BB&T European Editor and Staff Reports

PARIS – Building on a history of shared projects in the health field, France and the Canadian province of Quebec have agreed to work together on a program for e-health.

Signed at the ministerial level, the agreement bring together the respective agencies charged with building medical files and telemedicine networks to assure shared standards and, importantly, a shared language.

Other areas of focus for the working groups will be a telemedicine project, shared studies, and managing the governance of regional projects, which have proven to be a significant barrier for deploying e-health.

“Behind e-health there is a significant industrial challenge and we need e-health software and systems that are in French,“ said Jean-Yves Robin, head of France's Agency for Shared Health Information Systems (ASIP; Agence des Systèmes d'Information Partagés de santé).

He said that Québec is a small market with 7 million people, and even France with 65 million people is considered a small market for IT developers.

Medical nomenclature and semantic references play a key role in compiling patient care records, Robin told BB&T, “we need to bring together French-speaking countries to assure interoperability.“

The agreement itself provides a vivid example of the problem of how two regions historically joined by a language can diverge on terminology.

French is the ninth-ranked language worldwide with 200 million speakers. It is the official administrative language in southern Belgium, countries of West Africa and in French territories of Polynesia and the Caribbean.

Robin cites the example of the Systematized Nomenclature of Medicine (SNOMED) used by many e-health systems that is regularly updated but in English.

“Standardizing medical terms in any language is an emerging field,“ said Robin. “Since we do not live in a world that practices medicine only in English, it becomes very important that the major languages of Spanish, Arabic, French, German, and so forth, convert this nomenclature into their own standardized terms.“

For the telemedicine project, Robin said that with the vast distances of the Great North, Québec is ahead of France in providing remote expert consultation and care delivery.

Meanwhile, he said France brings to the partnership advanced standardization of patient files.

On a national level, Canada's Infoway is a benchmark in e-health, recognized as one of the few comprehensive systems to be established.

“Canada is definitely a leader in setting norms and standards, but Canada is not very far along in deploying its information support for patient care,“ Robin said.

He said Infoway funding was confided to the provinces according to Canada's federated structure, “and things are not being delivered as expected. They are experiencing the same governance problems that every country is encountering for deploying e-health.“

“The Obama administration has the same issues and barriers to overcome in the United States,“ he added.

“This subject is at the heart of our agreement and we are talking at once with both Infoway and Quebec on the problem of adopting international standards nationally and then seeing how each region interprets these choices.“

FIM artificial heart implant expected by year end

After winning the approval of engineers for a fully implantable artificial heart, Carmat (Paris) is accelerating its development program aiming for a first-in-man placement of the device before the end of 2011.

In July the mechanical heart was certified under International Organization Standards (ISO) for general industrial processes and specifically under ISO 13485, which defines requirements of quality management systems for the medical devices industry.

Now turning its attention to investors and regulatory authorities, the company hopes to win an additional €25.5 million ($35.7 million) in a special stock offering in August to power its drive to the clinic and then a green light in 4Q11 from the French health authority to conduct the initial clinical trial in patients.

Carmat went public one year ago on the NYSE-Euronext exchange at €18.75 ($23.72) and is currently trading 10 times higher at €185 ($258) giving the company a valuation of €712 million ($995 million).

The company is seeking a capital increase of €25.5 million through preferential subscription rights for existing shareholders and released its prospectus this week.

Pending approval from its board of directors, the new shares may be listed as soon at August 10.

The proceeds of the increase will be used to finance the clinical trials and industrialization of the Carmat artificial heart up to the submission for a CE mark.

“Given the progress made in our project, we are confident we will meet the goal of a first implant of the heart before the end of 2011,“ said CEO Marcello Conviti, subject to authorization from the French authority, Agence Française de Sécurité Sanitaire des Produits Santé (AFSSAPS) and the approval of patient protection committees.

He said the company remains on track for a commercial release in 2013.

Under AFSSAPS rules, bringing forward a new technology qualifies Carmat for a fast-track pre-submission procedure where a preliminary application can be submitted and later supplemented with further information as data become available.

In mid-June, Carmat met a contract milestone with the French innovation funding agency that triggers a payment of €3.6 million ($5 million) in subsidies and €1.7 million ($2.4 million) in repayable advances.

In November Carmat expects to meet criteria for a further €6.7 million ($9.4 million) from OSEO, payable in early 2012.

BIRD grants $8.1M for nine projects

During a recent meeting in Washington, the board of governors of the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD; Tel Aviv, Israel) approved $8.1 million of funding for nine new projects between Israeli and American companies. In addition to the grants from BIRD, the projects will access private sector funding, boosting the total value of all projects to $24 million.

The BIRD Foundation promotes collaboration between Israeli and American companies in various technological fields for the purpose of joint product development. Specifically, the Foundation assists by locating strategic partners from each country, making the necessary introductions, and providing conditional grants of up to $1 million for approved projects.

The nine projects approved by the board of governors add to the more than 820 projects in which the BIRD Foundation has invested over its 34 year history. To date, BIRD's total investment in these projects has exceeded $290 million, helping to generate direct and indirect sales of more than $8 billion.

Deadline for submission of executive summaries for the next BIRD cycle is Sept. 15. Approval of projects will take place in December.

Golden Meditech acquires hospital for $77.1M

Golden Meditech (Hong Kong) acquired a hospital facility in Beijing's Haidian District for a total consideration of HK$600 million ($77.1 million).

The acquisition target, with a site area of about 18,692 square meters and permissible construction area of 74,035 square meters will be completed in 2012. Upon completion of the acquisition, the GM Hospital Group will effectively own 57.91% of the new hospital. The new facility has obtained the relevant regulatory approvals for the construction of a 500-bed general hospital, five times the current capacity of 100-beds in the group's existing Daopei Hospital in Beijing, which will be able to relieve the shortage in bed spaces and cater to patients who are seeking to be admitted based on the hospital's strong reputation. This will both expand the scale of Beijing Daopei Hospital and further strengthen the Group's market presence in the hospital management market.

GM Hospital Group is the first foreign entity to be granted a nationwide hospital management license. It currently operates one of China's most renowned haematology hospitals under the Daopei brand name, located in Beijing and Shanghai respectively. In view of the growing demand and near maximum utilization at the Beijing hospital, the management, upon prudent evaluation, deems it a suitable time to expand the Beijing hospital and resolve the shortage in bed spaces as well as further enhance its position as a leading healthcare service provider in Beijing.

Golden Meditech is one of China's integrated-healthcare devices and service operators.

STU acquires TrueBeam system

Shantou University (STU; Shantou, China) Medical College's Affiliated-Cancer Hospital has become the first cancer treatment center in China to acquire and install the TrueBeam system for image-guided radiotherapy. The system, which was made by Varian Medical Systems (Palo Alto, California), was donated to the hospital by the Li Ka Shing (LKS) Foundation, a private charitable foundation established to nurture a culture of giving, support educational reforms and help advance medical research and services.

The TrueBeam machine was dedicated in a special ceremony held at the affiliated hospital on June 28.

TrueBeam was designed to treat tumors with increased speed and accuracy, including tumors that move during treatment as the patient breathes in and out.

TrueBeam was approved for sale in China by the Chinese State Food and Drug Administration earlier this year.

Cardiac Science wins Japanese approval

Cardiac Science (Bothell, Washington), a maker of automated external defibrillators (AEDs) and diagnostic cardiac monitoring devices, reported that the Japan Ministry of Health, Labor, and Welfare approved a new model of its Powerheart G3 AED. The company is partnering with Omron Healthcare (Kyoto, Japan) to distribute its AEDs in Japan. Omron is a healthcare company dedicated to prevention of heart disease.

Japan is the second largest AED market in the world with 65,000 AEDs sold annually. Cardiac Science and Omron Healthcare are currently engaged in market launch preparations, with commercial release and first revenue sales expected in August.

Biomoda granted new Japanese patent

Cancer diagnostics company Biomoda (Albuquerque, New Mexico) received notification that the Japan Patent Office has granted the company's patent application related to a method of using its proprietary porphyrin-based compound that binds to cancer cells and causes them to fluoresce under specific frequencies of light to detect cancer and pre-cancerous cells in body fluid and tissue samples.

“There are more than 30 million smokers in Japan, and although smoking rates have actually declined since 2008, lung cancer is the leading cause of cancer deaths in Japan,“ said Biomoda President John Cousins. “The market for an early-stage lung cancer diagnostic like our CyPath assay is truly global.“

Biomoda completed the pilot clinical trial of the CyPath assay in March and plans to seek FDA approval of its cytology-based diagnostic technology as a medical device.

Biosensors wins reimbursement approval in France

Biosensors International (Morges, Switzerland) said it has received approval for reimbursement in France for its BioMatrix Flex drug-eluting stent system. The addition of BioMatrix Flex to the Liste des Produits et Prestations Remboursables (LPPR) was published in the Journal Official on June 22. As a result of this action, BioMatrix Flex is now available to patients with coronary artery disease throughout France.

BioMatrix Flex offers the unique combination of Biolimus A9 (BA9) with a biodegradable poly-lactic acid (PLA) polymer, which is abluminally coated onto an advanced, highly flexible stent platform designed for enhanced deliverability. BA9 is an anti-restenotic drug developed and patented by Biosensors specifically for use with drug-eluting stents. It has the highest lipophilic profile of the common limus drugs, enabling rapid absorption by the tissue and minimizing systemic exposure. The PLA polymer fully degrades into carbon dioxide and water after six to nine months as it releases BA9.

BioMatrix Flex received CE mark approval in January 2010. It has been approved for use in treating a comprehensive range of indications, including STEMI, Acute Coronary Syndromes and diabetes mellitus. BioMatrix Flex is available in diameters ranging from 2.25 mm up to 4 mm.

Surveys show patients value CRC blood tests

Epigenomics (Berlin), a cancer molecular diagnostics company, reported the results of a survey conducted at europacolon's (London) first European CRC Patient Conference, The Power of Patient Voice 2011, showing that patients believe tests using blood samples would encourage more people to participate in regular screening for colorectal cancer.

Of the participants in the survey, more than 50% had previously heard of the possibility of CRC blood testing and more than 70% thought that using a blood test would encourage more people to participate in regular screening for colorectal cancer. Some of the most often mentioned reasons that survey participants gave for preferring blood tests were ease-of-use and simplicity, not having to handle stool samples as necessary for conventional non-invasive testing, and overall fit with other routine blood tests.

The survey was jointly conducted by Epigenomics and europacolon, the first European non-profit organization dedicated to colorectal cancer. europacolon's mission is to prevent deaths from colorectal cancer and improve the quality of life and support for those affected by the disease.

Epigenomics has developed an in vitro diagnostic blood test for the early detection of colorectal cancer known as the Septin9 Test and fully supports europacolon in its fight against colorectal cancer.

Bruker, IMM collaborate on Maldi Biotyper

Bruker (Billerica, Massachusetts) reported a collaboration with the Institute of Medical Microbiology (IMM) at the University of Zurich (Zurich, Switzerland). The IMM is using Bruker´s Maldi Biotyper system as its next-generation, rapid microbial identification system. The IMM is the Swiss national reference center for mycobacteria and its strain collections of coryneform bacteria, actinomycetes and fastidious gram negative bacteria and moulds are acknowledged worldwide. The IMM is faced with the characterization and identification of challenging microorganisms on a daily base. Therefore, the IMM has developed their own algorithms and workflows for identification and antibiotics susceptibility testing (AST). Their AST approaches are mainly based on Kirby-Bauer testing methods, which are now applied in combination with Maldi-TOF based identification technology.

The focus of the collaboration between the IMM and Bruker is the field of coryneform bacteria, actinomycetes, fastidious gram negative bacteria and moulds. The identification of these microorganisms is one of the most challenging tasks of many microbiological laboratories. The Maldi Biotyper provides a substantial contribution to a more thorough characterization of this group of microorganisms. Furthermore, the IMM microbiologists designed a study to validate the analytical performance of the Maldi Biotyper against their own molecular-characterized strain collection. Based on the results, the Maldi Biotyper reference library will be further extended. This will further improve its proven outstanding identification performance, the company noted.

Life Technologies launches new India distribution

Life Technologies (Carlsbad, California) has launched a regional distribution hub in India to address strong customer demand in the South Asia region. The new India Distribution Center (IDC; Bangalore), will boost the availability, timely delivery and quality of Life Technologies' products to its thousands of customers in the area.

“The scientific community in India is growing at a rapid rate,“ said Devashish Ohri, managing director of life technologies South Asia. “By locating the India Distribution Center in Bangalore, we can bring our innovative technologies more efficiently to our customers and partners in the region and help advance their science.“

Since the IDC's inception, Life Technologies' volume of items shipped per day in the region has increased fourfold, with dramatically improved order fulfillment time that is up to 50% faster in most cases.

“South Asia is one of the fastest growing regions in the world,“ said Mark Smedley, president of Asia Pacific and Japan for Life Technologies. “Opening the India Distribution Center here is a clear demonstration of Life Technologies' commitment to the scientific community to greatly enhance the timeliness, accuracy and reliability of our product distribution to our Indian customers.“