A Medical Device Daily

Amphion Innovations (London), a developer of life science and medical technology businesses, said it has invested £1 million in its latest partner company, Myconostica , a spin-out from the University of Manchester .

Myconostica says it specializes in a new type of molecular diagnostic test for infectious diseases, particularly life-threatening respiratory fungal infections, allowing faster and more precise diagnosis. The tests will reduce death rates, shorten recovery times and hospital stays, and reduce the cost of care for these types of patients, the company said.

The firm has secured an international intellectual property position in advances in molecular diagnostics, including licenses from the University of Manchester, the Public Health Research Institute (PHRI; Newark, New Jersey) and other leading research centers.

Amphion said its investment will give it a stake of 35% on a fully diluted basis and will allow Myconostica to develop its products and intellectual property and build its management and marketing teams. Amphion's participation also is intended to accelerate access to key U.S. markets.

Fungal infections remain the most common cause of infectious death in many types of acutely ill patients, for example those who have undergone transplants or those who are suffering from infections affecting their immune system, such as HIV. Myconostica said its tests produce results in hours, rather than the days currently required, greatly improving the time to treatment.

Clinical studies are scheduled to start in 1Q07, with international regulatory approvals anticipated in the second and third quarters of 2007.

The market size for respiratory diagnostics for fungal infection alone is estimated to be in excess of $100 million annually.

Professor David Denning, founder and acting chief executive of Myconostica, said, "The medical need for rapid diagnosis of respiratory fungal infections has never been so strong. Myconostica can provide a much faster and clearer diagnosis significantly improving the time to treat infected patients. Currently, these infections are responsible for mortality rates of 40% to 90%."

Amphion CEO Richard Morgan said, "In partnership with Amphion, we believe that Myconostica can become a leading supplier of a new generation of diagnostic tools that will provide more accurate diagnosis and in a fraction of the time currently required. This is a great market opportunity, which will also provide enormous benefits to patients worldwide."

ACM-Pivotal facility is CAP-certified

ACM-Pivotal (Rochester, New York) said that its Europe facility has received certification by the College of American Pathologists (CAP) based on the results of a recent on-site inspection of its central laboratory in York, England.

This globally recognized certification highlights the company's ability to provide comprehensive central laboratory support for clinical trials, ACM-Pivotal said.

"Achieving CAP certification is an endorsement of the internal standards that we continuously maintain," said Jerry Boxall, managing director, ACM-Pivotal Europe. "The addition of the CAP certification in Europe emphasizes the global presence of the company."

ACM-Pivotal Europe was established in 1999 and serves Western Europe, Central and Eastern Europe, Israel and South Africa. The company said the York facility has established "efficient and cost-effective logistics solutions for some of the most challenging locations in the region. It offers extensive laboratory facilities featuring a full range of routine and esoteric testing services."

ACM-Pivotal is the global central laboratory focused on the flexibility and precision to keep clinical research studies on schedule. With a staff of 360 laboratory science and clinical research experts, ACM-Pivotal's operations extend to more than 60 countries, offering a broad menu of safety and specialty services for clinical trials. The organization's research team performs 12 million tests a year, featuring more than 1,500 individual tests spanning all medical disciplines, including pathology, microbiology and pharmacogenomics.

Bone Scaffold product recalled

Artimplant (Vastra Frolunda, Sweden) has recalled its odontology product Bone Scaffold intended to increase bone volume of bone defects in the mouth after data has shown that the device does not achieve the necessary bone formation.

The product has been implanted in fewer than 20 patients.

Artimplant said it is developing a new design intended to better meet functional demands. It said clinical evaluation of that product is planned for 2007.

Artimplant is a biomaterials company focused on solutions to problems in orthopedic, odontological and reconstructive surgery.