• Intraop Medical(Santa Clara, California), manufacturer of the Mobetron, a mobile electron beam system designed for intraoperative radiotherapy (IORT) treatment, said that according to research presented in March at the 4th International Society of IORT meeting in Miami, IORT increases survival rates in patients with advanced or recurrent rectal cancer. Research showed the five-year survival rate in 260 advanced rectal cancer patients was 60% compared with the expected five-year survival of about 25% with conventional approaches. For 160 recurrent rectal cancer patients, researchers reported a five-year survival rate of 37% compared with the 5% to 10% survival seen with conventional approaches. In the subgroup in which the surgeon achieved complete removal of the tumor, the five-year survival rate with IORT for recurrent rectal cancer increased to 54%. Other presentations at the meeting reported benefits for IORT treatment in a variety of tumor locations, including early stage breast cancer, sarcomas, pediatric cancers, recurrent gynecological cancer, pancreatic cancer and gallbladder cancer.

• LifeTree eClinical (Temecula, California), a member of the FFF Enterprises family of companies and a provider of clinical electronic data capture and analysis systems, reported the launch of LifeTreeHub 1.0, an advanced platform for aggregating clinical trial documents, web-based messaging and virtual meeting capabilities. A stand-alone, customizable portal, LifeTreeHub provides a secure electronic repository for the storage and retrieval of medical documents and clinical information. LifeTree ICTM, an electronic data capture and analysis platform, is integrated with LifeTreeHub for a seamless transition from clinical functions to document sharing and retrieval.

• Nanogen (San Diego) said it has been issued two patents by the U.S. Patent and Trademark Office for technologies related to genetic analysis. Patent No. 6,884,584 claims the use of Nanogen’s MGB probes on traditional solid-phase support. Patent No. 6,887,362, relates to devices and methods for performing active, multi-step molecular and biological sample preparation and diagnostic analyses employing immunochemical techniques.

• Ortec International (New York) reported FDA recommendations regarding regulatory approval of OrCel (Bilayered Cellular Matrix) to heal chronic and acute wounds. The company said that after submitting clinical data that demonstrated clinical significance in both the Intent to Treat Population (all patients treated in the trial) as well as those patients with ulcers for which use of OrCel is indicated (partial and full thickness ulcers extending into dermis but not into the fascia), the FDA recommended that a confirmatory trial, involving only those patients for which OrCel is indicated, is necessary. While the FDA indicated the clinical data showed promise for the effective treatment of venous ulcers, the agency said it believes additional data is necessary to demonstrate reasonable assurance of safety and effectiveness of OrCel in patients with venous leg ulcers. The FDA said the analysis of the patients for which OrCel is indicated was not prospectively defined and accordingly recommended an additional prospective clinical trial to confirm the company’s findings. Ortec estimates that about 40 patients will be required in the study. The company said it intends to initiate a resolution process with the FDA.