• Corautus Genetics (Atlanta) reported that as the result of its scheduled interim safety analysis, the independent data monitoring committee (DMC) recommended the continuation of GENASIS (Genetic Angiogenic Stimulation Investigational Study), Corautus' Phase IIb clinical trial to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for the treatment of patients with severe angina. The planned interim safety analysis was conducted after the first 54 patients were treated in the trial. Based upon their review of the available data, the DMC recommended continuing the GENASIS trial. GENASIS is a randomized, double-blinded, dose-ranging and placebo-controlled Phase IIb multi-center clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific (Natick, Massachusetts) Stiletto endocardial direct injection catheter system.

• Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, said that it has submitted to the FDA an amendment to its corporate investigational new drug (IND) application for Lymphoseek. The amendment submission included updated results from clinical and pre-clinical evaluations completed to date with Lymphoseek. In addition, Neo-probe's submission included a complete draft of a proposed multi-center clinical evaluation of Lymphoseek and the Investigator's Brochure for the conduct of the study. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in a variety of tumor types. In connection with the establishment of the corporate IND for Lymphoseek, the FDA provided guidance that it would prefer to have Lymphoseek evaluated in a multi-center clinical study to confirm the findings observed by the University of California, San Diego researchers. The initial multi-center trial would then be followed by a confirmatory Phase III study using the final cGMP material. Neoprobe said it intends to begin enrollment in the first of the two multi-institutional studies as soon as the appropriate regulatory and institutional review board clearances are received.

• Reliant Technologies (Palo Alto, California), which is focused on aesthetic laser medicine, surgery and biomedical technologies, said that the FDA has granted 510(k) market approval of the Fraxel laser for skin resurfacing procedures, providing physicians a gentle and intelligent treatment approach to fast, remarkable results with minimal downtime and maximum safety. Fraxel Laser Treatment (FLT) is the only laser device specially designed to resurface a fraction of skin at a time without breaking the skin's protective outer barrier. FLT offers immediate results – softer, smoother and toned skin, with cumulative improvement in as few as four to eight weeks. This new indication for the Fraxel laser joins clearances obtained in 2003 for soft tissue coagulation and in 2004 for correction of periorbital wrinkles and pigmented lesions.

• Toshiba America Medical Systems (Tustin, California) said clinical researchers at Beth Israel Deaconess Medical Center (BIDMC; Boston) reported the completion of the first chest pain evaluation using electrocardiogram-gated (ECG-gated) imaging performed with the Toshiba Aquilion 64. Featuring advanced multi-detector computed tomography (CT) technologies, the Aquilion 64-detector CT uses Toshiba's 64-row Quantum detector, which enables the Aquilion CT scanner to acquire 64 simultaneous slices of 0.5 mm for precise volumetric imaging of any region of the body during a breath-hold under 10 seconds. At BIDMC, a patient with chest pains and significant shortness of breath during exertion was scanned with the recently installed Aquilion 64 to determine if the symptoms were related to a problem with the lungs or the heart. "We are just beginning to realize the full potential of using the Aquilion 64-slice CT, and we fully expect a leap in image quality from the previous 16- and 32-slice CT technology," said Melvin Clouse, MD, professor of radiology and director of research at BIDMC. Clouse recently discussed the results of the latest clinical studies performed with the Aquilion 64 at Snowmass 2005: Imaging with CR and MR meeting in Colorado in February.