• Delcath Systems (Stamford, Connecticut) said it was informed that the National Cancer Institute (NCI) institutional review board has approved expansion of the company’s ongoing Phase III trial to include additional clinical centers. The NCI is currently the only center treating patients in the Phase III pivotal trial of the Delcath System for the region-specific delivery of the chemotherapeutic agent, Melphalan, to patients with metastatic melanoma in the liver. The NCI will continue to treat patients and, under the terms of the recently signed cooperative research and development agreement between the company and the NCI, it will additionally serve as the coordinating center for the multicenter trial. The Phase III study is enrolling patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver, using Melphalan. The Delcath System isolates the blood flow within the patient’s liver in order to allow significantly higher doses of Melphalan to be administered while limiting the toxicities that result from current systemic chemotherapy treatments. Delcath Systems makes percutaneous perfusion technology for organ or region-specific delivery of therapeutic and chemotherapeutic agents.

• Derma Sciences (Princeton, New Jersey) reported FDA clearance for its MOBILITY-1 boot and compressor device for the treatment of chronic venous insufficiency (CVI), deep vein thrombosis (DVT) prevention, venous ulcers, lymphedema, and other conditions that require compression therapy, including the enhancement of blood circulation during recovery from coronary artery bypass graft surgery and orthopedic hip and knee replacements. MOBILITY-1 includes a lightweight wearable dynamic compression device that periodically inflates and deflates thereby producing segmented and therapeutically significant compression, generated either by the walking motion of the patient or through a small electronic compressor. The device incorporates several patented design mechanisms, including one which allows the compression to be driven by the walking motion of the patient, as well as the check valves within the internal flow system, which allow the device to control airflow and pressure internally, instead of by a larger external compressor. Derma Sciences makes advanced wound care products.

• FASgen (Baltimore) said it has expanded the potential use for its serum FAS (fatty acid synthase) ELISA diagnostic research test, FAS-Detect ELISA for the identification of Non-Alcoholic steatohepatitis (NASH). The current diagnostic technique for this disease is a liver needle biopsy. While only for research use presently, FASgen anticipates the opportunity for use of the non-invasive FAS-Detect ELISA NASH test in the future will be substantial. NASH commonly occurs as the result of fatty liver disease. Non-alcoholic fatty liver disease (NAFLD) is now common among the obese population, with an estimated 25 million adults harboring NAFLD, with up to 5% of these patients developing NASH. A large number of NASH patients go on to develop potentially fatal cirrhosis.

• Harvest Technologies (Plymouth, Massachusetts) reported that the FDA has granted investigational device exemption approval to commence a 48-patient ‘feasibility’ clinical trial using the company’s BMAC system to treat patients with Critical Limb Ischemia (CLI). The BMAC System is a point-of-care device for concentrating a patient’s own (autologous) bone marrow stem cells in about 15 minutes. The study’s design provides for injecting these cells into the affected limb to reduce the potential for limb amputation. It is believed that the injection of stem cells will arrest and possibly reverse the effects of CLI, a late-stage form of peripheral arterial disease. Until now, it has been difficult to process and concentrate a clinically significant dose of adult stem cells from a patient’s bone marrow at the point of care. Harvest Technologies improves patient outcomes by enhancing the body’s normal healing process using adult stem cells and growth factors.

• Iris International (Chatsworth, California) said that its new iChem Velocity fully automated urine chemistry system, using the company’s kinetic imaging technology, will be displayed at EUROMEDLAB 2007 in Amsterdam from June 3 through June 7, 2007. The iChem is designed for medium- to high-volume laboratories that typically process more than 100 urine samples per day. Iris International makes medical devices, diagnostic systems and consumables.