• Cardium Therapeutics (San Diego) reported that the FDA has granted fast track designation to the company’s lead product candidate, Generx (alferminogene tadenovec, Ad5FGF-4) for the potential treatment of myocardial ischemia. Generx represents a new therapeutic class of biologics designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle, following a one-time intracoronary administration from a standard cardiac infusion catheter. The natural biologic response to repeated transient ischemia is angiogenesis, the growth of new collateral blood vessels. These newly-formed vessels can effectively augment blood flow and oxygen delivery to parts of the patient’s heart downstream from a blockage in a coronary artery. Generx is an angiogenic therapeutic that is designed to promote the heart’s natural response of collateral growth and to increase blood flow in the microcirculation.

• Guardian Technologies International (Herndon, Virginia) reported the successful completion of a clinical study involving the evaluation of its signature mapping software solution product to an online database of mammographic X-ray exams known as the DDSM project. The study results are significant because no computer-aided detection technology has been able to assist radiologists in achieving such high levels of detection and with such low false-positive rates, the company said. The study showed that signature mapping achieved a 97.5% detection rate (sensitivity) on cancer cases, with just 2.5% false-negatives (cancer lesions undetected). On non-cancer cases, signature mapping accurately specified “no cancer” in 98.75% of the images, with a false-positive rate of just 1.25%. Guardian makes medical imaging and threat detection technology with applications for the healthcare and homeland security markets.