• ThermoGenesis (Rancho Cordova, California), a developer of enabling technologies for cell therapeutics, said that the FDA's Center for Biologics Evaluation and Research notified the company that it was reviewing the company's premarket application for CryoSeal FS. The submission was based on clinical results from a Phase III trial evaluating the safety and efficacy of CryoSeal FS as an adjunct to hemostasis in liver resection against a control, Instat, a collagen absorbable hemostat. The multi-center randomized and blinded clinical trial of 150 cancer patients showed that CryoSeal FS demonstrated superiority to the Instat control by causing statistically significant quicker time to hemostasis vs. the control group (p=<0.001). If approved, CryoSeal would be the only fibrin sealant produced from the patient's own blood on the market and an alternative to conventional fibrin sealants derived from bovine tissue and pooled human bloods which are currently used in a wide range of surgeries.

• Trimedyne (Irvine, California), a maker of lasers and fiber optic devices for minimally invasive surgery, reported receiving FDA clearance for its new VaporMAX Fiber for use with its Holmium Lasers for their FDA cleared indications, including the treatment of enlarged prostates. The clearance also covers marketing the VaporMAX Fiber for use with Holmium Lasers with a compatible connector made by others. The VaporMAX Fiber qualifies for reimbursement under the higher-paying APC Code Number 3525. Trimedyne's VaporMAX Side-Firing Laser Fibers vaporize an average of 3 grams of soft tissue per minute over 60 minutes of use, which is faster than other currently marketed laser devices, based on laboratory testing of animal tissue and published data. A faster vaporization rate minimizes both physician and operating room time. Testing also indicates the new VaporMAX Fibers are more durable than other side-firing laser fibers, meaning that one device should be sufficient to treat even large prostates.

• Zila (Phoenix) said it has enrolled the first patients in its Phase III clinical trial for OraTest, its oral cancer detection product. Zila began its new Phase III clinical trial after reaching an agreement under the FDA's special protocol assessment process. The trial is expected to require fewer than 4,000 high-risk, readily available patients, generally requiring a single visit and will be conducted at about 13 investigative sites in the U.S. and the Ukraine. The trial is expected to require about a year for completion, once all investigator sites are active, but will include an interim analysis to determine the total number of patients required. OraTest is a rinse for detecting pre-cancer and cancer in patients at elevated risk for oral cancer, applied as a chair-side oral rinse and swab and administered by either a dentist or medical practitioner.