A Medical Device Daily

VUCCC P/L (Zurich, Switzerland) reported that it has filed for patent protection of its new treatment regimen for Type 1 insulin-dependent diabetes through the European Patent Office.

The technology was developed with science emanating from collaborators at four European universities: Tübingen University (Tübingen, Germany); Heidelberg University (Heidelberg, Germany); the University of Manchester (Manchester, UK), and Uppsala University (Uppsala, Sweden). It is the result of more than a decade of clinical trial work with more than 15,000 patients, carried out in conjunction with the German Ministry of Health and other partners.

The treatment regimen is closely controlled in conjunction with the patient's doctor, guided by diagnostic testing proprietary to VUCCC. This development will see VUCCC establish diagnostic reference centers across Europe, to ascertain patients' potential treatment outcomes. VUCCC also said that it will establish a centralized teaching center, for controlling the standard of the ongoing testing program.

The company estimated there will be an average long term saving to the German Ministry of Health of EUR 70 billion per year. The estimate is based on existing costs of patient management and the number of patients treatable with this technology.

VUCCC said it will have an agreement in place with a major pharmaceutical company and an international laboratory network for marketing, distribution, sales and related laboratory services for the treatment. It will be launched in Germany in 2010. Release in other countries will follow.

The company said this development represents the next step in two years of commercialization work between VUCCC and P+S Business Advisory, a division of P + S Business Brokers (Melbourne, Australia), in bringing this technology to market. Further patents are pending, the company said.

Study to assess WBU for breast imaging

TechniScan (Salt Lake City) reported that, in collaboration with University Medical Center Freiburg (Freiburg, Germany), it has launched a clinical study to assess clinical utility of TechniScan's Warm Bath Ultrasound (WBU), a system designed for ultrasound technology, used in a warm water tank, to capture 3-D images of the breast as a woman lies prone on a table.

Clinicians will scan a total of at least 150 women within three defined groups: Those with normal mammography findings, those with known benign lesions and those with known malignancies. The study includes direct comparison of TechniScan's WBU images against mammogram, MRI and hand held ultrasound to directly evaluate the ability of WBU in providing comparative diagnostic findings.

Radiologists involved in the Freiburg study will use TechniScan's imaging network which provides them with the ability to archive, store, and retrieve anonymous WBU images and relevant medical records and will discuss and compare their results with other researchers.

"Our vision is to begin to create a database of thousands of anonymous breast images and related data," said Dave Robinson, CEO at TechniScan. "This scientific database will consist of anonymous mammograms, breast MRIs and WBU images, along with related pathology and other information, to provide researchers around the world an unprecedented opportunity to study breast cancer."

EC funds Smart Personal Health project

Continua Health Alliance (Beaverton, Oregon), an international organization of healthcare and technology companies, the European Telecommunications Standards Institute (ETSI; Nice, France), responsible for standardization of ICT within Europe, and Integrating the Healthcare Enterprise Europe (IHE-Europe; Brussels), reported receipt of funding from the European Commission (EC) for a 12-month project called Smart Personal Health. The product aims to promote awareness and a deeper understanding of the need for interoperability among personal health systems (PHS), devices and other e-health systems across Europe. Continua, ETSI and IHE-Europe are joined by project partners empirica (Bonn, Germany), a European research institute with a broad understanding of political, business and socio-economic issues surrounding electronic health services and telecom applications, as well as The Centre, a European expert in public affairs and event organization.

Solos inks consulting agreement with ER

Solos Endoscopy (Boston) reported that it has signed an agreement with Expert Resource (ER) to provide consulting services in support of the company's CE mark technical file development. Before Solos can place the CE-marking on their medical devices and legally sell within the European Union (EU) and Canada, the company must prepare a technical file with evidence of compliance to the EU Medical Device Directive.

"Expanding into the EU and Canada presents enormous sales opportunities for Solos Endoscopy," said Bov Segersten, president of Solos Endoscopy.

Solos makes instruments for the screening, diagnosis, treatment and management of medical conditions.