.

In addition, Quintiles’ lab operations in Singapore and Beijing have serviced more than 200 studies, with samples shipped in from 15 Asia Pacific countries.

A provider of clinical trial services, market intelligence and partnering solutions to biotechnology, medical device, pharmaceutical and other healthcare firms, Quintiles has 16,000 employees and offices in 50 countries.

Solectron opens facility in Singapore

Solectron (Milpitas, California), a provider of electronics manufacturing and integrated supply chain services, has opened a dedicated medical manufacturing facility in Singapore. The company said its medical center of excellence in Chai Chee, Singapore’s Techno Park, provides medical device manufacturers access to a lower-cost supply base and the rapidly growing Asian medical device market.

Daniel Tan, general manager of Solectron’s Chai Chee site,” said, “Expansion of our medical capabilities to Singapore allows us a critical gateway to Asia from a competitive sourcing and fulfillment perspective. It enables our OEM customers to be strategically positioned to tap into the rapidly expanding demand for medical products in Asia, including refurbishing medical and diagnostic medical equipment and devices for resale in China.”

Initial products manufactured at the site include high-performance liquid chromatographs and fluidics subassemblies.

“This new center in Singapore allows us to provide medical companies unprecedented outsourcing capabilities,” said Marc Onetto, executive vice president, operations. “Working cooperatively with Singapore’s Economic Development board, we are helping to attract medical instrumentation companies to the region. This is another step in our ongoing commitment to meet the needs of our medical customers.”

Solectron utilizes the Solectron Production System, which it said is built upon the fundamentals of Lean Six Sigma manufacturing, to help medical OEMs lower costs, improve quality, increase flexibility and improve time to market.

The company’s service offerings include new-product introduction, collaborative design, materials management, product manufacturing, product warranty and repair, and product end-of-life support. It operates in more than 20 countries on five continents and had sales from continuing operations of $10.4 billion in fiscal 2005.

OraQuick test launched in Mexico

OraSure Technologies (Bethlehem, Pennsylvania) has launched its OraQuick Advance Rapid HIV-1/2 Antibody test in Mexico. The company said the OraQuick Advance is the only FDA-approved and CLIA-waived oral fluid rapid HIV-1/2 test currently available in the U.S., and will be the only oral fluid rapid HIV test available in Mexico.

The OraQuick Advance test will be sold by the company’s exclusive distributor in Mexico, Spite SA de CV, to the National Health Sector, National Council for HIV/AIDS, state HIV programs, non-governmental organizations, hospitals, clinics, physicians and other healthcare providers.

“Mexico is committed to the prevention of HIV/AIDS through increased HIV testing and education,” said Dr. Jorge Saavedra, director-general of the Mexico Center for the Prevention and Control of HIV/AIDS. “Rapid tests such as the OraQuick Advance test will be an integral part of [our] HIV prevention campaign, enabling us to provide the most versatile and comprehensive rapid HIV tests available to our HIV testing agencies across the country.”

OraSure said that according to the Joint United Nations Program on HIV/AIDS, Mexico has 160,000 adults and children living with HIV/AIDS. AIDS caused around 5,000 deaths in 2003.

New Guidant lead gets CE mark

Guidant (Indianapolis) said it has received the CE mark for its Acuity Steerable heart-failure lead, used to connect the company’s implantable cardioverter defibrillators (ICDs) to the heart’s left ventricle.

It said the new lead makes implants faster and more predictable.

“In my experience, the Acuity Steerable lead . . . has enabled me to place the lead where I want to have it, even in very difficult anatomies,” said Dr. Martin Desaga of Amper Kliniken Dachau, near Munich, Germany.

Guidant said that since it introduced bipolar left ventricular leads in Europe in 2002, physicians have “overwhelmingly” adopted the technology. Some 90% of procedures involving a cardiac resynchronization therapy product from Guidant’s Renewal family of devices now also include bipolar leads.

The company said it anticipates launching the Acuity Steerable lead in the U.S. in 2006, upon its receipt of FDA approval.