A Medical Device Daily

Kensey Nash (Exton, Pennsylvania), a company that provides resorbable biomaterial solutions for a wide range of medical procedures, said it has received the CE mark for its cartilage repair device.

The device is a biphasic, bioresorbable scaffold intended to be implanted at the site of a focal articular cartilage lesion or osteochondral defect in the knee, the company said. It is intended to serve as a scaffold for cellular and matrix in-growth in osteochondral defect repair such as bone and/or cartilage, which is not intrinsic to the stability of the tissue, Kensey Nash added. The product is indicated to support the regeneration of hyaline cartilage and subchondral bone by promoting the correct cellular morphology and structural organization during the healing process.

"The CE marking of our cartilage repair device represents another critical milestone in our plans to build upon Kensey Nash's leadership position as a developer of innovative regenerative medicine products," said Douglas Evans, COO of Kensey Nash. "The device has the potential to benefit a large number of patients that suffer from articular cartilage injuries. We look forward to commercializing this device in the European community and to generating data necessary for reimbursement."

"Our R&D and clinical and regulatory teams are making great progress with this exciting technology and we are continuing to move forward with our plans to start a U.S. clinical trial as soon as possible," added Joe Kaufmann, CEO of Kensey Nash. "We estimate the worldwide sports medicine market for cartilage repair is approximately $2.2 billion annually. We are currently evaluating our marketing and distribution strategy options, including strategic partners."

Articular cartilage injury is commonly encountered in people with active lifestyles. Unlike other tissue types, cartilage possesses a limited capacity to heal. Surgical treatment options available today usually generate a repair tissue that is insufficient in absorbing or distributing loads and is prone to failure, according to the company. Worldwide, physicians perform nearly a million procedures a year to repair damaged articular cartilage in the knee and a majority of these are repeat procedures, illustrating the ineffectiveness of current therapeutic approaches, Kensey Nash said. Over time, debilitating osteoarthritis may develop in the afflicted joint, often ultimately requiring partial or total knee replacement. The company believes that an early and successful treatment of traumatized articular cartilage may prevent or postpone the onset of long-term osteoarthritis, and consequently reduce the number of radical knee joint replacement surgeries performed each year.

iSOFT to distribute MetaVision for iMDsoft

iMDsoft (Leiden, the Netherlands), a provider of clinical information systems for perioperative, critical, and acute care, and iSOFT Health (Sydney, Australia), a supplier of software applications for the healthcare sector, reported that iSOFT will begin distributing the MetaVision suite in Germany. iSOFT currently serves customers in 40 countries and is one of the world's largest healthcare information technology companies.

The agreement allows iSOFT to distribute the MetaVision suite of products, initially in Germany only. iMDsoft's offerings will complement and enhance iSOFT's range of products with a dedicated solution for perioperative and critical care in the country.

The MetaVision suite is designed to capture, document, analyze, report, and store the vast amount of patient-related data generated in critical care environments. MetaVision provides clinical decision support, computerized physician order entry for medications, and quality-of-care reporting. The system has been shown to significantly improve patient safety, quality measures, and financial performance, the company noted.

"iSOFT has a long history of offering innovative hospital-based data management solutions across the entire continuum of care. They share iMDsoft's passion for improving the healthcare experience for both patients and healthcare professionals, making us natural partners," said Phyllis Gotlib, CEO of iMDsoft. "I believe that iSOFT has the reach and expertise to enable a wider network of customers in Germany to enjoy the proven benefits that MetaVision brings to users worldwide."

ASI chosen for Lupas consortium in EU

Applied Spectral Imaging (ASI; Migdal Haemek, Israel), a provider of comprehensive imaging solutions for pathology and cytogenetics, said it was chosen by the European Union to be one of nine industry and academia groups to form the Lupas consortium. ASI said it possesses unique spectral technology that labels each region of the image with multiple colors beyond the basic red, green and blue colors that are available today in digital cameras.

Lupas seeks to develop new smart imaging molecular tools for combating neurodegenerative diseases. Via modern imaging technology, development and validation of novel, properly functionalized, luminescent conjugated polymers can give rise to entirely new and innovative methodology that can be used for biomedical research, diagnosis, monitoring and prognosis, and for support and guidance of therapeutic interventions for Alzheimer's disease and prior diseases, the company said. ASI says it harnesses its unique capabilities within Lupas to help identify and characterize amyloids that form the accumulation of plaques and proteins in the brain, usually associated with Alzheimer patients.

The consortium is composed of expert groups in experimental optics, polymer synthesis, MRI, and synthesis of functionalized magnetic nanoparticles, amyloid structure, AD mouse models, clinical AD and prior diseases. This project establishes strategic links between mainly SME based industries, expert researchers at universities and principal users in terms of hospitals. The project consortium will develop and share a plan for dissemination and exploitation of the project results.

"We hope that by the end of the third year, we will have a better understanding of Alzheimer's disease, 'mad cow disease' and others," said Limor Siphosh, CEO of ASI. "Knowledge will bring recognition and in time the ability to accurately diagnose and treat these diseases."

Genomic Vision inks pact for FSHD test

Genomic Vision (Paris), a biotechnology company focused on pioneering nanotechnology-based DNA analysis, said it has signed an agreement and received a €250,000 grant from the Association Fran aise contre les Myopathies (AFM; Evry, France) for the optimization and validation of a diagnostic test for facio-scapulo-humeral dystrophy (FSHD). The test, underpinned by Genomic Vision's Molecular Combing technology, is undergoing further development and validation in partnership with the Université de la Méditerranée and the Timone Hospital (both Marseille, France). The collaboration harnesses the benefits of Molecular Combing technology and aims to make this test routine in the clinic. The test is designed to make a radical change to the ease and reliability of FSHD diagnosis, the company said.

Genomic Vision expects final results from the clinical study at the Timone Hospital, Marseille in the spring. Internationally, around 30 laboratories specialize in the molecular testing for FSHD. Genomic Vision will offer the test to both public and private specialists.